Abstract
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.