Nucleic acid amplification tests(NAAT)have long been used in laboratory facilities and recently revolutionized the field of molecular diagnostics in point-of-care testing.Digital microfluidics(DMF)has emerged as a pro...Nucleic acid amplification tests(NAAT)have long been used in laboratory facilities and recently revolutionized the field of molecular diagnostics in point-of-care testing.Digital microfluidics(DMF)has emerged as a promising tool to complete the entire NAAT workflow in a miniaturized format with minimum human intervention.Based on electric fields to manipulate independent reaction droplets,the compact DMF system could perform multiple processes simultaneously and automatically in a programmable fashion.This combination is beginning to establish powerful sample-to-answer platforms in remote or resource-limited settings.Herein,we provide a comprehensive overview of the state-of-the-art DMF technology for point-of-care NAAT.This review focused on key principles of DMF platforms and the latest trends in system integration for automated processes of nucleic acid extraction,amplification,and detection.Also,this article discusses current challenges,including control systems,scalability and throughput,as well as future prospects of DMF-based NAAT strategy for the next generation of point-of-care diagnostics.展开更多
Background:Tuberculosis(TB)remains a major threat to human health,and TB diagnostic methods remain unsatisfactory.Nucleic acid amplification tests(NAATs)show higher sensitivity compared with culture for the diagnosis ...Background:Tuberculosis(TB)remains a major threat to human health,and TB diagnostic methods remain unsatisfactory.Nucleic acid amplification tests(NAATs)show higher sensitivity compared with culture for the diagnosis of pulmonary TB(PTB).However,NAATs are expensive and cannot be easily implemented outside major medical centers.To improve the sensitivity of NAATs for PTB diagnosis,we investigated the predictive factors that might optimize NAAT utilization.Methods:A total of 1263 patients with suspected PTB were enrolled for evaluation.The sensitivity,specificity,and accuracy of methods including smear-microbiology,culture of Mtb and NAAT for Mycobacterium tuberculosis(Mtb)detection in sputum and bronchoalveolar lavage fluid samples were compared.Odds ratios and 95%confidence intervals were used to assess variables that might be associated with positive NAAT results for sputum and bronchoalveolar lavage fluid from patients with suspected PTB.Results:NAAT showed higher sensitivity for Mtb detection(61.1%)when compared with smear(9.0%)and Mtb culture(47.8%).We found that an elevated erythrocyte sedimentation rate,the presence of cavities,and positive interferon-𝛾release assay(IGRA)results were indicative of positive Mtb detection by NAAT.Moreover,individuals who had all three of these characteristics showed an 86%diagnostic positivity for PTB from Mtb detection by NAAT.Conclusions:Our study suggests that an elevated erythrocyte sedimentation rate,a positive IGRA result,and the presence of pulmonary cavities are helpful factors for predicting positive Mtb detection by NAAT.Patients with the three positive clinical markers should undergo NAAT for Mtb detection because they are the most likely individuals to be bacteriologically confirmed as having TB.展开更多
BACKGROUND Rapid molecular testing has revolutionized the management of suspected viral meningitis and encephalitis by providing an etiological diagnosis in<90 min with potential to improve outcomes and shorten inp...BACKGROUND Rapid molecular testing has revolutionized the management of suspected viral meningitis and encephalitis by providing an etiological diagnosis in<90 min with potential to improve outcomes and shorten inpatient stays.However,use of molecular assays can vary widely.AIM To evaluate current practice for molecular testing of pediatric cerebrospinal fluid(CSF)samples across the United Kingdom using a structured questionnaire.METHODS A structured telephone questionnaire survey was conducted between July and August 2020.Data was collected on the availability of viral CSF nucleic acid amplification testing(NAAT),criteria used for testing and turnaround times including the impact of the coronavirus disease 2019 pandemic.RESULTS Of 196/212(92%)microbiology laboratories responded;63/196(32%)were excluded from final analysis as they had no on-site microbiology laboratory and outsourced their samples.Of 133 Laboratories included in the study,47/133(35%)had onsite facilities for viral CSF NAAT.Hospitals currently undertaking onsite NAAT(n=47)had much faster turnaround times with 39 centers(83%)providing results in≤24 h as compared to those referring samples to neighboring laboratories(5/86;6%).CONCLUSION Onsite/near-patient rapid NAAT(including polymerase chain reaction)is recommended wherever possible to optimize patient management in the acute setting.展开更多
