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艾滋病毒即时检测诊断:越南部分公社实施快速检测算法试点中预防误诊的经验

HIV point of care diagnosis: preventing misdiagnosis experience from a pilot of rapid test algorithm implementation in selected communes in Vietnam.

作者信息

Nguyen Van Thi Thuy, Best Susan, Pham Hong Thang, Troung Thi Xuan Lien, Hoang Thi Thanh Ha, Wilson Kim, Ngo Thi Hong Hanh, Chien Xuan, Lai Kim Anh, Bui Duc Duong, Kato Masaya

机构信息

World Health Organization, Vietnam Country Office, Hanoi, Vietnam.

Australian National Serology Reference Laboratory, Melbourne, Australia.

出版信息

J Int AIDS Soc. 2017 Aug 29;20(Suppl 6):21752. doi: 10.7448/IAS.20.7.21752.

DOI:10.7448/IAS.20.7.21752
PMID:28872279
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5625549/
Abstract

INTRODUCTION

In Vietnam, HIV testing services had been available only at provincial and district health facilities, but not at the primary health facilities. Consequently, access to HIV testing services had been limited especially in rural areas. In 2012, Vietnam piloted decentralization and integration of HIV services at commune health stations (CHSs). As a part of this pilot, a three-rapid test algorithm was introduced at CHSs. The objective of this study was to assess the performance of a three-rapid test algorithm and the implementation of quality assurance measures to prevent misdiagnosis, at primary health facilities.

METHODS

The three-rapid test algorithm (Determine HIV-1/2, followed by ACON HIV 1/2 and DoubleCheckGold HIV 1&2 in parallel) was piloted at CHSs from August 2012 to December 2013. Commune health staff were trained to perform HIV testing. Specimens from CHSs were sent to the provincial confirmatory laboratory (PCL) for confirmatory and validation testing. Quality assurance measures were undertaken including training, competency assessment, field technical assistance, supervision and monitoring and external quality assessment (EQA). Data on HIV testing were collected from the testing logbooks at commune and provincial facilities. Descriptive analysis was conducted. Sensitivity and specificity of the rapid testing algorithm were calculated.

RESULTS

A total of 1,373 people received HIV testing and counselling (HTC) at CHSs. Eighty people were diagnosed with HIV infection (5.8%). The 755/1244 specimens reported as HIV negative at the CHS were sent to PCL and confirmed as negative, and all 80 specimens reported as HIV positive at CHS were confirmed as positive at the PCL. Forty-nine specimens that were reactive with Determine but negative with ACON and DoubleCheckGold at the CHSs were confirmed negative at the PCL. The results show this rapid test algorithm to be 100% sensitive and 100% specific. Of 21 CHSs that received two rounds of EQA panels, 20 CHSs submitted accurate results.

CONCLUSIONS

Decentralization of HIV confirmatory testing to CHS is feasible in Vietnam. The results obtained from this pilot provided strong evidence of the feasibility of HIV testing at primary health facilities. Quality assurance measures including training, competency assessment, regular monitoring and supervision and an EQA scheme are essential for prevention of misdiagnosis.

摘要

引言

在越南,艾滋病毒检测服务仅在省级和区级卫生机构提供,基层卫生机构没有此项服务。因此,获得艾滋病毒检测服务的机会有限,尤其是在农村地区。2012年,越南在公社卫生站(CHS)试点开展艾滋病毒服务的下放和整合工作。作为该试点的一部分,在公社卫生站引入了三联快速检测算法。本研究的目的是评估三联快速检测算法的性能以及在基层卫生机构实施质量保证措施以防止误诊的情况。

方法

2012年8月至2013年12月在公社卫生站试点采用三联快速检测算法(先使用Determine HIV-1/2检测,随后并行使用ACON HIV 1/2和DoubleCheckGold HIV 1&2检测)。对公社卫生工作人员进行艾滋病毒检测培训。将公社卫生站的样本送往省级确认实验室(PCL)进行确认和验证检测。采取了质量保证措施,包括培训、能力评估、现场技术援助、监督和监测以及外部质量评估(EQA)。从公社和省级机构的检测日志中收集艾滋病毒检测数据,并进行描述性分析,计算快速检测算法的敏感性和特异性。

结果

共有1373人在公社卫生站接受了艾滋病毒检测和咨询(HTC)。80人被诊断为艾滋病毒感染(5.8%)。在公社卫生站报告为艾滋病毒阴性的755/1244份样本被送往省级确认实验室并确认为阴性,在公社卫生站报告为艾滋病毒阳性的所有80份样本在省级确认实验室也被确认为阳性。在公社卫生站与Determine检测呈反应性但与ACON和DoubleCheckGold检测呈阴性的49份样本在省级确认实验室被确认为阴性。结果显示该快速检测算法的敏感性和特异性均为100%。在接受两轮外部质量评估样本的21个公社卫生站中,20个提交了准确结果。

结论

在越南,将艾滋病毒确认检测下放到公社卫生站是可行的。该试点获得的结果为在基层卫生机构开展艾滋病毒检测的可行性提供了有力证据。包括培训、能力评估、定期监测和监督以及外部质量评估计划在内的质量保证措施对于预防误诊至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c8b/5625549/fcfc4cf6b56e/ZIAS_A_1345173_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c8b/5625549/be375ca2cfb3/ZIAS_A_1345173_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c8b/5625549/6c1c08f550a9/ZIAS_A_1345173_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c8b/5625549/fcfc4cf6b56e/ZIAS_A_1345173_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c8b/5625549/be375ca2cfb3/ZIAS_A_1345173_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c8b/5625549/6c1c08f550a9/ZIAS_A_1345173_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c8b/5625549/fcfc4cf6b56e/ZIAS_A_1345173_F0003_OC.jpg

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