Reliable Viral Load Results for Transplant Care
Behind every transplant outcome is a laboratory delivering timely, reliable viral load results. The Alinity m system supports cytomegalovirus (CMV), EpsteinBarr virus (EBV), and BK virus (BKV) viral load testing on a fully automated molecular platform designed to meet the operational demands of transplant laboratories.
With continuous and true random access testing, Alinity m enables testing to begin as samples arrive — without waiting to batch — helping labs respond quickly to changing priorities and urgent clinical needs.
In transplant care, timing matters.
Posttransplant patients require close viral load monitoring to support ongoing clinical management. CMV, EBV, and BKV are among the viruses commonly monitored in transplant patient populations. Delays in initiating testing can extend turnaround times and introduce uncertainty into downstream clinical processes.
Viral load measurements provide quantitative information that can be used alongside clinical findings to support routine surveillance, risk assessment, and follow up over time.
Alinity m helps laboratories initiate testing promptly, supporting established monitoring pathways and consistent reporting.
Designed for Continuous Transplant Workflows
Traditional batching can delay testing and reduce flexibility. Alinity m is designed around the realities of transplant lab operations.
With continuous and true random access, laboratories can:
- Start testing immediately as samples arrive without waiting to batch
- Prioritize STAT or urgent transplant samples when required
- Run multiple viral load assays at the same time with mixed sample loading
- Deliver the first result in under 120 minutes
By supporting continuous workflows, Alinity m helps labs maintain efficiency and predictable turnaround times—even on highvariability days.
Transplant Viral Load Testing on One Platform
Consolidate transplant viral load testing on a single, automated molecular system to help streamline operations and maintain assay consistency
Available assays on Alinity m:
Alinity m CMV Assay
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 |
Key features
- Dual-target assay design
- WHO standardized quantitation
- Fully automated processing on the Alinity m system
- First result in under 120 minutes
Alinity m EBV Assay
The Alinity m EBV assay is intended for use as an aid in the management of EBV in transplant patients, with results interpreted alongside other relevant clinical information.
Specimen typeEDTA plasma | Limit of DetectionApproximately 20 IU per mL |
Key features
- Dual‑target assay design
- WHO‑standardized quantitation
- High precision to support longitudinal monitoring
- First result in under 120 minutes
Alinity m BKV Assay
The Alinity m BKV assay is intended to support the diagnosis and management of BKV in transplant patients, when used as part of a broader clinical assessment.
Specimen typeEDTA plasma | Limit of Detection50 IU per mL |
Key features
- Validated for both plasma and stabilized urine
- WHO‑standardized quantitation
- Continuous access and STAT capability
- First result in under 120 minutes
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.
Connected to the Transplant Community
Abbott is a proud sponsor of the Transplant Games of America. Held every two years, the Games celebrate life after transplantation through athletic competition, community events, and educational programming. The Games raise awareness of the importance of organ, eye, and tissue donation while honoring the resilience of transplant recipients and the generosity of donors and their families.
Through our sponsorship, Abbott supports the transplant community beyond diagnostics, recognizing that transplant care extends far beyond the laboratory and clinic.
Learn more about the 2026 Transplant Games of America
Important Information
Intended Use and Limitations for the Alinity m CMV, EBV, and 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 quantitate cytomegalovirus (CMV) DNA in human EDTA plasma.
The Alinity m CMV assay is intended for use as an aid in the management of hematopoietic stem cell transplant and solid organ transplant patients who are undergoing anti‑cytomegalovirus therapy.
The Alinity m CMV assay can be used to assess virological response to anti‑cytomegalovirus therapy. Results from the Alinity m CMV assay must be interpreted within the context of all relevant clinical and laboratory findings.
The Alinity m CMV assay is not intended as a screening test for the presence of CMV DNA in blood or blood products.
Limitations
Optimal performance of this test requires appropriate specimen collection and handling. Human plasma (K2 EDTA, K3 EDTA, and plasma preparation tubes [PPT]) specimens may be used with the Alinity m CMV assay. The use of other plasma tubes has not been evaluated.
Debris within plasma specimens (for example, fibrin strands) may interfere with sample processing. Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
The instruments and assay procedures reduce the risk of contamination by amplification product; however, nucleic acid contamination from calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
Test results are to be interpreted by qualified licensed healthcare professionals in conjunction with clinical signs and symptoms and other relevant laboratory results. A specimen with a result of “Not Detected” cannot be presumed to be negative for CMV DNA.
Due to the potential for variability in CMV viral load measurements across different CMV assays, it is recommended that the same device be used for the quantitation of CMV viral load when managing CMV infection in individual patients.
