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Alinity m EBV Assay

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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.
 

  • 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 for both plasma and whole blood 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

Intended Use

Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Epstein-Barr Virus (EBV) DNA in human EDTA plasma or whole blood. Alinity m EBV is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised 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 intended to be used in screening blood, blood products, tissue, or organ donors for EBV.

To learn more about Alinity m EBV Assay please visit: https://www.molecular.abbott/int/en/Alinity-m-EBV-Assay

ABBOTT ALINITY m EBV ASSAY SPECIFICATIONS1-5
TechnologyReal-time PCR
Assay Run Time< 115 min time to first result
Throughput 300 samples in ~8 hours; 
Up to 1,080 samples in 24 hours*
Probe DesignSingle-stranded linear probes
Target RegionGP350 and EBNA1
Genotypes1 and 2
Specimen TypesPlasma: K2 EDTA; K3 EDTA; plasma preparation tubes (PPTs)
Whole Blood: K2 EDTA; K 3 EDTA

Sensitivity

Limit of Detection

Plasma: LoD = 20 IU/mL
Probit analysis determined that the concentration of EBV DNA detected with 95% probability was 14.29 IU/mL (95% CI: 11.81, 18.22 IU/mL)

Whole Blood: LoD = 40 IU/mL
Probit analysis determined that the concentration of EBV DNA detected with 95% probability was 21.53 IU/mL (95% CI: 17.72, 28.62 IU/mL)
LinearityPlasma: 10 to 400,000,000 IU/mL
Whole Blood: 35 to 400,000,000 IU/mL
Result UnitsIU/mL or Log (IU/mL)
PrecisionPlasma: ≤ 0.26 Log IU/mL Total SD
Whole Blood: ≤ 0.29 Log IU/mL Total SD
Sample Input Volume Plasma: 500 μL
Whole Blood: 300 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 workflow.

1. Alinity m EBV AMP Kit Package Insert: 53-608243/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.

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