Continuous Viral Load Testing For Transplant Care
Abbott supports laboratories managing post‑transplant patients with molecular testing solutions designed to accommodate the needs of laboratorians delivering critical viral load diagnostics. The Alinity m system supports CMV, EBV, and BKV viral load testing on a fully integrated and automated molecular platform built to perform reliably in dynamic clinical testing environments.
Beyond the laboratory, Abbott is proud to support the transplant community as a sponsor of the World Transplant Games Federation. Through this partnership, Abbott celebrates life after transplant and honors the resilience of transplant recipients, donor families, and the healthcare teams who support them. Learn more about the World Transplant Games Federation.
Designed for More Flexible Transplant Workflows
Traditional molecular batch processing can limit flexibility in laboratories managing post‑transplant testing workflows, particularly when testing volumes vary and urgent samples require timely attention. Holding samples until a full run is ready can introduce delays and make it difficult to respond to changing priorities.
The Alinity m system is designed to support post‑transplant testing workflows by enabling testing to begin as samples arrive. With continuous and true random access and STAT capability, laboratories can prioritize urgent post‑transplant samples while maintaining consistent and predictable turnaround times.
Operational Efficiency Through Consolidation
Beyond transplant viral load testing, Alinity m supports a broad molecular menu commonly used in immunocompromised patient populations. By consolidating multiple assays on a single platform, laboratories may simplify workflows, reduce system complexity, and support efficient use of laboratory resources, while maintaining flexibility to respond to changing clinical and operational demands.
What Our Customers Say
“With the Alinity m, you load the samples on and can load them on as they come in throughout the day. If a particular sample fails, you just put that one sample back on without having to rerun the entire batch.”
Sheryl Alberta, MT ASCP MB
Lead Technologist, Corewell Health Grand Rapids Hospital Lemmen Holton
“Our clinicians love that they get test results back within 24 hours, and it is really useful in managing both hematopoietic stem cell transplant patients as well as solid organ transplantations.”
Stefan Reidel, MD PhD D ABMM FCAP
Associate Medical Director, Clinical Microbiology Laboratories, Beth Israel Deaconess Medical Center
Testimonials herein are solicited. The testimonials are representative of customer experience. Experience will be unique and individual to each customer.
Transplant Viral Load Testing on One Platform
Alinity m transplant viral load assays are designed to support consistent and reliable testing workflows. Across CMV, EBV, and BKV, laboratories benefit from automated processing, standardized quantitation aligned to international standards, and time to first result under 120 minutes, offering flexibility with validated assays for both plasma and whole blood testing.
Available assays on Alinity m:
Cytomegalovirus (CMV)
Alinity m CMV Assay (PLASMA)
The Alinity m CMV assay is intended for use as an aid in the management of solid organ transplant and hematopoietic stem cell transplant patients undergoing anti‑CMV therapy, when interpreted in conjunction with clinical and laboratory findings.
Specimen typeEDTA plasma | Limit of Detection30 IU per mL |
ALINITY M CMV ASSAY (WHOLE BLOOD)
The Alinity m CMV WB assay is intended for use as an aid in the diagnosis and management of CMV in transplant patients and other immunocompromised patients.
Specimen typeWhole Blood | Limit of Detection100 IU/mL (2.00 Log IU/mL) |
Epstein-Barr Virus (EBV)
Alinity m EBV Assay
The Alinity m EBV assay is intended for use as an aid in the diagnosis and management of EBV in transplant and other immunocompromised patients with results interpreted alongside other relevant clinical information.
Specimen typeEDTA plasma | Limit of Detection20 IU per mL |
ALINITY M EBV ASSAY (WHOLE BLOOD)
Alinity m EBV WB is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients.
Specimen typeWhole Blood | Limit of DetectionLoD = 100 IU/mL (2.00 Log IU/mL) |
BK Virus (BKV)
Alinity m BKV Assay
The Alinity m BKV assay is intended to support the management of BKV in transplant patients, when used as part of a broader clinical assessment.
Specimen typeEDTA plasma | Limit of Detection50 IU per mL |
Important Information
Intended Use and Limitations for the Alinity m Cytomegalovirus (CMV), Alinity m Epstein-Barr Virus (EBV), and Alinity m BK Virus (BKV) assays are available in their dedicated section below.
Intended Use
The Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to detect and quantitate cytomegalovirus (CMV) DNA in human plasma. The Alinity m CMV assay is intended for use as an aid in the diagnosis and management of CMV in transplant patients and other immunocompromised patients. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in CMV DNA levels in plasma. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for CMV.
Intended User
The intended users for the Alinity m CMV 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 plasma (K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m CMV assay. The use of other plasma tubes have not been evaluated.
