The Access Bio, Inc. CareStartTM 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 swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare provider.
As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStartTM COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.
- Rapid results within 10 minutes
- No lab equipment or additional instrument required
- Nasopharyngeal swab specimen collection
- Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow assay
- Designated as a CLIA waived tests
- Identify individual’s current infection status to COVID-19
- Fast and easy to use in Point-of-Care setting
- Qualitatively detect the SARS-CoV-2 nucleocapsid protein
- Use nasopharyngeal (NP) swab specimens
- Reliable results only in 10 minutes
- No special equipment or training required
- All-in-one package including collection swabs
- High sensitivity (88.4%) and specificity (100%)
- 20 test devices
- 20 extraction vials and caps
- 20 NP swabs
- 1 positive and 1 negative controls
- Package insert
- Quick reference Instructions (QRI)
EUA letter (FDA): https://www.fda.gov/media/142916/download
IFU (Instructions for Use): https://carestartantigen.com/wp-content/uploads/2020/10/EUA-accessbio-CareSAntigen-ifu-1.pdf
Fact Sheet for Healthcare Providers: https://carestartantigen.com/wp-content/uploads/2020/10/EUA-accessbio-CareSAntigen-hcp-1.pdf
Fact Sheet for Patients: https://www.fda.gov/media/142918/download
The CareStartTM COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen,, not for any other viruses or pathogens; this test 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 Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.
The CareStart™ COVID-19 Antigen Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. 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., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. 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. 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. The CareStart™ COVID-19 Antigen is only for use under the Food and Drug Administration’s Emergency Use Authorization.