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.
- 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
|Items Per box||25x|
|Specimen type||Nasal and nasopharyngeal swab|
|Limit of detection||140 TCID50 / swab|
|Intended Use||For deteremining the presence of SARS-CoV-2|
|Shelf life||12 months|
|Storage condition||2-30ºC. 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.
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|
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 Test||Comparator 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)