Indeterminate HIV PCR results within South Africa's early infant diagnosis programme, 2010–2019. (April 2022)

• Record Type: Journal Article
• Authors: Radebe, Lebohang; Haeri Mazanderani, Ahmad; Sherman, Gayle G.
• Is Part Of: Clinical microbiology and infection. Volume 28:Number 4(2022)
• Page Start: 609.e7
• Page End: 609.e13
• Publication Date: 2022-04
• Subjects: Early infant diagnosis -- HIV PCR -- Indeterminate -- South Africa; Medical microbiology -- Periodicals; Diagnostic microbiology -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.01
• DOI: 10.1016/j.cmi.2021.08.002
• Languages: English
• ISSNs: 1198-743X

Abstract

Abstract: Objectives: We describe the extent of, and variables associated with, indeterminate HIV-PCR results and final HIV status within South Africa's early infant diagnosis (EID) programme between 2010 and 2019. Methods: Retrospective analysis of routine paediatric HIV-PCR laboratory data from South Africa's National Health Laboratory Service Data Warehouse between 2010 and 2019. Final HIV status was determined by linking patient results (including HIV-PCR, HIV viral load, HIV serology and CD4 counts) using a probabilistic matching algorithm. Multivariate logistic regression was performed to determine variables associated with final HIV status among patients with an indeterminate HIV-PCR result. Results: Among 4 429 742 specimens registered for HIV-PCR testing from 3 816 166 patients, 113 209 (2.97%) tested positive and 22 899 (0.6%) tested indeterminate. As a proportion of HIV-detected results, 15.7% (23 896/151 832) of total and 31.5% (4900/15 566), 18.8% (11 400/60 794) and 10.1% (7596/75 472) among patients aged <7 days, 7 days–3 months and ≥3 months, respectively, were reported as indeterminate. Overall, 39.7% of patients with an indeterminate result had a linked HIV test to determine HIV status, of which 53.6% were positive with a median time to repeat testing of 30 days (interquartile range 15–69). Among patients who tested indeterminate, variables associated with a significantly higher odds of having a positive HIV status included testing indeterminate at birth (adjusted odds ratio (AOR) 0.63 (0.48–0.83) and 0.52 (0.39–0.69) for testing indeterminate at 7 days–3 months and ≥3 months respectively compared with birth), within a hospital (AOR 2.45 (1.99–3.03)), and in districts with an intra-uterine transmission rate ≥1.1% (AOR 3.14 (1.84–5.35)) (p < 0.001). Discussion: Indeterminate HIV-PCR results represent a considerable burden of missed diagnostic opportunities, diagnostic dilemmas and delays in making a definite diagnosis among HIV-infected infants within South Africa's EID programme. Alternative EID verification practices are urgently needed.