Antigen Rapid Test
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COVID-19 (short for “Coronavirus disease 2019”) is a disease first recognized in 2019 that is caused by type of novel coronavirus called SARS-CoV-2. Due to its rapid spread, the World Health Organization (WHO) recognized the disease as a global pandemic on March 11, 2020. Many individuals with confirmed INDICAID COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all.
The virus is spread primarily from person to person through respiratory particles, even by individuals without symptoms. The INDICAID COVID-19 Antigen At-Home Test is a rapid qualitative
immunochromatographic assay for the determination of the presence of SARSCoV-2 antigens in anterior nasal swab specimens. Each INDICAID COVID-19 Antigen At-Home Test is single-use and can analyze one anterior nasal (nares) swab sample. The total time required to perform one test is approximately 20
minutes from clinical specimen collection to result.
SARS-CoV-2-specific antibodies and a control antibody are immobilized onto a nitrocellulose membrane support as two distinct lines. The test line (T) region contains monoclonal anti-SARS-CoV-2 antibodies and the control line (C) region contains polyclonal control antibodies. Polyclonal and monoclonal anti-SARS-CoV-2 antibodies conjugated with red-colored latex microspheres are used to detect the
SARS-CoV-2 antigen.
During the test, the swab containing patient sample is placed and mixed in a Buffer Solution Vial. That Buffer Solution is then applied to the sample well of the test device. If SARS-CoV-2 antigen is present, it will bind to the antibody-latex microsphere conjugate forming an immunocomplex. The immunocomplex will then travel across the strip via capillary action towards the test line. The immunocomplex will then bind to the anti-SARS-CoV-2 antibodies at the test line (T), forming a visible red-colored line to indicate detection of antigens. If SARS-CoV2 antigens are not detected in the sample, no color will appear at the test line (T).
Test results are interpreted visually at 20 minutes after the sample has been properly applied to the test according to the instructions. Results should not be read after 25 minutes.
The control (C) line is used for procedural control and should appear regardless of the test result. The appearance of the control line (C) serves to ensure the test is performing properly and the test result is valid. The INDICAID COVID-19 Antigen At-Home Test is validated for use from direct
specimens testing without transport media.
The test should be carried out at room temperature and the operation procedure is described below:
1. Clean your mouth 30 minutes before collecting the salivaPlace the tip oftongue against the upper or lower tooth root to enrich saliva, and then swallow saliva to the throat without ingesting saliva to esophagus, followed by returning saliva to mouth repeat for 5 times.
2. Deliver saliva into the collection cup.
3.Insert the sample diluent tube into the pipe rackmake sure that the tube is standing firm and reaches the bottom of the pipe rack.
4.Open the purple cap of the sample diluent tubeadd 12 drops(about 180ul) of collected saliva into the sample diluent tube which contains 0.3 mL ofthe diluent buffer.
5.Screw cap onto the collection tube,and invert gently 5 times to mix the saliva and sample diluent buffer thoroughly.
6.Open the small cap on the top of the sample dilution tube.Add 3-4 drops(~100uL) of the sample diluent buffer immediately to the sample well,allow the strip to develop for 10~15 minutes at room temperature. A visible band can be read by naked eyes. Keep all reagents to room temperature(15-30℃) prior to use.
Warnings and Precautions
• For in vitro diagnostic use only.
• This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA).
• This product is only authorized for the detection of proteins from SARS-CoV2, not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the declaration is terminated or authorization is revoked sooner.
Read the Instructions for Use carefully before performing test. Failure to
follow directions may produce inaccurate test results.
• Wear a facemask when collecting specimen from another individual.
• Do not use this test kit beyond the expiration date printed on the outside of
the box.
• Do not use if any of the test kit contents or packaging is damaged.
• Do not use the test on children under 2 years of age.
• Use only the contents provided in the test kit.
• All test components are single use. Do not re-use.
• Wash hands thoroughly for at least 20 seconds before and after using the
test.
• Do not open the kit contents until ready for use. Use within 2 hours of
opening the Test Device pouch.
• Leave the swab inside its packaging until instructed to swab the nose. Keep
the swab clean. Do not allow anything to touch the soft tip of the swab until
instructed to swab the nose.
• When collecting a sample, use only the nasal swab provided in the kit.
• Perform the test as soon as possible after swabbing both nostrils, and within
30 minutes after adding the swab to the vial.
• This test is read visually. User with impaired vision or color impaired vision
may not be able to read the test.
• Do not interpret the test result before 20 minutes or after 25 minutes,
following application of the sample to the Test Device.
• False negative results may occur if insufficient Buffer Solution is applied to
the Test Device (e.g. less than 3 drops).
Storage and Stability
• The INDICAID COVID-19 Rapid Antigen At-Home Test should be stored in a
cool, dry place between 2-30°C (35.6-86°F). Do not freeze. Avoid direct sunlight.
• Kit components in the INDICAID COVID-19 Rapid Antigen At-Home Test are stable until the expiration date printed on the label.
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• The test device must remain in the sealed foil pouch until use. Once the pouch has been opened, the test device should be used within 60 minutes.
• Test samples immediately after collection, but no more than 5 minutes after specimen collection before placement into extraction buffer or up to 2 hours after placement into extraction buffer, if kept at room temperature.