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.
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
For in vitro diagnostic use
|ABBOTT ALINITY m HCV ASSAY PERFORMANCE1,2|
|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|
Plasma: Acid Citrate Dextrose (ACD), K2EDTA, K3EDTA, Plasma Preparation Tubes (PPT)*
Sensitivity / Limit of Detection (LoD)
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).
10 Copies/mL to 20,000,000 Copies/mL
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.
< 0.27 Log copies/mL
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%).
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)|
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