CareStart™ COVID-19 Antigen Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen ORDERING INFORMATION Access Bio’s CareStart™ COVID-19 Antigen RAPID POC TEST 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 without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. NOTE: For Serial Screening of asymptomatic individuals. The serial screening indication is only applied to products manufactured by Access Bio Inc. after April 12, 2021. The product batches listed in the Official Notification Letter (click to see) should not be marketed or used for POC serial screening purposes. Lateral flow assay Detect SARS-CoV-2 nucleocapsid protein antigen Rapid results within 10-15 minutes Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use only For prescription use only For use with direct anterior nasal or nasopharyngeal swab specimens Clinical Performance 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab 87.18% PPAa and 100% NPAb when used with anterior nasal swab aPPA: Positive Percent Agreement bNPA: Negative Percent Agreement TEST PRINCIPLES PROCEDURE Peel off aluminum foil seal from the top of the extraction vial containing the extraction buffer. Place the swab into the extraction vial. Rotate the swab vigorously at least 5 times. Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab. Close the vial by pushing the cap firmly onto the vial. Mix thoroughly by flicking the bottom of the tube. Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well. 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