Advancing Hepatitis and Retrovirus Testing with Confidence
Hepatitis and Retrovirus testing, including HIV, HBV, and HCV, plays a critical role in patient management and public health programs, requiring consistent performance across diverse and evolving viral landscapes.
Through the Abbott Pandemic Defense Coalition, Abbott maintains a global surveillance network spanning more than 50 countries, analyzing over 170,000 samples to monitor how viruses evolve and spread.
This ongoing vigilance informs the design of Abbott’s Hepatitis and Retrovirus assays, helping ensure reliable detection across genotypes, geographies, and emerging variants, so you can rely on Abbott as your trusted partner for Hepatitis and Retrovirus testing.
SUPPORTING HIV-1 DETECTION AND VIRAL LOAD MONITORING
The Alinity m HIV-1 assay supports HIV-1 viral load monitoring and supplemental confirmation of HIV-1 infection on a fully automated molecular platform.
Designed to address the challenges of HIV genetic diversity, the assay targets two highly conserved regions of the HIV-1 genome to support detection and quantitation across diverse HIV-1 groups and subtypes.
By combining decades of HIV surveillance with ongoing scientific evaluation, Abbott continues to develop solutions that help laboratories confidently support HIV testing needs.
HIV-1 Assay
DESIGNED TO ADDRESS HIV-1 DIVERSITY
Limit of Detection20 copies per mL
| SUPPORTSHIV-1 Viral Load Monitoring (plasma) Supplemental Confirmation of HIV-1 Infection (plasma or serum)* |
*Following reactive HIV immunoassay results.
Incorporates partially double-stranded probe design targeting conserved regions to support reliable detection across diverse and evolving HIV-1 variants.
For In Vitro Diagnostic Use. Rx Only
Comprehensive infectious disease testing across connected care pathways
Quantitative viral load testing for HBV and HCV supports clinical management and treatment monitoring, with standardized performance aligned to international guidelines and delivered on a fully automated system.
In many settings, hepatitis and HIV testing are closely linked with broader screening programs, including sexually transmitted infections, creating opportunities to consolidate testing on a single platform.
HBV Assay
Reliable monitoring across diverse populations
Limit of Detection10 IU per mL in both plasma | Sample TypesPlasma and serum with broad compatibility across collection tubes |
Supports monitoring of chronic HBV infection with broad genotype
coverage across genotypes A-I
HCV Assay
Confident detection and treatment monitoring
Limit of Detection12 IU per mL with high sensitivity for early detection | Sample TypesPlasma and serum across a wide range of collection tubes |
Supports confirmation of active infection with accurate quantitation
across genotypes 1 to 6.
For In Vitro Diagnostic Use. Rx Only
BUILT TO SCALE HEPATITIS AND RETROVIRUS TESTING
The Alinity m system combines continuous and true random access with menu consolidation, enabling laboratories to manage HIV-1, HBV, and HCV testing on a single platform.
This flexibility allows labs to prioritize urgent samples without batching, support both routine and high demand testing, and respond to the increasing complexity of global testing programs.
In settings where HIV and hepatitis testing are closely linked with broader screening programs, this ability to consolidate workflows helps improve efficiency while maintaining consistent performance across assays.
Continuous and true random access workflow helps support urgent and routine testing on the same system
Time to first result under 120 minutes
Consolidates HIV-1, HBV, and HCV testing to simplify lab operations
Helps support growing testing demands without increasing workflow complexity
The Alinity m system and its assays are for in vitro diagnostic use only.
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Important Information
Intended Use and Limitations for the Alinity m HIV-1, HBV, and HCV assays are available in their dedicated section below.
Retrovirus
Intended Use
The Alinity m HIV-1 assay 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 on the automated Alinity m System for confirmation of HIV-1 infection or for monitoring 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 is intended for use to monitor disease prognosis by measuring baseline plasma HIV-1 RNA level and to assess response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels. Performance for quantitative monitoring is not established with serum specimens.
The Alinity m HIV-1 assay is also intended for use as a supplemental test to confirm HIV-1 infection in individuals who have reactive results with HIV immunoassays. Performance for supplemental use 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 device is not intended for use as a first line diagnostic test or for screening donors of blood, blood products, or human cells or tissues, or cellular and tissue-based products (HCT/Ps).
Intended User
The intended users of the Alinity m HIV assay are laboratory professionals.
Limitations
- Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of this package insert.)
- Only human serum (including SST) and plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens can be used with the Alinity m HIV-1 assay. The use of other anticoagulants have not been evaluated.
- Debris within plasma and serum specimens (eg, clots, fibrin strands) may interfere with sample processing.
- Performance of the supplemental test to confirm HIV-1 infection in individuals who have reactive results with HIV immunoassays was established for HIV-1 viral load at ≥100 Copies/mL.
- Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
- If the HIV-1 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- HIV-1 RNA concentration (ie, number of virus particles present in the samples) may be affected by patient factors (age, presence of symptoms) and/or stage of infection.
- Though rare, mutations within the highly conserved regions of a viral genome detected by Alinity m HIV-1 may affect primers and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus. To ensure assay robustness, the Alinity m HIV-1 assay is designed to target two highly conserved sequences within the HIV-1 genome.
- Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to evaluate technology differences. Users should follow their own specific policies/procedures.
- The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.
- Assay linearity for HIV-1 Group M subtype BF, subtype H and Group N quantification was tested up to 10,000Copies/mL for subtype BF, 300,000 Copies/mL for subtype H, and 1,000,000 Copies/mL for Group N, respectively.
Hepatitis
Intended Use
The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Alinity m HBV 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, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm the presence of HBV infection
Intended User
The intended users for the Alinity m HBV assay are laboratory professionals.
Limitations
- Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of this package insert).
- Human serum (including serum separator tubes and rapid-clot tubes) and plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m HBV assay. The use of other plasma and serum tubes have not been evaluated.
- Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
- Debris within serum and plasma specimens (e.g., clots, fibrin strands) may interfere with sample processing.
- Assay performance for determining the clinical stage of HBV infection has not been established.
- The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.
- If an increase in DNA levels is observed that is inconsistent with previous patient results, a retest of the sample should be considered by the physician or healthcare provider.
Intended Use
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.
The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.
The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.
Intended User
The intended users of the Alinity m HCV assay are laboratory professionals.
Limitations
- Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of this package insert).
- Human serum (including serum separator and rapid-clot tubes) and plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m HCV assay. The use of other plasma and serum tubes has not been evaluated.
- Debris within serum and plasma specimens (eg, clots, fibrin strands) may interfere with sample processing.
- The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.
- Though rare, mutations within the highly conserved regions of a viral genome covered by the Alinity m HCV may affect primer and/or probe binding resulting in the under‐quantitation of virus or failure to detect the presence of virus. The Alinity m HCV assay mitigates this risk by utilizing two unique probes in a highly conserved region of the HCV genome.
- Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used