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COVID-19 Testing: CareStart™ Rapid Antigen 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.

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

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

SUMMARY and EXPLANATION of the TEST

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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Frequently asked questions

What type of test is this?


The CareStart™ COVID-19 Antigen Test utilizes a nasopharyngeal swab and a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms. The CareStart™ COVID-19 Antigen tests have been authorized by the FDA under an emergency use authorization for the detection of proteins from SARS-CoV-2.




Who should use this test?


The test is indicated for all people aged 15 years or older and for children as young as 2 years old when samples are collected by an adult. The test can be used for people with and without symptoms.




Should people who were vaccinated use this test?


Testing will remain an essential part of our short- and long-term COVID-19 recovery strategy. Testing will be a key tool alongside vaccination as we get back to life. We don't yet know how long vaccines confer immunity and how variants will evolve.




How will people receive their test results?


All patients will receive access to their test results through a HIPAA compliant online portal system.




How long should people wait between taking Rapid Antigen Tests?


The tests should be administered twice over three days with at least 36 hours between tests.




Is this test authorized by the FDA?


The FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).




What does a positve result mean?


Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.




What does a negative result mean?


Negative results should be treated as 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. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.





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