About the product
Elecsys HTLV-I/II (Roche code CPS_000486) is an in vitro immunoassay used for the qualitative determination of HTLV-I and HTLV-II antibodies in human serum and plasma. According to the Roche product page, the method is named electrochemiluminescence immunoassay (ECLIA), and the test is defined for cobas e immunoassay analyzers. The page states that the test is designed for screening individual donors.
Measured parameter and clinical significance
According to the WHO fact sheet, HTLV-1 is a retrovirus that causes a chronic, lifelong infection, and most people who carry the infection have no symptoms. The virus is transmitted mainly through sexual contact, breastfeeding, sharing needles and unsafe blood transfusion. Transfusion of cellular blood products and solid organ transplantation carry a high risk of transmission.
According to the WHO, diagnosis usually begins with an enzyme immunoassay that looks for antibodies in the blood. A single test is not considered definitive, and a second test such as western blot, line immunoassay or PCR is needed to confirm infection. Confirmation also allows HTLV-1 to be distinguished from the less pathogenic HTLV-2. The WHO cites screening of blood donations for HTLV-1 as an important preventive measure.
Technical information
- Product: Elecsys HTLV-I/II (Roche, CPS_000486)
- Method: electrochemiluminescence immunoassay (ECLIA); qualitative antibody determination
- Sample: human serum and plasma. Roche states that the test is not designed for use with cord blood samples
- Area of use: individual screening of volunteer whole blood and blood component donors and of living organ, tissue and cell donors (Roche product page)
- Pack size: 100 tests and 200 tests (cobas e 411, 601 and 602)
- Pack size: 300 tests (cobas e 402 and cobas e 801)
- Pack size: 20 × 300 tests (cobas pro serology solution, cobas e 801 analytical unit)
Use and compatibility
The Roche product page lists these systems:
- cobas e 411
- cobas e 601 and cobas e 602
- cobas e 402 and cobas e 801
- cobas pro serology solution (with the cobas e 801 analytical unit)
System pages: cobas e 411 and cobas e 402. Other immunoassay reagents are on the test kits page.
Sample volume and test time are in the Roche method sheet. The confirmation algorithm for reactive results is the responsibility of the laboratory concerned and of national guidelines.
Frequently asked questions
According to the Roche product page, the test is an in vitro immunoassay used for the qualitative determination of HTLV-I and HTLV-II antibodies in human serum and plasma.
The Roche product page states that the test is not designed for use with cord blood samples.
According to the WHO, after antibody screening a second test such as western blot, line immunoassay or PCR is needed.
Contact
For product, quotation and technical information requests, use the contact form or write to info@tiliamedical.com.
