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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.
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 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 | |
Technology | Real-time PCR |
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)** |
Sensitivity 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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