The FDA has given approval for this company’s nucleic acid test (NAT) to be used by blood banks to simultaneously detect human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV). The combination HIV-1/HCV test system will be marketed by Chiron Corporation as the Procelix HIV-1/HCV Assay and the Procleix Semi-Automated System.
The Procleix Semi-Automated system and HIV-1/HCV External Quality Controls Kit have also received 510(k) clearance.
The Transcription Mediated Amplification (TMA) technology used in these tests allows significantly earlier detection of the infection than tests that rely on antibody or viral protein detection because the delay in the body’s formation of detectable antibodies after exposure to infectious organisms can be as long as 22 days for HIV and up to 80 days or more for HCV.
Keywords: blood banking, molecular diagnostics, HIV, HCV