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
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
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
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
In this editorial,we discuss the article in the World Journal of Gastroenterology.The article conducts a meta-analysis of the diagnostic accuracy of the urea breath test(UBT),a non-invasive method for detecting Helico...In this editorial,we discuss the article in the World Journal of Gastroenterology.The article conducts a meta-analysis of the diagnostic accuracy of the urea breath test(UBT),a non-invasive method for detecting Helicobacter pylori(H.pylori)infection in humans.It is based on radionuclide-labeled urea.Various methods,both invasive and non-invasive,are available for diagnosing H.pylori infection,inclu-ding endoscopy with biopsy,serology for immunoglobulin titers,stool antigen analysis,and UBT.Several guidelines recommend UBTs as the primary choice for diagnosing H.pylori infection and for reexamining after eradication therapy.It is used to be the first choice non-invasive test due to their high accuracy,specificity,rapid results,and simplicity.Moreover,its performance remains unaffected by the distribution of H.pylori in the stomach,allowing a high flow of patients to be tested.Despite its widespread use,the performance characteristics of UBT have been inconsistently described and remain incompletely defined.There are two UBTs available with Food and Drug Administration approval:The 13C and 14C tests.Both tests are affordable and can provide real-time results.Physicians may prefer the 13C test because it is non-radioactive,compared to 14C which uses a radioactive isotope,especially in young children and pregnant women.Although there was heterogeneity among the studies regarding the diagnostic accuracy of both UBTs,13C-UBT consistently outperforms the 14C-UBT.This makes the 13C-UBT the preferred diagnostic approach.Furthermore,the provided findings of the meta-analysis emphasize the significance of precise considerations when choosing urea dosage,assessment timing,and measurement techniques for both the 13C-UBT and 14C-UBT,to enhance diagnostic precision.展开更多
1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is...1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is important to evaluate their performances before use. We tested a rapid antigen detection of SARS-CoV-2, based on the immunochromatography (Boson Biotech SARS-CoV-2 Ag Test (Xiamen Boson Biotech Co., Ltd., China)) and the results were compared with the real time reverse transcriptase-Polymerase chain reaction (RT-PCR) (Gold standard) results;2) Methods: From November 2021 to December 2021, samples were collected from symptomatic patients and asymptomatic individuals referred for testing in a hospital during the second pandemic wave in Gabon. All these participants attending “CTA Angondjé”, a field hospital set up as part of the management of COVID-19 in Gabon. Two nasopharyngeal swabs were collected in all the patients, one for Ag test and the other for RT-PCR;3) Results: A total of 300 samples were collected from 189 symptomatic and 111 asymptomatic individuals. The sensitivity and specificity of the antigen test were 82.5% [95%CI 73.8 - 89.3] and 97.9 % [95%CI 92.2 - 98.2] respectively, and the diagnostic accuracy was 84.4% (95% CI: 79.8 - 88.3%). The antigen test was more likely to be positive for samples with RT-PCR Ct values ≤ 32, with a sensitivity of 89.8%;4) Conclusions: The Boson Biotech SARS-CoV-2 Ag Test has good sensitivity and can detect SARS-CoV-2 infection, especially among symptomatic individuals with low viral load. This test could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and curb viral transmission.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
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
BACKGROUND With rising angiography costs and risks,we explored whether a 5-minute femoral ultrasound can predict patients that actually require angiography.AIM To detect associations between atherosclerosis of periphe...BACKGROUND With rising angiography costs and risks,we explored whether a 5-minute femoral ultrasound can predict patients that actually require angiography.AIM To detect associations between atherosclerosis of peripheral arteries and coronary stenosis in patients with coronary heart disease(CHD).METHODS The study included a total of 218 patients(63±10.9 years of age;54%male)with CHD subjected to coronary angiography and routine diagnostic assessment,including ultrasound imaging to assess the extent of peripheral atherosclerotic lesions.Receiver operating characteristic analysis and binomial logistic regression were used to detect the associations.RESULTS We demonstrated for the first time that the presence of atherosclerotic plaque with≥70%stenosis in femoral arteries was associated with significant coronary stenosis,with 93%sensitivity and 90%specificity,and thus can be used as an additional diagnostic marker for coronary stenosis.The data indicated associations between femoral artery atherosclerosis and atherosclerotic lesions of coronary arteries,with a high correlation coefficient r=0.8(P<0.05).The presence of an atherosclerotic plaque in the femoral arteries with≥30% or≥70%stenosis was associated with a 30-or 70-fold higher odds ratio of coronary stenosis,respectively.CONCLUSION For resource-limited clinics,our findings suggest skipping carotids-femoral ultrasound alone may suffice to rule out severe CHD.Ultrasound imaging femoral artery atherosclerosis provides a simplified approach for patient stratification.展开更多
