(CV-0820) COVID-19, IndicAid Rapid Antigen Test (1 test)
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.
Kit Content
1 Test Device
1 Buffer Solution Vial
1 Nasal Swab
1 Product Insert
1 Quick Reference Guide
All sales final.
Nitrile or latex gloves should be worn when performing this test.
Product Advantage
Fast: Results in 20 minutes
Convenient: No equipment or training needed
High Sensitivity: Detect lower viral load samples against competitive products
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
Results Interpretation
| INDICATOR | RESULT | INTERPRETATION | |
|---|---|---|---|
 |
A line appears in regions (C) and (T) | Positive | The presence of both the control line (C) and line (T) indicates the presence of SARS-CoV-2 antigens. The result suggests current COVID-19 infection. |
 |
A line appears in region (C) | Negative | The presence of only the control line (C) and not the line (T) indicates no detection of SARS-CoV-2 antigens. |
 |
No line appears in region (C) | Invalid |
If the control line (C) does not appear, the result is invalid, regardless whether the line (T) is present. Repeat the test with a new test kit. |
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 |
Figure 1 – The results show that 100% detection of positive nasal samples can be achieved at the LoD of 140 TCID50 per swab.
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%) | ||
Figure 2 – The results show that INDICAID® COVID-19 Rapid Antigen Test reaches a positive percent agreement of 96% and a negative percent agreement of 100% with regard to the results of RT-PCR.
Recombinant N protein from UK (B.1.1.7), South Africa (B.1.351), US (B.1.2), and Brazil (B.1.1.28) variants were tested and found to be detectable by INDICAID® COVID-19 Rapid Antigen Test, suggesting that it may be able to detect the presence of these COVID-19 variants in patients.