Hepatitis C is a liver disease that is transmitted through contact with the blood of an infected person. An estimated 150 million individuals worldwide have been chronically infected with the hepatitis C virus(HCV). H...Hepatitis C is a liver disease that is transmitted through contact with the blood of an infected person. An estimated 150 million individuals worldwide have been chronically infected with the hepatitis C virus(HCV). Hepatitis C shows significant genetic variation in the global population, due to the high rate of viral RNA mutation. There are six variants of the virus(HCV genotypes 1, 2, 3, 4, 5, and 6), with 15 recorded subtypes that vary in prevalence across different regions of the world. A variety of devices are used to diagnose hepatitis C, including HCV antibody test, HCV viral load test, HCV genotype test and liver biopsy. Rapid, inexpensive, sensitive, and robust analytical devices are therefore essential for effective diagnosis and monitoring of disease treatment. This review provides an overview of current electrochemical immunosensor and genosensortechnologies employed in HCV detection.There are a limited number of publications showing electrochemical biosensors being used for the detection of HCV.Due to their simplicity,specificity,and reliability,electrochemical biosensor devices have potential clinical applications in several viral infections.展开更多
Despite the widespread use of malaria rapid diagnostic test(RDT)in clinical practice,there are a lot of challenges.We conducted a secondary analysis of 129 malaria RDT data from rounds 5–8 of the World Health Organiz...Despite the widespread use of malaria rapid diagnostic test(RDT)in clinical practice,there are a lot of challenges.We conducted a secondary analysis of 129 malaria RDT data from rounds 5–8 of the World Health Organization(WHO)product testing summary and discuss the causes of false-negative(FN)results with a focus on low parasite density,improper RDT storage,operation and interpretation,and Plasmodium falciparum with a pfhrp2/3 gene deletion.The results demonstrated that the malaria RDTs currently commercially available might cause FN results in practice.展开更多
The discovery of <em>Plasmodium</em> parasites and its incrimination as the principal cause of malaria in humans has continued to excite researchers towards inventing possible easier methods of diagnosing ...The discovery of <em>Plasmodium</em> parasites and its incrimination as the principal cause of malaria in humans has continued to excite researchers towards inventing possible easier methods of diagnosing and identifying these pathological agents in order to mitigate, control and eliminate its continuous scourge to humanity. Currently, three diagnostic methods have been proposed, but agreements as to whether the level of parasitaemia in an individual could connote likely confirmations in the three methods <em>i.e.</em> gold standard, RDTs’ and PCR/NESTED PCR, have continued to be a subject of debate. To lay to rest the debate as reported in many studies, we collected blood samples from 100 symptomatic patients who reported to the Jos-Nigeria hospital and using the gold standard methods, we were able to confirm that 30 (30%) samples out of the 100 blood samples collected were positive to P.<em> falciparum</em>, chiefly recorded among duffy-negative Africans. Excited with our findings, we prepared the thick blood films for each sample and used it to estimate the levels of parasitaemia (parasites density) per μl of blood (<em>i.e.</em> 1+;2+;3+ and 4+) per 100 high power fields (|HPF). We then subjected the individually confirmed parasite density samples to the other two methods <em>i.e.</em> Rapid Diagnostic Test (one-step RTD and optimal-IT<span style="white-space:nowrap;">®</span> RDT) and to molecular assay (PCR and the nested PCR). Interestingly, of the 30 positive samples, 18 (60%) were confirmed positive to the one-step and optimal-IT<span style="white-space:nowrap;">®</span> RDTS, while 3 (30%) out of the 10 (100%) samples of various parasite density subjected to molecular assay (PCR and the nested PCR) were positive to only P. <em>falciparum</em>. Statistical analysis of variance based on single factor computed using SPSS indicates a no significant difference (P > 0.05) in the parasitaemia levels of the four groups/categories of patients;<em>i.e.</em> variance ratio of 0.011976 calculated was less than F-critical (2.816466) at 5% (0.05). Whereas gold standard could be considered as the optimal method, for the PCR/NESTED PCR, the sensitivity is dependent on high level of parasitaemia.展开更多
<span style="font-family:Verdana;"><strong>Background:</strong></span><span><span><span style="font-family:""><span style="font-family:Verdana...<span style="font-family:Verdana;"><strong>Background:</strong></span><span><span><span style="font-family:""><span style="font-family:Verdana;"> The rapid diagnostic tests play a pivotal role in the screening of viral markers in blood qualification for transfusion in limited resource setting. Therefore, it is important to assess their analytical performances to ensure their proper functioning. </span><b><span style="font-family:Verdana;">Material</span></b> <b><span style="font-family:Verdana;">and</span></b> <b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"> We performed a cross-</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">sectional study by successive recruitment to assess the diagnostic value of rapid diagnostic tests algorithms using ELISA as a reference test. A total of 661 blood from donors were enrolled for this study. Rapid Diagnostic Tests (RDTs) and ELISA tests were performed for each sample by a couple of double-blinded biotechnologists. Data were collected on case report form and captured in Microsoft Excel then the file was imported and analyzed using R software version 4.0.3. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> The diagnostic accuracy for the algorithms are summarized in </span><b><span style="font-family:Verdana;">Table 1</span></b><span style="font-family:Verdana;">. For HIV-algorithm</span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> the internal validity parameters were as follow: sensitivity (sens) 99.0% (95% CI = 97.8, 99.5);specificity (spec) 98.3% (95% CI = 90.9, 99.7);positive likelihood ratio (PLR) 57.4 (95% CI = 8.2, 401.0);negative likelihood ratio (NLR) 0.01 (95% CI = 0.0005, 0.02);diagnostic odd ratio (DOR) 4710. HBV-Ag/Ab RDTs achieve the following diagnostic accuracy: sens 99.7% (95% CI = 98.3, 99.9);spec 98.8% (95% CI = 96.9, 95.5);PLR 81.8 (95% CI = 30.9, 217.0);NLR 0.003 (95% CI = 0.0004, 0.02);DOR</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">14</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">110. The analytical performances of HCV-Ab RDTs were as follow: sens 98.7% (95% CI = 97.5, 99.4);spec 93.1% (95% CI = 78.0, 98.1);PLR 14.3 (95% CI = 3.8, 54.5);NLR 1.5 (95% CI = 0.8, 2.8);DOR 962.6. The parameters evaluating the external validity of RDTs screening for the three viral markers when the theorical prevalence was <</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">5% are summarized in </span><b><span style="font-family:Verdana;">Figure </span></b></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">3</span></b></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">. At the prevalence < 5%, the NPV of the three RDTs were 99.96%</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> 99.99% and 99.94%. At the same prevalence</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> we found the following Positive Predictive Values (PPV) 70.82%, 77.59% and 37.35% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. The overall areas under the received operating characteristic (ROC) curves were 98.6%</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;"> 99.2% and 99.2%;95.9% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> RDTs algorithms can play a pivotal role in the screening of HIV-Ab/Ag, HBs-Ag in the setting of resources limited-countries where financial and technical expertise shortages are a standard fare. However, their use for diagnostic purposes must be done with great caution and the result must necessarily be confirmed with an ELISA or molecular technique particularly for HCV-RDTs algorithm which achieved a</span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">n</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> NLR value > 0.1.</span></span></span>展开更多
Background Histidine Rich Protein 2-based rapid diagnostic tests(HRP2-based RDTs)are widely used for malaria diagnosis in Malawi,but their accuracy may be compromised by Plasmodium falciparum parasites lacking the P.f...Background Histidine Rich Protein 2-based rapid diagnostic tests(HRP2-based RDTs)are widely used for malaria diagnosis in Malawi,but their accuracy may be compromised by Plasmodium falciparum parasites lacking the P.falciparum histidine rich protein 2(pfhrp2)and P.falciparum histidine rich protein 3(pfhrp3)genes.While such deletions have been reported in other malaria-endemic countries,their presence and diagnostic impact in Malawi remain unknown.This study aimed to determine the prevalence of pfhrp2/pfhrp3 gene deletions in Malawi and their effect on the diagnostic accuracy of HRP2-based RDTs relative to light microscopy and qPCR.Methods A cross-sectional study was conducted between December 2020 and June 2021,enrolling 1582 participants from referral hospitals in Mzuzu(n=1186)and Lilongwe(n=396).Malaria diagnosis was performed using RDTs,microscopy,and qPCR.A total of 391 P.falciparum positive samples were analyzed for pfhrp2/pfhrp3 gene deletions using multiplex qPCR.Diagnostic accuracy metrics,such as sensitivity and specificity,were calculated with 95%confidence intervals.Spearman correlation was applied to assess associations involving log-transformed parasitemia,unpaired t-tests were used to compare diagnostic methods,and Mann–Whitney tests were used to compare symptomatic and asymptomatic groups.Results Malaria prevalence was higher in Lilongwe(45.2%)than in Mzuzu(22.9%).Infections in Lilongwe were predominantly asymptomatic(94.2%),whereas Mzuzu had mostly symptomatic cases(97.1%)(P<0.0002).RDTs demonstrated higher sensitivity of 78.5%(95%CI:74.6–82.1%)than microscopy 64.8%(95%CI:60.3–69.1),but slightly lower specificity,with 93.6%(95%CI:92.0–95.0%)for RDT compared to 95.4%(95%CI:94.0–96.6%)for microscopy.Dual pfhrp2/3 gene deletions were found in 24(15.0%)isolates from Lilongwe and 24(10.4%)from Mzuzu.All dual-deleted samples were false negative by RDT but were positive by microscopy and qPCR.Conclusions This study is the first to report pfhrp2/3 gene deletions in Malawi.The presence of these deletions may compromise the performance of HRP2-based RDTs,indicating the need to reassess diagnostic strategies in affected regions.展开更多
