NGI UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV

STN# 125658
Proper Name:UltraQual® Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV Hepatitis B Virus.
Tradename: NGI UltraQual® Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV
Manufacturer: National Genetics Institute
Indication:

• The intended use of the National Genetics Institute’s (NGI) UltraQual® Multiplex PCR Assay is to screen source plasma for HCV, HIV-1, HIV-2 and HBV. A maximum number of 512 aliquots from individual donations will be pooled using Tecan Evo robotic pipetting devices. The pools will then be tested using the multiplex assay to detect the presence of hepatitis C virus, human immunodeficiency virus types 1 and 2, and hepatitis B virus. Any pooled samples that test positive for any of these viruses will then be retested, per NGI’s resolution algorithm, to identify the individual positive donation. The assay will discriminate between HCV, HIV-1, HIV-2 and HBV, but will not discriminate between HIV-1 Group M and Group O viruses.

Supporting Documents

• May 30, 2018 Approval Letter - NGI UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV
• May 25, 2018 Summary Basis for Regulatory Action - NGI Ultraqual Multiplex PCR Assay for HCV, HIV-1,HIV-2, and HBV