Malaria continues to pose a significant global health challenge despite a significant achievement in control and elimination in certain areas.Accurate and timely diagnosis is crucial for effective disease management a...Malaria continues to pose a significant global health challenge despite a significant achievement in control and elimination in certain areas.Accurate and timely diagnosis is crucial for effective disease management and control,and finally leading to elimination.However,microscopy and rapid diagnostic tests(RDTs)have traditionally been the primary malaria diagnostic tools used globally,with certain shortcomings,including their limited sensitivity,specificity,and inability to identify asymptomatic infections.Serological markers have emerged as promising alternatives in malaria serosurveillance,particularly in countries where targets have already been set for elimination.This review highlights the advantages of serological markers over conventional diagnostic techniques and discusses some of the most promising serological markers against Plasmodium species-specific antigens.The implementation of serosurveillance,coupled with the utilization of these serological markers represents a transformative shift in malaria surveillance.By capitalizing on the immune memory of individuals,serosurveillance also enables the identification of recent and past infections.This approach is particularly valuable in low-transmission settings and for tracking changes in malaria prevalence over time.While recognizing the use of serological markers across various global contexts,this review predominantly emphasizes their significance within the framework of India.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
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
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
AIM: To evaluate the impact of a preoperative "triple non-invasive diagnostic test" for diagnosis and/or exclusion of common bile duct stones. METHODS: All patients with symptomatic gallstone disease, operat...AIM: To evaluate the impact of a preoperative "triple non-invasive diagnostic test" for diagnosis and/or exclusion of common bile duct stones. METHODS: All patients with symptomatic gallstone disease, operated on by laparoscopic cholecystectomy from March 2004 to March 2006 were studied retrospectively. Two hundred patients were included and reviewed by using a triple diagnostic test including: patient's medical history, routine liver function tests and routine ultrasonography. All patients were followed up 2-24 mo after surgery to evaluate the impact of triple diagnostic test. RESULTS: Twenty-five patients were identified to have common bile duct stones. Lack of history of stones, negative laboratory tests and normal ultrasonography alone was proven to exclude common bile duct stones in some patients. However, a combination of these three components (triple diagnostic), was proven to be the most statistically significant test to exclude common bile duct stones in patients with gallstone disease. CONCLUSION: Using a combination of routinely used diagnostic components as triple diagnostic modality would increase the diagnostic accuracy of common bile duct stones preoperatively. This triple non-invasive test is recommended for excluding common bile duct stones and to identify patients in need for other investigations.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
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
Liver disease accounts for approximately 2 million deaths per year worldwide.All chronic liver diseases(CLDs),whether of toxic,genetic,autoimmune,or infectious origin,undergo typical histological changes in the struct...Liver disease accounts for approximately 2 million deaths per year worldwide.All chronic liver diseases(CLDs),whether of toxic,genetic,autoimmune,or infectious origin,undergo typical histological changes in the structure of the tissue.These changes may include the accumulation of extracellular matrix material,fats,triglycerides,or tissue scarring.Noninvasive methods for diagnosing CLD,such as conventional B-mode ultrasound(US),play a significant role in diagnosis.Doppler US,when coupled with B-mode US,can be helpful in evaluating the hemodynamics of hepatic vessels and detecting US findings associated with hepatic decompensation.US elastography can assess liver stiffness,serving as a surrogate marker for liver fibrosis.It is important to note that interpreting these values should not rely solely on a histological classification.Contrast-enhanced US(CEUS)provides valuable information on tissue perfusion and enables excellent differentiation between benign and malignant focal liver lesions.Clinical evaluation,the etiology of liver disease,and the patient current comorbidities all influence the interpretation of liver stiffness measurements.These measurements are most clinically relevant when interpreted as a probability of compensated advanced CLD.B-mode US offers a subjective estimation