Background It was recommended that malaria rapid diagnostic tests(RDTs)should be available in all epidemiological situations.But evidence was limited on the implementation of RDTs and its effectiveness in malaria elim...Background It was recommended that malaria rapid diagnostic tests(RDTs)should be available in all epidemiological situations.But evidence was limited on the implementation of RDTs and its effectiveness in malaria elimination settings.This study examined the implementation of RDTs and how it affected the diagnosis of imported malaria patients in Jiangsu Province,China.Methods To scale up RDTs,this study developed an intervention package with four major elements covering the supply of RDT test,the training on RDTs,the monitoring and management of RDT use,and the advocacy of RDTs.By using a pretest-posttest control group design,we implemented the interventions in 4 cities in Jiangsu Province with the rest nine cities as controlled areas,from January 2017 to January 2018.Difference-in-Difference approach was used to evaluate the impact of the scale-up of RDTs on the identification of malaria cases.Three binary outcome measures were included to indicate delayed malaria diagnosis,malaria cases with confirmed malaria diagnosis at township-level institutions,and severe malaria cases,respectively.Linear probability regression was performed with time and group fixed effects and the interaction term between time and group.Results Intervention areas received sufficient RDT test supply,regular professional training programs,monthly tracking and management of RDT supply and use,and health education to targeted population.The implementation of interventions was associated with 10.8%(P=0.021)fewer patients with delayed diagnosis.But intervention areas did not see a higher likelihood of having confirmed diagnosis from township-level institutions(coefficient=-0.038,P=0.185)or reduced severe malaria cases(coef.=0.040,P=0.592).Conclusions The comprehensive package of RDT implementation in this study is promising in scaling up RDT use and improving access to care among malaria patients,especially in malaria elimination settings.展开更多
Background and aims:Due to the invasiveness of upper gastrointestinal endoscopy,non-invasive diagnostic tests for varices in liver cirrhosis have been widely established by numerous studies.A questionnaire survey,whic...Background and aims:Due to the invasiveness of upper gastrointestinal endoscopy,non-invasive diagnostic tests for varices in liver cirrhosis have been widely established by numerous studies.A questionnaire survey,which was aimed at understanding the current knowledge about non-invasive diagnostic tests for varices in liver cirrhosis,was distributed among the members of Gastroenterology Branch of the Liaoning Medical Association.Methods:A questionnaire assessing the knowledge about non-invasive diagnostic tests for varices was sent to 42 members who participated in the entire ninth committee.They were from 33 hospitals in 13 cities of Liaoning Province,China.Results:Overall,97.6%(41/42)of participants responded to the questionnaire.A majority of participants were chief physicians(85.4%),had>20 years of experience in clinical work of digestive diseases(80.5%)and worked at tertiary hospitals(97.6%).In 46.3%of participants’departments,there were>200 patients with liver cirrhosis and gastroesophageal varices admitted every year.In 90.2%of participants’departments,upper gastrointestinal endoscopy was regularly employed for the diagnosis of gastroesophageal varices.Only six(15%)participants often used non-invasive diagnostic tests for varices in clinical practice.Thirty(75%)participants knew at least one non-invasive diagnostic test for varices.The knowledge of at least one non-invasive diagnostic test was significantly associated with the number of cirrhotic patients with varices(P¼0.038)or the regular use of gastrointestinal endoscopy to diagnose varices(P¼0.022).Conclusions:This questionnaire survey suggested that non-invasive diagnostic tests for varices in liver cirrhosis were rarely or never used in clinical practices in Liaoning Province,China.Reliable,non-invasive indexes should be further explored in a well-designed multi-center observational study.展开更多
OBJECTIVE:To reach consensus on the diagnostic criteria of syndrome of dampness obstruction in idiopathic membranous nephropathy(IMN)patients by literature research and expert investigation(interviews and a Delphi met...OBJECTIVE:To reach consensus on the diagnostic criteria of syndrome of dampness obstruction in idiopathic membranous nephropathy(IMN)patients by literature research and expert investigation(interviews and a Delphi method).METHODS:Our study was consistent with T/CACM 1336-2020.We searched the monographs and references published in the past 40 years(1983-2022),and established the diagnostic criteria pool of waterdampness syndrome and dampness-turbidity syndrome in Traditional Chinese Medicine(TCM)based on literature by using frequency statistics and correlation analysis.Expert investigation(interview method and two rounds of Delphi method)was used to form the diagnostic criteria of water-dampness syndrome and dampnessturbidity syndrome of idiopathic membranous nephropathy.Clinical diagnostic test research was carried out,and compared with“Diagnostic Criteria for dampness syndrome”(T/CACM 1454-2023)to evaluate the authenticity,reliability and clinical application value of the standard.RESULTS:A total of 122 relevant guides,standards,monographs and documents were included through searching books and Chinese databases.Four experts were interviewed and two rounds of delphi method(75 experts nationwide)were carried out.The experts'opinions are relatively concentrated and the differences are small.Based on the weight of each index,the diagnostic criteria indexes of water-dampness syndrome and dampness-turbidity syndrome were selected.After discussion by the core group members,the diagnostic model of"necessary symptoms and optional symptoms"was established,and the final diagnostic criteria of waterdampness syndrome and dampness-turbidity syndrome were established.One hundred and ninety-one inpatients and outpatients of Guangdong Provincial Hospital of Chinese Medicine from January 2021 to February 2023 were included in Diagnostic test study.There was no statistical difference in gender,age and course of disease(P>0.05).The sensitivity and specificity of the trial standard were 90.34%and 73.33%respectively,while the sensitivity and specificity of T/CACM 1454-2023 were 99.43%and 6.67%,respectively.CONCLUSIONS:The consensus-based diagnostic criteria for IMN can be widely incorporated in TCM.A further clinical study will be conducted to analyze the diagnosis value and cut-off score of our IMN criteria.展开更多
Objective Accuracy of diagnostic methods for detecting Helicobacter pylori (H. pylori) infection among patients with bleeding peptic ulcers has not been thoroughly investigated. The aim of this study was to compare th...Objective Accuracy of diagnostic methods for detecting Helicobacter pylori (H. pylori) infection among patients with bleeding peptic ulcers has not been thoroughly investigated. The aim of this study was to compare the diagnostic tests and their combined usage in detection of H. pylori infection in patients with bleeding gastric ulcers and without the use of nonsteroidal anti-inflammatory drugs.Methods A total of 57 patients who presented with bleeding gastric ulcers by endoscopy were enrolled. The status of H. pylori was identified by performing the rapid urease test (RUT), histology and 13C-labeled urea breath test (UBT). The criteria for having H. pylori infection was a minimum of two positive tests.Results The prevalence of H. pylori infection in our patient group was 80.7%. Among the three tests used: RUT, histology, and UBT, sensitivities were 56.5%, 97.8% and 100%, while specificities were 100%, 45.5% and 81.8%, respectively. The overall accuracies of the tests were 78.3%, 71.6% and 90.9%, respectively. Although UBT obtained significantly higher accuracy than histology (P=0.02) as opposed to RUT (P=0.11), UBT had significantly higher sensitivity than RUT (P<0.001). In terms of combining any two of the three tests, more accuracy (98.9%) was achieved when both UBT and histology were used to confirm the diagnosis of the other. Conversely, failure to use combined tests generated the potential of missing a proper H. pylori diagnosis.Conclusions UBT is superior to the other two tests in bleeding gastric ulcers. RUT lacks sensitivity for detection of H. pylori infection. However, the concomitant use of UBT and histology seems to be more accurate when gastric ulcers present with bleeding.展开更多
Background:Rapid diagnostic tests(RDT)can effectively manage malaria cases and reduce excess costs brought by misdiagnosis.However,few studies have evaluated the economic value of this technology.The purpose of this s...Background:Rapid diagnostic tests(RDT)can effectively manage malaria cases and reduce excess costs brought by misdiagnosis.However,few studies have evaluated the economic value of this technology.The purpose of this study is to systematically review the economic value of RDT in malaria diagnosis.Main text:A detailed search strategy was developed to identify published economic evaluations that provide evidence regarding the cost-effectiveness of malaria RDT.Electronic databases including MEDLINE,EMBASE,Biosis Previews,Web of Science and Cochrane Library were searched from Jan 2007 to July 2018.Two researchers screened studies independently based on pre-specified inclusion and exclusion criteria.The Consolidated Health Economic Evaluation Reporting Standards(CHEERS)checklist was applied to evaluate the quality of the studies.Then cost and effectiveness data were extracted and summarized in a narrative way.Fifteen economic evaluations of RDT compared to other diagnostic methods were identified.The overall quality of studies varied greatly but most of them were scored to be of high or moderate quality.Ten of the fifteen studies reported that RDT was likely to be a cost-effective approach compared to its comparisons,but the results could be influenced by the alternatives,study perspectives,malaria prevalence,and the types of RDT.Conclusions:Based on available evidence,RDT had the potential to be more cost-effective than either microscopy or presumptive diagnosis.Further research is also required to draw a more robust conclusion.展开更多
