Performance evaluation of newly developed product “Espline HTLV-I/II”

Abstract

A new anti-HTLV-I/II antibody detection reagent based on the principle of Immunochromatography (IC method) has been developed by Fuji Rebio Corporation. However, as its testing performance has not been objectively evaluated sufficiently, a validation study was conducted for accuracy control. A correlation test was performed using 50 samples of anti-HTLV-I/II antibody-negative, 59 samples of anti-HTLV-I antibody-positive, and 50 samples of anti-HTLV-II antibody-positive specimens. The IC, ECLIA, CLEIA, and PA methods were applied, and the concordance rates for each test determination were calculated. The concordance rate for negative specimens and anti-HTLV-II antibody-positive specimens was 100%. In the case of anti-HTLV-I antibody-positive specimens, only one case was determined as negative in the PA method, while all other specimens were determined as positive, resulting in a concordance rate of 98.3%. The comparison of detection sensitivity involved diluting one sample each of anti-HTLV-I antibody-positive and anti-HTLV-II antibody-positive specimens at 2n dilutions using negative specimens, and measuring with IC and PA methods. Compared to the PA method, the IC method was able to detect positivity at higher dilution ratios. As a result of the study, this reagent showed comparable or even higher sensitivity performance than the conventional methods in correlation and comparison of detection sensitivity. Particularly in the comparison of detection sensitivity, nearly equivalent performance results were obtained compared to an automated analyzer, suggesting that using this reagent instead of the PA method could lead to more rapid and accurate test results.