INDICAID™ COVID 19 Rapid Antigen Test
The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct anterior nasal swab specimens.
It is taken from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Anterior nasal swab specimens may be collected by a healthcare provider (HCP) or self-collected (by individuals 18 years of age or older, under the supervision of an HCP).
Indicaid covid test is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests.
This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, meet the requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Summary and Explanation of the Test
- NOT FOR HOME OR PERSONAL USE
- Professional use only
- For in vitro diagnostic use only
- For prescription use only.
- Results in 20 minutes
- No equipment or training needed
- Detect lower viral load samples against competitive products
- Bulk covid test price available
Included in covid 19 antigen test Pack:
- 25 Individually foil pouched test device
- 25 Vial with cap and integrated dispensing tip, containing 400 μL of buffer solution.
- Nasal Swabs 25 Individually wrapped, sterile specimen collector.
- Package Insert 1 Instructions for Use
- 1 Quick Reference Guide
- Instructions for use and Quick Reference Guide
How does it work
The INDICAID™ COVID Antigen Test is an immunochromatographic lateral flow assay that uses highly sensitive antibodies to detect antigen fromSARS-CoV-2 in direct anterior nasal swab samples from patients who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset.
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-2antibodies conjugated with red-colored colloidal gold particles 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-gold Page 5 of 22 IC04QS2021 | PI-2110400ENG | Rev B| November 2021 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-CoV-2 antigens are not detected in the sample, no color will appear at the test line (T).
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 Rapid Antigen Test is validated for use from direct specimens testing without transport media
Specimen Collection, Handling, and Transport indicaid covid test kit
The INDICAID™ COVID-19 Rapid Antigen Test should only be used with the swabs provided in the kit to collect direct nasal samples according to the procedures in these Instructions for Use.
Specimens should be tested immediately after collection for best performance. Do not transport or store specimens for later testing. Inadequate specimen collection or improper handling, storage, and transport may lead to incorrect results.
Do not test specimens 2 hours after collection.
Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
Reading the Covid rapid test
Positive - A line appears in regions (C) and (T)
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.
Negative - A line appears in region (C)
The presence of only the control line (C) and not the line (T) indicates no detection of SARS-CoV-2 antigens.
Invalid - No line appears in region (C)
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.
How to use INDICAID rapid antigen covid test
Remove the Swab and Test Device from their packaging. Place the Test Device on a horizontal (flat) surface for running the test.
Insert the entire collection tip of the swab provided (usually ½ to ¾ of an inch, or 1 to 1.5 cm) inside the nostril. Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 4 times. Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present on the swab.
Repeat in the other nostril using the same swab.
The Buffer Solution Vial cap is composed of two parts (purple and white). Remove the entire cap. Stir the swab into the Buffer Solution, ensuring that the swab head is fully submerged by tilting the vial. Twist the swab back and forth 20 times in the Buffer Solution. Roll the swab head against the inner wall of the vial to release the liquid from the swab, then discard the swab.
Close the entire vial cap tightly. Immediately proceed to the Test Procedures to process the sample.
Test Procedure for Patient Swabs
Note:
• Perform the following Test Procedures immediately after the specimen has been collected in the Buffer Solution Vial.
• The Test Device should be placed on a horizontal (flat) surface when running the test. Do not perform testing with the Test Device in any other orientation.
Remove the purple top half of the cap to expose the dropper tip.
Hold the vial vertically above the sample well (S). Slowly squeeze and apply 3 drops of the Buffer Solution
into the sample well (S) of the Test Device.
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