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ALINITY m EBV ASSAY

ALINITY m EBV ASSAY image
ALINITY m EBV ASSAY image
ALINITY m EBV ASSAY image

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

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

For in vitro diagnostic use. Rx Only.

  • 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 provides robust and accurate detection of EBV
    • Assay is standardized to the 1st World Health Organization (WHO) International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques (NIBSC code: 09/260)
    • Precise and sensitive results from plasma samples
    • Alinity m provides the ability to test Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) from a single sample, which is critical for transplant patients who are at risk of developing coinfections
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INTENDED USE
 

Alinity m EBV 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.

Alinity m EBV 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.

The results from Alinity m EBV must be interpreted within the context of all relevant clinical and laboratory findings. Alinity m EBV 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 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 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 (eg, 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 the 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.
  • Test results are to be interpreted by qualified licensed healthcare professionals in conjunction with clinical signs and symptoms and other relevant laboratory results.
  • As with any molecular test, mutations within the target regions of Alinity m EBV could affect primer and/or probe binding resulting in the 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 made 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.
  • This test 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 the presence of EBV infection in an immunocompetent population.

 

ABBOTT ALINITY m EBV ASSAY SPECIFICATIONS1-5
TechnologyReal-time PCR
Time to First Result< 115 minutes
Throughput300 samples in ~8 hours; 
Up to 1,080 samples in 24 hours*
ClaimAids in the management of EBV in transplant patients
Standardization1st World Health Organization (WHO) International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques
(NIBSC code: 09/260)
Probe DesignSingle-stranded linear probes
Target RegionsGP350 and EBNA1
Specimen TypePlasma: K2 EDTA; K3 EDTA; plasma preparation tubes (PPTs)**
Sensitivity
Limit of Detection (LoD)		LoD = 20 IU/mL
Probit analysis determined that the concentration of EBV DNA detected with 95% probability was 19.56 IU/mL with a 95% confidence interval (CI) of (13.09 IU/mL, 39.39 IU/mL)
Linearity50 IU/mL to 200,000,000 IU/mL
Result UnitsIU/mL or Log (IU/mL)
PrecisionAlinity m EBV within-laboratory standard deviation (SD) was less than or equal to 0.25 Log IU/mL for EBV DNA panels targeted in the range of 2.70 Log IU/mL to 8.30 Log UI/mL (500 IU/mL to 200,000,000 IU/mL), and less than or equal to 0.50 Log IU/mL for EBV DNA panels targeted in the range of 1.30 Log IU/mL to less than 2.70 Log IU/mL (20 IU/mL to less than 500 IU/mL)
Sample Input Volume 500 μL
ControlsNegative, low positive and high positive controls (single-use tubes)
Calibrator2 calibrator levels (single-use tubes)
Internal ControlDNA (Pumpkin)

*Number of actual samples per 24-hour period may vary based on laboratory practice and workflow. **Plasma Preparation Tubes are gel tubes. 1. Alinity m EBV AMP Kit Package Insert: 53-608247/R1.
2. Alinity m EBV CAL Kit Package Insert: 53-608245/R1.
3. Alinity m EBV CTRL Kit Package Insert 53-608244/R2. 4. Abbbott Data on File.
5. Alinity m Operations Manual: 54-605001/R10.

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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