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The INDICAID® COVID-19 Rapid Antigen Test (CE-IVD) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens in direct nasal swab samples.

Product Advantage
  • Fast: Results in 20 minutes
  • Convenient: No equipment or training needed
  • High Sensitivity: Detect lower viral load samples against competitive products

Antigen could be found on the surface of a 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

Instructions for Use
Please refer to the Instructions for Use page.

Product Code2110200
Items Per box25x
Specimen typeNasal and nasopharyngeal swab
Limit of detection140 TCID50 / swab
Intended UseFor deteremining the presence of SARS-CoV-2
Shelf life12 months
Storage condition2-30ºC. Do not freeze. Avoid direct sunlight

  • 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.

Concentration (TCID50/swab)Number of Positives/Total% Detected

Clinical Validation
The clinical performance of the INDICAID® COVID-19 Rapid Antigen Test was evaluated by testing 50 positive and 50 negative SARS-CoV-2 retrospective clinical specimens from unique donors that were previously confirmed by a molecular test. The 100 clinical specimens were nasopharyngeal swab samples eluted in saline. Testing was performed at one investigational site by two untrained operators who were blinded to the RT-PCR results of the samples. The samples were first randomized, then each sample eluate was inoculated onto kit-provided swabs and processed as instructed in test procedure. The INDICAID®COVID-19 Rapid Antigen Test correctly detected 48 / 50 positive samples and demonstrated no false positives for the negative samples.

INDICAID®COVID-19 Rapid Antigen TestComparator Method
Positive Percent Agreement (PPA)96% (95% CI: 86.3% - 99.5%)
Negative Percent Agreement (NPA)100% (95% CI: 92.9% - 100%)

(Information above provided by the factory)