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
本文首先概述了设置外对照的单臂试验的研究现状。然后重点介绍了采用非随机干预性研究偏倚评估工具(Risk of Bias in Non-randomized Study-of Interventions,ROBINS-I)评估设置了外对照的单臂试验,并举例说明偏倚评估流程和结果,为研...本文首先概述了设置外对照的单臂试验的研究现状。然后重点介绍了采用非随机干预性研究偏倚评估工具(Risk of Bias in Non-randomized Study-of Interventions,ROBINS-I)评估设置了外对照的单臂试验,并举例说明偏倚评估流程和结果,为研究者提高此类研究偏倚的识别与控制提供参考。综上,目前基于真实世界数据设置外对照的单臂试验尚在起步阶段,仍缺乏专用于其偏倚评估的工具,有待进一步研发。展开更多
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.
文摘本文首先概述了设置外对照的单臂试验的研究现状。然后重点介绍了采用非随机干预性研究偏倚评估工具(Risk of Bias in Non-randomized Study-of Interventions,ROBINS-I)评估设置了外对照的单臂试验,并举例说明偏倚评估流程和结果,为研究者提高此类研究偏倚的识别与控制提供参考。综上,目前基于真实世界数据设置外对照的单臂试验尚在起步阶段,仍缺乏专用于其偏倚评估的工具,有待进一步研发。
