Introduction: Timely diagnosis is necessary to avert early death in HIV-infected neonates. Birth PCR testing may improve early identification and facilitate access to care. We implemented a birth HIV diagnosis programme in Johannesburg, South Africa and present successes and challenges of the first two and a half years of operation.
Methods: Between June 2014 and December 2016, we sought to identify all HIV-exposed births and offer newborn HIV PCR testing before discharge after delivery. The programme identified newly delivered women who had tested positive during pregnancy and provided post-partum HIV antibody testing for women without recent negative results. HIV-positive women were required to consent for neonatal birth testing and asked to return a week later to obtain their results. Neonatal venous blood was sampled and tested at the national laboratory using Roche COBAS® TaqMan® HIV-1 Qualitative Test (Version 2.0). Non-negative results triggered active follow-up for confirmatory testing and appropriate treatment.
Results: Of 30,591 women with live births, 6864 (22.4%) were known to be HIV positive and an additional 221 women (1.4% of those tested) were identified during maternal postnatal testing. Of 7085 HIV-positive women, 6372 (89.9%) were interviewed and agreed to data collection, 6358 (99.8%) consented to birth testing for 6467 neonates and a blood sample was collected for 6377 (98.6%). If tested, 6210 (97.4%) tested negative, 91 (1.4%) positive, 57 (0.9%) revealed errors and 19 (0.3%) were indeterminate . Seven of the 19 neonates with indeterminate results and one with initial error result were found to be infected on subsequent testing yielding an intrauterine transmission rate of 1.6% (95% CI: 1.3-1.9). Sixteen (16%) of 99 infected infants were born to women (n = 221) identified during postnatal testing. With active outreach, 95/99 (96%) infected infants were initiated on antiretroviral therapy. Of 6261 neonates with negative results, 3251 (52%) returned to receive their test results.
Conclusion: Our programme successfully achieved high coverage and uptake of birth PCR testing and was able, with active tracking, to start almost all identified HIV-infected neonates on antiretroviral therapy. Implementation required additional staff for counselling, quality control and outreach. Return for negative results was low and neonates with indeterminate results required multiple repeat tests.
Keywords: HIV; birth; diagnosis; in–utero; neonate; polymerase chain reaction.