Carestart rapid antigen test instructions This Fact Sheet contains information to help you understand the risks and benefits of using this CareStart TM . Dr Amir Khan shows you how to test yourself for coronavirus (COVID-19) using a self-test rapid antigen test kit, as well as how to read your result and repor Access Bio’s rapid antigen test is CLIA Waiver and point-of-care authorized. Page 4 of 21 The CareStart™ COVID-19 Antigen is intended for use in point of care settings and operated by healthcare professionals or trained users specifically instructed in the use of the ™ CareStart The CareStart ™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. • The CareStart™ COVID-19 Antigen test should be ordered for the detection of COVID-19 in individuals who are suspected of COVID-19 by their healthcare provider and who are within five days of symptom onset. CareStartTM COVID-19 Antigen Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen IFU-RCHM71-E / Rev. Jan 17, 2023 · For in vitro diagnostic use only The CareStart™ COVID-19 Antigen is a rapid (approximately 10 Section 564(b)(1) of theFederal Food,Drug,and Cosmetic Act,21 U. * For children aged 2-11, the CareStart™ test should be conducted or supervised by a parent of legal guardian. The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals COVID-19 Antigen Home Test USER INSTRUCTIONS ENGLISH NOTE: The test results should be read at 10 minutes after the sample application. net) Your sample(s) was tested for COVID-19 using the CareStart™ COVID-19 Antigen test. For Professional Use Only. CARESTART™ COVID-19 ANTIGEN HOME TEST Access Bio, Inc. COVID-19 Antigen . • The CareStart™ COVID-19 Antigen test can be used to test directly collected nasopharyngeal or anterior nasal swab specimens. • The test device must remain in the sealed pouch until use. S. Storage and Stability • Store the test kit as packaged between 1 ~ 30°C. All users must achieve 100% on the training test. Food and Drug Administration The CareStart Antigen Home Test is suitable for use by those aged 12 years and above who have experienced COVID-19 like symptoms, including fever, cough, tiredness or a loss of taste or smell. On/Go is proudly manufactured in the United States. The test result must be read before 15 minutes as test results after 15 minutes may not be accurate. - Do not use beyond the RCLM-02571 CareStart Rapid Diagnostic Test for Detection of SARS -CoV-2 IgM/IgG Ab TM COVID-19 IgM/IgG IFU-RCLM71-E / Rev. However, it is possible for this test to give a negative result that is incorrect (false negative) in The On/Go™ COVID-19 Antigen Self-Test is an over-the-counter, self-administered rapid test that delivers results in just 10 minutes. CareStartTM COVID-19 Antigen Home Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen IFU-RCPM71-E / Rev. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is . Sep 8, 2021 · A step by step guide on how to administer the CareStart Rapid Antigen Test. Healthcare Provider Instructions for Use . The CareStart CareStart Rapid Diagnostic Test for Detection of SARS -CoV-2 Antigen TM COVID-19 Antigen IFU-RCHM71-E / Rev. Jan 17, 2025 · CareStart COVID-19 Antigen Home Test. . Do not use beyond the expiration date. m. Page 2 of 17 Intended Use The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. A ACCESS BIO, INC. D ACCESS BIO , INC. C / January 2022 Results Interpretation CareStart™ Mobile Application Make sure you wait Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen . - In the USA, this product has not been FDA cleared or approved CareStart TM COVID-19 Antigen Home Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen IFU-RCPM71-E / Rev. Nov 22, 2021 · CareStart COVID-19 Antigen Home Test Rapid Diagnostic Test for Detection of SARS -CoV-2 AntigenTM IFU-RCPM71-E / Rev. U. Page 4 of 21 is recommended. It is a requirement that users view, understand and complete the online training module prior to administering the test. Sep 8, 2021 · Step by step guide on how to self-administer the CareStart Rapid Antigen Test under the supervision of a medical or health practitioner CARESTART™ COVID-19 ANTIGEN HOME TEST Access Bio, Inc. E Access Bio, Inc. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. : 8 a. A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. Failure to follow the instructions may result in inaccurate test results. The CareStart ™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. CareStart TM COVID-19 Antigen Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen IFU-RCHM71-E / Rev. - For prescription and in vitro diagnostic use only. C. The following videos outline the correct procedure on how to administer the CareStart™ COVID-19 Rapid Antigen Test. Page 2 of 23 Table of Contents Jan 17, 2023 · CareStart ™ COVID-19 Antigen test does not diﬀerentiate between SARS-CoV and SARS-CoV-2. B ACCESS BIO , INC. Page 4 of 18 impacts on healthcare systems and the world economy including the U. CareStart-19 Antigen are stable until the expiration date printed on the outer packaging. Page 2 of 21 Intended Use The CareStart ™ COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. to Fri. CareStart™ COVID -19 Antigen Coronavirus Disease 2019 (COVID -19) 2 • What does it mean if I have a negative test result? is . To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. C ACCESS BIO , INC. If you have any questions, please contact Access Bio, Inc. - Read all instructions carefully before performing the test. If the internal procedural control line is still absent in the retest, please contact the Technical Support at +1-888-898-1270 (Available Hours: Mon. GoToKnow COVID-19 Antigen Rapid Please note that not all tests are the same. Aug 2, 2021 · The CareStart ™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals CareStart TM . With results in 15 minutes and a visual readout with no analyzer required, CareStart™ is the fastest way to diagnosis COVID-19. links to home use instructions for each test, and other details that may help you decide what test is right for you. QRI-RCOM-E / Rev. At-home rapid antigen tests are a key in s Step by step guide on how to administer the CareStart Rapid Antigen Test. This test is authorized for non-prescription home use for individuals with symptoms of COVID-19 within the first 7 days of symptom onset. If the external control results are invalid, please contact the Technical Support at CareStart™ COVID-19 Antigen ™ Instructions for use Nasal swab Process the test sample immediately after collection. RCPM-00171, RCPM-00271, RCPM-00471, RCPM-00571, RCPM-02071, RCPM-02571, RCPM-03071 Apr 15, 2021 · be tested using the swab test procedure provided in this package insert or the quick reference instruction card. • The reagents and materials in the ™ COVID. (info@accessbio. Read through the instructions included with the test before you begin. March 14, 2023 All individuals who use this assay COVID-19 Antigen Home Test Quick Reference Instructions before they use the test. cwxaaq yfny ojgsx gdrg eeai lfrrk gfwr doulp nxuav nole hlluap idg xkitb xdwh zcon