SwiftSwab™ Covid-19 Antigen Self Test

GBM-COV-01

Product Information

Product Code: COV-19NS1 (1 Pack), COV-19NS2 (2 Pack), COV-19NS4 (4 Pack), COV-19NS5 (5 Pack)
Sample: Nasal
Format: Cassette
Quantity: 1, 2, 4, or 5 Tests/Kit
Time to result: 15 minutes
Storage Condition: 2-30°C/36-86°F
Test Principle: Immunochromatographic Assay

Product Description

The SwiftSwab™ Covid-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The test is authorized for home use with self-collected anterior nasal (nares) swabs from individuals aged 14 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.  This test is authorized for home use with anterior nasal (nares) swab samples for:

  • Self-collection by an individual aged 14 years and older
  • Adult collecting for children aged 2 to 13 years

Contents
Components1 Test per
Box
2 Test per
Box
4 Test per
Box
5 Test per
Box
SwiftSwab™ COVID-19 Antigen Self Test Device1245
Sterilized Swab1245
Extraction Buffer Tube1245
Tube Holder1111
Quick Reference Instructions1111
Frequently Asked Questions

COVID-19 is an acute respiratory infectious disease caused by th e SARS- CoV-2 virus, a novel Beta coronavirus. SARS- CoV-2 is mostly spread person-to-person, both by individuals with symptoms of COVID-19 and by infected people without symptoms. Based on the current knowledge, the incubation period is 1 to 14 days, mostly 4-5 days.

Symptoms include fever, fatigue, and cough. For a full list of symptoms, click here

If no control line shows up on the test, the result is invalid (even if any test line shows up) An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and the test should be run again, using all new test components.

No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from your healthcare provider.

Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test results (see Result Interpretation section).

Potential benefits include:

• The results, along with other information, can help you and your healthcare provider make informed decisions about your care.

• The results of this test may help limit the spread of COVID-19 to your family and others in your community

For more information on self testing click here.

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests, such as the Rapid SAR S-CoV -2 Antigen Test detect proteins from the virus. Antigen tests are very specific for the COVID-19 virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test is necessary and if you should continue isolating at home.

More information…

The performance of the SwiftSwab COVID-19 Antigen Self Test was established in a prospective clinical study of symptomatic individuals using an EUA molecular test as a comparator method. The data from this study were analyzed using the minimum recommended number of low positives demonstrating that the test correctly identified 82.7% of positive samples and correctly identified 99.1% of negative samples. For more detailed information on test performance please see Section 2.6 of the Health Care Provider Instructions for Use. A negative result in individuals with or without symptoms does not rule out COVID-19. You can still infect others if you have a negative result. COVID-19 antigen tests are less sensitive than molecular (PCR) tests. The performance of antigen tests can vary with the amount of virus in your sample. Therefore, you should contact your healthcare provider to determine if additional testing with a highly sensitive COVID-19 molecular test is needed.

Additional information is available in the Healthcare Provider Instructions for Use at www.genebiomedical.com.

Yes. Please see the Healthcare Provider Instruct ions for Use available at www.genebiomedical.com for additional information. The performance of this test is still being studied in patients without signs and symptoms of respiratory infection and for serial screening. Performance may differ in these populations.

Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. Serial testing (i.e. testing every day or every other day) is more likely to detect COVID-19. Testing should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.

A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result. Your healthcare provider will work with you to determine how best to care for you based on your test result, medical history, and symptoms.

A negative test result indicates that antigens from the virus that causes COVID-19 were not found in your sample. You should test again in 24 to 48 hours. If you receive a second negative result 24 to 48 hours after your first negative result, then you are likely not infected with COVID-19. However, negative results do not rule out SARS-Co V-2 infection.

It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. For example, you may get a false negative result if you did not perform the test correctly or if the level of antigen from the virus causing COVID-19 was below the test limits. The amount of antigen in a sample may decrease the longer you have symptoms of infection. If you test negative and continue to experience symptoms of fever, cough and/ or shortness of breath you should seek follow up care with your healthcare provider. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the next steps you should take.