Background Passive diagnosis of human African trypanosomiasis(HAT)at the health facility level is a major component of HAT control in Guinea.We examined which clinical signs and symptoms are associated with HAT,and as...Background Passive diagnosis of human African trypanosomiasis(HAT)at the health facility level is a major component of HAT control in Guinea.We examined which clinical signs and symptoms are associated with HAT,and assessed the performance of selected clinical presentations,of rapid diagnostic tests(RDT),and of reference laboratory tests on dried blood spots(DBS)for diagnosing HAT in Guinea.Method The study took place in 14 health facilities in Guinea,where 2345 clinical suspects were tested with RDTs(HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT).Seropositives underwent parasitological examination(reference test)to confirm HAT and their DBS were tested in indirect enzyme-linked immunoassay(ELISA)/Trypanosoma brucei gambiense,trypanolysis,Loopamp Trypanosoma brucei Detection kit(LAMP)and m18S quantitative PCR(qPCR).Multivariable regression analysis assessed association of clinical presentation with HAT.Sensitivity,specificity,positive and negative predictive values of key clinical presentations,of the RDTs and of the DBS tests for HAT diagnosis were determined.Results The HAT prevalence,as confirmed parasitologically,was 2.0%(48/2345,95%CI:1.5–2.7%).Odds ratios(OR)for HAT were increased for participants with swollen lymph nodes(OR=96.7,95%CI:20.7–452.0),important weight loss(OR=20.4,95%CI:7.05–58.9),severe itching(OR=45.9,95%CI:7.3–288.7)or motor disorders(OR=4.5,95%CI:0.89–22.5).Presence of at least one of these clinical presentations was 75.6%(95%CI:73.8–77.4%)specific and 97.9%(95%CI:88.9–99.9%)sensitive for HAT.HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT were respectively 97.5%(95%CI:96.8–98.1%),99.4%(95%CI:99.0–99.7%)and 97.9%(95%CI:97.2–98.4%)specific,and 100%(95%CI:92.5–100.0%),59.6%(95%CI:44.3–73.3%)and 93.8%(95%CI:82.8–98.7%)sensitive for HAT.The RDT’s positive and negative predictive values ranged from 45.2–66.7%and 99.2–100%respectively.All DBS tests had specificities≥92.9%.While LAMP and m18S qPCR sensitivities were below 50%,trypanolysis and ELISA/T.b.gambiense had sensitivities of 85.3%(95%CI:68.9–95.0%)and 67.6%(95%CI:49.5–82.6%).Conclusions Presence of swollen lymph nodes,important weight loss,severe itching or motor disorders are simple but accurate clinical criteria for HAT referral in HAT endemic areas in Guinea.Diagnostic performances of HAT Sero-K-Set and SD Bioline HAT are sufficient for referring positives to microscopy.Trypanolysis on DBS may discriminate HAT patients from false RDT positives.展开更多
Background:There is significant need for accurate diagnostic tools for Cryptosporidium spp.and Qiordia duodenalis infections in resource limited countries where diarrhoeal disease caused by these parasites is often pr...Background:There is significant need for accurate diagnostic tools for Cryptosporidium spp.and Qiordia duodenalis infections in resource limited countries where diarrhoeal disease caused by these parasites is often prevalent.The present study assessed the diagnostic performance of three commercially available rapid diagnostic tests(RDTs)based on faecal-antigen detection for Cryptosporidium spp.and/or G.duodenalis infections in stool samples of children admitted with severe acute malnutrition(SAM)and diarrhoea.An established multiplex PCR was used as reference test.Methods:Stool samples from children with SAM and diarrhoea enrolled in a randomized controlled trial(registered at clinicaltrials.gov/ct2/show/NCT02246296)in Malawi(n=175)and Kenya(n=120)between December 2014 and December 2015 were analysed by a multiplex PCR for the presence of Cryptosporidium sppv G.duodenalis or Entomoebo histolytica parasite DNA.Cryptosporidium-positive samples were species typed using restriction fragment length polymorphism analysis.A sub-sample of the stool specimens(n=236)was used for testing with three different RDTs.Diagnostic accuracy of the tests under evaluation was assessed using the results of PCR as reference standard using MedCalc software.Pearson Chi-square test and Fisher's exact test were used to determine(significant)difference between the number of cryptosporidiosis or giardiasis cases found by PCR in Malawi and Kenya.The overall diagnostic accuracy of each RDT was calculated by plotting a receiver operating characteristic(ROC)curve for each test and to determine the area under the curve(AUC)using SPSS8 software.Results:Prevalence of Cryptosporidium spp.by PCR was 20.0 and 21.7%in Malawi and Kenya respectively,mostly C.hominis.G.duodenalis prevalence was 23.4 and 5.8%in Malawi and Kenya respectively.E histolytica was not detected by PCR.RDT testing followed the same pattern of prevalence.RDT sensitivities ranged for cryptosporidiosis from 42.9 to 76.9%and for G.duodenalis from 48.2 to 85.7%.RDT specificities ranged from 88.4 to 100%for Cryptosporidium spp.and from 91.2 to 99.2%for G.duodenalis infections.Based on the estimated area under the curve(AUC)values,all tests under evaluation had an acceptable overall diagnostic accuracy(>0.7),with the exception of one RDT for Cryptosporidium spp.in Malawi.Conclusions:All three RDTs for Cryptosporidium spp.and Giardia duodenalis evaluated in this study have a moderate sensitivity,but sufficient specificity.The main value of the RDTs is within their rapidness and their usefulness as screening assays in surveys for diarrhoea.展开更多
To compare the diagnostic value of four signs for superior labrum anterior and posterior (SLAP) lesions of the shoulder.Methods The physical examination was performed randomly on 81 cases with abnormalities of the sho...To compare the diagnostic value of four signs for superior labrum anterior and posterior (SLAP) lesions of the shoulder.Methods The physical examination was performed randomly on 81 cases with abnormalities of the shoulder.There were four tests,including Kibler anterior sliding test,Liu crank test,O’Brien active compression test and Kim biceps load test Ⅱ.The arthroscopic examination were also performed.The result of the arthroscopic examination was considered as a golden standard,so that we could estimate the diagnosis value of the four tests according to the method of evaluation of diagnosis test on clinical epidemiology,their sensitivity,specificity,positive and negative predictive value,accuracy.Results There were 21 cases diagnosed as SLAP lesions by arthroscopy.The diagnosis value of Kim biceps load test Ⅱ was the highest among the four tests,in which 19 of true positive,59 of true negative,1 of false positive,only 2 of false negative cases;while the sensitivity was 90.48%,specificity was 98.33%,positive predictive value was 95.00%,negative predictive value was 96.72%,and accuracy was 96.30%.However the sensitivity,specificity,positive predicitive value,negative predictive vale and accuracy of Kibler anterior sliding test were 76.19%,96.67%,88.89%,92.06%,91.33%;and those of Liu crank test were 85.71%,93.33%,81.82%,94.92%,91.35%;those of O’Brien active compression test were 80.95%,91.66%,77.27%,93.22%,88.89%.Conclusion Kim Biceps load test Ⅱ may be the best for clinical diagnosis of SLAP lesions of the shoulder.9 refs,4 figs,2 tabs.展开更多
Objective The aim of this study was to evaluate the diagnostic performance of T-SPOT.TB for tuberculous lymphadenitis.Methods Suspected tuberculous lymphadenitis patients between September 2010 and September 2018 who ...Objective The aim of this study was to evaluate the diagnostic performance of T-SPOT.TB for tuberculous lymphadenitis.Methods Suspected tuberculous lymphadenitis patients between September 2010 and September 2018 who had both peripheral blood T-SPOT.TB test and lymph node biopsy were retrospectively enrolled in this study.The cutoff value of T-SPOT.TB test for peripheral blood was set as 24 spot forming cell(SFC)/106 periphreral blood monocyte cell(PBMC)according to the instruction of testing kits.The gold standard for diagnosis of TBL was the combination of microbiology results,histopathology results and patient's response to anti-TB treatment.Diagnostic efficacy of T-SPOT.TB was evaluated,including sensitivity,specificity,accuracy,predictive values,and likelihood ratio.Results Among 91 patients who met the inclusion criteria,we excluded 8 cases with incomplete clinical information and 6 cases who lost to follow-up.According to the gold standard,there were 37 cases of true TBL(9 confirmed TBL and 28 probable TBL),30 cases of non-TBL,and 10 cases of clinically indeterminate diagnosis who were excluded from the final analyses.The T-SPOT.TB tests yielded 43 cases of positive response and 24 cases of negative response.The sensitivity,specificity,accuracy,positive predictive value(PPV),negative predictive value(NPV),positive likelihood ratio(PLR)and negative likelihood ratio(NLR)of peripheral blood T-SPOT.TB for diagnosing TBL were 89.2%,66.7%,79.1%,76.7%,83.3%,2.68 and 0.16,respectively.The number of SFCs of T-SPOT.TB in TBL patients[432(134-1264)/106 PBMCs]was higher than that in non-TBL patients[0(0-30)/106 PBMCs]with a significant difference(Z=-5.306,P<0.001).Conclusion T-SPOT.TB is a rapid and simple diagnostic test for TBL with a high sensitivity and negative predictive value.展开更多
