Alinity m SARS-CoV-2 Assay with Claim Extension
For more information, contact Abbott.
For more information, contact Abbott.
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INTENDED USE (09N78-091)
The Alinity m SARS-CoV-2 assay is a reverse transcription polymerase chain reaction (RT-PCR) test for use with automated Alinity m System for the qualitative detection of nucleic acid from SARS-CoV-2 from patients with or without signs and symptoms of COVID-19 infection in the following specimen types
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results from pooled testing should not be treated as definitive. If patient’s clinical signs and symptoms are inconsistent with a negative result and if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.
The Alinity m SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
To learn more about Alinity m SARS-CoV-2 Assay please visit: https://www.molecular.abbott/int/en/alinity-m-sars-cov-2-assay
| ABBOTT ALINITY m SARS-COV-2 ASSAY SPECIFICATIONS | |
| Technology | Qualitative real-time PCR |
| Assay Run Time | < 115 min time to first results (12 results), 12 more results 16 min thereafter (assumption 100% efficiency) |
| Assay Design | Dual-target, single-stranded linear probe |
| Target Region | RdRp and N-genes |
| Specimen Types | Nasopharyngeal (NP) swabs, oropharyngeal (OP) swabs, nasal swabs, saliva, and pooled sample containing aliquots of transport media from up to 5 individual nasal, NP, and OP swabs |
| Result Interpretation | Positive / Negative |
| Minimum Sample Volume | Depending on tube type between 0.8 mL and 1.4 mL (see package insert for details) |
| Controls | One negative and one positive control per 48 hours |
| Internal Control | Armored RNA® from pumpkin gene, added to each specimen and control |
| Throughput | Up to 1080 samples in 24 hours (Number of actual samples per 24-hour period may vary based on laboratory practice and workflow) |
| Limit of Detection | Recombinant Virus in SNM and Saliva*: 100 virus copies/mL; CGIV** in NP and Nasal Swab: 0.009; TCID50/mL (or 55 GE/mL; CGIV** in Saliva: 55 GE/mL |
1. Alinity m SARS-CoV-2 with Claim Extension AMP kit Package Insert (PI) 53-608278/R1. 2. Alinity m SARS-CoV-2 CTRL Kit PI 53-608194/R1; 3. Alinity m Operations Manual 54-605001/R10; * Simulated Nasal Matrix; **Cultured Gamma-Irradiated Virus
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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.