Access Bio CareStart™ COVID-19 Rapid POC Antigen Test, 20 Kits/Box
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RAPID POC TEST
PRODUCT MANUFACTURED WITH 6 MONTH EXPIRATION DATE
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 with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
- 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
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.
|Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times.||Remove 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.||Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.||Invert 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.|
|Covid-19 Positive||Covid-19 Negative||Invalid|
- 20 Test devices
- 20 Assay buffer
- 20 Extraction vials and caps
- 20 Specimen collection swabs
- 1 Positive and 1 negative
- 1 Instructions for Use
CAT NUMBER: RCHM-02071
PACKAGING: 20 TESTS/KIT