CareStart™ COVID-19 Ag

Due to the highly contagious nature and global spread, 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 SARSCoV-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 Ag Test helps provide critical answers about active infections to patients and healthcare workers alike.

Features of

CareStart COVID-19 Ag


  1. Fast and easy to use in Point-of-Care setting
  2. Qualitatively detect the SARS-CoV-2 nucleocapsid protein
  3. Use for Nasopharyngeal and Nasal swab specimen
  4. Fast result only in 10 minutes

Clinical Features

  1. Detect SARS-CoV-2 nucleocapsid protein antigen
  2. Clinical performance 96.8% Positive Percent Agreement and 100% Negative Percent Agreement in Nasopharyngeal
  3. Clinical performance 100% Positive Percent Agreement and 100% Negative Percent Agreement in Nasal

Test Principles

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.

Procedure of

CareStart COVID-19 Ag

Results Interpretation

CareStart COVID-19 Ag

Read the result at 10 minutes. The test result should not be read after 15 minutes

SARS-CoV-2 antigen present does not rule out co-infection with other pathogens. The color intensity in the test region will vary depending on the amount of SARS-CoV-2 antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.

Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions. It is recommended that these results be confirmed by a molecular testing method, if necessary for patient management.

Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.