B-080 Analytical Performance of ESPLINE HTLV-I/II

Abstract Background The human T-cell lymphotropic virus (HTLV) infects a type of white blood cell called or T-lymphocyte. There are two types HTLV, HTLV-I and HTLV-II, which closely related to C retroviruses. is endemic in the Caribbean, Japan, South America, parts Africa. has been recognized as cause adult leukemia (ATL) HTLV-associated myelopathy/tropical spastic paraparesis (HAM/TSP). HTLV-II found among Africa Americas, injecting drug users many cities Western Europe North America. Currently, an effective vaccine against HTLV not available, clinical treatment limited. diagnosis identification patients very important for controlling spread infection. HTLV-infected lymphocytes peripheral patients, but little serum plasma can be detected. Therefore, screening tests that generally detect antibodies using reagents need dedicated instruments. We have developed anti-HTLV-I/II reagent ( ESPLINE HTLV-I/II) based on immunochromatography principal enzyme immunometric assay easily both anti-HTLV-I anti-HTLV-II plasma. This report evaluates its efficacy. Methods test line coated with recombinant protein peptides derived from three env gene proteins (HTLV-I gp21, gp46, gp46) antibodies. sample bind antigens labelled alkaline phosphatase (ALP), then immunocomplexes formed. These complexes captured by line, blue detected ALP enzymatic reaction colorimetric substrate. It only takes 15 minutes obtain results without any To evaluate fundamental performance, we tested specificity, limit detection, method comparison Lumipulse HTLV-I/II, Presto Serodia HTLV-I, following CLSI protocol. Commercially available and/or were used most evaluations. Results Regarding 1014 negative samples, confirmed highly sensitive CLEIA HTLV-I/II. Then, all samples shown nonreactive, demonstrating specificity 100.0%. analysis serial dilution 2 positive specimens, HTLV-I/II showed high sensitivity compared conventional HTLV-I. comparison, 57 30 different individuals tested. All ELPLINE G Particle Agglutination Conclusion novel assay, higher than had good concordance system complete min. procedure considered useful situations such on-site at health centers, medical institutions small number other emergency tests.