Nitrile or latex gloves should be worn when performing this test.
Fast: Results in 20 minutes
Convenient: No equipment or training needed
High Sensitivity: Detect lower viral load samples against competitive products
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
A line appears in regions (C) and (T)
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)
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)
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.
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.
Number of Positives/Total
Figure 1 – The results show that 100% detection of positive nasal samples can be achieved at the LoD of 140 TCID50 per swab.
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
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.