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.
The Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate cytomegalovirus (CMV) DNA in human EDTA plasma. The Alinity m CMV assay is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant and Solid Organ Transplant patients who are undergoing anti-cytomegalovirus therapy. The Alinity m CMV assay can be used to assess virological response to anti-cytomegalovirus therapy. The results from the Alinity m CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The Alinity m CMV test is not intended as a screening test for the presence of CMV DNA in blood or blood products.
LIMITATIONS OF THE PROCEDURE
|ABBOTT ALINITY m CMV 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 and monitoring of CMV in immunocompromised and transplant patients|
|Standardization||1st World Health Organization (WHO) International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC code: 09/162)|
|Probe Design||Single-stranded linear probes|
|Target Region||UL34 and UL80.5|
|Genotypes||gB1, gB2, gB3, gB4|
|Specimen Type||Plasma: K2 EDTA; K3 EDTA; plasma preparation tubes (PPTs)**
Limit of Detection (LOD)
|LoD = 30 IU/mL
Probit analysis of the data using the least sensitive lot (Lot 3) determined that the concentration of CMV DNA in plasma detected with 95% probability was 21.52 IU/mL (95% CI: 13.22 to 54.92 IU/mL)
|Linearity||30 to 100,000,000 IU/mL
|Result Units||IU/mL or Log (IU/mL)|
|Precision||≤ 0.25 Log IU/mL Total SD
|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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