Summary
Background
Performance of Point-of-Care testing (POCT) amongst HIV-exposed
infants, compared to laboratory-based testing (LABT), may improve linkage to
care. We present a field evaluation of HIV-1 POCT at birth in the context of
universal LABT in a maternity hospital in Johannesburg, South Africa and
describe our implementation experience.
Methods
We conducted our field evaluation study between October
2014–April 2016 at an urban public delivery facility. We aimed to
sample consecutive neonates at birth for POCT (Cepheid
Xpert® HIV-1 Qualitative test) and compared results
to LABT (Roche COBAS® TaqMan® HIV-1 Qualitative test) with
respect to performance (sensitivity, specificity, positive and negative
predictive value [PPV and NPV] and Cohen’s kappa
coefficient), result return, antiretroviral treatment (ART) initiation and
coverage.
Findings
Amongst 3970 infants with LABT, 57 (1.4%) tested positive,
3906 (98.5%) negative, 2 (0.1%) indeterminate, and 5
(0.1%) had an error result. 2238 (56.4%) of these infants
had concurrent POCT. POCT detected all 30 HIV-infected neonates (sensitivity
100%; 95% CI: 88.4–100%) with two additional
false positive results (specificity 99.9%; 95% CI:
99.7–100%). All positive and 96.2% of negative POCT
results were returned compared with 88.9% of positive and
52.8% of negative LABT results. While each POCT required 90 minutes
of instrument time, 2.6 hours (IQR: 2.3–3.1) elapsed between
phlebotomy and result return. In days, median time of result return for POCT
was one day, significantly earlier than ten days for LABT
(p<0.0001). Antiretroviral treatment was initiated in 30
(100%) neonates with positive POCT compared to 24 (88.9%,
p=0.10) of 27 infants who had LABT only, with initiation occurring a
median of 5 days earlier in the POCT group (p<0.0001). POCT
implementation required additional staff and weekend cover.
Interpretation
Compared to LABT, POCT was associated with excellent performance,
improved rates of result return and reduced time to ART initiation.
Resources needed to integrate POCT into a routine birth testing program
require further evaluation.
Funding
The study was supported in part by the National Institutes of Health
U01 HD080441 and USAID/PEPfAR.