Respiratory Test Kit Metrix™ COVID-19 Bundle 50 Tests

Features

• 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 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
• 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
• 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
• 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
• 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 is the first OTC molecular test authorized by FDA to work with saliva or swab sample
• 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)
• For external QCs see 1245689 (RED-S-19/99-P-01)

More Information

• Metrix COVID-19 Test FDA EUA Letter
• Metrix COVID-19 Test Kit OTC IFU
• Metrix COVID-19 Test Kit Healthcare Providers Fact Sheet
• Metrix COVID-19 Test Healthcare Providers IFU
• Metrix COVID-19 Test Sales Sheet