INTENDED USE:
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.
SPECIFICATIONS:
ALINITY m HIV ASSAY PERFORMANCE | |
 Limit of Detection (LoD) | 20 Copies/mL (Plasma and Serum)
400 Copies/mL (DBS) |
Claim | Monitoring and Confirmatory (Plasma and Serum)
Monitoring (DBS) |
Linear Range | 10 Copies/mL to 20,000,000 Copies/mL (Plasma and Serum)
400 Copies/mL to 10,000,000 Copies/mL (DBS) |
 Precision | ≤0.19 Total SD (Plasma and Serum)
Precision across quantifiable range not to exceed 0.18 Total SD (DBS) |
Specificity | Plasma: 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%) |
 Target Region | Dual Target: Integrase 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 Type | Plasma, Serum
DBS |
 Internal Control | Yes |
Sample input volume | 600μL (Plasma and Serum)
Minimum 70μL whole blood on DBS card |