Innogenetics is the manufacturer of kit-based line probe assays (LiPA)** which are marketed exclusively by Bayer Diagnostics.**
GENERAL INFORMATION
Assay Names
Genotype
INNO-LiPA HIV-1 RT, INNO-LiPA Protease
Collaborators/Distributors
Innogenetics
Availability
Commercially available for research use only.
Regulatory Status
INNO-LiPA HIV-1 RT and INNO-LiPA Protease are available for "Investigational Use Only" under an FDA-approved IDE in CLIA certified labs. Bayer Diagnostics markets but does not perform clinical laboratory tests.
DNA line probe assays determine point mutations in the viral genome by nucleic acid sequencing or hybridization techniques using DNA probes on nitrocellulose strips. The Innogenetics LiPA tests use reverse hybridization techniques in a multi parameter assay that simultaneously detects wild-type amino acids and mutations in the HIV-1 RT and protease genes.
Oligonucleotide probes specific for the codons 41, 69, 70, 74, 184, 214 and 215 (RT) and 30, 46, 48, 50, 54, 82, 84, 90 (protease) are coated as discrete lines on a nitrocellulose membrane in a strip format. Amplified biotinylated DNA material, if present, hybridizes with the specific probes. After hybridization, streptavidin labelled with alkaline phosphatase is added and bound to any biotinylated hybrid previously formed, which allows for detection following incubation with BCIP/NBT chromogen (a purple/brown precipitate is formed).
