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
For In Vitro Diagnostic Use Only
Professional Use Only
Available soon to the US
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
Instruction For Use
2
Tilt your head back. Gently insert the swab about 1 inch into one of your nostrils.Rub the swab against the walls of one of your nostrils 5 times in a large circular path. Repeat with your other nostril.
3
Remove the entire cap. Stir the swab into the buffer solution 20 times.
Throw away the swab and screw back the cap.
6
Hold the vial vertically. Squeeze and drip 3 drops of the solution into the circular opening (S) of the test device.
7
Leave for 20 minutes and read the results. Do not read after 25 minutes.
Refer to “Interpreting Your Results” section below.
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.
Frequently Asked Questions (FAQs)
How far should I insert the swab into my nostrils?
Inserting the swab 1 inch into your nostril should be far enough to collect samples for this test. You can stop pushing the swab when you feel a slight resistance and proceed to collecting your sample. Samples should be collected gently.
What do I do with the test unit after reading the results?
After recording your results, carefully wrap and seal all product components and dispose by throwing it into the garbage just like any household trash. Wash your hands thoroughly after handling and disposing the components.
How does the test work?
This test is designed to detect the presence of SARS-CoV-2 antigens from nasal swab samples. Antigens are present in the SARS-CoV-2 virus, and can be used as markers for disease exposure.
What if I tested negative?
Rapid antigen tests can only detect the presence of antigens at the time of the test. A false negative result may be produced when the level of antigen in the sample is below the detection limit of the test, the sample is collected improperly, or when the test was performed incorrectly. If you had contact with a known or suspected COVID-19 cases, as a best practice, performing the test at least once every week is recommended.
What if I tested positive?
If you tested positive for COVID-19 antigens, we recommend contacting your local health authorities to organize a follow-up molecular diagnostics test for diagnosis.