The phenomenon of ground vibration amplification caused by railway traffic was found and proved. In order to study the reasons which cause the amplification, a drop-weight test was performed. Then, the model for both ...The phenomenon of ground vibration amplification caused by railway traffic was found and proved. In order to study the reasons which cause the amplification, a drop-weight test was performed. Then, the model for both homogeneous and layered soil subjected to a harmonic vertical load was built. With the help of this model, displacement Green's function was calculated and the propagation laws of ground vibration responses were discussed. Results show that: 1) When applying a harmonic load on the half-space surface, the amplitude of ground vibrations attenuate with fluctuation, which is caused by the superposition of bulk and Rayleigh waves. 2) Vibration amplification can be enlarged under the conditions of embedded source and the soil layers. 3) In practice, the fluctuant attenuation should be paid attention to especially for the vibration receivers who are sensitive to single low frequencies(<10 Hz). Moreover, for the case of embedded loads, it should also be paid attention to that the receivers are located at the place where the horizontal distance is similar to embedded depth, usually 10 to 30 m for metro lines.展开更多
Clostridium difficile (C. difficile) is a spore-forming, toxin-producing, gram-positive anaerobic bacterium that is the principal etiologic agent of antibiotic-associated diarrhea. Infection with C. difficile (CDI) is...Clostridium difficile (C. difficile) is a spore-forming, toxin-producing, gram-positive anaerobic bacterium that is the principal etiologic agent of antibiotic-associated diarrhea. Infection with C. difficile (CDI) is characterized by diarrhea in clinical syndromes that vary from selflimited to mild or severe. Since its initial recognition as the causative agent of pseudomembranous colitis, C. difficile has spread around the world. CDI is one of the most common healthcare-associated infections and a significant cause of morbidity and mortality among older adult hospitalized patients. Due to extensive antibiotic usage, the number of CDIs has increased. Diagnosis of CDI is often difficult and has a substantial impact on the management of patients with the disease, mainly with regards to antibiotic management. The diagnosis of CDI is primarily based on the clinical signs and symptoms and is only confirmed by laboratory testing. Despite the high burden of CDI and the increasing interest in the disease, episodes of CDI are often misdiagnosed. The reasons for misdiagnosis are the lack of clinical suspicion or the use of inappropriate tests. The proper diagnosis of CDI reduces transmission, prevents inadequate or unnecessary treatments, and assures best antibiotic treatment. We review the options for the laboratory diagnosis of CDI within the settings of the most accepted guidelines for CDI diagnosis, treatment, and prevention of CDI.展开更多
Diagnostic testing plays a fundamental role in the mitigation and containment of coronavirus disease 2019(COVID-19),as it enables immediate quarantine of those who are infected and contagious and is essential for the ...Diagnostic testing plays a fundamental role in the mitigation and containment of coronavirus disease 2019(COVID-19),as it enables immediate quarantine of those who are infected and contagious and is essential for the epidemiological characterization of the virus and estimating the number of infected cases worldwide.Confirmation of viral infections,such as COVID-19,can be achieved through two general approaches:nucleic acid amplification tests(NAATs)or molecular tests,and serological or antibody-based tests.The genetic material of the pathogen is detected in NAAT,and in serological tests,host antibodies produced in response to the pathogen are identified.Other methods of diagnosing COVID-19 include radiological imaging of the lungs and in vitro detection of viral antigens.This review covers different approaches available to diagnosing COVID-19 by outlining their advantages and shortcomings,as well as appropriate indications for more accurate testing.展开更多
