Evaluation of a nested multiplex polymerase chain reaction test for the detection of HTLV-1

Serrano-Segura K.; Miranda-Ulloa E.; Romero-Ruiz S.; Cárdenas-Bustamante F.; Quiroz-Ruiz H.R. · Gaceta Medica Boliviana (2023) · DOI: 10.47993/gmb.v46i2.770

Resumen

Peru is an endemic area for human T-lymphotropic virus type 1 (HTLV-1) and for its diagnostic confirmation serological tests are used, which can give inconclusive results. Objectives: to evaluate a nested multiplex PCR test to diagnose HTLV-1. Methods: PCR validation was performed with primers targeting the Pol and LTR regions of HTLV-1. The β-globin gene was used as an internal endogenous control and the detection limit was evaluated with MT2 cells. Diagnostic accuracy parameters were evaluated against 95 Reference blood samples. Results: the evaluated test obtained a detection limit of 0,5 ng/μL of DNA; diagnostic sensitivity=97,1%, diagnostic and analytical specificity=100%, vpn=97,2%, vpp, repeatability and reproducibility=100%; Kappa, Youden Index=0,97. Conclusions: the evaluated test has a high diagnostic performance and due to its low cost, its implementation in the HTLV-1 diagnosis algorithm in Peru is recommended.

Instituciones: Universidad Privada del Norte