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The Indicaid omicron antigen home test for easy detection of nucleocapside antigens in direct nasal swab samples.

1. You can test yourself at home with result in only 20 minutes
2. Very easy because there is no equipment or training needed
3. High Sensitivity: Detect lower viral load samples against orther rapid tests
4. lower price and faster than PCR
5. for frequent self testing

FDA approved for In Vitro Diagnostic Use 

How Indocaid works?

1. Omicron Antigens are present in the nose and troad fluids, and can bind to nucleaocapside antibodies.
2. When viral particles enter a human body if they are abundant enough they will start to multiply when a treshold or multiplicity of infection or MOI is reached in the body. 
3. After 2-4 days viral antigens and possibly symptoms will start.
4. The INDICAID Antigen Test Rapid detects antigens from Omicron and Delta variants and can be used for screening during active infection

Protocol

1. Remove the top half of the vial cap to expose the dropper tip.
2. Hold the vial vertically. Squeeze and drip 3 drops of the solution into the circular opening (S) of the test device.
3. Leave for 20 minutes and read the results. Do not read after 25 minutes.
   Refer to “Interpreting Your Results” section below.
4. Open the package and take out the test device.
5. Tilt your head back. Gently insert the swab about 1 inch into one of your nostrils.Rub the swab against the walls of one of your nostrils 5 times in a large circular path. Repeat with your other nostril.
6. Remove the entire cap. Stir the swab into the buffer solution 20 times.
   Throw away the swab and screw back the cap.
7. Close the entire vial cap tightly.
8. Remove the top half of the vial cap to expose the dropper tip.
9. Hold the vial vertically. Squeeze and drip 3 drops of the solution into the circular opening (S) of the test device.
10. Leave for 20 minutes and read the results. Do not read after 25 minutes.
    Refer to “Interpreting Your Results” section below.
11. Open the package and take out the test device.
12. Tilt your head back. Gently insert the swab about 1 inch into one of your nostrils.Rub the swab against the walls of one of your nostrils 5 times in a large circular path. Repeat with your other nostril.
13. Remove the entire cap. Stir the swab into the buffer solution 20 times.
    Throw away the swab and screw back the cap.

Indicaid results

1. A line appears in regions (C) and (T) Positive 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.
2. A line appears in region (C) Negative The presence of only the control line (C) and not the line (T) indicates no detection of SARS-CoV-2 antigens.
3. No line appears in region (C) Invalid 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.

Limitations

1. The test is designed for using nasal swab samples.
2. Negative results do not rule out infection, especially if you have been in contact with the virus. Follow up molecular testing should be considered to rule out infection.
3. Positive results may be due to present infection with other SARS virus strains, such as SARS-CoV.
4. Results from antigen testing should not be used as the sole basis to diagnose or exclude infection.
5. Read the result at 20 minutes. Do not interpret the result after 25 minutes.
6. Please follow the product insert when testing.

Data / Performance
The performance of INDICAID Antigen Test has been validated clinically. Below are the results of in-house and independent clinical validation.

In-house Validation
INDICAID 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 Antigen Test LoD in nasal matrix was confirmed to be 140 TCID50 per swab.

Concentration (TCID50/swab) Number of Positives/Total % Detected
140 20/20 100
Figure 1 – The results show that 100% detection of positive nasal samples can be achieved at the LoD of 140 TCID50 per swab.

Clinical 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 test procedure. The INDICAID Antigen Test correctly detected 48 / 50 positive samples and demonstrated no false positives for the negative samples.

INDICAID Rapid Antigen Test Method

1. Positive Negative Total
2. Positive 48 0 48
3. Negative 2 50 52
4. Total 50 50 100
5. Positive Percent Agreement (PPA) 96% (95% CI: 86.3% – 99.5%)
6. Negative Percent Agreement (NPA) 100% (95% CI: 92.9% – 100%)
7. 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.
8. 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.

Frequently Asked Questions (FAQs)

• 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.
• How far should I insert the swab into my nostrils?
  What do I do with the test unit after reading the results?
  How does the test work?
  What if I tested negative?
  What if I tested positive?