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CE Marked
For In Vitro Diagnostic Use
The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) in whole blood spotted on cards as dried blood spots (DBS) (i.e. obtained via venipuncture or capillary blood) or human plasma from HIV-1 infected individuals.
Precise performance when meeting HIV challenges
The Abbott RealTime HIV-1 assay provides:
Addressing the Challenges of HIV
The Abbott RealTime HIV-1 assay is engineered to address the challenges of HIV:
The genetic heterogeneity of HIV-1 presents a significant challenge to the development of assays capable of reliably detecting and quantifying HIV-1 nucleic acid. Although certain subtypes dominate in specific areas, studies show that the spread of different HIV-1 groups and subtypes is increasing globally.
HIV-1 diversity can be attributed to:
Physiological Blip or Random Assay Variation?
A detectable low-level viremia following a previous viral load below the limit of detection or undetectable may be:
Each HIV-1 positive viral load result can generate anxiety among both clinicians and patients concerning the adequacy of therapy. In cases where these results are driven by random assay variation this may lead to unnecessary additional testing.
Abbott RealTime HIV-1 assay demonstrates high precision around the clinical decision point and minimizes the risk of reporting a low-level viremia result due to random assay variation.
Detection of HIV-1 Subtypes and Groups
A total of 90 clinical specimens, ten of each Group M subtype (A, B, C, D, CRF01-AE, F, CRF02-AG, G) and of Group O, were tested with the RealTime HIV-1 assay and by two other approved HIV-1 quantitative assays referred to as Comparator 1 (FDA-approved version used) and Comparator 2 (CE-Marked version used). The numbers in parentheses are the number of specimens that had lower quantitation values by more than 1.00 log copies/mL when compared to RealTime HIV-1 assay.
GROUP/SUBTYPES | N | REALTIME DETECTED | COMPARATOR 1 DETECTED | COMPARATOR 2 DETECTED |
M/Subtype A | 10 | 10 | 10 (1) | 10 (1) |
M/Subtype B | 10 | 10 | 10 (0) | 10 (0) |
M/Subtype C | 10 | 10 | 10 (0) | 10 (0) |
M/Subtype D | 10 | 10 | 10 (0) | 10 (0) |
M/Subtype AE | 10 | 10 | 10 (0) | 10 (0) |
M/Subtype F | 10 | 10 | 10 (0) | 10 (0) |
M/Subtype AG | 10 | 10 | 10 (3) | 10 (1) |
M/Subtype G | 10 | 10 | 10 (2) | 10 (1) |
Group O | 10 | 10 | 0 (NA) | 7 (7) |
Correlation to Comparator Assay
Intended Use
The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) in whole blood spotted on cards as dried blood spots (DBS) (i.e. obtained via venipuncture or capillary blood) or human plasma from HIV-1 infected individuals. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
Design Philosophy
The unique combination of Abbott RealTime HIV-1 assay design features ensures reliable detection of all HIV-1 groups and subtypes with a high degree of precision.
Precise Performance When Measuring Low-Level Viremia
Precise External Calibration: This assay's design features allow the use of two-point external calibration for accurate and precise quantification.
Primers and Probe Target
Primers and probe are targeted to the integrase region of the polymerase gene. Selection of the conserved target region (integrase region of polymerase gene) was facilitated by the Abbott HIV Global Surveillance Program. Abbott RealTime HIV-1 continues to demonstrate the capacity to tolerate mutations with no impact on assay performance.
Partially Double Stranded Probe Design
Unique Probe Design: A new class of probes, the partially double stranded probe, developed by Abbott allows for accurate quantification across genetically polymorphic targets.
Cycling Conditions: Low Temperature Read Cycles
Optimal Cycling Conditions: Unique probe design ensures optimization of cycling conditions, which includes lower read temperature, contributing to mismatch tolerance.
Abbott RealTime HIV-1 |
Plasma | Whole Blood (DBS) |
Sensitivity | 40 copies/mL for 1.0 mL sample volume 40 copies/mL for 0.6 mL sample volume 75 copies/mL for 0.5 mL sample volume 150 copies/mL for 0.2 mL sample volume |
839 copies/mL (one-spot, 70uL) |
Linear Range | 40 copies/mL (1.6 log copies/mL) to 10 million copies/mL (7.0 log copies/mL) | LoD up to 7 log copies/mL |
Specificity | 100%* | ≥99.5% |
Target region | Integrase region of polymerase gene | Integrase region of polymerase gene |
Subtype Detection | Group M subtypes A—H, Group O and Group N | Group M subtypes A—H, Group O and Group N |
Internal control | Non-competitive pumpkin RNA, added to lysis buffer during extraction | Non-competitive pumpkin RNA, added to lysis buffer during extraction |
Standardization | Virology Quality Assurance (VQA) Laboratory of the AIDS Clinical Trial Group World Health Organization (WHO) 1st International Standard for HIV-1 RNA (97/656) | Virology Quality Assurance (VQA) Laboratory of the AIDS Clinical Trial Group World Health Organization (WHO) 1st International Standard for HIV-1 RNA (97/656) |
Specimen Type | Plasma (ACD-A and EDTA) | One spot whole blood 1/2" DBS (12mm) circle |
Input volume | 0.2 mL; 0.5 mL; 0.6 mL; 1.0 mL | 70uL added to DBS (12mm) circle |
Sample preparation | m2000sp, m24sp and manual | m2000sp |
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