Thank you “Sportsman” for Fact Sheet on Acuvid for TSXV:THRM by isnarain

FACT SHEET FOR HEALTHCARE PROVIDERS
Therma Bright Inc. September 12, 2021 AcuVid™COVID Antigen Coronavirus Disease 2021 (COVID-19) This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the AcuVid™COVID Antigen test. AcuVid™COVID Antigen test is authorized for the detection of SARS-CoV-2 using direct saliva specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first six days from the onset of symptoms. All patients whose specimens are tested with this test will receive the Fact Sheet for Patients: AcuVid™COVID Antigen. What are the symptoms of COVID-19? Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that, when present, symptoms include cough,shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat, new loss of taste or smell, nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom onset is approximately 5 days. For further information on the symptoms of COVID-19 please see the link provided in “Where can I go for updates and more information?” section. Public health officials have identified cases of COVID-19

infection throughout the world, including the United States.

Please check theCDC COVID-19webpage (see link provided in “Where can I go for updates and more information?” section at the end of this document) or your local jurisdiction’s website for the most up to date information. This test is to be performed only using saliva swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first six days from the onset of symptoms. What do I need to know about COVID-19 testing? Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information?” section). • The AcuVid™COVID Antigen test is to be used to test sub buccal saliva specimens directly from collection. The swab provided in the AcuVid™COVID Antigen test kit is intended to be used to swab the inner cheek, rubbing around the cheek cavity three times on each side to obtain adequate sample. • The AcuVid™COVID Antigen test can be used to test sub buccal saliva from COVID-19 symptomatic individuals within the first six days of symptom onset. • The AcuVid™COVID Antigen Test has received conditional

approval for in home testing in the United States, certified

under the Clinical Testing Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. The AcuVid™COVID Antigen Test is authorized for use for at home testing; Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions is available at the CDC’s website (see links provided in “Where can I go for updates and more information?” section). Use appropriate personal protective equipment when collecting and handling specimensfromindividualssuspected

of having COVID-19 as outlined in the CDC Interim Laboratory

Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For

additional information, refer to CDC Interim Guidelines for

Collecting, Handling, and Testing Clinical Specimens from

Persons Under Investigation

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