Alinity m HIV-1 Assay

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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.

  • 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
INTENDED USe
 

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.

specifications
 
ALINITY m HIV-1 ASSAY PERFORMANCE
Limit of Detection (LoD) Probit analysis determined that the concentration of HIV-1 RNA detected with 95% probability was 13.88 Copies/mL (95% CI 11.16 to 18.98 Copies/mL).
Linear Range 10 copies to 20,000,000 copies/mL
Specificity

 

Plasma: 100.0% (95% Cl: 98.5 to 100.0%)

Serum: 100.0% (95% Cl: 98.5 to 100.0%)

Overall: 100.0% (95% Cl: 99.2 to 100.0) 

Target Region Dual Target: Integrase and LTR
Subtype Detection Group M subtypes (A, BF, C, D, CRF01-AE, F, CFR02-AG, G and H); Group O, Group N
Confirmatory Yes
Internal Control Yes 
Standardization 3rd World Health Organization (WHO) [NIBSC code: 10/152; group M subtype B]
Specimen Type

 

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

Serum: Serum; Serum Separator Tubes (SST)*

*Gel tubes

Input Volume  600 µL

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