Testing of drug‑resistant CMV specimens has not been evaluated in the clinical study.
Test performance characteristics have been evaluated only for individuals who have undergone solid organ transplant and hematopoietic stem cell transplant, and who have been diagnosed with CMV disease and are undergoing treatment. No information is available on test performance in patients undergoing other types of transplant procedures, neonates or pediatric patients, or AIDS or other immunocompromised patients.
This test is not intended for use as a screening test for the presence of CMV in blood or blood products and has not been evaluated as a diagnostic test to confirm the presence of CMV infection.
Intended Use
The Alinity m EBV assay is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Epstein‑Barr virus (EBV) DNA in human EDTA plasma on the automated Alinity m System.
The Alinity m EBV assay is intended for use as an aid in the management of EBV in transplant 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.
Results from the Alinity m EBV assay must be interpreted within the context of all relevant clinical and laboratory findings.
The Alinity m EBV assay is not cleared for use as a screening test for donors of blood, blood products, or human cells, tissues, and cellular and tissue‑based products (HCT/Ps) for EBV.
Limitations
Optimal performance of this test requires appropriate specimen collection and handling. Human plasma (K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m EBV assay. The use of other specimen types or plasma tubes has not been evaluated.
Debris within plasma specimens (for example, fibrin strands) may interfere with sample processing. Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
The instruments and assay procedures reduce the risk of contamination by amplification product; however, nucleic acid contamination from calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
Due to the potential for variability in EBV viral load measurements across different EBV assays, it is recommended that the same device be used for the quantitation of EBV viral load when managing individual patients.
Negative test results do not preclude viral infection or tissue‑invasive viral disease. Test results must not be the sole basis for patient management decisions.
As with any molecular test, mutations within the target regions of the Alinity m EBV assay could affect primer and or probe binding, resulting in under‑quantitation of virus or failure to detect the presence of virus.
While elevated EBV viral load may suggest post‑transplant lymphoproliferative disorders (PTLD), the diagnosis of PTLD is based on histological evaluation of tissue biopsy. PTLD may be present without detectable EBV viral load, and an increase in EBV viral load is not necessarily diagnostic of PTLD.
The assay is not intended for use as a screening test for the presence of EBV in blood or blood products and has not been evaluated as a diagnostic test to confirm EBV infection in immunocompetent individuals.
Intended Use
The Alinity m BKV assay is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma (K2 EDTA, K3 EDTA, and PPT) and urine stabilized using the Alinity m Urine Transport Kit on the automated Alinity m System.
In EDTA plasma and stabilized urine, the Alinity m BKV assay is intended for use as an aid in the diagnosis and 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.
Results from the Alinity m BKV assay must be interpreted in conjunction with clinical signs and symptoms and other relevant laboratory findings.
The Alinity m BKV assay is not cleared as a screening test for blood or blood products or for human cells, tissues, and cellular and tissue‑based products.
Limitations
The Alinity m BKV assay has been evaluated only for use in combination with the Alinity m BKV Control Kit, Alinity m BKV Calibrator Kit, Alinity m Lysis Solution, Alinity m Diluent Solution, and Alinity m Vapor Barrier Solution on the Alinity m System.
Optimal performance requires appropriate specimen collection and handling. Human EDTA plasma (K2 EDTA, K3 EDTA, and PPT) and urine specimens stabilized using the Alinity m Urine Transport Kit may be used. Other specimen types have not been evaluated.
Plasma and stabilized urine BKV DNA level measurements are not directly comparable. Quantitation of BKV DNA may be affected by sample collection methods, patient factors, and stage of infection.
Degradation of BKV DNA in neat urine can affect quantification. Transfer of urine into the Alinity m Urine Transport Kit is required to achieve specimen stability.
Debris within plasma specimens may interfere with sample processing. Diluted plasma specimens must be tested within 2 hours and should not be frozen.
Test results are to be interpreted by qualified licensed healthcare professionals in conjunction with clinical and laboratory findings. Negative test results do not preclude viral infection or tissue‑invasive disease and must not be used as the sole basis for patient management decisions.
Quantitative variability of BKV DNA inherent to urine has been observed in different aliquots of the same sample. Due to variability across assays, it is recommended that the same device be used for quantitation when managing BKV infection in individual patients.
Assay interference has been observed with mucus and peripheral blood mononuclear cells at elevated concentrations. Performance for BKV subgroup or subtype Ic and II was established using armored DNA only.
For In Vitro Diagnostic Use. Rx Only.