Pilot implementation of GeneXpert HIV-1 Qualitative assay in selected health facilities
lessons learned from Ethiopia
DOI:
https://doi.org/10.20372/ejphn.v6i2.212Keywords:
HIV-1, EID, GenXpert, Qualitative Assay, POC, PCRAbstract
Background: Access to Early Infant Diagnosis (EID) using the conventional DNA PCR method is challenging because it requires technical expertise and has long turn-around time for results. Innovative point-of-care HIV testing could bridge this gap. This study aimed to verify the performance of Point of Care (POC) GeneXpert HIV-1 Qualitative Assay POC for HIV-EID.
Methods: This study was conducted from May 2017 to April 2018. Initially, the performance of the GeneXpert HIV-1 Qualitative assay POC method was verified by comparing with the conventional (Roche CAP/CTM HIV-1 Qualitative PCR) method; this was followed by a baseline assessment of the pilot implementation of the assay, which had two categories. The first pilot was EID testing in eight hospitals in different regions of the country as a standalone testing for EID. The second part of the pilot was integrated to TB/EID testing in two hospitals and one health center, using the existing GeneXpert devices being used for MTB/Rif testing. Data was analyzed using SPSS version 26 (IBM Corp., Armonk, NY).
Results: Overall, 1,216 HIV-1 exposed infants were included in the study out of which the positivity rate was 48 (4%) using the GeneXpert HIV-1 Qualitative assay. The sensitivity and specificity of the GeneXpert HIV-1 Qualitative assay was 100% and accuracy was also 100% (95% CI, 97.3-100), with an overall error/invalid rate of 6.8% for Xpert HIV-1Qualitative assay. Out of 1,216 samples, 993(62.6%) were tested with Xpert HIV-1 Qualitative assay, and the results were delivered within the same day. Turnaround time (TAT) was significantly lower in Xpert POC testing compared with CAP/CTM conventional testing methods. TAT predictor analysis showed that, almost 50% of the delay occurred from sample collection at the patient care setting until it reached the central testing laboratory.
Conclusion: This study showed excellent diagnostic performance of Xpert HIV-1 Qualitative assay compared with the PCR method. Additionally, the pilot assessment showed that Xpert HIV-1 Qualitative assay improved access to same day testing of HIV Exposed Infants (HEIs) and facilitated to put them on ART as soon as possible, if they tested positive. Therefore, since Xpert HIV-1 Qualitative assay can offer significantly improved care for HEI, strategic addition of GeneXpert POC testing to diagnostic algorithms to improve EID and treatment is recommended.
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