Indicaid Covid-19 Rapid Antigen Test FDA USA – Box of 25

Description

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 COVID-19 Rapid Antigen Test has received Emergency Use Authorization from the US Food & Drug Administration (FDA) and the European CE Mark. The kit has been widely adopted in COVID-19 testing centers, hospitals, government and private corporations, supermarkets, hotels and schools in Hong Kong and overseas. INDICAID™ is currently available in 33 countries, and is the best-selling rapid test kit in Hong Kong.

FDA EUA EUA210259 COVID-19 Antigen Rapid Test is for the qualitative detection of SARS-COV-2 antigen. It detects nucleocapsid proteins inside the SARS-COV-2 virus.

For use under Emergency Use Authorization (EUA) only
For in vitro diagnostic use only
For prescription use only

Each Box Contains

25x Test Devices, individually packed sterile specimen swab, and a buffer solution

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®COVID-19 Rapid Antigen Test correctly detected 48 / 50 positive samples and demonstrated no false positives for the negative samples.

Figure 2 – 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.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.

The COVID-19 antigen rapid test device is a lateral flow in-vitro immunoassay intended to be used for the qualitative detection of the SARS-CoV-2 viral nucleoprotein. This device will detect both viable and nonviable virus in both nasopharyngeal and Nasal secretions.

1 Open the package and take out the test device.

2 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.

3 Remove the entire cap. Stir the swab into the buffer solution 20 times. Throw away the swab and screw back the cap.

4 Close the entire vial cap tightly.

5 Remove the top half of the vial cap to expose the dropper tip.

6 Hold the vial vertically. Squeeze and drip 3 drops of the solution into the circular opening (S) of the test device.

7 Leave for 20 minutes and read the results. Do not read after 25 minutes.
Refer to “Interpreting Your Results” section below.

BACK

Limitations

1. The test is designed for using nasal swab samples.
2. This test is recommended for Healthcare professional use only.
3. The test procedure, precautions and interpretation of results for this test must be followed strictly when testing. Failure to follow the Test Procedure and Interpretations of Test Results may adversely affect test performance and/or invalidate the Test Result.
4. The test should be used for the qualitative detection of SARS-CoV-2 antigen in human nasal swab specimens. Neither the quantitative value nor the rate of SARS-CoV-2 antigen concentration can be determined by this qualitative test.
5. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
6. Positive results may be due to present infection with non SARS-CoV-2 coronavirus strains, such as SARS-CoV.
7. Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
8. Positive test results do not rule out co-infections with other pathogens.
9. False-negative test results are more likely during peak activity when prevalence of disease is high.
10. False-positive test results are more likely during periods of low SARS-CoV-2 activity when prevalence is moderate to low.
11. Results from antigen testing should not be used as the sole basis to diagnose or exclude COVID-19 infection.