Aptitude Metrix Molecular Bundle
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Description
Sekisui Diagnostics Aptitude Metrix Molecular Bundle.
Features
- Positive results do not rule out bacterial infection or co-infection with other viruses.
- Individuals who test positive with the Metrix Covid-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
- Metrix is the first OTC molecular test authorized by FDA to work with saliva or swab sample.
- Metrix Covid-19 Test & Reader Starter Bundle - includes 2 Metrix Covid-19 Test Kits ( 1244258 - MTRX-C1925PK) and 1 reusable Metrix Reader (1244259 - MTRX-RDR).
- The Metrix Covid-19 Test (Metrix) is a single-use molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes Covid-19.
- The Metrix Covid-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2.
- This test is authorized for non-prescription home use with anterior nasal (nares) swab and saliva specimens, self-collected from any individual aged 14 years or older, or adult-collected from any individual aged 2 years or older, including individuals without symptoms or other epidemiological reasons to suspect Covid-19.
- Positive results indicate the presence of viral RNA, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status.
- Negative results from saliva samples are presumptive and should be confirmed by molecular testing of an alternative sample type if clinically indicated; negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual, including infection control decisions.
- Metrix Reader is intelligent: Metrix Reader comes with Bluetooth and WiFi modules; in the near future, you can access the test results of your reader anywhere, and receive tailored suggestions.
- Works with a standard USB-C plug or a battery pack.
- The Metrix COVID-19 test has not been FDA-cleared or approved; it has been authorized by the FDA under an Emergency Use Authorization (EUA).
Product Specifications
| Reading Type: | Machine Read |
|---|---|
| Sample Type: | Nasal Swab / Saliva Sample |
| Specialty: | Molecular |
| Technology: | Nucleic Acid Amplification Technology (NAAT) |
| Test Format: | Test Device Format |
| Test Kit Type: | Rapid |
|---|---|
| Test Method: | Mult-Gene Amplification |
| Time to Results: | 30-Minute Results |
| UNSPSC Code: | 41116144 |
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