The U.S. Food and Drug Administration has approved the first nucleic acid test (NAT) to simultaneously detect HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV). Manufactured by Roche and called the cobas TaqScreen MPX Test, v2.0, the assay identifies the three viruses in whole blood and blood components, including source plasma.

“Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale,” Roland Diggelmann, chief operating officer of Roche Diagnostics, said in a press release. “By continually developing these innovative products we are striving for the highest level of safety for patients and efficiency for blood and plasma centers. This latest approval supports that commitment.”

This nucleic acid test looks for the direct genetic presence of each virus, as opposed to antibodies or antigens. Nucleic acid tests have various drawbacks when compared with antibody or antigen tests, including greater expense. Consequently, Roche’s new test is meant to screen pools of six samples of whole blood or blood components, and up to 96 samples of source plasma donations. A major benefit of nucleic acid testing is it can detect the presence of viruses earlier than antibody or antigen tests.

CDC testing protocol for HIV in particular calls for a nucleic acid test only after a positive result to the “fourth generation” test—which looks for both the p24 HIV-1 antigen and antibodies to the virus—and then a negative or indeterminate result to a test that both detects HIV antibodies and differentiates between HIV-1 and HIV-2. A negative result to the subsequent nucleic acid test indicates a false positive result on the fourth generation test, while a positive result indicates an acute, or very early, infection.

To read the press release, click here.