of fatty infiltration and has limited sensitivity for mild steatosis.The controlled attenuation parameter requires a dedicated device,and cutoff values are not clearly defined.Quan-titative US parameters for liver fat estimation include the attenuation coefficient,backscatter coefficient,and speed of sound.These parameters offer the advantage of providing fat quantification alongside B-mode evaluation and other US parameters.Multiparametric US(MPUS)of the liver introduces a new concept for complete noninvasive diagnosis.It encourages examiners to utilize the latest features of an US machine,including conventional B-mode,liver stiffness evaluation,fat quantification,dispersion imaging,Doppler US,and CEUS for focal liver lesion characterization.This comprehensive approach allows for diagnosis in a single examination,providing clinicians worldwide with a broader perspective and becoming a cornerstone in their diagnostic arsenal.MPUS,in the hands of skilled clinicians,becomes an invaluable predictive tool for diagnosing,staging,and monitoring CLD.展开更多
BACKGROUND Application of indocyanine green(ICG)fluorescence has led to new developments in gastrointestinal surgery.However,little is known about the use of ICG for the diagnosis of postoperative gut leakage(GL).In a...BACKGROUND Application of indocyanine green(ICG)fluorescence has led to new developments in gastrointestinal surgery.However,little is known about the use of ICG for the diagnosis of postoperative gut leakage(GL).In addition,there is a lack of rapid and intuitive methods to definitively diagnose postoperative GL.AIM To investigate the effect of ICG in the diagnosis of anastomotic leakage in a surgical rat GL model and evaluate its diagnostic value in colorectal surgery patients.METHODS Sixteen rats were divided into two groups:GL group(n=8)and sham group(n=8).Approximately 0.5 mL of ICG(2.5 mg/mL)was intravenously injected postoperatively.The peritoneal fluid was collected for the fluorescence test at 24 and 48 h.Six patients with rectal cancer who had undergone laparoscopic rectal cancer resection plus enterostomies were injected with 10 mL of ICG(2.5 mg/mL)on postoperative day 1.Their ostomy fluids were collected 24 h after ICG injection to identify the possibility of the ICG excreting from the peripheral veins to the enterostomy stoma.Participants who had undergone colectomy or rectal cancer resection were enrolled in the diagnostic test.The peritoneal fluids from drainage were collected 24 h after ICG injection.The ICG fluorescence test was conducted using OptoMedic endoscopy along with a near-infrared fluorescent imaging system.RESULTS The peritoneal fluids from the GL group showed ICG-dependent green fluorescence in contrast to the sham group.Six samples of ostomy fluids showed green fluorescence,indicating the possibility of ICG excreting from the peripheral veins to the enterostomy stoma in patients.The peritoneal fluid ICG test exhibited a sensitivity of 100%and a specificity of 83.3%for the diagnosis of GL.The positive predictive value was 71.4%,while the negative predictive value was 100%.The likelihood ratios were 6.0 for a positive test result and 0 for a negative result.CONCLUSION The postoperative ICG test in a drainage tube is a valuable and simple technique for the diagnosis of GL.Hence,it should be employed in clinical settings in patients with suspected GL.展开更多
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.
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 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In this editorial,we discuss the article in the World Journal of Gastroenterology.The article conducts a meta-analysis of the diagnostic accuracy of the urea breath test(UBT),a non-invasive method for detecting Helicobacter pylori(H.pylori)infection in humans.It is based on radionuclide-labeled urea.Various methods,both invasive and non-invasive,are available for diagnosing H.pylori infection,inclu-ding endoscopy with biopsy,serology for immunoglobulin titers,stool antigen analysis,and UBT.Several guidelines recommend UBTs as the primary choice for diagnosing H.pylori infection and for reexamining after eradication therapy.It is used to be the first choice non-invasive test due to their high accuracy,specificity,rapid results,and simplicity.Moreover,its performance remains unaffected by the distribution of H.pylori in the stomach,allowing a high flow of patients to be tested.Despite its widespread use,the performance characteristics of UBT have been inconsistently described and remain incompletely defined.There are two UBTs available with Food and Drug Administration approval:The 13C and 14C tests.Both tests are affordable and can provide real-time results.Physicians may prefer the 13C test because it is non-radioactive,compared to 14C which uses a radioactive isotope,especially in young children and pregnant women.Although there was heterogeneity among the studies regarding the diagnostic accuracy of both UBTs,13C-UBT consistently outperforms the 14C-UBT.This makes the 13C-UBT the preferred diagnostic approach.Furthermore,the provided findings of the meta-analysis emphasize the significance of precise considerations when choosing urea dosage,assessment timing,and measurement techniques for both the 13C-UBT and 14C-UBT,to enhance diagnostic precision.
