CARESTART™
COVID-19
Antigen
Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen
ORDERING INFO
ACCESS BIO’S CARESTART™ COVID-19 Antigen
RAPID POC Test
Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.
As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStart™ COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.
- Lateral flow assay
- Rapid results in 10 minutes
- Nasopharyngeal swab specimen collection
- 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
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity
- Designated as a CLIA waived tests
TEST PRINCIPLES
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers.
PROCEDURE
Procedure
1Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times
2Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
3Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.
4Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
RESULTS INTERPRETATION
Results Interpretation
Covid-19 Positive
Covid-19 Negative
Invalid
ORDERING INFORMATION
Order Information
Cat. No.
RCHM-02071
PACKAGE UNIT
20 Tests / Kit
Kit Component
20 Test devices
20 Assay buffer
20 Extraction vials and caps
20 Specimen collection swabs
1 Positive and 1 negative control swabs
1 Instructions for UsePRODUCT DOCUMENTATION
