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WorkCare is offering Access Bio’s CareStart™ COVID-19 diagnostic test in workplaces where rapid results are needed to help keep healthy workers on the job and those with COVID-19 in isolation at home until they are cleared for safe return to work.
The CareStart point-of-care test detects antigens specific to SARS-CoV-2, the coronavirus that causes COVID-19. WorkCare onsite clinicians use a nasopharyngeal swab to collect nasal secretions that may contain infectious particles from employees. Results appear on a test strip in 10 minutes.
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the test in mid-October 2020. Access Bio reported 88.4 percent sensitivity and 100 percent test specificity in a related document describing intended use.
The rapid antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein. After a specimen is collected – optimally within five days of symptom onset – the swab is placed in an extraction buffer solution. The extracted swab sample is added to the well of a test device. When the sample migrates through the test strip, SARS-CoV-2 viral antigens bind to anti-SARS-CoV-2 nucleocapsid protein antibodies to form an immune complex that is captured by the device.
Results are indicated by lines that appear on the device. Two colored lines in control region “C” and test region “T” indicate the presence of viral antigens. One colored line in control region “C” indicates a negative result. The absence of a colored line in region “C” indicates an invalid test. No additional equipment or specialized instruments are needed for sample analyses.
The CareStart test is authorized for use at point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
While positive results indicate the presence of viral antigens, clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial (rather than a viral) infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for patient management or infection control decisions. Negative results should be considered in the context of a test subject’s exposure history and the presence of clinical signs and symptoms consistent with COVID-19, according to the developer.
Each CareStart COVID-19 antigen test kit can be used to administer up to 20 tests. The kit includes test devices, assay buffer, extraction vials and caps, specimen collection swabs, positive and negative control swabs, and user instructions.
Access Bio is a New Jersey-based company that develops and manufactures diagnostic tests for infectious diseases. The test is distributed by Intrivo Diagnostics, a Los Angeles-based company.
Please refer to WorkCare’s COVID-19 Testing FAQ for comparisons of testing methodologies. To learn more, contact WorkCare’s business development team: firstname.lastname@example.org.
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