文摘1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is important to evaluate their performances before use. We tested a rapid antigen detection of SARS-CoV-2, based on the immunochromatography (Boson Biotech SARS-CoV-2 Ag Test (Xiamen Boson Biotech Co., Ltd., China)) and the results were compared with the real time reverse transcriptase-Polymerase chain reaction (RT-PCR) (Gold standard) results;2) Methods: From November 2021 to December 2021, samples were collected from symptomatic patients and asymptomatic individuals referred for testing in a hospital during the second pandemic wave in Gabon. All these participants attending “CTA Angondjé”, a field hospital set up as part of the management of COVID-19 in Gabon. Two nasopharyngeal swabs were collected in all the patients, one for Ag test and the other for RT-PCR;3) Results: A total of 300 samples were collected from 189 symptomatic and 111 asymptomatic individuals. The sensitivity and specificity of the antigen test were 82.5% [95%CI 73.8 - 89.3] and 97.9 % [95%CI 92.2 - 98.2] respectively, and the diagnostic accuracy was 84.4% (95% CI: 79.8 - 88.3%). The antigen test was more likely to be positive for samples with RT-PCR Ct values ≤ 32, with a sensitivity of 89.8%;4) Conclusions: The Boson Biotech SARS-CoV-2 Ag Test has good sensitivity and can detect SARS-CoV-2 infection, especially among symptomatic individuals with low viral load. This test could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and curb viral transmission.
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.
文摘BACKGROUND With rising angiography costs and risks,we explored whether a 5-minute femoral ultrasound can predict patients that actually require angiography.AIM To detect associations between atherosclerosis of peripheral arteries and coronary stenosis in patients with coronary heart disease(CHD).METHODS The study included a total of 218 patients(63±10.9 years of age;54%male)with CHD subjected to coronary angiography and routine diagnostic assessment,including ultrasound imaging to assess the extent of peripheral atherosclerotic lesions.Receiver operating characteristic analysis and binomial logistic regression were used to detect the associations.RESULTS We demonstrated for the first time that the presence of atherosclerotic plaque with≥70%stenosis in femoral arteries was associated with significant coronary stenosis,with 93%sensitivity and 90%specificity,and thus can be used as an additional diagnostic marker for coronary stenosis.The data indicated associations between femoral artery atherosclerosis and atherosclerotic lesions of coronary arteries,with a high correlation coefficient r=0.8(P<0.05).The presence of an atherosclerotic plaque in the femoral arteries with≥30% or≥70%stenosis was associated with a 30-or 70-fold higher odds ratio of coronary stenosis,respectively.CONCLUSION For resource-limited clinics,our findings suggest skipping carotids-femoral ultrasound alone may suffice to rule out severe CHD.Ultrasound imaging femoral artery atherosclerosis provides a simplified approach for patient stratification.
文摘Malaria continues to pose a significant global health challenge despite a significant achievement in control and elimination in certain areas.Accurate and timely diagnosis is crucial for effective disease management and control,and finally leading to elimination.However,microscopy and rapid diagnostic tests(RDTs)have traditionally been the primary malaria diagnostic tools used globally,with certain shortcomings,including their limited sensitivity,specificity,and inability to identify asymptomatic infections.Serological markers have emerged as promising alternatives in malaria serosurveillance,particularly in countries where targets have already been set for elimination.This review highlights the advantages of serological markers over conventional diagnostic techniques and discusses some of the most promising serological markers against Plasmodium species-specific antigens.The implementation of serosurveillance,coupled with the utilization of these serological markers represents a transformative shift in malaria surveillance.By capitalizing on the immune memory of individuals,serosurveillance also enables the identification of recent and past infections.This approach is particularly valuable in low-transmission settings and for tracking changes in malaria prevalence over time.While recognizing the use of serological markers across various global contexts,this review predominantly emphasizes their significance within the framework of India.
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 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 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.
文摘AIM: To evaluate the impact of a preoperative "triple non-invasive diagnostic test" for diagnosis and/or exclusion of common bile duct stones. METHODS: All patients with symptomatic gallstone disease, operated on by laparoscopic cholecystectomy from March 2004 to March 2006 were studied retrospectively. Two hundred patients were included and reviewed by using a triple diagnostic test including: patient's medical history, routine liver function tests and routine ultrasonography. All patients were followed up 2-24 mo after surgery to evaluate the impact of triple diagnostic test. RESULTS: Twenty-five patients were identified to have common bile duct stones. Lack of history of stones, negative laboratory tests and normal ultrasonography alone was proven to exclude common bile duct stones in some patients. However, a combination of these three components (triple diagnostic), was proven to be the most statistically significant test to exclude common bile duct stones in patients with gallstone disease. CONCLUSION: Using a combination of routinely used diagnostic components as triple diagnostic modality would increase the diagnostic accuracy of common bile duct stones preoperatively. This triple non-invasive test is recommended for excluding common bile duct stones and to identify patients in need for other investigations.