We isolated and characterized 17 microsatellite DNA loci for the odorous frog Odorrana margaretae from its transcriptome sequence data. These loci were screened with 24 individuals from Mt. Emei. All loci were polymor...We isolated and characterized 17 microsatellite DNA loci for the odorous frog Odorrana margaretae from its transcriptome sequence data. These loci were screened with 24 individuals from Mt. Emei. All loci were polymorphic, with the number of alleles ranging from 2 to 8. The observed and expected heterozygosity, polymorphism information content, ranged from 0.04 to 1, 0.04 to 0.81, and 0.040 to 0.763, respectively. All loci were in linkage equilibrium and six loci were significantly deviated from Hardy-Weinberg equilibrium after sequential Bonferroni corrections. Cross- species amplification test was conducted for ten odorous frog species, and 12 loci were amplifiable in most species. With the high cross-species amplification rates, thesc markers will provide useful molecular tools for conservation genetic and phylogeographic studies on the genus Odorrana and Bamburana.展开更多
Infections by nonpolio enteroviruses(EVs)are highly prevalent,particularly among children and neonates,where they may cause substantial morbidity and mortality.Laboratory diagnosis of these viral infections is importa...Infections by nonpolio enteroviruses(EVs)are highly prevalent,particularly among children and neonates,where they may cause substantial morbidity and mortality.Laboratory diagnosis of these viral infections is important in patient prognosis and guidance of clinical management.Although the laboratory diagnosis of non-polio EVs is mainly based on molecular techniques,classical virus-isolation techniques are still used in refer-ence laboratories.Other techniques,such as antigen detection and serology,are becoming obsolete and rarely used in diagnosis.An important part of diagnosis and surveillance of EV infections is viral typing by VP1 gene sequencing using conventional Sanger technique and more recently,full-genome next-generation sequencing.The latter allows the typing of all EVs,better investigation of EV outbreaks,detection of coinfec-tion,and identification of severity markers in the EV genome.展开更多
Objective:Laboratory capacity for Chlamydia trachomatis (C.trachomatis) detection is important in the diagnosis and treatment of C.trachomatis infection,appropriate clinical management of patients,and providing eviden...Objective:Laboratory capacity for Chlamydia trachomatis (C.trachomatis) detection is important in the diagnosis and treatment of C.trachomatis infection,appropriate clinical management of patients,and providing evidence for prevention programs.We conducted this study to assess laboratory capabilities for detecting C.trachomatis in China by analysis of external quality assessment (EQA) results from 2013 to 2018.Methods:Overall,310/1,048 (29.58%) laboratories at national sexually transmitted disease (STD) sentinel site with 252-272 laboratories per time participated in six times of EQA.Each laboratory was requested to test the samples from EQA organization by the common method used,and the test results were reported to EQA organization for assessment.Z test and multinomial logistic regression analyses were used for data analyses.Results:Immunochromatographic test,nucleic acid amplification test (NAAT),and ELISA were used and accounted for 76.69%,21.54%,1.77%,respectively of all participating laboratories from 2013 to 2018.The total specificity for negative samples was 94.76%,the sensitivity for positive samples with medium and high concentration of C.trachomatis samples were 94.31% and 95.51%,respectively,but the sensitivity for sample with low concentration of Co trachomatis was 36.89%,and the immunochromatographic test had the worst sensitivity for detection of this sample (21.17% [95% C/s:18.93%-23.60%]) among the three methods.Three factors were found to be significantly associated with the sensitivity of the low-concentration sample:the location