GenBody Rapid COVID-19 Antigen Nasal Test Kit (25 Tests Per Box)
(25 Tests Per Box)
FDA EMERGENCY USE AUTHORIZED/ CLIA WAIVED POC DEVICE
Shallow Nasal Collection Method Approved
Please allow 3-5 Business Days For Shipment – All Orders Placed Will Be Sent Out With UPS Next Day Air Upon Reaching Place In Shipping Queue
|1 - 9 boxes||10 - 19 boxes||20+ boxes|
|$300.00 per box||$275.00 per box||$250.00 per box|
What is this rapid COVID test kit?
This rapid COVID test for sale is available to qualified healthcare professionals, as well as business owners looking to secure a supply of rapid COVID tests for onsite testing. This rapid test kit will give an easy to read result in about 10 minutes for an active COVID infection. This rapid test kit was also recently approved for a shallow nasal collection, making sample collection much more efficient and comfortable.
This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA 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., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Positive Percent Agreement: 92.31%
Negative Percent Agreement: 99.04%
CPT CODE: 87426
What is included with this kit?
This COVID-19 rapid antigen nasal test kit is sold in boxes of 25 individual testing cassettes and includes the following:
- (25) Rapid Testing Cassettes
- Foil pouched test device containing one test strip which
is encased in plastic device cassette.
- Foil pouched test device containing one test strip which
- (2) Extraction Solution Vials
- The extraction vials each contain 9mL of Extraction Solution
- (25) Extraction Tubes
- (25) Single-Use Dropper Tips
- (25) Anterior Nasal Swabs
- Swabs for shallow nasal specimen collection
- (1) Positive Control Swab
- (1) Negative Control Swab
- (1) Instruction For Use Insert
Clinical Accuracy Findings
Intended Use of Rapid COVID-19 Antigen Nasal Test Kit
- This COVID-19 Antigen test is a lateral flow immunochromatographic assay
intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
nasopharyngeal swab specimens directly collected, or collected in BD universal transport media,
from individuals suspected of COVID-19 by their healthcare provider within five days of symptom
- 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
- Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen
is generally detectable in anterior nasal swab specimens during the acute phase of infection.
- Positive results indicate the presence of viral antigens, but the clinical correlation with patient
history and other diagnostic information is necessary to determine infection status. Positive
results do not rule out a 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 are presumptive and confirmation with a molecular assay, if necessary, for
patient management may be performed. 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
- The GenBody COVID-19 Antigen is intended for use by medical professionals or trained
operators who are proficient in performing tests and trained clinical laboratory personnel or
individuals trained in point of care settings. The GenBody COVID-19 Antigen is only for use
under the Food and Drug Administration’s Emergency Use Authorization.
Instructions for Collection and Use
Anterior Nasal Swab Sample Collection Procedure
• Process the test sample immediately after collection.
• Use only provided or recommended anterior nasal swab for specimen collection.
• Collect the specimen wearing safety gloves to avoid contamination.
• Do not touch the tip (specimen collection area) of the swab.
• Collect samples as soon as possible after the onset of symptoms.
- Allow test devices, reagents, specimens, and/or controls to equilibrate to room
temperature (15~30°C) prior to testing.
- Remove the GenBody™ COVID-19 Antigen test device and extraction vial from its foil
pouch immediately before testing.
- The GenBody™ COVID-19 Antigen kit IS INTENDED to be used only with a direct
nasopharyngeal or anterior nasal swab specimen or a swab in BD universal transport media.
- The GenBody™ COVID-19 Antigen kit IS NOT INTENDED for testing other liquid
samples such as nasal wash or aspirate samples as results can be compromised by over
Summary of Antigen Testing
COVID-19 Antigen Tests are designed to detect protein antigen from the SARS-CoV-2 virus from nasal specimen samples. Antigen tests can detect the SARS-CoV-2 virus during the active phase of the infection. The collection process is only a couple of steps, and the results are directly onsite in about 10 minutes with no machinery required. Providers can quickly and effectively test large numbers of patients and receive immediate results to help facilitate timely treatment decisions when using a rapid antigen test kit.
Similar to a PCR test, rapid antigen tests can detect the presence of the SARS-CoV-2 virus during the acute stage infection. Although much more efficient in providing timely results, rapid antigen tests can have a lower sensitivity rating when compared to PCR testing, Any negative result on a rapid antigen test should be verified with a PCR test confirmation to appropriately diagnose and treat the case.