96T

serum, plasma

Human

This ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to Human T-Cell Lymphotropic Virus types 1 and/or 2 (HTLV-1/2) in human serum or plasma. It is intended for screening of blood donors and as an aid for the diagnosis of clinical conditions related to infection with HTLV-1 and/or HTLV-2.

1. Microwell plate
2. Negative Control: 1x0.5ml
3. Positive Control: 1x0.5ml
4. HRP-Conjugate: 1x6ml
5. Wash Buffer: 1x50ml
6. Chromogen Solution A: 1x7ml
7. Chromogen Solution B: 1x7ml
8. Stop Solution: 1x7ml

The components of the kit will remain stable through the expiration date indicated on the label and package when stored between 2-8°C, do not freeze. To assure maximum performance of this ELISA kit, during storage, protect the reagents from contamination with microorganism or chemicals.

The clinical performances of this assay have been evaluated by a panel of samples obtained from 22145 healthy blood donors from 3 blood banks and by a panel of samples from 125 HTLV 1/2 positive patients (105 HTLV 1 and 20 HTLV 2 samples from patients with well characterized clinical history and confirmed Western Blot and PCR positive results). The evaluation results are given below.

Analytical Specificity:
No cross reactivity was observed with specimens from patients infected with HAV, HCV, HBV, HIV, CMV and TP.
No interference was observed from rheumatoid factors up to 2000U/ml.
No high dose hook effect observed during clinical testing.
The assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.
Frozen specimens have been tested to check for interferences due to collection and storage.

Performance on BBI anti-HTLV panel:


Performance on Pasteur Institute anti-HTLV panel:

The human T-cell lymphotropic viruses (HTLV) is a member of the family of Retroviridae, consisting of enveloped double stranded RNA viruses and genetically not related to HIV1&2; however, they have similar routes of transmission and can have extremely long period of latency prior to manifestation of disease. HTLV type 1 was reported in 1980 as the first retrovirus shown to be pathogenic to humans. The virus preferentially infects CD4+ lymphocytes while the infections of CD8+ T lymphocytes are rare. In contrast to HTLV 1, HTLV type 2 can infect all type of lymphocytes as well as the macrophages. HTLV 1&2 is transmitted transplacentally, parenterally, by sexual contacts and by infected blood. The diseases associated with HTLV infection are usually classified as malignant or nonmalignant clinical presentations. HTLV 1 is endemic in southern Japan, the Caribbean and the US and many other scattered population through the world. HTLV 2 is endemic in some North American Indian tribes but is detected mostly in intravenous drug users and their sexual partners.