COVID-19 Antigen

A Rapid POC Test

RAPID POC TEST

The CareStartâ„¢ 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.

As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStartâ„¢ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.


Features

  • Lateral flow assay
  • Rapid results in 10 minutes
  • Nasopharyngeal swab specimen collection
  • Intended at POC setting (i.e., inpatient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation

Clinical Features

  • 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

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.

01.

Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times

02.

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.

03.

Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.

04.

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

Covid-19 Invalid

Cat No.RCHM-02072
Package Unit20 tests/kit
Kit Component20 Test devices
20 Assay buffer
20 Extraction vials and caps
20 Specimen collection swabs
1 Positive and 1 negative control swabs
1 Instructions for use