CareStart™ COVID-19 Antigen Home Test Self Test for SARS-CoV-2 Antigen Detection 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. Under FDA’s EUA, CareStart™ COVID-19 Antigen Home 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. This test is also authorized for non-prescription home use with adult-collected nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. ORDERING INFORMATION For use under Emergency Use Authorization Only For In Vitro Diagnostic Use Only Compatible OS Systems: iOS13 or newer for Apple iPhone Android10 or newer for Android Phone Disclaimer: As of November 22, 2021, CareStart™ COVID-19 Antigen Home Test is authorized to use with individual anterior nasal swab specimens from individuals age 14 years and older (self-collected), or 2 years and older (collected with adult assistance) for non-prescription home use by FDA under the EUA (EUA210314/S002). The authorized labeling has been changed with the new indication (Quick Reference Instructions (QRI) and Fact Sheet for Individuals, Instructions for Use (IFU) for Healthcare Providers (HCP), Fact Sheet for HCP, and kit package); however, CareStart™ COVID-19 Antigen Home Test will continue to be distributed with the labeling previously authorized per EUA210314/S001 on the FDA’s enforcement discretion in efforts to increase the testing accessibility for COVID-19. Since the differences between the CareStart™ COVID-19 Antigen Home Test kit previously authorized (EUA210314/S001) and currently authorized (EUA210314/S002) are limited to the authorized labeling, you may use the CareStart™ COVID-19 Antigen Home Test kit with the new indication for use (described above). Features Fast and easy to self-test at anywhere Easy to interpret the results using mobile application Qualitatively detect the SARS-CoV-2 nucleocapsid protein Use for nasal swab specimen Fast results only in 10 minutes Identify individual’s current infection status to COVID-19 TEST PRINCIPLES PROCEDURE RESULTS INTERPRETATION ORDER INFORMATION PRODUCT DOCUMENTATION CONTACT US CONTACT US FOR MORE INFORMATION ON HOW TO ORDER. Please provide your information, and we will contact you within one business day. COUNTRY?* USA South Korea All Other Countries INQUIRY PURPOSE?* Outside US Market Inside US Market Selling General Inquiry Product Inquiry HR Inquiry IR Inquiry Other PRODUCT?* COVID-19 DETECTION KITS RAPID DIAGNOSTIC TESTS ANALYZERS MOLECULAR DIAGNOSTICS 65 Clyde Rd. Suite A Somerset, NJ 08873 USA +1. 732.873.4040 E-mail : info@accessbio.net ABOUT US Overview Vision CEO Message Global Operations PRODUCTS Product List Covid-19 Tests Rapid Diagnostic Tests Analyzers Molecular Diagnostics NEWS News and Events CAREERS Open Positions INVESTORS Investors Relations Korean Investors LEGAL Privacy Policy Terms & Conditions The information, software, products, and services included in or available through the site may include inaccuracies or typographical errors. Changes are periodically added to the information herein. Access bio and/or its suppliers may make improvements and/or changes in the site at any time. Access bio and/or its suppliers make no representations about the suitability, reliability, availability, timeliness, and accuracy of the information, software, products, services and related graphics contained on the site for any purpose. To the maximum extent permitted by applicable law, all such information, software, products, services, and related graphics are provided “as is” without warranty or condition of any kind. © 2021 ACCESS BIO. ALL RIGHTS RESERVED. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent. Cookie Settings Accept All