COVID-19 Testing: CareStart™ Rapid Antigen Test

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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.

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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.

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Anterior Nares Swab: 87.2% clinical sensitivity and 100% clinical specificity
Nasopharyngeal Swab: 93.8 % clinical sensitivity and 99.3% clinical specificity

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CareStart™ COVID-19 Antigen Test: a breakthrough antigen test

• Simple test procedure using a nasal swab, and a test kit the size of a credit card

• Receive results in 15 minutes

• Detects active COVID-19 infection

• Intended for individuals suspected of COVID-19 within the first seven days of symptom onset

• 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 and nasopharyngeal swab specimens

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SUMMARY and EXPLANATION of the TEST

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Coronaviruses are a large family of viruses that may cause illness in animals or humans. SARS-CoV-2 is an enveloped, single-stranded RNA virus of the β genus. The virus can cause mild to severe respiratory illness and has spread globally, including in the United States. The CareStart Rapid Antigen Test is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 directly from nasal swabs, without viral transport media.

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