Field evaluation of the performance of Alere and Cepheid qualitative HIV assays for paediatric point-of-care testing in a Soweto academic hospital, South Africa.

5 years ago

Field evaluation of the performance of Alere and Cepheid qualitative HIV assays for paediatric point-of-care testing in a Soweto academic hospital, South Africa.

Sherman GG, Sipambo N, Nakwa F, Murray TY, Carmona S, MacLeod WB, Velaphi S

Point-of-care (POC) technologies for HIV diagnosis in infants have the potential to overcome logistical challenges that delay treatment initiation and prevent improvements in morbidity and mortality. This study aimed to evaluate the performance of two POC technologies against the current standard of care (SOC) laboratory-based assay in South Africa, when operated by nurses in a hospital environment. Children <18 months of age that were treatment naïve (excluding prophylaxis) and in whom an HIV PCR test was indicated, were eligible for the study. To increase the rate of enrolment of HIV PCR-positive children, HIV-exposed neonates at high risk of mother-to-child transmission and children requiring confirmatory HIV testing were preferentially enrolled. The two POC technologies demonstrated excellent concordance, with 315 (97.8%) results consistent with the SOC. POC yielded 102 positive and 220 negative tests each. The SOC had 101 positive and 214 negative results, 4 indeterminate, 1 invalid, and 2 specimen-rejected results. To include the indeterminate results in sensitivity/specificity calculations, a sensitivity analysis was performed that yielded a simulated sensitivity of 0.9904 (IQR 0.9808, 0.9904) and specificity of 0.9954 (IQR 0.9954, 1.0). This study confirmed that both POC technologies can be successfully used outside the laboratory environment to yield precise sensitivity/specificity values for paediatric, including neonatal, HIV testing.

Publisher URL: https://www.ncbi.nlm.nih.gov/pubmed/28855305

DOI: PubMed:28855305