For In Vitro Diagnostic Use
The Abbott RealTime HIV-1 Viral Load assay is for quantitation of Human Immunodeficiency Virus 1 (HIV-1).
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For In Vitro Diagnostic Use
The Abbott RealTime HIV-1 Viral Load assay is for quantitation of Human Immunodeficiency Virus 1 (HIV-1).
For Information Only - Not a Controlled Copy
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.
The coefficient of variation observed in low viral load patient specimens (three patient samples with viral load below 100 coples/mL; 10 replicates each, was significantly lower with Abbott RealTime HIV (26%-31%) than that of a comparator assay (37-59%).
Detection of HIV-1 Subtypes and Groups
| 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) |
N = number of specimens tested
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.
Correlation to Comparator Assay
A total of 301 specimens collected from HIV-1 infected patients were tested with the RealTime HIV-1 assay at three external sites and with the comparator method at a central laboratory site. The results from a total of 259 specimens that fell within the common assay dynamic range were analyzed by the Passing-Bablok linear regression method.
Indications and Limitations of Use
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) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. 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.
Limitations
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.
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.
Utility of external calibration curve reduces variability of the viral load calculation compared to an internal calibration as there are no competitive effects in the PCR reaction. Random assay variation is minimized, resulting in highly accurate viral quantification at the clinical decision point and providing confidence in a patient's response to therapy.
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.
The integrase region of the polymerase gene is a conserved region of the HIV-1 genome.
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.
Extended length - higher mismatch tolerance: in the absence of target, the probe hybridizes to the quencher oligonucleotide, preventing fluorescent signal generation.
In the presence of target, the probe prefers to hybridize with the target sequence, disassociating from the quencher oligonucleotide and allowing fluorescent detection..
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-1PLASMA | |
| 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 |
| Linear Range | 40 copies/mL (1.6 log copies/mL) to 10 million copies/mL (7.0 log copies/mL) |
| Specificity | 100%1 |
| Target region | Integrase region of polymerase gene |
| Subtype Detection | Group M subtypes A—H, Group O and Group N |
| Internal control | 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) |
| Specimen Type | Plasma (ACD-A and EDTA) |
| Input volume | 0.2 mL; 0.5 mL; 0.6 mL; 1.0 mL |
| Sample preparation | m2000sp |
1The specificity of the RealTime HIV-1 assay was evaluated at three external sites by testing 514 HIV-1 seronegative plasma specimens from volunteer blood donors. HIV-1 RNA was not detected for all 514 specimens and the RealTime HIV-1 assay specificity was estimated to be 100% (514/514), (95% CI 99.28 to 100%).
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