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.
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
|ABBOTT ALINITY m EBV ASSAY Specifications1-5|
|Time to First Result||< 115 minutes|
|Throughput||300 samples in ~8 hours;
Up to 1,080 samples in 24 hours*
|Claim||Aids in the management of EBV in transplant patients|
|Standardization||1st World Health Organization (WHO) International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques
(NIBSC code: 09/260)
|Probe Design||Single-stranded linear probes|
|Target Regions||GP350 and EBNA1|
|Specimen Type||Plasma: K2 EDTA; K3 EDTA; plasma preparation tubes (PPTs)**
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)
|Linearity||50 IU/mL to 200,000,000 IU/mL|
|Result Units||IU/mL or Log (IU/mL)|
|Precision||Alinity 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
|Controls||Negative, low positive and high positive controls (single-use tubes)|
|Calibrator||2 calibrator levels (single-use tubes)|
|Internal Control||DNA (Pumpkin)|
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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