In Peru, the existence of a normative diagnostic algorithm is unknown, it is assumed that it is similar to HIV, therefore a multiple nested PCR test was standardized and validated for the diagnosis of HTLV-1 in proviral DNA samples of reference material of the MT-2 cell line. The test was validated with proviral DNA samples from whole blood, it was determined in 70 samples characterized by serology, its sensitivity and analytical specificity, veracity and accuracy in comparison with the immunoblot test (gold standard). The results of the validation showed a limit of detection of 0.5 ng of DNA per reaction of 25 μL of the Pol and LTR gene and an accuracy with a 100% detection rate for 0.4, 0.5 and 0.6 ng of DNA. In addition, in comparison with an Immunoblot test (INNOLIA) considered a reference test for our study, the multiple nested PCR obtained 97% sensitivity, 100% specificity, a posi...

Objectives: To standardize and validate a western blot test for the diagnosis of human immunodeficiency virus. Methods: A prospective observational study was carried out during 2017 and 2018. The western blot test was standardized, using the polyacrylamide gel electrophoresis technique with sodium dodecyl sulfate (SDS PAGE), being the nitrocellulose blot strips prepared with an Optimal HIV-1 antigen concentration of 2.71 µg / mm. The western blot was validated in the laboratory against 400 reference samples (300 sera and 100 plasmas): 200 positive and 200 negatives for antibodies against HIV-1, being the reference test the Immunoblot of the Fujirebio brand. Diagnostic performance parameters were estimated using Epidat v3.1 and Excel. Results: Eight important bands of the HIV-1 antigen were identified: p17, p24, p31, p39, gp41, p55, p66, and gp120. According to t...