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HIV Testing with the Alinity m System: Accurate and Efficient HIV Testing Solution
HIV Testing with the Alinity m Automated System
The Alinity m HIV test is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Human Immunodeficiency Virus Type 1 (HIV-1) RNA using plasma, serum, and dried blood spot (DBS) samples.
Research-Based Dual-Target Design
With a dual-target assay design, Alinity m HIV-1 delivers accurate results by utilizing a partially double-stranded probe that enables precise quantification of viral load in samples.
Efficiency in HIV Virus Confirmation and Quantification
The combination of confirmation and viral load determination in a single test increases operational efficiency, saving time and resources for laboratories.
Optimized Design with Specific Target Extraction Protocol
Alinity m HIV-1 employs specific target extraction protocols, ensuring that differences in viral load reflect actual variances. Non-detection of the virus truly signifies no risk of transmission.
High Sensitivity with Dried Blood Spot (DBS)
DBS samples offer high sensitivity (LoD = 400 copies/mL), meeting regional and international guidelines for HIV treatment monitoring. This enhances accessibility and expands HIV-1 surveillance in remote areas, supporting countries in achieving the 95-95-95 targets by 2030.
With Alinity m HIV-1, laboratories and healthcare facilities can enhance their capability to detect and monitor HIV-1, contributing to the global public health care goals.
Alinity m HIV Testing System: Use with Plasma and Serum
The Alinity m HIV-1 test is an in vitro RT-PCR assay performed with the automated Alinity m system for detecting and quantifying HIV-1 RNA. This test is used in the clinical management of individuals infected with HIV-1, in conjunction with clinical presentations and other laboratory markers.
The Alinity m HIV-1 test can be used to monitor disease prognosis by measuring baseline HIV-1 plasma RNA levels and to assess viral response to antiretroviral treatment by measuring changes in HIV-1 plasma RNA levels. Quantitative performance has not been established with serum samples.
The Alinity m HIV-1 test may also serve as a diagnostic tool to assist in confirming HIV-1 infection in individuals with repeatedly positive HIV test results. Diagnostic performance has been established with both plasma and serum samples.
Results from the Alinity m HIV-1 test must be interpreted in the context of all clinical and laboratory findings. This test is not intended for screening blood, blood products, tissues, or organ donors for HIV.
Use with Dried Blood Spot (DBS)
The Alinity m HIV-1 test is an in vitro RT-PCR assay performed with the automated Alinity m system for detecting and quantifying HIV-1 RNA in whole blood dried on a card (DBS), collected from venous or capillary blood. This test is used in the clinical management of individuals infected with HIV-1, in conjunction with clinical presentations and other laboratory markers.
Monitoring Disease Prognosis
Testing HIV-1 RNA with DBS using Alinity m can be used to monitor disease prognosis by measuring baseline HIV-1 RNA levels and evaluating viral response to antiretroviral treatment through changes in HIV-1 RNA levels.
Results from the Alinity m HIV-1 test must be interpreted in the context of all clinical and laboratory findings. This test is not intended for screening blood, blood products, tissues, or organ donors for HIV or as a diagnostic test to confirm the presence of HIV-1 infection.
Criteria | Details |
---|---|
Technology | RT-PCR |
Indications | Monitoring and Confirmation (Plasma and Serum) Monitoring (DBS) |
Time to First Result | <115 minutes |
Standardization | Virology Quality Assurance (VQA) Program of the AIDS Clinical Trials Group |
Probe Design | Partially double-stranded DNA probe design |
Target Regions | Dual targets: 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 |
Sample Types | Plasma: Acid Citrate Dextrose (ACD); K2 EDTA; K3 EDTA; Plasma Preparation Tube (PPT) Serum: Serum; Serum Separator Tube (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 the concentration of HIV-1 RNA detected with 95% probability is 13.88 Copies/mL (95% CI: 11.16-18.98 Copies/mL) 400 Copies/mL (DBS) Probit analysis determined the concentration of HIV-1 RNA detected with 95% probability is 393.15 Copies/mL (95% CI: 331.92 to 487.93 Copies/mL) |
Linear Range | 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) Precision within quantifiable range does not exceed 0.18 Total SD (DBS) |
Input Sample Volume | 600μL (Plasma and Serum) Minimum 70μL whole blood on DBS card |
Specificity | Plasma: 100.0% (95% CI: 98.5 to 100.0… |