- Debris within plasma specimens (eg, 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 the package insert.
- If the CMV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- A specimen with a result of “Not Detected” cannot be presumed to be negative for CMV DNA.
- When serially monitoring the CMV viral load in patients, 1 specimen type should be used throughout the monitoring period. Follow institutional/society guidelines as appropriate.
- 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 qualify technology differences. Users should follow their own specific policies/procedures.
Intended Use
The Alinity m CMV WB assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to detect and quantitate cytomegalovirus (CMV) DNA in human whole blood. The Alinity m CMV WB assay is intended for use as an aid in the diagnosis and management of CMV in transplant patients and other immunocompromised patients. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in CMV DNA levels in whole blood. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for CMV products.
Intended User
The intended users for the Alinity m CMV WB 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 whole blood specimens (K2 EDTA or K3 EDTA) may be used with the Alinity m CMV WB assay. The use of other specimen types or collection tubes have not been evaluated.
- 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 the CMV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- A specimen with a result of “Not detected” cannot be presumed to be negative for CMV DNA.
- When serially monitoring the CMV viral load in patients, 1 specimen type should be used throughout the monitoring period. Follow institutional/society guidelines as appropriate.
- 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 qualify technology differences. Users should follow their own specific policies/procedures.
Intended Use
Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Epstein-Barr Virus (EBV) DNA in human EDTA plasma.
Alinity m EBV is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.
The results from Alinity m EBV must be interpreted within the context of all relevant clinical and laboratory findings. Alinity m EBV is not intended to be used in screening blood, blood products, tissue, or organ donors for EBV.
Intended User
The intended users for the Alinity m EBV 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 plasma (K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m EBV assay. The use of other plasma tubes has not been evaluated.
- Debris within plasma specimens (eg, 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 the package insert.
- If the EBV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- A specimen with a result of “Not Detected” cannot be presumed to be negative for EBV.
- Results from the Alinity m EBV assay should be interpreted in conjunction with other clinical laboratory findings.
Intended Use
Alinity m EBV WB is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Epstein-Barr Virus (EBV) DNA in human whole blood. Alinity m EBV WB is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. The results from Alinity m EBV WB must be interpreted within the context of all relevant clinical and laboratory findings. Alinity m EBV WB is not intended to be used in screening blood, blood products, tissue, or organ donors for EBV
Intended User
The intended users for the Alinity m EBV WB 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 whole blood (K2 EDTA or K3 EDTA) specimens may be used with the Alinity m EBV WB assay. The use of other specimen types or collection tubes has not been evaluated.
- 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 the EBV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- A specimen with a result of “Not Detected” cannot be presumed to be negative for EBV.
- Results from the Alinity m EBV WB assay should be interpreted in conjunction with other clinical laboratory findings.
- 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 qualify technology differences. Users should follow their own specific policies/procedures.
Intended Use
Alinity m BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma and urine stabilized in transport buffer on the automated Alinity m System.
In EDTA plasma and urine stabilized in transport buffer, Alinity m BKV is intended for use as an aid in the management of BKV in transplant patients.
In patients undergoing monitoring of BKV in EDTA plasma, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.
The results from Alinity m BKV must be interpreted in conjunction with clinical signs and symptoms and other relevant laboratory findings. Test results must not be the sole basis for patient management decisions.
Alinity m BKV is not intended for use as a screening test for blood or blood products or human cells, tissues, and cellular and tissue-based products.
Intended User
The intended users for the Alinity m BKV 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 EDTA plasma (K2 EDTA, K3 EDTA, and PPT) and urine specimens may be used with the Alinity m BKV assay. The use of other specimen types has not been evaluated.
- Debris within plasma specimens (eg, 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 the package insert.
- If the BKV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
- A specimen with a result of “Not Detected” cannot be presumed to be negative for BKV.
- Results from the Alinity m BKV assay should be interpreted in conjunction with other clinical laboratory findings.
- Quantitative variability of BKV DNA inherent to urine has been observed in different aliquots of the same sample (neat urine and urine stabilized in transport buffer).
- Due to inherent differences between technologies, prior to switching from one technology to the next, users may perform method correlation studies in their laboratory to evaluate technology differences. Users should follow their own specific policies/procedures.
- Due to the potential for variability in BKV viral load measurements across different BKV assays, it is recommended that the same device be used for the quantitation of BKV viral load when managing individual patients.
- Assay interference was observed with mucus at > 0.4% w/v and peripheral blood mononuclear cells (PBMCs) at >1 × 105 cells/mL in urine specimens.
For In Vitro Diagnostic Use. Rx Only.