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

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.