GenBody COVID-19 Ag Immunochromatographic Rapid Diagnostic Test Instructions
- June 4, 2024
- GenBody
Table of Contents
GenBody COVID-19 Ag Quick Reference
Instructions
For Use Under an Emergency Use Authorization (EUA) Only
Intended Use
The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test
(RDT) intended for the qualitative detection of nucleocapsid protein antigen
from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab
specimens from individuals who are suspected of COVID-19 by their healthcare
provider within the first six days of symptom onset. 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,
high or waived complexity 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.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen
is generally detectable in nasopharyngeal (NP) or anterior nasal (AN) swab
specimens during the acute phase of infection. Positive results indicate the
presence of viral antigens, 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 the
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.
The GenBody COVID-19 Ag is intended for use by medical professionals or
operators trained in performing tests in point-of-care settings. The GenBody
COVID-19 Ag is only for use under the Food and Drug Administration’s Emergency
Use Authorization.
**Conditions of Authorization
**
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 certified
under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate,
high, or waived complexity 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. This product has been authorized only for the detection of
proteins from SARS-CoV-2, not for any other viruses or pathogens. 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 authorization is revoked sooner.
IMPORTANT: See Package Insert, including the Quality Control section, for
complete use instructions, warnings, precautions, and limitations.
EXTERNAL QUALITY CONTROL: Test control swabs included in the GenBody
COVID-19 Ag kit in the same manner as patient specimens. The positive control
should show a reddish-purple line at the C (Control) and T (Test) positions.
The negative control should show a reddish-purple line at the C position only.
If external controls do not perform as expected, do not use the test and
contact Technical Support.
SWAB SPECIMEN COLLECTION: Swab specimens collected from patients should
be tested immediately after collection for best performance. The collected
swab specimen can be tested for up to 60 minutes following specimen
collection. The extracted specimen can be tested for up to 5 hours if stored
between 2-30°C.
Part 1. Sample Collection Procedure
Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing
Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19).
Nasopharyngeal Samples
- Remove a nasopharyngeal swab from the pouch.
- With the patient’s head tilted backward at 70 degrees, carefully insert the swab into the nostril that presents the most secretion under visual inspection.
- Gently and slowly insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx.
- Leave the swab in place for several seconds to absorb secretions.
- Rotate the swab 3-5 times against the posterior nasopharynx.
- Using gentle rotation, remove the swab from the nostril; insert it into the Extraction Tube.
- All specimens should be tested as soon as they are prepared.
Anterior Nasal Samples
- Remove an anterior nasal swab from the pouch.
- Insert the Swab ½ to ¾ of an inch into the RIGHT nostril.
- In a circular motion, rub the swab around the entire wall of the nostril with some pressure. This should be performed for at least 5 circles and 15 seconds.
- Withdraw the swab and repeat the same process on the LEFT nostril.
- Withdraw the swab from the second nostril. Immediately after BOTH nostrils have been swabbed, place the swab into the Extraction Tube.
- All specimens should be tested as soon as they are prepared.
Part 2. Test Procedure
Open the Test Device just prior to use, lay it flat, and perform the assay
as below
• Add the Extraction solution to the Fill Line indicated on the Extraction
Tube.| • Insert the collected specimen swab into the Extraction Solution.
• Mix by squeezing the tube and simultaneously rotating the swab 8~10 times.
• Place the Dropper Tip. Inadequate swab rotation can result in incorrect
results.
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• Place Test Device on a level surface.
• Add 4 drops of the solution to the sample well.| • Read the test result for
15~20 minutes.
• Do Not read the results after 20 minutes.
False positive or false negative results can occur if the test device is read
before 15 minutes or after 20 minutes
Part 3. Result Interpretation
Negative Results
Only one reddish purple line on the control line (C) position appears with no
line on the test line position (T).
Positive Results
| Two reddish purple lines appear in the test window, one on the test line
position (T) and the other on the control line position (C).
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Any visible reddish-purple-colored line at the T position is positive.
Invalid Results
| If a line does not appear on the control line position (C) in 15 minutes,
the test result is invalid.
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Re-test with a new GenBody COVID- 19 Ag Test Device.
© 2021 GenBody Inc, All rights reserved.
All trademarks referenced are trademarks of GenBody Inc.
COVAG025-U
COVAG025-NU
Technical Support (US)
Tel: 888-552-5204
Email: ts@genbodyamerica.com
|
Manufacturer
Gennady, Inc.
3-18, Eopseong 2-Gil, Seobuk-gu
Cheonan-si, Chungcheongnam-do, 31077,
Republic of Korea
Tel: +82-41-523-8993
Email: contact@genbody.co.kr
Website: http://genbody.co.kr
|
US Distributor / US Agent
Kwell Laboratories, LLC
3420 De Forest Circle
Jurupa Valley, CA 91752
USA
Tel: 949-561-0664
Email: inquire@kwelllabs.com
Website: www.kwelllabs.com
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Date of Last Revision
2021.09.243 (Rev.1)