Accurate Early Infant HIV Diagnosis in Primary Health Clinics Using a Point-of-Care Nucleic Acid Test

Objective: To evaluate the accuracy of a point-of-care (POC) nucleic acid-based test (NAT) for early infant HIV diagnosis (EID) in primary health clinics in Mozambique. Methods: POC and laboratory NAT EID tests were conducted on matched blood samples collected from 827 HIV-exposed infants younger than 18 months who were enrolled consecutively at 4 periurban primary health clinics and the central hospital in Maputo. Lancet heel draw blood collected by nurses was tested on site for HIV-1/-2 RNA on the Alere HIV NAT POC device and also used to create dried blood spots for later laboratory EID testing on the Roche Cobas Taqman/Ampliprep instrument. Results were used to determine the sensitivity, specificity, and agreement between the POC and laboratory NAT EID tests. Results: The sensitivity and specificity of POC NAT EID testing were 98.5% (95% confidence interval (CI): 91.7 to 99.9, n = 65) and 99.9% (95% CI: 99.3 to 100, n = 762), respectively, compared with laboratory EID tests. Overall agreement was high (Cohen kappa = 0.981; 95% CI: 0.96 to 1.00). Positive (98.5%; 95% CI: 96.3 to 100) and negative 99.9% (95% CI: 99.7 to 100) test agreement was also high. Conclusions: Primary health care nurses accurately performed POC NAT EID testing within primary health care clinics. On-site nucleic acid-based EID testing is technically feasible in clinic settings and could be used in efforts to improve access to pediatric HIV antiretroviral treatment.