CareStart™ COVID-19 Antigen Rapid Test
• Lateral flow, visual read assay.
• Detects the SARS-CoV-2 nucleocapsid protein antigen.
• Rapid results within 10 – 15 minutes.
• Intended for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. This test is authorized for use at the Point of Care (POC), 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 and nasopharyngeal swab specimens.
The Access Bio, Inc. CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal or anterior nares swab specimens directly collected from symptomatic individuals who are 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 high, moderate or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings by medical professionals 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.
The antigen is generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. 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 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. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The CareStart™ COVID-19 Antigen is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings.
Important Additional Information
• The CareStart™ COVID-19 Antigen test has not been FDA cleared or approved.
• This test has been authorized by the United States FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
• This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen and not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.