of laboratories (East China:adjusted odds ratio [AOR] =2.98,95% C/s:1.69-5.25,P < 0.05;South China:AOR =3.34,95% CIs:1.38-5.48,P < 0.05;Southwest China:AOR=2.75,95% CIs:1.37-5.48,P<0.05,as compared with Northwest China);the types of hospitals (prevention and control agencies:AOR =0.56,95% CIs:0.40-0.80,P < 0.05,as compared with general hospitals);and the method used (NAAT:AOR=46.99,95% CIs:28.49-77.48,P< 0.050;ELISA:AOR=5.42,95% CIS:2.40-12.25,P<0.05,as compared with immunochromatographic test).Conclusion:Immunochromatographic test is widely used for C.trachomatis antigen in China;however,based on its suboptimal detection sensitivity,methods with high sensitivity such as NAAT-based point-of-care diagnostic method are recommended to apply for C.trachomatis detection,and efforts should be performed to promote the high-sensitivity methods among laboratories.展开更多
The rising incidence of gonorrhea presents a global public health challenge,emphasizing the importance of accurate Neisseria gonorrhoeae detection for effective diagnosis,treatment and prevention.This study assessed t...The rising incidence of gonorrhea presents a global public health challenge,emphasizing the importance of accurate Neisseria gonorrhoeae detection for effective diagnosis,treatment and prevention.This study assessed the performance of sexually transmitted disease laboratories for N.gonorrhoeae detection in Guangdong,southern China.A questionnaire about N.gonorrhoeae detection and external quality assessments(EQAs)with five samples for culture and five for nucleic acid amplification tests(NAATs)were conducted annually from 2020 through 2022.The questionnaire was responded to by 1047 laboratories,with the results showing that Gram staining and culture were most commonly used by 44.3%and 40.4%of the laboratories,respectively,whereas NAATs were adopted by only 11.7%.The number of clinical samples tested for N.gonorrhoeae increased from 536,369 in 363 laboratories in 2020 to 1,093,147 in 582 laboratories in 2022(P>0.05),with an overall male-to-female testing ratio of 1:3.4 and a positive ratio of 3.6:1.The EQA results revealed a concordance rate of 90.8%for gonococcal culture and 93.1%for NAATs.NAATs demonstrated a decreasing detection rate(from 100.0%to 84.5%)with reducing gonococcal DNA copies and 89.0%specificity with the interference-negative sample.The overall concordance rates of four widely used commercial NAAT kits ranged from 95.7%to 88.5%.Gram staining and culture were widely used to detect N.gonorrhoeae in Guangdong.NAAT has long been recognized as a highly sensitive and specific method for detecting gonorrhea and should be more widely implemented in China.展开更多
基金support from The Ivan Bowen Family Foundation and the Department of Physiology and Biomedical Engineering at Mayo Clinic,Rochester MN.
文摘Nucleic acid amplification tests(NAAT)have long been used in laboratory facilities and recently revolutionized the field of molecular diagnostics in point-of-care testing.Digital microfluidics(DMF)has emerged as a promising tool to complete the entire NAAT workflow in a miniaturized format with minimum human intervention.Based on electric fields to manipulate independent reaction droplets,the compact DMF system could perform multiple processes simultaneously and automatically in a programmable fashion.This combination is beginning to establish powerful sample-to-answer platforms in remote or resource-limited settings.Herein,we provide a comprehensive overview of the state-of-the-art DMF technology for point-of-care NAAT.This review focused on key principles of DMF platforms and the latest trends in system integration for automated processes of nucleic acid extraction,amplification,and detection.Also,this article discusses current challenges,including control systems,scalability and throughput,as well as future prospects of DMF-based NAAT strategy for the next generation of point-of-care diagnostics.
基金This work was supported by the Natural Science Foundation of China(No.81,873,958,81,802,058)the National Key Research and Development Plan(No.2019YFC0840602,2020YFA0907201)+2 种基金the Guang-dong Scientific and Technological Foundation(No.2019B1515120041,2020B1111170014)the Shen-zhen Scientific and Technological Foundation(No.JCYJ20180228162336873,JCYJ20180228162321234,KCXFZ202002011007083)the China Postdoctoral Science Foundation(No.2020M670085ZX).
