Overview: The document describes the Avioq HTLV-I/II Microelisa System, an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Type II (HTLV-II) in human serum or plasma. It is used for screening donated organs and blood to prevent HTLV transmission and aids in clinical diagnosis.

Specifications: The system boasts 100% sensitivity and 99.95% specificity, with a 95% confidence interval of 99.89% to 99.98%. The test format is efficient, requiring only 20µl of sample and is suitable for automation due to its 8-well strip format.

Procedure: The test involves coating microwells with HTLV-I and HTLV-II viral lysate and a recombinant HTLV-I antigen. Antibodies in the sample form complexes with these antigens. After incubation and washing, an enzyme conjugate is added, followed by a substrate, and the reaction is stopped for reading.

Performance: The system shows high reactivity with HTLV-I and HTLV-II positive specimens, with 100% reactivity in tested groups such as adult T-cell leukemia and intravenous drug abusers. In normal donor populations, the test showed 0.04% initial reactivity in serum and 0.06% in plasma, with no positive results upon supplemental testing.

Features: The system offers a fast and convenient procedure with a total incubation time of 2 hours and 30 minutes. It allows direct dilution into microplate wells, reducing time and costs. The 8-well strip format is adaptable to various testing volumes and automation, providing same-day results and reducing unnecessary repeat testing.

Product Information: The Avioq HTLV-I/II Microelisa System is available in different packaging sizes, with wash buffer concentrate available separately. The product is manufactured by AVIOQ, INC., located in Research Triangle Park, NC, USA.