Antifen

INDICAID COVID-19 Rapid Antigen Test

The INDICAID COVID-19 Rapid Antigen Test is a quick and reliable tool designed to detect the SARS-CoV-2 virus. This lateral flow immunoassay works by using highly sensitive antibodies to identify the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab samples. The test is intended for use within the first five days of symptom onset, as well as in individuals without symptoms who are suspected of having COVID-19.

Key Features:

• Detection Method: Lateral flow immunoassay.
• Sample Type: Direct anterior nasal swab.
• Use: For suspected COVID-19 cases within the first five days of symptoms or in asymptomatic individuals.
• Components:
• 25 individually foil-pouched test devices.
• 25 vials of buffer solution.
• 25 individually wrapped, sterile nasal swabs.
• 1 package insert with instructions for use.

How It Works:

1. **Sample Collection:** Collect a direct anterior nasal swab from the patient.

2. **Buffer Solution Application:** Mix the swab in a buffer solution vial.

3. **Test Device Application:** Apply the buffer solution to the sample well of the test device.

4. **Result Interpretation:** The test line will appear if the SARS-CoV-2 antigen is present. The control line ensures the test is working correctly.

Important Information:

• Prescription Use Only: This test is for in vitro diagnostic use only and requires a prescription.
• Emergency Use Authorization: In the USA, this product has been authorized by the FDA under an Emergency Use Authorization for the duration of the COVID-19 pandemic.
• Quality Control: The test includes internal and external quality control procedures to ensure accuracy.

Limitations:

• Cross-reactivity: The test may show false positives due to cross-reactivity with other substances.
• Microbial Interference: Certain microbial substances may interfere with the test results.
• High Dose Hook Effect: High levels of antigen may cause false negative results.

Storage and Stability:

• Store the test devices and buffer solution at room temperature..
• Use the test devices within the expiration date indicated on the package..

For more detailed instructions and to ensure accurate results, please refer to the package insert provided with the test kit.