Indicaid Rapid Antigen
COVID-19 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.
Indicaid Rapid Antigen Test - The Most Economical and Effective Solution
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.
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
COVID-19
Indicaid Rapid COVID-19 Antigen Test
A Rapid Point of Care Test
- Sensitivity and Specificity
− COVID-19 – Sensitivity 100%, Specificity 98% - FDA Emergency Use Authorization (EUA)
- Visually read in 10 minutes
- For use in CLIA waived Point of Care facilities operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
COVID Clinical Evaluation
COVID-19 Sensitivity
100%
Specificity
98%
Kit Components
COVID-19 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 the test procedure.
The INDICAID®COVID-19 Rapid Antigen Test correctly detected 48 / 50 positive samples and demonstrated no false positives for the negative samples.
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 the test procedure.
The INDICAID®COVID-19 Rapid Antigen Test correctly detected 48 / 50 positive samples and demonstrated no false positives for the negative samples.
Interpretation of Results
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FAQ
I accidentally spilled the test solution. Is it harmful?
If the test solutions have been spilled, flush abundantly with water upon disposal. Avoid having the test solutions come into contact with your eyes, skin and mouth. If contact occurs with the eyes, flush with water immediately and seek medical help. If contact occurs with your skin, wash the area with soap and rinse with water.
Do not ingest or inhale the test solutions. If accidental ingestion occurs, please seek medical help immediately.
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 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.
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.
