Fundamental Evaluation for the HIV Ag+Ab Screening Assay Kit by Automated Chemiluminescent Enzyme Immunoassay Analyzer "HISCL-2000i"

• Fundamental Evaluation for the HIV Ag+Ab Screening Assay Kit by Automated Chemiluminescent Enzyme Immunoassay Analyzer "HISCL-2000i"

AUTHOR(S)

Kiyoto TSUCHIYA and Shinichi OKA

AIDS Clinical Center, National Center for Global Health and Medicine

SUMMARY

We evaluated HISCL HIV Ag+Ab Assay Kit ( hereafter referred to as the assay ) developed by Sysmex Corporation using the HISCL-2000i , a fully automated immunoassay system employing the chemiluminescent enzyme immunoassay ( CLEIA ) process for detection. This assay exhibited competent results in terms of within-run and between-day reproducibility as well as interferent and prozone effect susceptibility. The assay also detected a positive in serum specimens prospectively collected from 300 HIV-1 infected patients who are undergoing treatment at our clinic and who provided informed consent. Specificity for HIV-positive specimens was 100%. In analytical sensitivity verification using a commercially available HIV-1 antigen sensitivity panel, the assay proved its high sensitivity by positively detecting HIV-1 p24 antigens at concentrations of up to approximately 2 pg/mL. In tests using a commercially available performance panel, the assay also positively detected HIV-1 group M subtypes A-G and CRF B/D, HIV-1 group O and HIV-2. In tests using 5 HIV seroconversion panels obtained from commercial vendors, the assay showed satisfactory acute phase sensitivity by appropriately detecting increases in HIV-1 antigens and antibodies in blood samples. Based on these results, we conclude HISCL HIV Ag+Ab Assay Kit that is highly sensitive and specific assay is an effective screening test for HIV infection.

KEY WORDS

Antibodies, Antigens, 4th Generation, Screening, HIV, HISCL

NOTE(S)

This article is translated and republished from Igaku-to-Yakugaku 2011; 66 (6): 1091-1098, with kind permission from the publisher and authors.