文摘Background:Tuberculosis(TB)remains a major threat to human health,and TB diagnostic methods remain unsatisfactory.Nucleic acid amplification tests(NAATs)show higher sensitivity compared with culture for the diagnosis of pulmonary TB(PTB).However,NAATs are expensive and cannot be easily implemented outside major medical centers.To improve the sensitivity of NAATs for PTB diagnosis,we investigated the predictive factors that might optimize NAAT utilization.Methods:A total of 1263 patients with suspected PTB were enrolled for evaluation.The sensitivity,specificity,and accuracy of methods including smear-microbiology,culture of Mtb and NAAT for Mycobacterium tuberculosis(Mtb)detection in sputum and bronchoalveolar lavage fluid samples were compared.Odds ratios and 95%confidence intervals were used to assess variables that might be associated with positive NAAT results for sputum and bronchoalveolar lavage fluid from patients with suspected PTB.Results:NAAT showed higher sensitivity for Mtb detection(61.1%)when compared with smear(9.0%)and Mtb culture(47.8%).We found that an elevated erythrocyte sedimentation rate,the presence of cavities,and positive interferon-𝛾release assay(IGRA)results were indicative of positive Mtb detection by NAAT.Moreover,individuals who had all three of these characteristics showed an 86%diagnostic positivity for PTB from Mtb detection by NAAT.Conclusions:Our study suggests that an elevated erythrocyte sedimentation rate,a positive IGRA result,and the presence of pulmonary cavities are helpful factors for predicting positive Mtb detection by NAAT.Patients with the three positive clinical markers should undergo NAAT for Mtb detection because they are the most likely individuals to be bacteriologically confirmed as having TB.
文摘BACKGROUND Rapid molecular testing has revolutionized the management of suspected viral meningitis and encephalitis by providing an etiological diagnosis in<90 min with potential to improve outcomes and shorten inpatient stays.However,use of molecular assays can vary widely.AIM To evaluate current practice for molecular testing of pediatric cerebrospinal fluid(CSF)samples across the United Kingdom using a structured questionnaire.METHODS A structured telephone questionnaire survey was conducted between July and August 2020.Data was collected on the availability of viral CSF nucleic acid amplification testing(NAAT),criteria used for testing and turnaround times including the impact of the coronavirus disease 2019 pandemic.RESULTS Of 196/212(92%)microbiology laboratories responded;63/196(32%)were excluded from final analysis as they had no on-site microbiology laboratory and outsourced their samples.Of 133 Laboratories included in the study,47/133(35%)had onsite facilities for viral CSF NAAT.Hospitals currently undertaking onsite NAAT(n=47)had much faster turnaround times with 39 centers(83%)providing results in≤24 h as compared to those referring samples to neighboring laboratories(5/86;6%).CONCLUSION Onsite/near-patient rapid NAAT(including polymerase chain reaction)is recommended wherever possible to optimize patient management in the acute setting.
基金Project(51278043)supported by National Natural Science Foundation of China
文摘The phenomenon of ground vibration amplification caused by railway traffic was found and proved. In order to study the reasons which cause the amplification, a drop-weight test was performed. Then, the model for both homogeneous and layered soil subjected to a harmonic vertical load was built. With the help of this model, displacement Green's function was calculated and the propagation laws of ground vibration responses were discussed. Results show that: 1) When applying a harmonic load on the half-space surface, the amplitude of ground vibrations attenuate with fluctuation, which is caused by the superposition of bulk and Rayleigh waves. 2) Vibration amplification can be enlarged under the conditions of embedded source and the soil layers. 3) In practice, the fluctuant attenuation should be paid attention to especially for the vibration receivers who are sensitive to single low frequencies(<10 Hz). Moreover, for the case of embedded loads, it should also be paid attention to that the receivers are located at the place where the horizontal distance is similar to embedded depth, usually 10 to 30 m for metro lines.