In China,50%of Knee Osteoarthritis(KOA)patients will be treated with Traditional Chinese Medicine or a combination of Traditional Chinese and Western Medicine,which call for objective efficacy evaluation methods.The c...In China,50%of Knee Osteoarthritis(KOA)patients will be treated with Traditional Chinese Medicine or a combination of Traditional Chinese and Western Medicine,which call for objective efficacy evaluation methods.The collection,processing and fusion of multisource data were taken as the main methods,with 150 KOA patients and 100 healthy people as an example to design prospective clinical tests.Data were collected with tongue inspection APP,infrared instrument and channel instrument,etc.And the analysis,screening,fusion and modelling of multi-source data were conducted.The traditional clinical tests have been combined with the customized information platform in this study,which is convenient for clinical tests,medical follow-ups and timely feedback to statistical analysis of data.展开更多
OBJECTIVE:To evaluate the diagnostic efficacy of Qisexingtai hand diagnostic method in the diagnosis of coronary artery disease(CAD).METHODS:This was an investigator-initiated,prospective,multi-center,cross-sectional ...OBJECTIVE:To evaluate the diagnostic efficacy of Qisexingtai hand diagnostic method in the diagnosis of coronary artery disease(CAD).METHODS:This was an investigator-initiated,prospective,multi-center,cross-sectional study.All the participants from three hospitals in China had been diagnosed by both Qisexingtai hand diagnostic method and coronary angiography.We compared the two diagnostic methods to calculate the sensitivity,the specificity,the omission diagnostic rate,the mistaken diagnostic rate and accuracy in order to evaluate the diagnostic efficacy of Qisexingtai hand diagnostic method for CAD.RESULTS:A total of 326 subjects were enrolled,diagnosed by both Qisexingtai hand diagnostic method and coronary angiography.As a result,there were 166 positive cases according to Qisexingtai hand diagnostic method,and 131 positive cases according to coronary angiography.Compared with the results of coronary angiography,the sensitivity of Qisexingtai hand diagnostic method was 80.2%,the specificity was 68.7%,the omission diagnostic rate was 19.8%,the mistaken diagnostic rate was 31.3%,and the accuracy was 73.3%.Area under the receiver operating characteristic curve was estimated as 0.735 for all,and 0.718,0.735,0.783 for the three sub-centers.CONCLUSION:Qisexingtai hand diagnostic method with high accuracy and sensitivity has certain application value in the diagnosis of CAD.展开更多
BACKGROUND The diagnostic and economic value of carcinoembryonic antigen(CEA),carbohydrate antigen 19-9(CA19-9)and CA72-4 for gastrointestinal malignant tumors lacked evaluation in a larger scale.AIM To reassess the d...BACKGROUND The diagnostic and economic value of carcinoembryonic antigen(CEA),carbohydrate antigen 19-9(CA19-9)and CA72-4 for gastrointestinal malignant tumors lacked evaluation in a larger scale.AIM To reassess the diagnostic and economic value of the three tumor biomarkers.METHODS A retrospective analysis of all 32857 subjects who underwent CEA,CA19-9,CA72-4,gastroscopy and colonoscopy from October 2006 to May 2018 was conducted.Then,we assessed the discrimination and clinical usefulness.Total cost,cost per capita and cost-effectiveness ratios were used to evaluate the economic value of two schemes(gastrointestinal endoscopy for all people without blood tests vs both gastroscopy and colonoscopy when blood tests were positive).RESULTS The analysis of 32857 subjects showed that CEA was a qualified biomarker for colorectal cancer(CRC),while the diagnostic efficiencies of CA72-4 were catastrophic for all gastrointestinal cancers(GICs).Regarding early diagnosis,only CEA could be used for early CRC.The combination of biomarkers didn’t greatly increase the area under the curve.The economic indicators of CEA were superior to those of CA19-9,CA72-4 and any combination.At the threshold of 1.8μg/L to 10.4μg/L,all four indicators of CEA were lower than those in the scheme that conducted gastrointestinal endoscopy only.Subgroup analysis implied that the health checkup of CEA for people above 65 years old was economically valuable.CONCLUSION CEA had qualified diagnostic value for CRC and superior economic value for GICs,especially for elderly health checkup subjects.CA72-4 was not suitable as a diagnostic biomarker.展开更多
BACKGROUND Helicobacter pylori(H.pylori)infection has been well-established as a significant risk factor for several gastrointestinal disorders.The urea breath test(UBT)has emerged as a leading non-invasive method for...BACKGROUND Helicobacter pylori(H.pylori)infection has been well-established as a significant risk factor for several gastrointestinal disorders.The urea breath test(UBT)has emerged as a leading non-invasive method for detecting H.pylori.Despite numerous studies confirming its substantial accuracy,the reliability of UBT results is often compromised by inherent limitations.These findings underscore the need for a rigorous statistical synthesis to clarify and reconcile the diagnostic accuracy of the UBT for the diagnosis of H.pylori infection.AIM To determine and compare the diagnostic accuracy of 13C-UBT and 14C-UBT for H.pylori infection in adult patients with dyspepsia.METHODS We conducted an independent search of the PubMed/MEDLINE,EMBASE,and Cochrane Central databases until April 2022.Our search included diagnostic accuracy studies that evaluated at least one of the index tests(^(13)C-UBT or ^(14)C-UBT)against a reference standard.We used the QUADAS-2 tool to assess the methodo-logical quality of the studies.We utilized the bivariate random-effects model to calculate sensitivity,specificity,positive and negative test likelihood ratios(LR+and LR-),as well as the diagnostic odds ratio(DOR),and their 95%confidence intervals.We conducted subgroup analyses based on urea dosing,time after urea administration,and assessment technique.To investigate a possible threshold effect,we conducted Spearman correlation analysis,and we generated summary receiver operating characteristic(SROC)curves to assess heterogeneity.Finally,we visually inspected a funnel plot and used Egger’s test to evaluate publication bias.endorsing both as reliable diagnostic tools in clinical practice.CONCLUSION In summary,our study has demonstrated that ^(13)C-UBT has been found to outperform the ^(14)C-UBT,making it the preferred diagnostic approach.Additionally,our results emphasize the significance of carefully considering urea dosage,assessment timing,and measurement techniques for both tests to enhance diagnostic precision.Nevertheless,it is crucial for researchers and clinicians to evaluate the strengths and limitations of our findings before implementing them in practice.展开更多
Logit regression analysis is widely applied in scientific studies and laboratory experiments, where skewed observations on a data set are often encountered. A number of problems with this method, for example, oudiers ...Logit regression analysis is widely applied in scientific studies and laboratory experiments, where skewed observations on a data set are often encountered. A number of problems with this method, for example, oudiers and influential observations, can cause overdispersion when a model is fitted. In this study a systematic statistical approach, including the plotting of several indices is used to diagnose the lack-of-fit of a logistic regression model. The outliers and influential observations on data from laboratory experiments are then detected. Specifically we take account of the interaction of an internal sohtary wave （ISW） with an obstacle, i.e., an underwater ridge, and also analyze the effects of the ridge height, the lower layer water depth, and the potential energy on the amplitude-based transmission rate of the ISW. As concluded, the goodness-of-fit of the revised logit regression model is better than that of the model without this approach.展开更多
The expression of P53,p21WAF1 and proliferating cell nuclear antigen(PCNA)was detected in 114 samples of lung cancer patients(with 89 cases benign lung tissue as control)and the diagnostic value of these markers was e...The expression of P53,p21WAF1 and proliferating cell nuclear antigen(PCNA)was detected in 114 samples of lung cancer patients(with 89 cases benign lung tissue as control)and the diagnostic value of these markers was evaluated.The results show the following:(1)The positive expression rates of P53,p21WAF1 and PCNA in samples of lung cancer were 47.37%,75.44%and 80.70%,respectively,which were significantly higher than that in the samples of benign lung diseases(p〈0.001).The odds ratios were 39.15,5.75,and 6.76,respectively.This indicates that the expression of P53,p21WAF1 and PCNA was helpful for the diagnosis of lung cancer.(2)For the diagnosis of lung cancer,the positive likelihood ratio of P53 was 21.08,which were significantly higher than that of p21WAF 1(2.16),PCNA(2.11)and of all the combined tests.This shows that P53 expression was the most valuable for diagnosis of lung cancer.(3)For the diagnosis of lung cancer,the negative likelihood ratio of P53/p21WAF 1/PCNA parallel test was 0.0571,which was lower than that of other single and combined tests.This indicates that P53/p21WAF 1/PCNA parallel test has high diagnostic value for exclusion of lung cancer.展开更多
基金Supported by Brazilian funding agencies(Sao Paulo Research Foundation-FAPESP and National Council for Scientific and Technological Development-CNPq)
文摘Hepatitis C is a liver disease that is transmitted through contact with the blood of an infected person. An estimated 150 million individuals worldwide have been chronically infected with the hepatitis C virus(HCV). Hepatitis C shows significant genetic variation in the global population, due to the high rate of viral RNA mutation. There are six variants of the virus(HCV genotypes 1, 2, 3, 4, 5, and 6), with 15 recorded subtypes that vary in prevalence across different regions of the world. A variety of devices are used to diagnose hepatitis C, including HCV antibody test, HCV viral load test, HCV genotype test and liver biopsy. Rapid, inexpensive, sensitive, and robust analytical devices are therefore essential for effective diagnosis and monitoring of disease treatment. This review provides an overview of current electrochemical immunosensor and genosensortechnologies employed in HCV detection.There are a limited number of publications showing electrochemical biosensors being used for the detection of HCV.Due to their simplicity,specificity,and reliability,electrochemical biosensor devices have potential clinical applications in several viral infections.
