Evaluation of a confirmatory serum test for incorporation into the Peruvian HIV diagnosis algorithm

Miranda-Ulloa E.; Romero-Ruiz S.; Briceño-Espinoza R.; Suárez-Agüero D.; Mamani-Huamán E.; Acuña M. · Revista Chilena de Infectologia (2024) · DOI: 10.4067/s0716-10182024000500149

Resumen

When confirmatory tests of the Peruvian HIV diagnosis algorithm generate inconclusive results, they delay the opportunity for their results. The diagnostic performance of the Bio-Rad GeeniusTM HIV-1/2 rapid confirmatory immunochromatographic test was evaluated. A total of 242 sera were analyzed, 116 positives for HIV-1 and 126 negative for HIV-1/2 (reference: INNO-LIA HIV I/II), diagnostic accuracy and precision were estimated. No false positives and negatives were found; 100% sensitivity, repeatability and reproducibility were obtained; specificity of 98.4% (visual reading) and 97.6% (Geenius reader). There was 100% agreement in resolving “indeterminate” sera by immunofluorescence. We conclude that, due to its high diagnostic efficiency and its application at the point of care, the Bio-Rad Geenius™ HIV-1/2 confirmatory test in serum samples should be included in the Peruvian HIV diagnosis algorithm.