HIV-1 QUANTITATIVE
Alinity m HIV-1 Assay
For more information, contact Abbott.
For more information, contact Abbott.
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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 using plasma, serum and dried blood spot (DBS).
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.
To learn more about Alinity m HIV-1 Assay please visit: https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-hiv-1-assay
| ALINITY m HIV-1 ASSAY PERFORMANCE | |
| Technology | RT-PCR |
| Claim | Monitoring and Confirmatory (Plasma and Serum) Monitoring (DBS) |
| Time to first result | <115 min |
| Standardization | Virology Quality Assurance (VQA) Laboratory of the AIDS Clinical Trial Group |
| Probe Design | Partially double stranded DNA probe design |
| 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 types | Plasma: 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) |
| Linearity | 10 Copies/mL to 20,000,000 Copies/mL (Plasma and Serum) 400 Copies/mL to 10,000,000 Copies/mL (DBS) |
| Result Units | Copies/mL, Log [Copies/mL], IU/mL or Log [IU/mL] |
| Precision | ≤0.19 Total SD (Plasma and Serum) ≤0.18 Total SD (DBS) |
| Sample input volume | 600μL (Plasma and Serum) Minimum 70μL whole blood on DBS card |
| Specificity | Plasma: 100.0% (95% CI: 98.5 to 100.0%) Serum: 100.0% (95% CI: 98.5 to 100.0%) DBS: 100.0% (95% CI: 96.7.2 to 100.0%) |
| Controls | Negative, Low Positive, and High Positive controls–single use tubes |
| Calibrator | 2 Calibrator levels–single use tubes |
| Internal Control | Armored RNA |
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.