Flex flow covid test1/18/2024 The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. The agent detected may not be the definite cause of disease. Positive results do not rule out bacterial infection or co-infection with other viruses. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. This antigen is generally detectable in upper respiratory samples during the acute phase of infection. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. The SARS-CoV-2 Antigen Rapid Test can also test specimens from individuals without symptoms or other reasons to suspect COVID-19 infection when tested twice over two (or three days) with at least 24 hours (and no more than 36 hours) between tests. Assembled and Distributed by MedSup Medical, Montréal, QC.Expiry date: 24 months after manufacturing (current batch expires 2024-02).Conservation: Keep at 2℃ - 30℃, keep dry.Contents: 5 Test Cassettes, 5 Extraction Buffer Tubes, 5 Disposable Nasal Swabs, 1 Packaging Insert.Flowflex COVID-19 Antigen Home Test Shelf-life Expiration Extension Letter 3.15.The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.Acon FlowFlex Labeling Changes Mar 2023 A rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal and nasopharyngeal swab.FlowFlex COVID-19 Antigen Home Test Quick Reference Instructions.FlowFlex COVID-19 Antigen Home Test Package Insert for Healthcare Providers.FlowFlex COVID-19 Antigen Home Test Healthcare Providers Fact Sheet.FlowFlex COVID-19 Antigen Home Test Package Insert.FlowFlex COVID-19 Antigen Home Test FDA EUA Letter.Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19Ĭlinical performance showed 93% sensitivity and 100% specificity Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed ![]() Individuals who test positive should self-isolate and consult their healthcare provider as additional testing may be necessary and for public health reporting Positive results do not rule out bacterial infection or co-infection with other viruses ![]() ![]() Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status ![]() This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older Product ships with minimum 60 days dating Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection
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