Alinity m CMV Assay
For more information, contact Abbott.
For more information, contact Abbott.
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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 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.
To learn more about Alinity m CMV Assay please visit: https://www.molecular.abbott/int/en/Alinity-m-CMV-Assay
| 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: K2 EDTA; K3 EDTA; plasma preparation tubes (PPTs) Whole Blood: K2 EDTA; K3 EDTA |
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 period 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.
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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.