INDICAID Antigen Rapid Test (Nasal Test Kit)

The INDICAID® C-19 Antigen Rapid Test (CE-IVD) is a lateral flow immunoassay designed for the qualitative detection of antigens in direct nasal swab specimens.

Product advantage

• Fast: Results in 20 minutes
• Convenient – ​​no equipment or training needed
• High sensitivity – detect lower viral load samples vs. competitive products

Beginning

• The antigens are present on the virus and can bind to specific antibodies.
• When a virus enters the human body and begins to multiply, the body begins to react to the viral antigens, possibly causing symptoms.
• The INDICAID® C-19 Antigen Rapid Test detects virus antigens and can be used for the detection of C-19 during active infection

Limitations

• The test is designed to use nasal swab samples.
• Negative results do not rule out C-19 infection, especially if you have been in contact with the virus. Follow-up molecular tests should be considered to rule out infection.
• Positive results may be due to the presence of infection with coronavirus strains other than , such as SARS-CoV.
• Antigen test results should not be used as the sole basis for diagnosing or excluding C-19 infection.
  Read the result at 20 minutes. Do not interpret the result after 25 minutes.
• Follow the product insert when testing.

Data / Performance

The performance of the INDICAID® C-19 Rapid Antigen Test has been clinically validated. The results of internal and independent clinical validation are shown below.

Internal validation

The limit of detection (LoD) of the INDICAID® C-19 Rapid Antigen Test was determined by testing limiting dilutions of inactivated virus in pooled human nasal matrix from negative presumptive donors. Each test concentration was inoculated onto swabs provided

by the kit and processed according to the test procedure. The LoD was determined by confirming the lowest detectable concentration of where 95% of the 20 replicates tested resulted in a positive test. The LoD of the INDICAID® C-19 Antigen Nasal Matrix Rapid

Test was confirmed to be 140 TCID50 per swab.

Clinical Validation

The clinical performance of the INDICAID® C-19 Rapid Antigen Test was evaluated by testing 50 positive and 50 negative retrospective clinical specimens from single donors that were previously confirmed by a molecular test. All 100 clinical specimens were

saline eluted nasopharyngeal swab samples. The test was performed at a research site by two untrained operators who were blinded to the RT-PCR results of the samples. Samples were first randomized, then each sample eluate was inoculated onto swabs

provided by the kit and processed according to the test procedure instructions. The INDICAID® C-19 Rapid Antigen Test correctly detected 48/50 positive samples and showed no false positives for negative samples.

FAQs

I accidentally spilled the test solution. Is it harmful?

If test solutions have been spilled, rinse thoroughly with water before disposal. Avoid contact of test solutions with eyes, skin and mouth. If contact with eyes occurs, rinse immediately with water and seek medical help. If contact with your skin occurs, wash

the area with soap and rinse with water. Do not ingest or inhale the test solutions. If accidental ingestion occurs, seek medical help immediately.

How far should I insert the swab into my nostrils?

Inserting the swab 1 inch into the nostril should be enough to collect samples for this test. You can stop pushing the swab when you feel slight resistance and proceed to collect your sample. Samples must be collected carefully.

What do I do with the test unit after reading the results?

After recording your results, carefully wrap and seal all components of the product and dispose of in the normal household waste. Wash hands thoroughly after handling and disposing of components.

How to Use Indicaid Antigen Nasal Kit Instructions Step by Step