Expensive and technically complex diagnostics for Early Infant Diagnosis (EID) have put appropriate staging, treatment monitoring, and infant diagnosis out of reach for many patients in resource-limited settings. Simplified diagnostic tools, especially point-of-care (POC) technology, must play in efforts to further expand access to treatment. In resource-limited settings, POC testing has the potential to significantly impact health care delivery and to address the challenges of health disparities. The aim of the study is to assess (pilot) the feasibility and program management aspects in rolling out GeneXpert HIV-1 Qual testing for improved turn-around time (TAT) and early initiation of treatment for HIV-exposed infants.
A total of eleven sites were used for the pilot, eight for EID testing only and three for integration with TB selected based on their distance from DNA PCR testing Laboratories, high caseload, and ability to conduct all aspects of Xpert HIV-1 Qual testing. Test operators were trained on Xpert HIV-1 Qual testing and required to pass individual certification to run Xpert HIV-1 Qual testing. During the initial stages of testing at each site, a verification procedure was carried out in order to validate the performance of each pilot site and each test operator. In order to carry out this procedure twenty HIV positive and negative DBS samples, prepared and tested using COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, v2.0 assay by the Ethiopian Public Health Institute (EPHI) HIV Molecular Laboratory, were distributed to all pilot sites to be tested by trained laboratory professionals on Xpert HIV-1 Qual.
The results of the pilot study indicate that a total of 1,225 EID tests were done in the pilot period, of which 215 were done using whole blood and 1,100 using DBS. Out of the total of 1,225 EID specimens tested, 1,117 specimens were negative and 48 specimens were positive. The overall % positivity was 4% during the pilot period. The average TAT improved from more than two months, as per the baseline data, to same-day to and the maximum was 31 days after implementation of Xpert HIV-1 testing. Among the samples with complete data, close to 50% of the results were delivered to the PMTCT clinic within the same day and 97.8% of the results were delivered to PMTCT clinic within 11 days. A positive Xpert HIV-1 result prompted ART initiation and confirmatory testing.
The pilot showed Xpert HIV-1 Qual assay improved access to same-day testing of HIV Exposed Infants and facilitated to put them on ART as soon as possible if they tested positive. The practicability of this assay makes it suitable for health facilities far from DNA PCR testing labs with a high caseload.

• Early Infant Diagnosis
• Human Immunodeficence Virus
• Point of Care
• Turnaround Time
• Dried Blood spot
• GeneXpert

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This dataset is generated by a GeneXpert HIV-1 Qual Assay pilot study conducted in selected health facilities from different areas of Ethiopia with the aim of assessing the feasibility of HIV-EID POC testing using GeneXpert and to examine all aspects of program management in rolling out POC EID testing in 2017. The dataset captures information on the total number of POC EID 1225 samples tested in eleven health facilities including facility name, number of negatives, number of positives tests in each pilot site, Number of Spoke sites referring EID specimens to pilot sites, on TAT for all specimen types and on-site, spoke and TB/EID integration (order to collection, collection to send to the lab, received at the lab to test done,), number of days to receive the result (TAT). Thus, this dataset is used as a baseline to scale-up the study finding in other health facilities in order to reduce- turn-around time (TAT), increase in total Xpert HIV-1 Qual EID testing volume, and Improved utilization of GeneXpert devices through strategic integration of TB/EID testing in better practice.

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