MicroELISA

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The EIAgen HTLV I-II Ab Kit assay, is a solid phase enzyme immunoassay utilizing a mixture of antigens for the in vitro diagnostic screening in human serum or plasma (EDTA, Heparin, Sodium Citrate) of   antibodies to Human T-cell Lymphotropic Virus type I&II or HTLV I&II Ab. The kit may be used for the screening of blood units of HTLV I&II-infected patients. For Research Use Only.

Human T-cell Lymphotropic virus type I (HTLV-I) is a Type-C retrovirus ^{1, 2} not related genetically to HIV ³, implicated as the causative agent of adult T-cell leukemia/lymphoma. It is also linked to a type of neuromyelopathy ⁴. A second human T-cell lymphotropic virus, designated HTLV-II, shares similar structural features, antigenic properties, genome organization and route of transmission. However, HTLV‑II is not specifically associated with any specific disease.

Serological cross-reactivity between HTLV-I and HTLV-II is highly variable, necessitating the inclusion of antigens from both HTLV-I and HTLV-II to ensure detection of antibodies to both HTLV-I and HTLV-II. The presence of anti-HTLV-I and/or HTLV-II antibodies in the blood indicates that the blood probably contains viruses and should not be used for transfusion or for manufacture of injectable products.

HTLV-I is endemic in southern Japan, the Caribbean and the US and many other scattered populations through the world. HTLV-II is endemic in some native American populations but is detected mostly in intravenous drug users and their sexual partners.

HTLV-I and HTLV-II are transmitted transplacentally, parentally; the transmission may also come from sexual contact and infected blood.

The EIAgen HTLV I-II Ab Kit is based on the ‘sandwich’ principle, a solid-phase enzyme-linked immunoassay technique, to measure antibodies to HTLV-I and HTLV-II levels in serum or plasma.

Mixure of recombinant antigen and peptides representing immunodominant epitopes of HTLV I p19, gp21, gp46 and HTLV-II gp21 and gp46 are coated onto wells of a microplate. Serum or plasma specimens and Assay Diluent are added to these wells, followed by a solution of biotinylated antigens.

If antibodies specific to the antigens (IgG, IgM or IgA) are present in the specimen, they form stable complexes with the HTLV antigens attached to the well and the biotinylated antigens. Antigen-antibody complexes are then identified through the addition of HRP-Streptavidin conjugate. The catalytic activity of HRP allows for the quantification of these antibody-antigen complexes.

HRP substrate solution is next added, and the catalytic activity of the bound HRP conjugate allows for the proportional revelation (in blue colour) of these antibody-antigen complexes, thus establishing their presence or absence in the specimen. Wells containing specimens negative for anti-HTLV antibodies remain relatively colourless.

A stop solution is added to each well and the resulting yellow color is read on a microplate reader at 450 nm and if available at 405 nm and 600-650nm.

The kit contains reagents for 96 tests (code 081321).