基金supported by the National Grand Program on Key Infectious Disease(2018ZX10103002-001-007)the Biosafety Special Program(19SWAQ 13)。
文摘Despite the widespread use of malaria rapid diagnostic test(RDT)in clinical practice,there are a lot of challenges.We conducted a secondary analysis of 129 malaria RDT data from rounds 5–8 of the World Health Organization(WHO)product testing summary and discuss the causes of false-negative(FN)results with a focus on low parasite density,improper RDT storage,operation and interpretation,and Plasmodium falciparum with a pfhrp2/3 gene deletion.The results demonstrated that the malaria RDTs currently commercially available might cause FN results in practice.
文摘The discovery of <em>Plasmodium</em> parasites and its incrimination as the principal cause of malaria in humans has continued to excite researchers towards inventing possible easier methods of diagnosing and identifying these pathological agents in order to mitigate, control and eliminate its continuous scourge to humanity. Currently, three diagnostic methods have been proposed, but agreements as to whether the level of parasitaemia in an individual could connote likely confirmations in the three methods <em>i.e.</em> gold standard, RDTs’ and PCR/NESTED PCR, have continued to be a subject of debate. To lay to rest the debate as reported in many studies, we collected blood samples from 100 symptomatic patients who reported to the Jos-Nigeria hospital and using the gold standard methods, we were able to confirm that 30 (30%) samples out of the 100 blood samples collected were positive to P.<em> falciparum</em>, chiefly recorded among duffy-negative Africans. Excited with our findings, we prepared the thick blood films for each sample and used it to estimate the levels of parasitaemia (parasites density) per μl of blood (<em>i.e.</em> 1+;2+;3+ and 4+) per 100 high power fields (|HPF). We then subjected the individually confirmed parasite density samples to the other two methods <em>i.e.</em> Rapid Diagnostic Test (one-step RTD and optimal-IT<span style="white-space:nowrap;">®</span> RDT) and to molecular assay (PCR and the nested PCR). Interestingly, of the 30 positive samples, 18 (60%) were confirmed positive to the one-step and optimal-IT<span style="white-space:nowrap;">®</span> RDTS, while 3 (30%) out of the 10 (100%) samples of various parasite density subjected to molecular assay (PCR and the nested PCR) were positive to only P. <em>falciparum</em>. Statistical analysis of variance based on single factor computed using SPSS indicates a no significant difference (P > 0.05) in the parasitaemia levels of the four groups/categories of patients;<em>i.e.</em> variance ratio of 0.011976 calculated was less than F-critical (2.816466) at 5% (0.05). Whereas gold standard could be considered as the optimal method, for the PCR/NESTED PCR, the sensitivity is dependent on high level of parasitaemia.
文摘<span style="font-family:Verdana;"><strong>Background:</strong></span><span><span><span style="font-family:""><span style="font-family:Verdana;"> The rapid diagnostic tests play a pivotal role in the screening of viral markers in blood qualification for transfusion in limited resource setting. Therefore, it is important to assess their analytical performances to ensure their proper functioning. </span><b><span style="font-family:Verdana;">Material</span></b> <b><span style="font-family:Verdana;">and</span></b> <b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"> We performed a cross-</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">sectional study by successive recruitment to assess the diagnostic value of rapid diagnostic tests algorithms using ELISA as a reference test. A total of 661 blood from donors were enrolled for this study. Rapid Diagnostic Tests (RDTs) and ELISA tests were performed for each sample by a couple of double-blinded biotechnologists. Data were collected on case report form and captured in Microsoft Excel then the file was imported and analyzed using R software version 4.0.3. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> The diagnostic accuracy for the algorithms are summarized in </span><b><span style="font-family:Verdana;">Table 1</span></b><span style="font-family:Verdana;">. For HIV-algorithm</span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> the internal validity parameters were as follow: sensitivity (sens) 99.0% (95% CI = 97.8, 99.5);specificity (spec) 98.3% (95% CI = 90.9, 99.7);positive likelihood ratio (PLR) 57.4 (95% CI = 8.2, 401.0);negative likelihood ratio (NLR) 0.01 (95% CI = 0.0005, 0.02);diagnostic odd ratio (DOR) 4710. HBV-Ag/Ab RDTs achieve the following diagnostic accuracy: sens 99.7% (95% CI = 98.3, 99.9);spec 98.8% (95% CI = 96.9, 95.5);PLR 81.8 (95% CI = 30.9, 217.0);NLR 0.003 (95% CI = 0.0004, 0.02);DOR</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">14</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">110. The analytical performances of HCV-Ab RDTs were as follow: sens 98.7% (95% CI = 97.5, 99.4);spec 93.1% (95% CI = 78.0, 98.1);PLR 14.3 (95% CI = 3.8, 54.5);NLR 1.5 (95% CI = 0.8, 2.8);DOR 962.6. The parameters evaluating the external validity of RDTs screening for the three viral markers when the theorical prevalence was <</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">5% are summarized in </span><b><span style="font-family:Verdana;">Figure </span></b></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">3</span></b></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">. At the prevalence < 5%, the NPV of the three RDTs were 99.96%</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> 99.99% and 99.94%. At the same prevalence</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> we found the following Positive Predictive Values (PPV) 70.82%, 77.59% and 37.35% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. The overall areas under the received operating characteristic (ROC) curves were 98.6%</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;"> 99.2% and 99.2%;95.9% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> RDTs algorithms can play a pivotal role in the screening of HIV-Ab/Ag, HBs-Ag in the setting of resources limited-countries where financial and technical expertise shortages are a standard fare. However, their use for diagnostic purposes must be done with great caution and the result must necessarily be confirmed with an ELISA or molecular technique particularly for HCV-RDTs algorithm which achieved a</span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">n</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> NLR value > 0.1.</span></span></span>
基金supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute(KHIDI)funded by the Ministry of Health&Welfare(HI22C0820&RS-2025-02309009)+1 种基金the National Research Foundation of Korea(NRF)funded by the Ministry of Education(RS-2023-00240627)the Regional Innovation System&Education(RISE)program through the Gangwon RISE Center,funded by the Ministry of Education(MoE)and Gangwon State(G.S.),Republic of Korea(2025-RISE-10-002)(J-H.H.).
文摘Background Histidine Rich Protein 2-based rapid diagnostic tests(HRP2-based RDTs)are widely used for malaria diagnosis in Malawi,but their accuracy may be compromised by Plasmodium falciparum parasites lacking the P.falciparum histidine rich protein 2(pfhrp2)and P.falciparum histidine rich protein 3(pfhrp3)genes.While such deletions have been reported in other malaria-endemic countries,their presence and diagnostic impact in Malawi remain unknown.This study aimed to determine the prevalence of pfhrp2/pfhrp3 gene deletions in Malawi and their effect on the diagnostic accuracy of HRP2-based RDTs relative to light microscopy and qPCR.Methods A cross-sectional study was conducted between December 2020 and June 2021,enrolling 1582 participants from referral hospitals in Mzuzu(n=1186)and Lilongwe(n=396).Malaria diagnosis was performed using RDTs,microscopy,and qPCR.A total of 391 P.falciparum positive samples were analyzed for pfhrp2/pfhrp3 gene deletions using multiplex qPCR.Diagnostic accuracy metrics,such as sensitivity and specificity,were calculated with 95%confidence intervals.Spearman correlation was applied to assess associations involving log-transformed parasitemia,unpaired t-tests were used to compare diagnostic methods,and Mann–Whitney tests were used to compare symptomatic and asymptomatic groups.Results Malaria prevalence was higher in Lilongwe(45.2%)than in Mzuzu(22.9%).Infections in Lilongwe were predominantly asymptomatic(94.2%),whereas Mzuzu had mostly symptomatic cases(97.1%)(P<0.0002).RDTs demonstrated higher sensitivity of 78.5%(95%CI:74.6–82.1%)than microscopy 64.8%(95%CI:60.3–69.1),but slightly lower specificity,with 93.6%(95%CI:92.0–95.0%)for RDT compared to 95.4%(95%CI:94.0–96.6%)for microscopy.Dual pfhrp2/3 gene deletions were found in 24(15.0%)isolates from Lilongwe and 24(10.4%)from Mzuzu.All dual-deleted samples were false negative by RDT but were positive by microscopy and qPCR.Conclusions This study is the first to report pfhrp2/3 gene deletions in Malawi.The presence of these deletions may compromise the performance of HRP2-based RDTs,indicating the need to reassess diagnostic strategies in affected regions.