文摘Clostridium difficile (C. difficile) is a spore-forming, toxin-producing, gram-positive anaerobic bacterium that is the principal etiologic agent of antibiotic-associated diarrhea. Infection with C. difficile (CDI) is characterized by diarrhea in clinical syndromes that vary from selflimited to mild or severe. Since its initial recognition as the causative agent of pseudomembranous colitis, C. difficile has spread around the world. CDI is one of the most common healthcare-associated infections and a significant cause of morbidity and mortality among older adult hospitalized patients. Due to extensive antibiotic usage, the number of CDIs has increased. Diagnosis of CDI is often difficult and has a substantial impact on the management of patients with the disease, mainly with regards to antibiotic management. The diagnosis of CDI is primarily based on the clinical signs and symptoms and is only confirmed by laboratory testing. Despite the high burden of CDI and the increasing interest in the disease, episodes of CDI are often misdiagnosed. The reasons for misdiagnosis are the lack of clinical suspicion or the use of inappropriate tests. The proper diagnosis of CDI reduces transmission, prevents inadequate or unnecessary treatments, and assures best antibiotic treatment. We review the options for the laboratory diagnosis of CDI within the settings of the most accepted guidelines for CDI diagnosis, treatment, and prevention of CDI.
基金supported by the Protein Research Center of Shahid Beheshti University.
文摘Diagnostic testing plays a fundamental role in the mitigation and containment of coronavirus disease 2019(COVID-19),as it enables immediate quarantine of those who are infected and contagious and is essential for the epidemiological characterization of the virus and estimating the number of infected cases worldwide.Confirmation of viral infections,such as COVID-19,can be achieved through two general approaches:nucleic acid amplification tests(NAATs)or molecular tests,and serological or antibody-based tests.The genetic material of the pathogen is detected in NAAT,and in serological tests,host antibodies produced in response to the pathogen are identified.Other methods of diagnosing COVID-19 include radiological imaging of the lungs and in vitro detection of viral antigens.This review covers different approaches available to diagnosing COVID-19 by outlining their advantages and shortcomings,as well as appropriate indications for more accurate testing.
基金supported by the National Natural Science Foundation of China(Grant No.31172061)
文摘We isolated and characterized 17 microsatellite DNA loci for the odorous frog Odorrana margaretae from its transcriptome sequence data. These loci were screened with 24 individuals from Mt. Emei. All loci were polymorphic, with the number of alleles ranging from 2 to 8. The observed and expected heterozygosity, polymorphism information content, ranged from 0.04 to 1, 0.04 to 0.81, and 0.040 to 0.763, respectively. All loci were in linkage equilibrium and six loci were significantly deviated from Hardy-Weinberg equilibrium after sequential Bonferroni corrections. Cross- species amplification test was conducted for ten odorous frog species, and 12 loci were amplifiable in most species. With the high cross-species amplification rates, thesc markers will provide useful molecular tools for conservation genetic and phylogeographic studies on the genus Odorrana and Bamburana.
基金This study was funded by the Russian Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing,grant ID 121041500041−1.
文摘Infections by nonpolio enteroviruses(EVs)are highly prevalent,particularly among children and neonates,where they may cause substantial morbidity and mortality.Laboratory diagnosis of these viral infections is important in patient prognosis and guidance of clinical management.Although the laboratory diagnosis of non-polio EVs is mainly based on molecular techniques,classical virus-isolation techniques are still used in refer-ence laboratories.Other techniques,such as antigen detection and serology,are becoming obsolete and rarely used in diagnosis.An important part of diagnosis and surveillance of EV infections is viral typing by VP1 gene sequencing using conventional Sanger technique and more recently,full-genome next-generation sequencing.The latter allows the typing of all EVs,better investigation of EV outbreaks,detection of coinfec-tion,and identification of severity markers in the EV genome.
