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Abstract：
BACKGROUND: Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries.
METHODS: HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated.
RESULTS: Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing.
CONCLUSIONS: Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.
METHODS: HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated.
RESULTS: Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing.
CONCLUSIONS: Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.
摘要：
背景：性传播感染（STIs）如梅毒和HIV仍然是世界范围内的重要公共卫生问题。双重快速即时测试（POCT）已显示出检测HIV和梅毒抗体的希望，但尚未在该领域得到充分评估。我们的研究通过在七个国家的参考实验室及其相关临床站点提供艾滋病毒和梅毒检测的外部质量评估（EQA），支持了WHOProSpeRo关于性传播感染即时检测（STIPOCT）的研究。
方法：由CDC制备HIV/梅毒血清液和干管标本（DTS）板。使用商业和本地可用的基于实验室的血清学测试，将液体面板分发给参考实验室进行三轮测试。使用AbbottSDBIOLINEHIV/梅毒Duo测试（以下称为SDBIOLINE）和Chembio双路径平台（DPP）HIV-梅毒测定，将DTS面板发送到临床测试站点进行8轮POC测试。使用快速血浆Reagin（RPR）测试和梅毒螺旋体颗粒凝集测定（TP-PA）在CDC测试了EQA面板的梅毒抗体。遗传系统HIV-1/HIV-2加上OEIA，GeeniusHIV补充测定和OraquickAdvanceHIV测试用于检测EQA面板中的HIV抗体。将参考实验室和POCT站点的结果与CDC获得的结果进行比较，并计算出百分比一致性。
结果：在参考实验室进行的定性RPR和TP-PA与CDC结果符合95.4-100％，而定量RPR和TP-PA测试则符合87.7％和89.2％。分别。在实验室中进行定性HIV检测时，一致率为93.8％。使用双重测试在临床站点进行的EQA测试显示，HIV抗体检测的一致性为98.7％和99.1％，10个站点中有8个对梅毒检测的一致性>95.8％。然而,两个临床站点显示SDBIOLINE的一致性仅为65.0-66.7％，DPP的一致性为84.0-86.7％，分别,梅毒检测.
结论：总体而言，实验室在这项研究中表现出很高的EQA性能。两种HIV/梅毒POCT在使用DTS的基于临床的评估中都给出了预期的结果。然而,在一些测试站点中发现了测试错误，这表明需要持续培训和监控POC测试的质量。
方法：由CDC制备HIV/梅毒血清液和干管标本（DTS）板。使用商业和本地可用的基于实验室的血清学测试，将液体面板分发给参考实验室进行三轮测试。使用AbbottSDBIOLINEHIV/梅毒Duo测试（以下称为SDBIOLINE）和Chembio双路径平台（DPP）HIV-梅毒测定，将DTS面板发送到临床测试站点进行8轮POC测试。使用快速血浆Reagin（RPR）测试和梅毒螺旋体颗粒凝集测定（TP-PA）在CDC测试了EQA面板的梅毒抗体。遗传系统HIV-1/HIV-2加上OEIA，GeeniusHIV补充测定和OraquickAdvanceHIV测试用于检测EQA面板中的HIV抗体。将参考实验室和POCT站点的结果与CDC获得的结果进行比较，并计算出百分比一致性。
结果：在参考实验室进行的定性RPR和TP-PA与CDC结果符合95.4-100％，而定量RPR和TP-PA测试则符合87.7％和89.2％。分别。在实验室中进行定性HIV检测时，一致率为93.8％。使用双重测试在临床站点进行的EQA测试显示，HIV抗体检测的一致性为98.7％和99.1％，10个站点中有8个对梅毒检测的一致性>95.8％。然而,两个临床站点显示SDBIOLINE的一致性仅为65.0-66.7％，DPP的一致性为84.0-86.7％，分别,梅毒检测.
结论：总体而言，实验室在这项研究中表现出很高的EQA性能。两种HIV/梅毒POCT在使用DTS的基于临床的评估中都给出了预期的结果。然而,在一些测试站点中发现了测试错误，这表明需要持续培训和监控POC测试的质量。