文摘Background It was recommended that malaria rapid diagnostic tests(RDTs)should be available in all epidemiological situations.But evidence was limited on the implementation of RDTs and its effectiveness in malaria elimination settings.This study examined the implementation of RDTs and how it affected the diagnosis of imported malaria patients in Jiangsu Province,China.Methods To scale up RDTs,this study developed an intervention package with four major elements covering the supply of RDT test,the training on RDTs,the monitoring and management of RDT use,and the advocacy of RDTs.By using a pretest-posttest control group design,we implemented the interventions in 4 cities in Jiangsu Province with the rest nine cities as controlled areas,from January 2017 to January 2018.Difference-in-Difference approach was used to evaluate the impact of the scale-up of RDTs on the identification of malaria cases.Three binary outcome measures were included to indicate delayed malaria diagnosis,malaria cases with confirmed malaria diagnosis at township-level institutions,and severe malaria cases,respectively.Linear probability regression was performed with time and group fixed effects and the interaction term between time and group.Results Intervention areas received sufficient RDT test supply,regular professional training programs,monthly tracking and management of RDT supply and use,and health education to targeted population.The implementation of interventions was associated with 10.8%(P=0.021)fewer patients with delayed diagnosis.But intervention areas did not see a higher likelihood of having confirmed diagnosis from township-level institutions(coefficient=-0.038,P=0.185)or reduced severe malaria cases(coef.=0.040,P=0.592).Conclusions The comprehensive package of RDT implementation in this study is promising in scaling up RDT use and improving access to care among malaria patients,especially in malaria elimination settings.
文摘Background and aims:Due to the invasiveness of upper gastrointestinal endoscopy,non-invasive diagnostic tests for varices in liver cirrhosis have been widely established by numerous studies.A questionnaire survey,which was aimed at understanding the current knowledge about non-invasive diagnostic tests for varices in liver cirrhosis,was distributed among the members of Gastroenterology Branch of the Liaoning Medical Association.Methods:A questionnaire assessing the knowledge about non-invasive diagnostic tests for varices was sent to 42 members who participated in the entire ninth committee.They were from 33 hospitals in 13 cities of Liaoning Province,China.Results:Overall,97.6%(41/42)of participants responded to the questionnaire.A majority of participants were chief physicians(85.4%),had>20 years of experience in clinical work of digestive diseases(80.5%)and worked at tertiary hospitals(97.6%).In 46.3%of participants’departments,there were>200 patients with liver cirrhosis and gastroesophageal varices admitted every year.In 90.2%of participants’departments,upper gastrointestinal endoscopy was regularly employed for the diagnosis of gastroesophageal varices.Only six(15%)participants often used non-invasive diagnostic tests for varices in clinical practice.Thirty(75%)participants knew at least one non-invasive diagnostic test for varices.The knowledge of at least one non-invasive diagnostic test was significantly associated with the number of cirrhotic patients with varices(P¼0.038)or the regular use of gastrointestinal endoscopy to diagnose varices(P¼0.022).Conclusions:This questionnaire survey suggested that non-invasive diagnostic tests for varices in liver cirrhosis were rarely or never used in clinical practices in Liaoning Province,China.Reliable,non-invasive indexes should be further explored in a well-designed multi-center observational study.
基金the Special Project of State Key Laboratory of Dampness Syndrome of Chinese Medicine:Study on Criteria for Diagnosis of Dampness Syndrome of Idiopathic Membranous Nephropathy,Cohort Study on Pathogenesis and Material Basis of Dampness Syndrome of Idiopathic Membranous Nephropathy,Randomized Controlled Clinical Study of Sanqi Qushi Granule in Treatment of Membranous Nephropathy(No.SZ2021ZZ02,SZ2021ZZ09 and SZ2021ZZ36)the 2020 Guangdong Provincial Science and Technology Innovation Strategy Special Fund:Guangdong-Hong Kong-Macao Joint Lab(No.2020B1212030006)+2 种基金the Natural Science Foundation of Guangdong Province:Study on the Mechanism of Sanqi Qushi Prescription Delaying Podocellular Senescence in Membranous Nephropathy based on Cyclic Guanosine Monophosphate-Adenosine Monophosphate Synthase-Stimulator of Interferon Genes-Nuclear Factor Kappa-B Signaling Pathway(No.2022A1515011628)the Guangzhou Science and Technology Plan Project:to Explore the Mechanism of Treating Membranous Nephropathy from the Perspective of Regulating Amino Acid Metabolism Disorder(No.2023A03J0746)Special Funding for Scientific and Technological Research on Traditional Chinese Medicine,Guangdong Provincial Hospital of Chinese Medicine:a Multimodular Machine Learning Prediction Model based on Pathological Image-transcriptomics and Traditional Chinese Medicine Syndromes was Used to Investigate the Prognostic Correlation of Long non-coding RNA Molecules in Nephropathy and the Intervention Mechanism of Sanqi Qushi Formula,to Investigate the Pathogenesis and Microbiological Mechanism of Dampness Syndrome of Membranous Nephropathy based on the Microecological Changes of Tongue Coating(No.YN2023MB02,YN2023MB10)。
文摘OBJECTIVE:To reach consensus on the diagnostic criteria of syndrome of dampness obstruction in idiopathic membranous nephropathy(IMN)patients by literature research and expert investigation(interviews and a Delphi method).METHODS:Our study was consistent with T/CACM 1336-2020.We searched the monographs and references published in the past 40 years(1983-2022),and established the diagnostic criteria pool of waterdampness syndrome and dampness-turbidity syndrome in Traditional Chinese Medicine(TCM)based on literature by using frequency statistics and correlation analysis.Expert investigation(interview method and two rounds of Delphi method)was used to form the diagnostic criteria of water-dampness syndrome and dampnessturbidity syndrome of idiopathic membranous nephropathy.Clinical diagnostic test research was carried out,and compared with“Diagnostic Criteria for dampness syndrome”(T/CACM 1454-2023)to evaluate the authenticity,reliability and clinical application value of the standard.RESULTS:A total of 122 relevant guides,standards,monographs and documents were included through searching books and Chinese databases.Four experts were interviewed and two rounds of delphi method(75 experts nationwide)were carried out.The experts'opinions are relatively concentrated and the differences are small.Based on the weight of each index,the diagnostic criteria indexes of water-dampness syndrome and dampness-turbidity syndrome were selected.After discussion by the core group members,the diagnostic model of"necessary symptoms and optional symptoms"was established,and the final diagnostic criteria of waterdampness syndrome and dampness-turbidity syndrome were established.One hundred and ninety-one inpatients and outpatients of Guangdong Provincial Hospital of Chinese Medicine from January 2021 to February 2023 were included in Diagnostic test study.There was no statistical difference in gender,age and course of disease(P>0.05).The sensitivity and specificity of the trial standard were 90.34%and 73.33%respectively,while the sensitivity and specificity of T/CACM 1454-2023 were 99.43%and 6.67%,respectively.CONCLUSIONS:The consensus-based diagnostic criteria for IMN can be widely incorporated in TCM.A further clinical study will be conducted to analyze the diagnosis value and cut-off score of our IMN criteria.
文摘Objective Accuracy of diagnostic methods for detecting Helicobacter pylori (H. pylori) infection among patients with bleeding peptic ulcers has not been thoroughly investigated. The aim of this study was to compare the diagnostic tests and their combined usage in detection of H. pylori infection in patients with bleeding gastric ulcers and without the use of nonsteroidal anti-inflammatory drugs.Methods A total of 57 patients who presented with bleeding gastric ulcers by endoscopy were enrolled. The status of H. pylori was identified by performing the rapid urease test (RUT), histology and 13C-labeled urea breath test (UBT). The criteria for having H. pylori infection was a minimum of two positive tests.Results The prevalence of H. pylori infection in our patient group was 80.7%. Among the three tests used: RUT, histology, and UBT, sensitivities were 56.5%, 97.8% and 100%, while specificities were 100%, 45.5% and 81.8%, respectively. The overall accuracies of the tests were 78.3%, 71.6% and 90.9%, respectively. Although UBT obtained significantly higher accuracy than histology (P=0.02) as opposed to RUT (P=0.11), UBT had significantly higher sensitivity than RUT (P<0.001). In terms of combining any two of the three tests, more accuracy (98.9%) was achieved when both UBT and histology were used to confirm the diagnosis of the other. Conversely, failure to use combined tests generated the potential of missing a proper H. pylori diagnosis.Conclusions UBT is superior to the other two tests in bleeding gastric ulcers. RUT lacks sensitivity for detection of H. pylori infection. However, the concomitant use of UBT and histology seems to be more accurate when gastric ulcers present with bleeding.
基金This study supported by the Natural Science Foundation of Jiangsu Province(No.BK20150001)the Jiangsu Provincial Department of Science and Technology(BE2018020)+1 种基金the Jiangsu Provincial Project of Invigorating Health Care through Science,Technology and EducationThe funders had no role in the study design,data collection,analysis,decision to publish,or preparation of the manuscript.
文摘Background:Rapid diagnostic tests(RDT)can effectively manage malaria cases and reduce excess costs brought by misdiagnosis.However,few studies have evaluated the economic value of this technology.The purpose of this study is to systematically review the economic value of RDT in malaria diagnosis.Main text:A detailed search strategy was developed to identify published economic evaluations that provide evidence regarding the cost-effectiveness of malaria RDT.Electronic databases including MEDLINE,EMBASE,Biosis Previews,Web of Science and Cochrane Library were searched from Jan 2007 to July 2018.Two researchers screened studies independently based on pre-specified inclusion and exclusion criteria.The Consolidated Health Economic Evaluation Reporting Standards(CHEERS)checklist was applied to evaluate the quality of the studies.Then cost and effectiveness data were extracted and summarized in a narrative way.Fifteen economic evaluations of RDT compared to other diagnostic methods were identified.The overall quality of studies varied greatly but most of them were scored to be of high or moderate quality.Ten of the fifteen studies reported that RDT was likely to be a cost-effective approach compared to its comparisons,but the results could be influenced by the alternatives,study perspectives,malaria prevalence,and the types of RDT.Conclusions:Based on available evidence,RDT had the potential to be more cost-effective than either microscopy or presumptive diagnosis.Further research is also required to draw a more robust conclusion.
