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ALINITY m CMV ASSAY

ALINITY m CMV ASSAY image
ALINITY m CMV ASSAY image
ALINITY m CMV ASSAY image

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

The Alinity m CMV 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 ensure protection against potential drug resistance mutations
    • Assay is standardized to the 1st World Health Organization (WHO) International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC Code: 09/162)
    • 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
 

The Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to detect and quantitate cytomegalovirus (CMV) DNA in human plasma. The Alinity m CMV assay is intended for use as an aid in the diagnosis and management of CMV in transplant patients and other immunocompromised patients. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in CMV DNA levels in plasma. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for CMV.

 

ABBOTT ALINITY m CMV ASSAY SPECIFICATIONS1-5
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 RegionUL34 and UL80.5 
GenotypesgB1, gB2, gB3, gB4
Specimen TypesPlasma: K2 EDTA; K3 EDTA; plasma preparation tubes (PPTs)

Sensitivity

Limit of Detection

LoD = 30 IU/mL
Probit analysis determined that the concentration of CMV DNA detected with 95% probability was 18.98 IU/mL (95% CI: 11.16, 62.82 IU/mL)
Linearity30 to 100,000,000 IU/mL
Result UnitsIU/mL or Log (IU/mL)
Precision≤ 0.29 Log IU/mL Total SD
Sample Input Volume Plasma: 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 perid may vary based on laboratory practice and workflow. 1. Alinity m CMV AMP Kit Package Insert: 53-608185/R1.  2. Alinity m CMV CAL Kit Package Insert: 53-608183/R1.   3. Alinity m CMV CTRL Kit Package Insert 53-608184/R1. 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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