Today's clinical molecular diagnostics laboratory must have confidence in the quality of the HIV-1 patient results. As a result of our real-time PCR development philosophy, Abbott RealTime HIV-1 Qualitative is engineered to tolerate the genetic diversity of HIV-1 subtypes.
HIV-1 diversity can be attributed to:
- Error-prone reverse transcriptase enzyme
- Recombination of subtypes
- Cross-species transmission
Detection of HIV-1 Subtypes and Groups
|GROUP/SUBTYPES||N*||DETECTED BY ABBOTT REALTIME HIV-1 QUALITATIVE ASSAY|
|Group M/Subtype A||10||10|
|Group M/Subtype B||10||10|
|Group M/Subtype C||10||10|
|Group M/Subtype D||10||10|
|Group M/Subtype AE||10||10|
|Group M/Subtype F||10||10|
|Group M/Subtype AG||10||10|
|Group M/Subtype G||10||10|
|Group M/Subtype H||10||10|
*n represents the number of clinical specimens tested. For Group M/ Subtype H and Group N, n represents the number of replicates of transcript samples tested. The Abbott RealTime HIV-1 Qualitative assay detected all groups and subtypes tested.
Correlation to Comparator Assay
The performance of the Abbott RealTime HIV-1 Qualitative assay in detecting HIV-1 infection was evaluated by testing specimens randomly collected from infants approximately 6 weeks to 18 months old who were born to HIV-1 positive mothers. The plasma samples from 367 subjects and DBS samples from 288 subjects were tested with the Abbott RealTime HIV-1 Qualitative assay. The whole blood sample from each subject was tested with a comparator assay following instructions for use.
The overall agreement between the Abbott RealTime HIV-1 Qualitative results and the comparator assay results was 95.5% and 97.8% for the DBS and plasma assay procedures, respectively.
The Abbott RealTime HIV-1 Qualitative is an in vitro amplification assay for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acids from human plasma and dried blood spots (DBS).
The Abbott RealTime HIV-1 Qualitative is intended to be used as an aid in the diagnosis of HIV-1 infection in pediatric and adult subjects. This assay is not intended to be used as a donor screening test for HIV-1.