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ALINITY m BKV ASSAY

ALINITY m BKV ASSAY image
ALINITY m BKV ASSAY image
ALINITY m BKV ASSAY image
Unique dual target assay design, precise and sensitive results on a random access system supports confident decision making to help reduce the risk of transplant rejection.
Patients: Helps reduce the risk of transplant rejection or complications
Clinicians: Accuracy in viral load monitoring helps provide guidance on treatment decisions
Laboratories: Random access, mixed-sample loading, and the ease of running up to 20 different tests at once without compromising throughput supports the lab in improving operational efficiencies
Healthcare systems: Strive to reduce costs through consolidation while supporting critical clinician decisions

ABBOTT'S HIGH PERFORMING TESTING AT DECISIVE MOMENTS IN TRANSPLANT PATIENT CARE

The Alinity m BKV Assay combined with the Alinity m system delivers accurate and timely viral load results, which helps clinicians guide patient care with confidence.

Improved Operational Efficiency

  • Alinity m is a continuous and random-access molecular analyzer with a time to first result of less than 115 minutes that provides the ability to eliminate batching procedures and lead to improved laboratory workflow
  • Random access and STAT prioritization provide timely results that support clinicians in their decision to initiate and manage treatment effectively

Improved Confidence

  • Dual-target assay design helps provides robust, accurate and sensitive detection of BKV
  • Assay is standardized to the 1st World Health Organization (WHO) International Standard for BK virus DNA, NIBSC code 14/212, intended for the standardization of nucleic amplification technique-based assays for BKV
  • Alinity m provides the ability to test Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and BK Virus from a single plasma sample, which is critical for transplant patients who are at risk of developing coinfections
  • Plasma and Urine specimen types can be used with the Alinity m BKV assay on the Alinity m System
Instructions For Use
VIEW ORDERING INFORMATION

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.

 

LIMITATIONS OF THE PROCEDURE
 

  • 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.

 

AssayAlinity m BKV
TechnologyReal-time PCR
Assay Run Time< 115 min time to first result
Throughput300 samples in ~8 hours;
Up to 1,080 samples in 24 hours*
Probe DesignSingle-stranded linear probes
Target RegionsVP2/VP3 and small T antigen genes2
Sample TypesPlasma: K2 EDTA; K3 EDTA; plasma preparation tube (PPT)a
Urine: Alinity m Urine Transport Kit (List No. 09N85-001)
Limit of Detection (LOD)Plasma and Urine: 50 IU/mL (1.70 Log IU/mL)
Linear RangePlasma and Urine: 1.70 Log IU/mL to 9.00 Log IU/mL
PrecisionPlasma 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 UnitsIU/mL or Log (IU/mL)
Input Volume (Aspirated)500 µL
Standardization1st World Health Organization (WHO) International Standard for BK Virus for Nucleic Acid Amplification Techniques (NIBSC code: 14/212)
Internal ControlYes, Plasmid DNA
External ControlsNegative, Low Positive, High Positive
Calibrators2 calibrator levels (single-use tubes)

*Number of actual samples per 24-hour perid may vary based on laboratory practice and workflow.
aPlasma preparation tubes are gel tubes.
1. Alinity m BKV AMP Kit Package Insert 53-608288/R3
2. Abbbott Data on File.
3. Alinity m Operations Manual: 54-605001/R13.
The Alinity m BKV AMP Kit is an in vitro diagnostic device, which is CE-marked. Notified body number 2797.

AMPLIFY YOUR IMPACT WITH ALINITY M
 

Alinity m is a fully integrated and automated molecular diagnostics analyzer that uses ReadiFlex technology to deliver the next level of flexibility and efficiency to your lab. 
 

FLEXIBILITY: True random access to perform any test, any time
TURNAROUND TIME: <115 minutes time to first result
THROUGHPUT: 300 samples in ~8 hours

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