基金supported by the Chinese Academy of Medical Sciences Initiative for Innovative Medicine (2016I2M-3–021)
文摘Objective:Laboratory capacity for Chlamydia trachomatis (C.trachomatis) detection is important in the diagnosis and treatment of C.trachomatis infection,appropriate clinical management of patients,and providing evidence for prevention programs.We conducted this study to assess laboratory capabilities for detecting C.trachomatis in China by analysis of external quality assessment (EQA) results from 2013 to 2018.Methods:Overall,310/1,048 (29.58%) laboratories at national sexually transmitted disease (STD) sentinel site with 252-272 laboratories per time participated in six times of EQA.Each laboratory was requested to test the samples from EQA organization by the common method used,and the test results were reported to EQA organization for assessment.Z test and multinomial logistic regression analyses were used for data analyses.Results:Immunochromatographic test,nucleic acid amplification test (NAAT),and ELISA were used and accounted for 76.69%,21.54%,1.77%,respectively of all participating laboratories from 2013 to 2018.The total specificity for negative samples was 94.76%,the sensitivity for positive samples with medium and high concentration of C.trachomatis samples were 94.31% and 95.51%,respectively,but the sensitivity for sample with low concentration of Co trachomatis was 36.89%,and the immunochromatographic test had the worst sensitivity for detection of this sample (21.17% [95% C/s:18.93%-23.60%]) among the three methods.Three factors were found to be significantly associated with the sensitivity of the low-concentration sample:the location of laboratories (East China:adjusted odds ratio [AOR] =2.98,95% C/s:1.69-5.25,P < 0.05;South China:AOR =3.34,95% CIs:1.38-5.48,P < 0.05;Southwest China:AOR=2.75,95% CIs:1.37-5.48,P<0.05,as compared with Northwest China);the types of hospitals (prevention and control agencies:AOR =0.56,95% CIs:0.40-0.80,P < 0.05,as compared with general hospitals);and the method used (NAAT:AOR=46.99,95% CIs:28.49-77.48,P< 0.050;ELISA:AOR=5.42,95% CIS:2.40-12.25,P<0.05,as compared with immunochromatographic test).Conclusion:Immunochromatographic test is widely used for C.trachomatis antigen in China;however,based on its suboptimal detection sensitivity,methods with high sensitivity such as NAAT-based point-of-care diagnostic method are recommended to apply for C.trachomatis detection,and efforts should be performed to promote the high-sensitivity methods among laboratories.
基金supported by grants from the National Natural Science Foundation for Young Scholars of China(No.82104626)the Guangzhou Science and Technology Plan Project(No.202201000007)The funders had no role in study design,data collection or analysis,decision to publish,or preparation of the manuscript.
文摘The rising incidence of gonorrhea presents a global public health challenge,emphasizing the importance of accurate Neisseria gonorrhoeae detection for effective diagnosis,treatment and prevention.This study assessed the performance of sexually transmitted disease laboratories for N.gonorrhoeae detection in Guangdong,southern China.A questionnaire about N.gonorrhoeae detection and external quality assessments(EQAs)with five samples for culture and five for nucleic acid amplification tests(NAATs)were conducted annually from 2020 through 2022.The questionnaire was responded to by 1047 laboratories,with the results showing that Gram staining and culture were most commonly used by 44.3%and 40.4%of the laboratories,respectively,whereas NAATs were adopted by only 11.7%.The number of clinical samples tested for N.gonorrhoeae increased from 536,369 in 363 laboratories in 2020 to 1,093,147 in 582 laboratories in 2022(P>0.05),with an overall male-to-female testing ratio of 1:3.4 and a positive ratio of 3.6:1.The EQA results revealed a concordance rate of 90.8%for gonococcal culture and 93.1%for NAATs.NAATs demonstrated a decreasing detection rate(from 100.0%to 84.5%)with reducing gonococcal DNA copies and 89.0%specificity with the interference-negative sample.The overall concordance rates of four widely used commercial NAAT kits ranged from 95.7%to 88.5%.Gram staining and culture were widely used to detect N.gonorrhoeae in Guangdong.NAAT has long been recognized as a highly sensitive and specific method for detecting gonorrhea and should be more widely implemented in China.
