Successful Use of Near Point-of-Care Early Infant Diagnosis in NAMPHIA to Improve Turnaround Times in a National Household Survey

Abstract

Background: In the population-based HIV impact assessment surveys, early infant diagnosis (EID) was provided to infants ,18 months without a prior diagnosis. For the Namibia population-based HIV impact assessment (NAMPHIA), the Gen-eXpert platform was assessed for the feasibility of near POC EID testing compared with the standard Roche COBAS AmpliPrep/ COBAS TaqMan (CAP/CTM) platform. Quality assurance measures and turnaround time were compared to improve EID results reporting.Methods: NAMPHIA participants were screened for HIV exposure using Determine HIV-1/2 rapid test; samples reactive on Determine received EID testing on the GeneXpert instrument and Xpert HIV-1 Qual assay using whole blood. Results were confirmed at the Namibia Institute of Pathology using dried blood spots on the Roche CAP/CTM platform per national guidelines.Results: Of the 762 screened infants, 61 (8.0%) were Determinereactive and considered HIV-exposed. Of the 61 exposed infants, 2 were found to be HIV-infected whereas 59 were negative on both GeneXpert and Roche platforms, achieving 100% concordance. Average turnaround time was 3.4 days for the Xpert HIV-1 Qual assay, and average time from collection to testing was 1.0 days for GeneXpert compared with 10.7 days for Roche. No samples failed using GeneXpert whereas 1 sample failed using Roche and was repeated. Conclusion:Quality POC EID testing is feasible in a national survey through extensive training and external quality assurance measures. The use of decentralized POC EID for national testing would provide rapid diagnosis and improve TATs which may prevent loss to follow-up, ensure linkage to care, and improve clinical outcomes for infants.

Data Architecture to Support Real-Time Data Analytics for the Population-Based HIV Impact Assessments

“…For example, in Côte d’Ivoire where HIV-2 is prevalent, the differentiation of HIV-1 and HIV-2 infection was only made at the laboratory; the results were required to be returned to participants. In Kenya and Namibia, 12 GeneXpert (Cepheid, Sunnyvale, CA) was used for preliminary early infant diagnosis with CL confirmation because regional laboratories where SLs were hosted had existing capacity to run the tests. Each of these tests types was an additional data source for data collection and processing.…”

“…A staging database excluding all PII was set up in Google Drive within a G Suite for Education 12 instance to facilitate cleaning, merging, and preparing analytic data sets containing field-based and laboratory-based data, including data from household, SL, and CL, which were linked through unique PTIDs. The staging database was used to merge household and LDMS data twice a week in the DWH to order laboratory-based tests in the CL.…”

HIV General Population Surveys: Shedding Light on the Status of HIV Epidemics and Informing Future Actions

“…Other notable contributions on the laboratory front come from Domaoal et al who described improvements to early infant diagnosis and return of results, achieved through near point-of-care testing in the Namibia survey 18 and from Voetsch et al who demonstrated how antiretroviral drug testing, in addition to viral load as part of a recent infection testing algorithm, can improve the accuracy of incidence estimates by identifying those with a long-term infection who are on ART who were misclassified as recently infected. 19…”

“…16 Bray et al explored the association between interview length and consent for blood testing in several countries and found that longer interviews did not necessarily result in lower consent rates for blood testing. 17 Other notable contributions on the laboratory front come from Domaoal et al who described improvements to early infant diagnosis and return of results, achieved through near point-of-care testing in the Namibia survey 18 and from Voetsch et al who demonstrated how antiretroviral drug testing, in addition to viral load as part of a recent infection testing algorithm, can improve the accuracy of incidence estimates by identifying those with a long-term infection who are on ART who were misclassified as recently infected. 19 Summary reports of preliminary findings and full final reports from each country survey can be accessed online.…”