The Alinity m BKV assay combines the performance the labs need to deliver results to clinicians fast and helps to reduce the risk of transplant rejection.
For In Vitro Diagnostic Use. Rx Only.
The Alinity m BKV assay combines the performance the labs need to deliver results to clinicians fast and helps to reduce the risk of transplant rejection.
Fast and accurate detection for BK Virus (BKV) viral load in Solid Organ Transplant (SOT) and Hematopoietic Stem Cell Transplantation (HSCT) patients is critical for1
Unique dual-target assay design helps provide robust, accurate and sensitive detection of BKV.
Plasma and Urine specimen types can be used with the Alinity m BKV assay on the Alinity m System.
Low limit of detection, high sensitivity and precise results, helps ensure confidence in test results.
Assay is standardized to the 1st World Health Organization (WHO) International Standard for BK virus DNA.
Test for cytomegalovirus (CMV), Epstein-Barr virus (EBV), and BKV from a single plasma sample, crucial for transplant patients facing the risk of coinfections.
Random access and STAT capability of Alinity m provides timely results that support clinicians to manage transplant patient treatment effectively
In EDTA plasma (K2 EDTA, K3 EDTA, and PPT) and urine stabilized using the Alinity m Urine Transport Kit, Alinity m BKV 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.
The results from Alinity m BKV must be interpreted in conjunction with clinical signs and symptoms and other relevant laboratory findings.
Alinity m BKV is not cleared as a screening test for blood or blood products or human cells, tissues, and cellular and tissue-based products.
Alinity m BKV has been evaluated only for use in combination with the Alinity m BKV CTRL Kit, Alinity m BKV CAL Kit, Alinity m Lysis Solution, Alinity m Diluent Solution, and Alinity m Vapor Barrier Solution on the Alinity m System.
• 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 stabilized using the Alinity m Urine Transport Kit may be used with the Alinity m BKV assay. The use of other specimen types has not been evaluated. Plasma and stabilized urine DNA level measurements are not directly comparable to each other and to those of other sample types.
• Quantitation of BKV DNA may be affected by sample collection methods, patient factors (eg, age, presence of symptoms), and/or 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 (eg, fibrin strands) may interfere with sample processing.
• Diluted plasma 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 the 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.
• Negative test results do not preclude viral infection or tissue invasive viral disease and test results must not be 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 (urine stabilized using the Alinity m Urine Transport Kit).
• 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.
• Performance characteristics for BKV subgroup/subtype Ic and II were established using armored DNA only.
Technology | Real-time PCR |
Claim | Intended for use as an aid in the diagnosis and management of BKV in transplant patients. |
Standardization | 1st World Health Organization (WHO) International Standard for BK Virus for Nucleic Acid Amplification Techniques (NIBSC code: 14/212) |
Assay Run Time | < 120 min time to first result |
Throughput | Up to 300 samples in ~8 hours |
Probe Design | Single-stranded linear probes |
Target Regions | VP2/VP3 and small T antigen genes |
Genotypes | Detection of BKV subgroups Ia and Ic, and subtypes II, III, and IV at the claimed LoD in urine and plasma |
Sample Types | Plasma: K2 EDTA; K3 EDTA; plasma preparation tube (PPT)a |
Sensitivity Limit of Detection (LOD) | Plasma and Urine: 50 IU/mL (1.70 Log IU/mL) |
Linear Range | Plasma and Urine: 1.70 Log IU/mL to 9.00 Log IU/mL |
Precision | Plasma and Urine: < 0.25 Log IU/mL from 2.70 to 9.00 Log IU/mL; < 0.50 Log IU/mL from 1.70 to < 2.70 Log IU/mL |
Results Units | IU/mL or Log (IU/mL) |
Input Volume (Aspirated) | 500 µL |
Specificity | 100.0% (95% CI: 99.2% to 100.0%) |
Internal Control | Yes, Plasmid DNA |
External Controls | Negative, Low Positive, High Positive (single-use tubes) |
Calibrators | 2 calibrator levels (single-use tubes) |
Talk to your Molecular sales representative to learn more.
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1. Cohen-Bucay A, Ramirez-Andrade SE, Gordon CE, Francis JM, Chitalia VC. Advances in BK Virus Complications in Organ Transplantation and Beyond. Kidney Med. 2020 Oct 11;2(6):771-786. doi: 10.1016/j.xkme.2020.06.015. PMID: 33319201; PMCID: PMC7729234.
2. Alinity m BKV Package Insert 53-608402/R1
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