Rapid Coronavirus Antigen (COVID-19) Test Cassette (Swab)
COVID-19 is an infectious disease caused by a new coronavirus that can be transmitted from person to person. Symptoms of COVID-19 can range from mild (or no symptoms) to serious illness. The Rapid Coronavirus Antigen (COVID-19) Test Cassette (swab) is an in vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in nasopharyngeal swab (NP) samples for the clinical diagnosis of COVID-19.
Each box contains:
20 test devices, 20 sterile swabs, 20 extraction vials / caps, 1 positive / negative control swab, and 1 insert
Relative Sensitivity: 88.37%, Relative Specificity: 100.0%
Sample Type: Nasopharyngeal Swab
Detection Method: Colloidal Gold
Detection Time: 15 minutes
- This test has not been reviewed by the FDA.
- This kit is only available outside of North America.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic test should be considered to rule out infection in these people.
- Use of this test is limited to laboratories certified to perform highly complex testing, including point-of-care testing when the site is covered by the laboratory. CLIA Certificate of High Complexity Testing.
- This test is not for home use or home sample collection.
How does the rapid COVID-19 antigen test cassette work?
The rapid COVID-19 antigen test is for the detection of the SARS-CoV-2 nucleocapsid protein antigen, detectable in samples from the upper respiratory tract during the acute phase of infection. Positive results indicate the presence of viral antigens.
COVID-19 Rapid Antigen Test Cassette Instructions for Use
1. Collection of samples
- Remove a nasopharyngeal swab from the bag.
- Place the swab in one of the patient’s nostrils until it reaches the posterior nasopharynx; Hold the insert until you meet resistance or the distance is equivalent to that of the ear to the patient’s nostril.
- Slowly roll the swab 3-5 times over the surface of the posterior nasopharynx
- Slowly remove the swab from the nostril while rotating it.
- Collecting samples from the COVID-19 antigen test kit
2. Sample preparation
- Peel off the aluminum foil seal from the top of the extraction vial containing the extraction buffer.
- Place the swab in the extraction vial. Swirl the swab vigorously at least 5 times.
- Remove the swab by twisting against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly dispose of the swab.
- Close the vial with the supplied cap and press firmly on the vial.
- Mix well by shaking the bottom of the tube.
- Invert the extraction vial and hold the sample vertically over the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well. 2 drops of the sample are required as a minimum volume to start the test and invalid results will be obtained if 1 drop of sample is added to the cassette. Sample leakage is possible when 6 or more drops of the sample are added.
- Read and interpret the test result at 10 minutes. The test result should not be read or interpreted after 15 minutes.
Limitation of rapid coronavirus antigen test
- This test is recommended for the exclusive use of healthcare professionals.
- The test procedure, precautions, and interpretation of the results of this test must be strictly followed when performing the test. Failure to follow the test procedure and interpretations of test results may adversely affect test performance and/or invalidate the test result.
- The test should be used for the qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swab specimens. This qualitative test cannot determine either the quantitative value or the antigen concentration rate of SARS-CoV-2.
- A negative test result can occur if the level of antigen in a sample is below the detection limit of the test.
- Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
- Positive test results do not rule out coinfections with other pathogens.
- False-negative test results are more likely during peak activity when the prevalence of the disease is high.
- False-positive test results are more likely during periods of low SARS-CoV-2 activity when the prevalence is moderate to low.