文摘Background Passive diagnosis of human African trypanosomiasis(HAT)at the health facility level is a major component of HAT control in Guinea.We examined which clinical signs and symptoms are associated with HAT,and assessed the performance of selected clinical presentations,of rapid diagnostic tests(RDT),and of reference laboratory tests on dried blood spots(DBS)for diagnosing HAT in Guinea.Method The study took place in 14 health facilities in Guinea,where 2345 clinical suspects were tested with RDTs(HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT).Seropositives underwent parasitological examination(reference test)to confirm HAT and their DBS were tested in indirect enzyme-linked immunoassay(ELISA)/Trypanosoma brucei gambiense,trypanolysis,Loopamp Trypanosoma brucei Detection kit(LAMP)and m18S quantitative PCR(qPCR).Multivariable regression analysis assessed association of clinical presentation with HAT.Sensitivity,specificity,positive and negative predictive values of key clinical presentations,of the RDTs and of the DBS tests for HAT diagnosis were determined.Results The HAT prevalence,as confirmed parasitologically,was 2.0%(48/2345,95%CI:1.5–2.7%).Odds ratios(OR)for HAT were increased for participants with swollen lymph nodes(OR=96.7,95%CI:20.7–452.0),important weight loss(OR=20.4,95%CI:7.05–58.9),severe itching(OR=45.9,95%CI:7.3–288.7)or motor disorders(OR=4.5,95%CI:0.89–22.5).Presence of at least one of these clinical presentations was 75.6%(95%CI:73.8–77.4%)specific and 97.9%(95%CI:88.9–99.9%)sensitive for HAT.HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT were respectively 97.5%(95%CI:96.8–98.1%),99.4%(95%CI:99.0–99.7%)and 97.9%(95%CI:97.2–98.4%)specific,and 100%(95%CI:92.5–100.0%),59.6%(95%CI:44.3–73.3%)and 93.8%(95%CI:82.8–98.7%)sensitive for HAT.The RDT’s positive and negative predictive values ranged from 45.2–66.7%and 99.2–100%respectively.All DBS tests had specificities≥92.9%.While LAMP and m18S qPCR sensitivities were below 50%,trypanolysis and ELISA/T.b.gambiense had sensitivities of 85.3%(95%CI:68.9–95.0%)and 67.6%(95%CI:49.5–82.6%).Conclusions Presence of swollen lymph nodes,important weight loss,severe itching or motor disorders are simple but accurate clinical criteria for HAT referral in HAT endemic areas in Guinea.Diagnostic performances of HAT Sero-K-Set and SD Bioline HAT are sufficient for referring positives to microscopy.Trypanolysis on DBS may discriminate HAT patients from false RDT positives.
基金This research project was financially supported Stichting Dioraphte(The Netherlands).
文摘Background:There is significant need for accurate diagnostic tools for Cryptosporidium spp.and Qiordia duodenalis infections in resource limited countries where diarrhoeal disease caused by these parasites is often prevalent.The present study assessed the diagnostic performance of three commercially available rapid diagnostic tests(RDTs)based on faecal-antigen detection for Cryptosporidium spp.and/or G.duodenalis infections in stool samples of children admitted with severe acute malnutrition(SAM)and diarrhoea.An established multiplex PCR was used as reference test.Methods:Stool samples from children with SAM and diarrhoea enrolled in a randomized controlled trial(registered at clinicaltrials.gov/ct2/show/NCT02246296)in Malawi(n=175)and Kenya(n=120)between December 2014 and December 2015 were analysed by a multiplex PCR for the presence of Cryptosporidium sppv G.duodenalis or Entomoebo histolytica parasite DNA.Cryptosporidium-positive samples were species typed using restriction fragment length polymorphism analysis.A sub-sample of the stool specimens(n=236)was used for testing with three different RDTs.Diagnostic accuracy of the tests under evaluation was assessed using the results of PCR as reference standard using MedCalc software.Pearson Chi-square test and Fisher's exact test were used to determine(significant)difference between the number of cryptosporidiosis or giardiasis cases found by PCR in Malawi and Kenya.The overall diagnostic accuracy of each RDT was calculated by plotting a receiver operating characteristic(ROC)curve for each test and to determine the area under the curve(AUC)using SPSS8 software.Results:Prevalence of Cryptosporidium spp.by PCR was 20.0 and 21.7%in Malawi and Kenya respectively,mostly C.hominis.G.duodenalis prevalence was 23.4 and 5.8%in Malawi and Kenya respectively.E histolytica was not detected by PCR.RDT testing followed the same pattern of prevalence.RDT sensitivities ranged for cryptosporidiosis from 42.9 to 76.9%and for G.duodenalis from 48.2 to 85.7%.RDT specificities ranged from 88.4 to 100%for Cryptosporidium spp.and from 91.2 to 99.2%for G.duodenalis infections.Based on the estimated area under the curve(AUC)values,all tests under evaluation had an acceptable overall diagnostic accuracy(>0.7),with the exception of one RDT for Cryptosporidium spp.in Malawi.Conclusions:All three RDTs for Cryptosporidium spp.and Giardia duodenalis evaluated in this study have a moderate sensitivity,but sufficient specificity.The main value of the RDTs is within their rapidness and their usefulness as screening assays in surveys for diarrhoea.
文摘To compare the diagnostic value of four signs for superior labrum anterior and posterior (SLAP) lesions of the shoulder.Methods The physical examination was performed randomly on 81 cases with abnormalities of the shoulder.There were four tests,including Kibler anterior sliding test,Liu crank test,O’Brien active compression test and Kim biceps load test Ⅱ.The arthroscopic examination were also performed.The result of the arthroscopic examination was considered as a golden standard,so that we could estimate the diagnosis value of the four tests according to the method of evaluation of diagnosis test on clinical epidemiology,their sensitivity,specificity,positive and negative predictive value,accuracy.Results There were 21 cases diagnosed as SLAP lesions by arthroscopy.The diagnosis value of Kim biceps load test Ⅱ was the highest among the four tests,in which 19 of true positive,59 of true negative,1 of false positive,only 2 of false negative cases;while the sensitivity was 90.48%,specificity was 98.33%,positive predictive value was 95.00%,negative predictive value was 96.72%,and accuracy was 96.30%.However the sensitivity,specificity,positive predicitive value,negative predictive vale and accuracy of Kibler anterior sliding test were 76.19%,96.67%,88.89%,92.06%,91.33%;and those of Liu crank test were 85.71%,93.33%,81.82%,94.92%,91.35%;those of O’Brien active compression test were 80.95%,91.66%,77.27%,93.22%,88.89%.Conclusion Kim Biceps load test Ⅱ may be the best for clinical diagnosis of SLAP lesions of the shoulder.9 refs,4 figs,2 tabs.
基金Fund supported by the Ministry of Science and Technology of the People’s Republic of China(2014ZX10003003)Chinese Academy of Medical Sciences Initiative for Innovative Medicine(2016-12M-1-013)Chinese Academy of Medical Sciences Fund for Tuberculosis Research(2016ZX310183-4)~~
文摘Objective The aim of this study was to evaluate the diagnostic performance of T-SPOT.TB for tuberculous lymphadenitis.Methods Suspected tuberculous lymphadenitis patients between September 2010 and September 2018 who had both peripheral blood T-SPOT.TB test and lymph node biopsy were retrospectively enrolled in this study.The cutoff value of T-SPOT.TB test for peripheral blood was set as 24 spot forming cell(SFC)/106 periphreral blood monocyte cell(PBMC)according to the instruction of testing kits.The gold standard for diagnosis of TBL was the combination of microbiology results,histopathology results and patient's response to anti-TB treatment.Diagnostic efficacy of T-SPOT.TB was evaluated,including sensitivity,specificity,accuracy,predictive values,and likelihood ratio.Results Among 91 patients who met the inclusion criteria,we excluded 8 cases with incomplete clinical information and 6 cases who lost to follow-up.According to the gold standard,there were 37 cases of true TBL(9 confirmed TBL and 28 probable TBL),30 cases of non-TBL,and 10 cases of clinically indeterminate diagnosis who were excluded from the final analyses.The T-SPOT.TB tests yielded 43 cases of positive response and 24 cases of negative response.The sensitivity,specificity,accuracy,positive predictive value(PPV),negative predictive value(NPV),positive likelihood ratio(PLR)and negative likelihood ratio(NLR)of peripheral blood T-SPOT.TB for diagnosing TBL were 89.2%,66.7%,79.1%,76.7%,83.3%,2.68 and 0.16,respectively.The number of SFCs of T-SPOT.TB in TBL patients[432(134-1264)/106 PBMCs]was higher than that in non-TBL patients[0(0-30)/106 PBMCs]with a significant difference(Z=-5.306,P<0.001).Conclusion T-SPOT.TB is a rapid and simple diagnostic test for TBL with a high sensitivity and negative predictive value.
