NIDS COVID-19 Antigen Rapid Test Kit User Guide

NIDS®COVID-19
Antigen Rapid Test
Quick Reference Guide

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

Directly Collected Mid-Turbinate Nasal Swab

The NIDS COVID-19 Antigen Rapid Test Kit is a lateral flow immunoassay (LFI) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct mid-turbinate (MT) nasal swabs from individuals who are suspected of having COVID-19 by their healthcare provider within the first seven (7) 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 36 hours between tests. Testing 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 test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. The NIDS COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein. The antigen is generally detectable in MT nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. The NIDS COVID-19 Antigen Rapid test is intended for use by medical professionals or operators who are performing tests in point of care settings. The NIDS COVID-19 Antigen Rapid Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.
See Instructions for Use for complete use instructions, warnings, precautions, and limitations.
In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under a EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and in the USA, – 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 the detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.

1. Collect specimen
   Prior to collecting the nasal swab, the patient should be instructed to blow their nose.
   Tilt head back 70 degrees. Carefully insert a swab into the nostril, parallel with thebridge of the nose, no more than 1″ deep, or until you feel resistance at the turbinates. Rotate the swab in a circular path at least 4 times around the entire inside nostril’s wall for approximately 15 seconds. Repeat with the same swab in the other nostril.

2. Remove white cap and immerse swab in buffer
   Remove the white cap of the collection tube and insert test swab into the buffer.

3. Plunge swab up and down for 15 seconds
   Carefully plunge the swab up and down for 15 seconds. DO NOT SPILL CONTENTS OR CONTAMINATE THE SWAB.

4. Remove swab and cap tube with affixed clear dropper
   Remove the test swab while pressing and rotating the tip against the inside wall of the tube to extract the liquid. Discard the swab and cap tube with an affixed clear dropper tip.

5. Invert the tube and dispense 5 drops into the sample well

6. Read results at 15 minutes

Remove test device from foil pouch and lay it flat. Invert the capped collection tube and tap the side to remove air bubbles from the dropper tip. Hold the tube vertically, 1/4 inch above the device. Squeezing gently, dispense five (5) drops of sample solution to the sample well. Test Devices should be on a flat surface to avoid spillage and inaccurate results. Adding fewer drops may produce invalid or inaccurate results.

Read results in test window at 15 minutes.
RESULTS READ BEYOND 30MINUTES MAY BE INACCURATE.
Notes:

• Testing must be performed within 30 minutes of specimen collection.
• Do not use visually bloody or overly viscous specimens.
• Inadequate specimen collection or improper sample handling/storage may yield erroneous results.
• Use only the swab provided in the test kit.

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

RESULTS INTERPRETATION

Negative

A negative specimen will give a single red/pink colored Control Line in the top half of the window, indicating a presumptive negative result. ThisControl Line means that the detection part of the test was done correctly, but no SARS- CoV-2 nucleocapsid protein antigen was detected. If the first test result is negative for individuals without symptoms, individuals should be retested with a second test after 24 hours but no more than 36 hours. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.

Note: For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary after second negative result for asymptomatic patients, if there is a high likelihood of SARS-CoV-2 infection, such in an individual with as a close contract with COVID-19 or with suspected exposure to COVID19 or in communities with a high prevalence of infection. Additional confirmatory testing with a molecular test for positive results with and without serial testing may also be necessary if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with a low prevalence of infection.
Positive
A positive specimen will give two red/pink colored lines. This means that the SARS-CoV-2 nucleocapsid protein antigen was detected. Specimens with low levels of antigen may give a faint test line. Any visible pink/purple-colored line is positive.

Invalid
If no control line or test line are seen, the test is invalid.
If the test line is seen, but the control line is not, the test is invalid. Invalid tests should be repeated. If the problem persists, contact ANP Technical Support. IMPORTANT
Negative Procedural Control
The clearing of the test strip’s background color in the results viewing window is a built-in negative control, indicating that the test has been performed correctly. The test area’s color in the window should turn from dark red to light pink or white within 15 minutes and allow for a clear interpretation of the test result. If the background color remains dark red and interferes with the reading of the test result, then the test is invalid. Should this occur, review the procedure, and repeat the test with a new patient sample using a new test device. Do not reuse patient samples and swabs.

TEST DEVICE

Positive Specimen Indication
Any visible pink/purple-colored test line is positive. All six examples below are positive.

At 15 minutes read the result by either:

1. Holding the Visual Guide Card next to the test device.
   OR

2. Laying the test device directly onto the outline image here and use as the guide incorporated herein.

Do not read the test beyond 30 minutes, as results interpreted after 30 minutes may result in a false positive, false negative, or invalid results.

ANP Technologies, Inc.
824 Interchange Blvd. Newark, DE 19711
Tel:+1 302-283-1730 / +1 888-283-0685 (8:00 AM – 5:00 PM EST)
Technical Help: Techhelp@anptinc.com (24/7)
Document No.: QRG-016F
Effective Date: September 2021
Version 04

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