INDICAID Point of Care (POC) COVID-19 Rapid Antigen Test

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Covid Tests

V1001_000022_L853_CS

INDICAID COVID-19 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 be 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 the SARS-CoV-2 virus and can be used for COVID-19 screening during active infection.

A Rapid Point Of Care COVID-19 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-19 Test Validation

The clinical performance of the INDICAID COVID 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 diluted 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 Test correctly detected 48/50 positive samples and demonstrated no false positives for the negative samples.

Materials Provided In Kit:

1. 25 individually wrapped Test Devices
2. 25 Buffer Solution Vials
3. 25 individually wrapped Swabs
4. 1 IFU and Quick Reference Guide

FAQs About The Rapid Antigen INDICAID COVID Test

How does the INDICAID Rapid Antigen COVID-19 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.

How far should I insert the testing swab into my nostrils?

Inserting the swab 1 inch into your nostril should be far enough to collect samples for the INDICAID COVID-19 test. You can stop pushing the swab when you feel a slight resistance and proceed to collect your sample. Samples should be collected gently.

Is it harmful if the testing solution has been spilled?

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 Should I do with my test unit after reading the results?

After recording your COVID-19 test results, carefully wrap and seal all of the product components and dispose of them by throwing them into the garbage just like any other household trash. Wash your hands thoroughly after handling and disposing of the components.

Is the INDICAID Covid test FDA approved?

Although the INDICAID COVID-19 Rapid Antigen Test is not FDA approved, it has been authorized by the FDA under an Emergency Use Authorization.

    Specs:

      Quantity 25/Box
      Specimen Type Direct Anterior Nasal swab
      Intended Use Qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab samples from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset, or within 2 to 3 days of potential exposure to a person suspected of being infected with COVID-19.
      Storage Condition 36º-86ºF (2º-30ºC) Do not freeze. Avoid direct sunlight.
      Shelf Life Expiration is labeled during manufacturing, and it’s currently calculated 6 months from manufacturing date. However, the FDA has recently approved actual expiration to be extended 3 months beyond the date printed on the INDICAID® packaging (i.e. 9 months from date of manufacture).

      Downloads:

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