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>
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.
文摘Liver disease accounts for approximately 2 million deaths per year worldwide.All chronic liver diseases(CLDs),whether of toxic,genetic,autoimmune,or infectious origin,undergo typical histological changes in the structure of the tissue.These changes may include the accumulation of extracellular matrix material,fats,triglycerides,or tissue scarring.Noninvasive methods for diagnosing CLD,such as conventional B-mode ultrasound(US),play a significant role in diagnosis.Doppler US,when coupled with B-mode US,can be helpful in evaluating the hemodynamics of hepatic vessels and detecting US findings associated with hepatic decompensation.US elastography can assess liver stiffness,serving as a surrogate marker for liver fibrosis.It is important to note that interpreting these values should not rely solely on a histological classification.Contrast-enhanced US(CEUS)provides valuable information on tissue perfusion and enables excellent differentiation between benign and malignant focal liver lesions.Clinical evaluation,the etiology of liver disease,and the patient current comorbidities all influence the interpretation of liver stiffness measurements.These measurements are most clinically relevant when interpreted as a probability of compensated advanced CLD.B-mode US offers a subjective estimation of fatty infiltration and has limited sensitivity for mild steatosis.The controlled attenuation parameter requires a dedicated device,and cutoff values are not clearly defined.Quan-titative US parameters for liver fat estimation include the attenuation coefficient,backscatter coefficient,and speed of sound.These parameters offer the advantage of providing fat quantification alongside B-mode evaluation and other US parameters.Multiparametric US(MPUS)of the liver introduces a new concept for complete noninvasive diagnosis.It encourages examiners to utilize the latest features of an US machine,including conventional B-mode,liver stiffness evaluation,fat quantification,dispersion imaging,Doppler US,and CEUS for focal liver lesion characterization.This comprehensive approach allows for diagnosis in a single examination,providing clinicians worldwide with a broader perspective and becoming a cornerstone in their diagnostic arsenal.MPUS,in the hands of skilled clinicians,becomes an invaluable predictive tool for diagnosing,staging,and monitoring CLD.
基金Supported by the Science and Technology Projects in Guangzhou,No.202201010623 and No.2024A03J1016Guangzhou Science and Technology Project of Traditional Chinese Medicine and Combined Chinese and Western Medicine,No.20242A011001Guangdong Medical Science and Research Foundation,No.A2024088.
文摘BACKGROUND Application of indocyanine green(ICG)fluorescence has led to new developments in gastrointestinal surgery.However,little is known about the use of ICG for the diagnosis of postoperative gut leakage(GL).In addition,there is a lack of rapid and intuitive methods to definitively diagnose postoperative GL.AIM To investigate the effect of ICG in the diagnosis of anastomotic leakage in a surgical rat GL model and evaluate its diagnostic value in colorectal surgery patients.METHODS Sixteen rats were divided into two groups:GL group(n=8)and sham group(n=8).Approximately 0.5 mL of ICG(2.5 mg/mL)was intravenously injected postoperatively.The peritoneal fluid was collected for the fluorescence test at 24 and 48 h.Six patients with rectal cancer who had undergone laparoscopic rectal cancer resection plus enterostomies were injected with 10 mL of ICG(2.5 mg/mL)on postoperative day 1.Their ostomy fluids were collected 24 h after ICG injection to identify the possibility of the ICG excreting from the peripheral veins to the enterostomy stoma.Participants who had undergone colectomy or rectal cancer resection were enrolled in the diagnostic test.The peritoneal fluids from drainage were collected 24 h after ICG injection.The ICG fluorescence test was conducted using OptoMedic endoscopy along with a near-infrared fluorescent imaging system.RESULTS The peritoneal fluids from the GL group showed ICG-dependent green fluorescence in contrast to the sham group.Six samples of ostomy fluids showed green fluorescence,indicating the possibility of ICG excreting from the peripheral veins to the enterostomy stoma in patients.The peritoneal fluid ICG test exhibited a sensitivity of 100%and a specificity of 83.3%for the diagnosis of GL.The positive predictive value was 71.4%,while the negative predictive value was 100%.The likelihood ratios were 6.0 for a positive test result and 0 for a negative result.CONCLUSION The postoperative ICG test in a drainage tube is a valuable and simple technique for the diagnosis of GL.Hence,it should be employed in clinical settings in patients with suspected GL.
