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RAPID Test
COVID-19 Antigen Rapid Test
- EASY TO USE
- RESULTS ARE READ AT 10 MINUTE
- HIGH ACCURACY
- NO EQUIPMENT REQUIRED
*CLIA Certificate of Waiver number required for purchase.
*This test is only approved in a Point-of-Care setting
Application:
General Population Screening
- Allows rapid examination
Hospitals, Physician Offices, Laboratories
- Can screen carriers who are asymptomatic
- Can help determine if patient recently affected by virus, even if virus is no longer present
Intended Use:
The CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for then detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset. The test if for professional use only.
*CLIA Certificate of Waiver number required for purchase.
*This test is only approved in a Point-of-Care setting
Principle:
The CareStartTM COVID-19 Antigencan be used to test freshly collected anterior nasal swab samples directly using a dual nares collection (swab inserted in both nares, 5 rotations per naris).
The CareStartTM COVID-19 Antigen should be ordered for the detection of COVID-19 in individuals who are suspected of COVID-19 by their healthcare provider and who are within the first five days of onset of symptoms or in 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.
The CareStartTM COVID-19 Antigen is only authorized for use in laboratories in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high and 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.
COVID-19 Antigen Rapid 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.
*CLIA Certificate of Waiver number required for purchase.
*This test is only approved in a Point-of-Care setting
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
FEATURES & BENEFITS
Reliable results reads at 10 minutes
Intuitive visual interpretation
No special equipment or training required
All-in-one package including collection swabs