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ALINITY m HIV-1 ASSAY

The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay to detect and quantitate Human Immunodeficiency Virus type 1 (HIV-1) RNA using plasma, serum and dried blood spot (DBS).

  • Research driven dual target assay design
  • Partially double stranded probe provides accurate quantitation
  • Confirmation and viral load in the same test provides operational efficiencies
  • Designed with target specific extraction protocols ensuring differences in viral loads are true differences and an undetectable result is truly un-transmittable
  • Dried Blood Spot (DBS) sample provides high sensitivity (LoD = 400 copies/mL) that meets regional and international guidelines for therapy monitoring.  It helps to enhance accessibility and scalability of HIV-1 monitoring in remote areas, which better enables countries to achieve the 95-95-95 targets by 2030.

For use with Plasma and Serum

 

The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate Human Immunodeficiency Virus type 1 (HIV-1) RNA. 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 viral response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels. Performance for quantitative results is not established with serum specimens.

The Alinity m HIV-1 assay may also be used as a diagnostic test to aid in the diagnosis of HIV-1 infection by confirming HIV-1 infection in individuals that have repeat reactive results with HIV immunoassays. Performance of the diagnostic confirmatory interpretation is established with both plasma and serum specimens.

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 to be used in screening blood, blood products, tissue or organ donors for HIV

For Use with DBS

 

The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate Human Immunodeficiency Virus type 1 (HIV-1) RNA in whole blood spotted on cards as dried blood spots (DBS) (i.e. obtained via venipuncture or capillary blood). 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 testing DBS may be used to monitor disease prognosis by measuring baseline HIV-1 RNA level and to assess viral response to antiretroviral treatment by measuring changes in 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 to be used in screening blood, blood products, tissue or organ donors for HIV or as a diagnostic test to confirm the presence of HIV-1 infection.

ALINITY m HIV-1 ASSAY PERFORMANCE1,2
TechnologyRT-PCR
ClaimMonitoring and Confirmatory (Plasma and Serum)
Monitoring (DBS)
Time to first result<115 min
StandardizationVirology Quality Assurance (VQA) Laboratory of the AIDS Clinical Trial Group
Probe DesignPartially double stranded DNA probe design
Target RegionDual Target: Integrase and LTR
Groups and SubtypesGroup M subtypes (A, BF, C, D, CRF01-AE, F, CFR02-AG, G and H); Group O, Group N
Specimen typesPlasma: Acid Citrate Dextrose (ACD); K2 EDTA; K3 EDTA; Plasma Preparation Tubes (PPT)
Serum: Serum; Serum Separator Tubes (SST)
Whole blood spotted on Ahlstrom-Munktell TFN or Whatman 903 DBS cards
Sensitivity
Limit of Detection (LoD)		20 Copies/mL (Plasma and Serum) 
Probit Analysis determined that the concentration of HIV-1 RNA detected with 95% probability was 13.88 Copies/mL (95% CI: 11.16-18.98 Copies/mL)
400 Copies/mL (DBS)
Probit Analysis determined that the concentration of HIV-1 RNA detected with 95% probability was 393.15 Copies/mL (95% CI 331.92 to 487.93 Copies/mL)
Linearity10 Copies/mL to 20,000,000 Copies/mL (Plasma and Serum)
400 Copies/mL to 10,000,000 Copies/mL (DBS)
Result UnitsCopies/mL, Log [Copies/mL], IU/mL or Log [IU/mL]
Precision≤0.19 Total SD (Plasma and Serum)
Precision across quantifiable range not to exceed 0.18 Total SD (DBS)
Sample input volume600μL (Plasma and Serum)
Minimum 70μL whole blood on DBS card
SpecificityPlasma: 100.0% (95% CI: 98.5 to 100.0%)
Serum: 100.0% (95% CI: 98.5 to 100.0%)
DBS: 100% (95% CI: 96.7 to 100.0%)
ControlsNegative, Low Positive, and High Positive controls–single use tubes
Calibrator2 Calibrator levels–single use tubes
Internal ControlArmored RNA

1. Alinity m HIV-1 AMP kit package insert 53-608055/R3.  2. Alinity m DBS Supplement to HIV-1 assay package insert 53-608187/R1

ALINITY m

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