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.
A unified HIV-1 testing solution across patient needs
The Alinity m HIV-1 solution supports a comprehensive range of clinical needs across validated specimen types, bringing diagnosis, viral load monitoring, and Early Infant Diagnosis (EID) together on a single platform.
All testing needs are supported by a single Alinity m HIV-1 AMP Kit, helping laboratories streamline workflows, simplify inventory, and reduce operational complexity.
HIV-1 Assay
STREAMLINED testing across clinical needs
Limit of Detection20 copies per mL with plasma 400 copies per mL with dried blood spots | Sample TypesPlasma and serum for core laboratory testing Dried blood spots (DBS) for viral load monitoring and Early Infant Diagnosis (EID), helping expand access to HIV testing across diverse care settings |
Incorporates partially double-stranded probe design targeting conserved regions to support reliable detection across diverse and evolving HIV-1 variants.
Comprehensive infectious disease testing across connected care pathways
Quantitative viral load testing for HBV and HCV supports clinical management and treatment decisions, 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 global populations
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.
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 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.
Intended User
The intended users for the Alinity m HIV-1 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 the package insert.
- Human serum (including serum separator) and plasma (ACD, EDTA, and PPT) specimens may be used with the Alinity m HIV-1 assay. The use of other anticoagulants have not been evaluated.
- Debris within serum and plasma specimens (eg, clots, fibrin strands) may interfere with sample processing.
- If the HIV-1 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- 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 the package insert.
Intended Use
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) (ie, 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.
Intended User
The intended users for the Alinity m HIV-1 assay are laboratory professionals.
Limitations
- For In Vitro Diagnostic Use
- DBS specimens prepared using either capillary or venipuncture whole blood collected in an EDTA tube may be used with the Alinity m HIV-1 assay. For the use of other specimen types evaluated with the Alinity m HIV-1 assay, refer to the Alinity m HIV-1 AMP Kit Package Insert.
- Ahlstrom-Munktell TFN and Whatman 903 DBS cards may be used. The use of other cards has not been validated with Alinity m HIV-1.
- This test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the IFU).
- Only personnel proficient in DBS preparation and pre-processing, the procedures of a molecular diagnostic assay, and the Alinity m System should perform this procedure.
- Inappropriate collection, drying, storage, and handling of DBS cards may lead to inaccurate test results.
- If the HIV-1 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- The systems 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
the IFU.
Intended Use
The Alinity m HIV-1 qualitative assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System for detection of Human Immunodeficiency Virus type 1 (HIV-1) RNA in whole blood spotted on cards as dried blood spots (DBS) (ie, capillary blood or obtained via venipuncture). The Alinity m HIV-1 qualitative assay is intended for use as an aid in diagnosis of HIV-1 infection in HIV-exposed infants and children younger than 18 months of age.
The results from the Alinity m HIV-1 qualitative assay must be interpreted within the context of all relevant clinical and laboratory findings.
The Alinity m HIV-1 qualitative assay is not intended to be used for viral load monitoring or for screening blood, blood products, tissue, or organ donors for HIV.
Intended User
The intended users for the Alinity m HIV-1 assay are laboratory professionals.
Limitations
- For In Vitro Diagnostic Use.
- Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform comparison studies in their laboratory to evaluate technology differences. Users should follow their own specific policies/procedures.
- Amplification technologies, such as PCR, are sensitive to accidental introduction of product from previous amplification reactions. Incorrect results could occur if either the clinical specimen or the reagents used become contaminated by accidental introduction of even a few molecules of amplification product. Measures to reduce the risk of contamination in the laboratory include physically separating the activities involved in the handling of contaminated waste in compliance with good laboratory practices.
- DBS specimens prepared using either capillary or venipuncture whole blood collected in an EDTA tube may be used with the Alinity m HIV-1 qualitative assay for DBS EID. For the use of other specimen types (plasma and serum) evaluated with the Alinity m HIV-1 assay, refer to the Alinity m HIV-1 AMP Kit Package Insert. For DBS quantitative assay see DBS supplements to Alinity m HIV-1 Assay.
- Ahlstrom-Munktell TFN and Whatman 903 DBS cards may be used. The use of other cards has not been validated with Alinity m HIV-1 qualitative assay for DBS EID.
- This test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the IFU).
- Only personnel proficient in DBS preparation and pre-processing, the procedures of a molecular diagnostic assay, and the Alinity m System should perform this procedure.
- Inappropriate collection, drying, storage, and handling of DBS cards may lead to inaccurate test results.
- If the HIV-1 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- The systems and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the IFU.
- Patients undergoing medical treatments that use HIV-1 based lentiviral vectors, such as chimeric antigen receptor (CAR) T-cell therapies or hematopoietic stem cell-based gene therapies, may receive inaccurate quantitation or detection results due to the presence of conserved HIV-1 sequences detected by the assay in the transfected cell population.
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 and monitoring 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, tissue or organ donors for HBV, 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 the package insert).
- Human serum (including serum collected in separator tubes or rapid-clot tubes) and plasma (ACD, 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.
- Debris within serum and plasma specimens (eg, clots, fibrin strands) may interfere with sample processing.
- If the HBV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- 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 the 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 use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma. The Alinity m HCV assay is intended for use in the clinical management of HCV-infected patients undergoing antiviral therapy in conjunction with clinical presentation and other laboratory markers.
The Alinity m HCV assay may also be used as a diagnostic test to confirm active HCV infection. The results from the Alinity m HCV
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 HCV.
Intended User
The intended users for 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 the package insert).
- Human serum (including serum separator) and plasma (ACD, EDTA, and PPT) specimens may be used with the Alinity m HCV assay. The use of other anticoagulants have not been evaluated.
- Debris within serum and plasma specimens (eg, clots, fibrin strands) may interfere with sample processing.
- If the HCV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- 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 the package insert.