Alinity m CMV Assay

Alinity m CMV AMP Kit Package Image_CE.jpg


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)
    • 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

VIEW ORDERING INFORMATION

Product Details
 

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 and whole blood. 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 and whole blood. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for CMV.

specifications
 

 

ABBOTT ALINITY m CMV ASSAY Specifications1-5
Technology Real-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 Design Single-stranded linear probes
Target Region UL34 and UL80.5 
Genotypes gB1, gB2, gB3, gB4
Specimen Types Plasma: KEDTA; KEDTA; plasma preparation tubes (PPTs)
Whole Blood: KEDTA; KEDTA

Sensitivity

Limit of Detection

Plasma: 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)
Whole Blood: LoD = 75 IU/mL
Probit analysis determined that the concentration of CMV DNA detected with 95% probability was 53.04 IU/mL (95% CI: 43.55, 68.29 IU/mL)
Linearity Plasma: 30 to 100,000,000 IU/mL
Whole Blood: 75 to 100,000,000 IU/mL
Result Units IU/mL or Log (IU/mL)
Precision Plasma: ≤ 0.29 Log IU/mL Total SD
Whole Blood: ≤ 0.43 Log IU/mL Total SD
Sample Input Volume  Plasma: 500 μL
Whole Blood: 300 μL
Controls Negative, low positive and high positive controls (single-use tubes)
Calibrator 2 calibrator levels (single-use tubes)
Internal Control DNA (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.   
 
 

Ordering Info

Related Product
 

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

Learn More

alinity_m_right_no_shadow_edited2_thumbnail.png

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.

Do you wish to continue and exit this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No