Alinity m HIV-1 Assay

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Assay design that addresses today's challenges and safeguards for the future in detecting all HIV groups/subtypes, as well as emerging strains, is critical to aid in HIV patient management.  The Alinity m HIV-1 assay is in an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay to detect and quantitate HIV-1 RNA in human plasma.

  • Dual target design ensures detection of current strain and safeguards against viral evolution
  • Robust quality program including Abbott's Global Surveillance Program monitorsassay performance against emerging strains
  • High sensitivity and excellent precision meet clinical guidelines and provide confidence in results.
  • High correlation with the gold standard m2000 RealTime HIV assay.

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Product Details
 

INTENDED USE

The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA on the automated Alinity m System in human plasma from 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 may be used to monitor disease prognosis by measuring the baseline plasma HIV-1 RNA level and to assess response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels.

The results from the Alinity m HIV-1 assay must be interpreted within the context of all relevant clinical and laboratory findings.

This assay is not intended for use in screening blood, blood products, tissue or organ donors for HIV.

The assay is not intended as an aid in diagnosis or to confirm HIV-1 infection.

LIMITATIONS OF THE PROCEDURE

  • Human plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m HIV-1 assay. The use of other anticoagulants have not been evaluated.
  • Performance has not been established with serum specimens.
  • If the HIV-1 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
  • HIV-1 RNA concentration (i.e., number of virus particles present in the samples) may be affected by patient factors (age, presence of symptoms) and/or stage of infection.
  • Though rare, mutations within the highly conserved regions of a viral genome detected by Alinity m HIV-1 may affect primers and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus. To ensure assay robustness, the Alinity m HIV-1 assay is designed to target two highly conserved sequences within the HIV-1 genome.
  • Assay linearity for HIV-1 Group M subtype BF, subtype H and Group N quantification was tested up to 10,000 Copies/mL for subtype BF, 300,000 Copies/mL for subtype H, and 1,000,000 Copies/mL for Group N, respectively.
  • Debris within plasma specimens (eg, clots, fibrin strands) may interfere with sample processing.
  • Diluted specimens must be tested within 2 hours after dilution and should not be frozen.

For in vitro diagnostic use

Rx Only

 

specifications
 

 

ABBOTT ALINITY m HCV ASSAY PERFORMANCE1,2
Technology RT-PCR
Intended Use Monitoring
Time to Result < 115 min
Standardization Virology Quality Assurance (VQA) Laboratory of the AIDS Clinical Trial Group
Probe Design Partially double stranded DBS probe design
Target Region Dual Target: Conserved Integrase gene in pol region and LTR  
Groups and Subtypes Group M subtypes (A, BF, C, D, CRF01-AE, F, CFR02-AG, G and H); Group O, Group N
Specimen Types

 

Plasma: Acid Citrate Dextrose (ACD), K2EDTA, K3EDTA, Plasma Preparation Tubes (PPT)*

*Gel tubes 

Sensitivity / Limit of Detection (LoD)

20 Copies/mL

Probit Analysis determined that the conventration of HIV-1 RNA detected with 95% probability was 13.99 copies/mL (95% CI 11.69 copies/mL to 19.22 copies/mL). 

Linearity

10 Copies/mL to 20,000,000 Copies/mL

Result Units

Copies/mL, Log [Copies/mL], IU/mL or Log [IU/mL]. 1 International Unit (IU)=0.61 Copies for HIV-1. 1 Copy=1.63 IUs.

Precision

0.27 Log copies/mL

Specificity

The specificity of the Alinity m HIV-1 was determined by testing 250 HIV-1 negative plasma specimens from individual donors.  HIV-1 RNA was not detected in any of the specimens tested (specificity 100.0%; 95% CI: 98.5 to 100.0%).

Controls

 

Negative, Low Positive, and High Positive controls - single use tubes

Sample Input Volume 600 µL 
Calibrator 2 Calibrator Levels - single use tubes
Internal Control Yes; Armored RNA (Pumpkin Kinase)
1. Alinity m HIV-1 AMP Kit Package Insert (PI): 53-608158/R1; 2. Abbott Data on File
 
 

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