PMA number: BP200455
Proper Name: In vitro reverse transcription polymerase chain reaction (PCR)-based assay for detection of HIV-1 RNA
Trade Name: Alinity m HIV-1
Manufacturer:Abbott Molecular, Inc.
Indication for Use:
- The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the detection and quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA on the automated Alinity m System for confirmation of HIV-1 infection or for monitoring HIV-1 infected individuals.
- The Alinity m HIV-1 assay is intended for use in the clinical management of HIV-1 infected individuals in conjunction with clinical presentation and other laboratory markers.
- The Alinity m HIV-1 assay is intended for use to monitor disease prognosis by measuring baseline plasma HIV-1 RNA level and to assess response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels. Performance for quantitative monitoring is not established with serum specimens.
- The Alinity m HIV-1 assay is also intended for use as a supplemental test to confirm HIV-1 infection in individuals who have reactive results with HIV immunoassays. Performance for supplemental use is established with both plasma and serum specimens.
- The results from the Alinity m HIV-1 assay must be interpreted within the context of all relevant clinical and laboratory findings.
- This device is not intended for use as a first line diagnostic test or for screening donors of blood, blood products, or human cells or tissues, or cellular and tissue-based products (HCT/Ps).