Respiratory Test Kit, COVID-19 Multi-gene Amplification Rapid Test, for Metrix Reader, Contents Include: Cap, Collector, Swab, Sensor, Quick Ref Instruction, sold as 25/Kit by Metrix, Sekisui Diagnostics MTRX-C19-25PK

Features

• 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
• Requires Metrix Reader (not included)
• Metrix is the first OTC molecular test authorized by FDA to work with saliva or swab sample