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For In Vitro Diagnostic Use
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).
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:
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 |
Group O | 10 | 10 |
Group N | 10 | 10 |
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.
Intended Use
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.
Assay accuracy is dependent upon a combination of:
Target Region
The Abbott RealTime HIV-1 Qualitative assay’s primers and probe are targeted to the integrase region of the polymerase gene.
Partially Double Stranded Probe Design
Abbott realtime HIV-1 Qualitative | |
Sensitivity | 110 copies/mL for plasma samples 2,500 copies/mL for whole blood samples using the DBS procedure |
Specificity | 100%* |
Target region | Integrase region of polymerase gene |
Subtype detection | Group M subtypes A, B, C, D, CRF01-AE, F, CRF02-AG, G, subtype H and Group N, Group O |
Internal control | Non competitive armored pumpkin RNA, added to lysis buffer during extraction |
Specimen Type | Plasma (EDTA and ACD) Dried Blood Spots |
Input volume | 0.1 mL for DBS (2 spots 50 ul each), 0.2 mL for plasma |
Sample preparation | m2000sp Manual Sample Preparation |
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