Principle

Antigens are present in the SARS-CoV-2 virus, and can bound with specific antibodies.

When a virus enters a human body and begins to multiply, the body begins to react to the viral antigens, possibly resulting in symptoms.

The INDICAID® COVID-19 Rapid Antigen Test Rapid detects antigens from SARS-CoV-2 virus and can be used for COVID-19 screening during active infection

Limitations

• The test is designed for using nasal swab samples.
• Negative results do not rule out COVID-19 infection, especially if you have been in contact with the virus. Follow up molecular testing should be considered to rule out infection.
• Positive results may be due to present infection with non SARS-CoV-2 coronavirus strains, such as SARS-CoV.
• Results from antigen testing should not be used as the sole basis to diagnose or exclude COVID-19 infection.
• Read the result at 20 minutes. Do not interpret the result after 25 minutes.
• Please follow the product insert when testing.

• Data / Performance

  The performance of INDICAID® COVID-19 Rapid Antigen Test has been validated clinically. Below are the results of in-house and independent clinical validation.

  In-house Validation

  INDICAID® COVID-19 Rapid Antigen Test limit of detection (LoD) was determined by testing limiting dilutions of inactivated SARS-CoV-2 virus in pooled human nasal matrix from presumed negative donors. Each test concentration was inoculated onto kit-provided swabs and processed according to the test procedure. The LoD was determined by confirming the lowest detectable concentration of SARS-CoV-2 at which 95% of the 20 replicates analyzed resulted in a positive test. The INDICAID® COVID-19 Rapid Antigen Test LoD in nasal matrix was confirmed to be 140 TCID₅₀ per swab.