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
| Features | Specifications | |
| Product Code | 2110200 | |
| 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 | |
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 |
| 140 | 20/20 | 100 |
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 Test | Comparator Method | ||
| Positive | Negative | Total | |
| Positive | 48 | 0 | 48 |
| Negative | 2 | 50 | 52 |
| Total | 50 | 50 | 100 |
| 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)