基金Supported by National Natural Science Foundation of China:Research on TCM Equipment Aided Diagnosis Model Based on Multisource Information Fusion and Domain Ontology:a Case Study of Knee Osteoarthritis(No.82074334)Beijing Natural Science Foundation of China:Multi Source Four Diagnostic Information Collection and Fusion Model Based on Portable Equipment(No.7192140)+2 种基金CACMS Innovation Fund:Joint Experimental Platform for Integrated Application of TCM Diagnosis and Treatment Equipment(No.CI2021A00113)Basic Research Business Expenses of China Academy of Chinese Medical Science:Research on TCM Aided Diagnosis Model of Coronary Heart Disease Stable Angina Pectoris Based on Modern Literature(No.YZ-202015)CACMS Special Program for Training Excellent Young Talents:Research on Matching Method of TCM Theory for Instrument Measurement Signal(No.zz13-yq-110)。
文摘In China,50%of Knee Osteoarthritis(KOA)patients will be treated with Traditional Chinese Medicine or a combination of Traditional Chinese and Western Medicine,which call for objective efficacy evaluation methods.The collection,processing and fusion of multisource data were taken as the main methods,with 150 KOA patients and 100 healthy people as an example to design prospective clinical tests.Data were collected with tongue inspection APP,infrared instrument and channel instrument,etc.And the analysis,screening,fusion and modelling of multi-source data were conducted.The traditional clinical tests have been combined with the customized information platform in this study,which is convenient for clinical tests,medical follow-ups and timely feedback to statistical analysis of data.
基金Supported by National Key R&D Program of China-Study on Operating Principles of Screening,Evaluation,Promotion and Application for Diagnosis and Treatment Technology of Characteristic Folk Traditional Chinese Medicine(No.2019YFC1708400)。
文摘OBJECTIVE:To evaluate the diagnostic efficacy of Qisexingtai hand diagnostic method in the diagnosis of coronary artery disease(CAD).METHODS:This was an investigator-initiated,prospective,multi-center,cross-sectional study.All the participants from three hospitals in China had been diagnosed by both Qisexingtai hand diagnostic method and coronary angiography.We compared the two diagnostic methods to calculate the sensitivity,the specificity,the omission diagnostic rate,the mistaken diagnostic rate and accuracy in order to evaluate the diagnostic efficacy of Qisexingtai hand diagnostic method for CAD.RESULTS:A total of 326 subjects were enrolled,diagnosed by both Qisexingtai hand diagnostic method and coronary angiography.As a result,there were 166 positive cases according to Qisexingtai hand diagnostic method,and 131 positive cases according to coronary angiography.Compared with the results of coronary angiography,the sensitivity of Qisexingtai hand diagnostic method was 80.2%,the specificity was 68.7%,the omission diagnostic rate was 19.8%,the mistaken diagnostic rate was 31.3%,and the accuracy was 73.3%.Area under the receiver operating characteristic curve was estimated as 0.735 for all,and 0.718,0.735,0.783 for the three sub-centers.CONCLUSION:Qisexingtai hand diagnostic method with high accuracy and sensitivity has certain application value in the diagnosis of CAD.
基金The study was reviewed and approved by the Zhongshan Hospital of Fudan University Institutional Review Board(Approval No.B2018-234).
文摘BACKGROUND The diagnostic and economic value of carcinoembryonic antigen(CEA),carbohydrate antigen 19-9(CA19-9)and CA72-4 for gastrointestinal malignant tumors lacked evaluation in a larger scale.AIM To reassess the diagnostic and economic value of the three tumor biomarkers.METHODS A retrospective analysis of all 32857 subjects who underwent CEA,CA19-9,CA72-4,gastroscopy and colonoscopy from October 2006 to May 2018 was conducted.Then,we assessed the discrimination and clinical usefulness.Total cost,cost per capita and cost-effectiveness ratios were used to evaluate the economic value of two schemes(gastrointestinal endoscopy for all people without blood tests vs both gastroscopy and colonoscopy when blood tests were positive).RESULTS The analysis of 32857 subjects showed that CEA was a qualified biomarker for colorectal cancer(CRC),while the diagnostic efficiencies of CA72-4 were catastrophic for all gastrointestinal cancers(GICs).Regarding early diagnosis,only CEA could be used for early CRC.The combination of biomarkers didn’t greatly increase the area under the curve.The economic indicators of CEA were superior to those of CA19-9,CA72-4 and any combination.At the threshold of 1.8μg/L to 10.4μg/L,all four indicators of CEA were lower than those in the scheme that conducted gastrointestinal endoscopy only.Subgroup analysis implied that the health checkup of CEA for people above 65 years old was economically valuable.CONCLUSION CEA had qualified diagnostic value for CRC and superior economic value for GICs,especially for elderly health checkup subjects.CA72-4 was not suitable as a diagnostic biomarker.
基金Supported by Scientific Initiation Scholarship Programme(PIBIC)of the Bahia State Research Support Foundationthe Doctorate Scholarship Program of the Coordination of Improvement of Higher Education Personnel+1 种基金the Scientific Initiation Scholarship Programme(PIBIC)of the National Council for Scientific and Technological Developmentand the CNPq Research Productivity Fellowship.
文摘BACKGROUND Helicobacter pylori(H.pylori)infection has been well-established as a significant risk factor for several gastrointestinal disorders.The urea breath test(UBT)has emerged as a leading non-invasive method for detecting H.pylori.Despite numerous studies confirming its substantial accuracy,the reliability of UBT results is often compromised by inherent limitations.These findings underscore the need for a rigorous statistical synthesis to clarify and reconcile the diagnostic accuracy of the UBT for the diagnosis of H.pylori infection.AIM To determine and compare the diagnostic accuracy of 13C-UBT and 14C-UBT for H.pylori infection in adult patients with dyspepsia.METHODS We conducted an independent search of the PubMed/MEDLINE,EMBASE,and Cochrane Central databases until April 2022.Our search included diagnostic accuracy studies that evaluated at least one of the index tests(^(13)C-UBT or ^(14)C-UBT)against a reference standard.We used the QUADAS-2 tool to assess the methodo-logical quality of the studies.We utilized the bivariate random-effects model to calculate sensitivity,specificity,positive and negative test likelihood ratios(LR+and LR-),as well as the diagnostic odds ratio(DOR),and their 95%confidence intervals.We conducted subgroup analyses based on urea dosing,time after urea administration,and assessment technique.To investigate a possible threshold effect,we conducted Spearman correlation analysis,and we generated summary receiver operating characteristic(SROC)curves to assess heterogeneity.Finally,we visually inspected a funnel plot and used Egger’s test to evaluate publication bias.endorsing both as reliable diagnostic tools in clinical practice.CONCLUSION In summary,our study has demonstrated that ^(13)C-UBT has been found to outperform the ^(14)C-UBT,making it the preferred diagnostic approach.Additionally,our results emphasize the significance of carefully considering urea dosage,assessment timing,and measurement techniques for both tests to enhance diagnostic precision.Nevertheless,it is crucial for researchers and clinicians to evaluate the strengths and limitations of our findings before implementing them in practice.
基金Science Council of Taiwan Province under Grant Nos.NSC 96-2628-E-366-004-MY2 and 96-2628-E-132-001-MY2
文摘Logit regression analysis is widely applied in scientific studies and laboratory experiments, where skewed observations on a data set are often encountered. A number of problems with this method, for example, oudiers and influential observations, can cause overdispersion when a model is fitted. In this study a systematic statistical approach, including the plotting of several indices is used to diagnose the lack-of-fit of a logistic regression model. The outliers and influential observations on data from laboratory experiments are then detected. Specifically we take account of the interaction of an internal sohtary wave （ISW） with an obstacle, i.e., an underwater ridge, and also analyze the effects of the ridge height, the lower layer water depth, and the potential energy on the amplitude-based transmission rate of the ISW. As concluded, the goodness-of-fit of the revised logit regression model is better than that of the model without this approach.
基金Supported by the Foundation of Health Department of Hubei Province(302140786)
文摘The expression of P53,p21WAF1 and proliferating cell nuclear antigen(PCNA)was detected in 114 samples of lung cancer patients(with 89 cases benign lung tissue as control)and the diagnostic value of these markers was evaluated.The results show the following:(1)The positive expression rates of P53,p21WAF1 and PCNA in samples of lung cancer were 47.37%,75.44%and 80.70%,respectively,which were significantly higher than that in the samples of benign lung diseases(p〈0.001).The odds ratios were 39.15,5.75,and 6.76,respectively.This indicates that the expression of P53,p21WAF1 and PCNA was helpful for the diagnosis of lung cancer.(2)For the diagnosis of lung cancer,the positive likelihood ratio of P53 was 21.08,which were significantly higher than that of p21WAF 1(2.16),PCNA(2.11)and of all the combined tests.This shows that P53 expression was the most valuable for diagnosis of lung cancer.(3)For the diagnosis of lung cancer,the negative likelihood ratio of P53/p21WAF 1/PCNA parallel test was 0.0571,which was lower than that of other single and combined tests.This indicates that P53/p21WAF 1/PCNA parallel test has high diagnostic value for exclusion of lung cancer.
