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INDICAID®


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

Principle
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.

Specifications
FeaturesSpecifications
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


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.

Concentration (TCID50/swab)Number of Positives/Total% Detected
14020/20100

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
PositiveNegativeTotal
Positive48048
Negative25052
Total5050100
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)