News

FDA approves blood screening assay


 

Bags and vials of blood

Photo by Daniel Gay

The US Food and Drug Administration has approved the blood screening assay cobas® MPX for use on the cobas® 6800 and 8800 Systems.

cobas® MPX is a nucleic acid test designed to screen donated blood and plasma for human immunodeficiency virus (HIV),hepatitis B virus (HBV), and hepatitis C virus (HCV).

The test can detect 5 viral targets—HIV-1 Group M, HIV-1 Group O, HIV-2, HBV, and HCV—in a single sample.

cobas® MPX features a dual-target approach with amplification of separate regions of HIV-1 and dual probes for HCV. It eliminates both the need for discriminatory testing between HIV, HBV, and HCV and the potential for discrepant results.

cobas® MPX is a product of Roche Molecular Diagnostics and can be used on Roche’s cobas® 6800 System or cobas® 8800 System.

These systems are used for routine molecular testing in the areas of donor screening, viral load monitoring, women’s health, and microbiology.

Both systems make it possible for labs to perform up to 3 tests in the same run with no pre-sorting required.

In an 8-hour shift, the cobas® 6800 System can provide 384 results, and the cobas® 8800 System can provide 960 results.

The cobas® 6800 system enables up to 8 hours of walk-away time with minimal user interaction, and the cobas® 8800 enables up to 4 hours of walk-away time.

Recommended Reading

Hematology analyzer cleared for use in US
MDedge Hematology and Oncology
SpHb monitoring may reduce use of RBC transfusion
MDedge Hematology and Oncology
Blood sample collection, storage impacts protein levels
MDedge Hematology and Oncology
Study may explain why blood type affects cholera severity
MDedge Hematology and Oncology
Test approved to screen donated blood for sickle cell trait
MDedge Hematology and Oncology
Age of blood doesn’t affect risk of death, study shows
MDedge Hematology and Oncology
FDA clears analyzer for high-volume transfusion labs
MDedge Hematology and Oncology
‘Fresher’ RBCs no safer than standard RBCs, AABB says
MDedge Hematology and Oncology
Plasmapheresis system cleared by FDA
MDedge Hematology and Oncology
EMA says plasma/urine-derived meds are safe from Zika
MDedge Hematology and Oncology