Over the counter or home use COVID-19 test kits will include all necessary materials needed to perform the test, including a nasal/nasopharyngeal swab, extraction tube, workstation, and a test device. It is important to read the instructions provided with your test kit carefully before using the test, as not all COVID-19 test kits follow the same instructions. 

Potential risks include possible discomfort during sample collection and errors in sample collection leading to possible incorrect results.

Potential benefits include the results, which along with other information, can help your healthcare provider make informed recommendations about your care. The results of this test may help limit the spread of COVID-19 to your family and others in your community.

If you have a positive test result, it is very likely that you have COVID-19 because proteins from the SARS-CoV-2 virus that causes COVID-19 were found in your sample. There is a very small chance that the test may produce a false positive result. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. If you test positive, you should self-isolate and seek follow-up care with your healthcare provider. Additional testing may be necessary.

A negative test result indicates that COVID-19 virus was not detected. It is possible for the test to give a false negative result. An individual may still have COVID-19 even though the test is negative. The amount of antibodies or antigens may be below detectable levels in individuals who have been exhibiting symptoms for less than 15 days, or are not present during the stage of disease in which a sample is collected. A negative result does not preclude SARS-CoV-2 infection and should be confirmed via molecular assay (e.g., PCR). If you test negative but continue to have COVID-19 symptoms, seek follow up care from your healthcare provider.

Yes, our team follows research on new variants of COVID-19 to ensure that any changes in the variant will not impact the performance of the test. Both the Rapid Response® COVID-19 Antigen Rapid Test Cassette – At Home (COV-19C25B) and Rapid Response® COVID-19 Antigen Rapid Test Device (COV-19C25 / COV-19C5) were tested with Omicron variants BA.1, BA.2 BA.4 and BA.5 recombinant proteins and with positive samples, confirmed by sequencing. It was confirmed that both tests accurately detect these strains at or near the same limit of detection. Read a statement here [BA1-BA2-BA4-BA5-Statement-COV-19C25B-and-COV-19C25.pdf (btnx.com) ]

Individuals confirmed to have COVID-19 often exhibit symptoms of fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. Currently known symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat or new loss of taste or smell, nausea or vomiting or diarrhea. While the severity can range from mild to intense, some individuals infected with COVID-19 may have no symptoms at all. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the average time to symptom onset is approximately 5 days.

Serial testing involves testing an individual for COVID-19 more than once. Since antigen tests are not as sensitive as other testing methods and can sometimes give false results, repeated testing is recommended to better identify cases. By repeating testing, it can help lead to faster detection of COVID-19 cases and reduce the spread of infection. Depending on the individual’s risk factors and test results, further molecular testing for COVID-19 may be required. It is important that you work with your healthcare provider to help you understand the next steps you should take.

Molecular tests, also referred to as PCR tests, identify the virus’ genetic material. In contrast, antigen tests detect proteins from the virus. Antigen tests are precise in detecting the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not necessarily rule out infection when using an antigen test.

Rapid COVID-19 test kits typically provide results in 10-15 minutes. Please read the instructions carefully with your kit for accurate results.

Time to Results:

• COV-19C1AD - 10 minutes
• COV-19C25AD - 10 minutes
• COV-19C25IND INDICAID COVID-19 Rapid Antigen Test - 20 minutes
• COV-19C20CS CareStart™ COVID-19 Antigen Test - 10 minutes

Yes, the COVID-19 test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.

Repeat testing is needed to improve test accuracy. The CDC suggests that if you get a negative test result, you should take a second test 48 hours later. If the second test is also negative and you don’t have symptoms, a third test 48 hours after is recommended. If you are exposed to COVID-19, testing should occur at least 5 full days after exposure and may be repeated in 48-hour intervals for a total of three tests. 

Source: https://www.cdc.gov/coronavirus/2019-ncov/testing/self-testing.html#:~:text=,virus%20if%20you%20have%20symptoms

COVID-19 test kits for home use are authorized by the FDA under an Emergency Use Authorization.

COV-19C25AD

• Product Name: Advin COVID-19 Antigen Test
• Type: Antigen
• Use: OTC Home Test and Point of care. CLIA Waived. Authorized by the FDA under an EUA.

COV-19C1AD

• Product Name: Advin COVID-19 Antigen Test @Home
• Type: Antigen
• Use: OTC Home Test. CLIA Waived. Authorized by the FDA under an EUA.

COV-19C25IND

• Product Name: INDICAID COVID-19 Rapid Antigen Test
• Type: Antigen
• Use: OTC Home Test. Authorized by the FDA under an EUA.

COV-19C20CS

• Product Name: CareStart™ COVID-19 Antigen Test
• Type: Antigen
• Use: Point of care. CLIA Waived. Authorized by the FDA under an EUA.

COVID-19 test kits can be used for travel or before returning to work/school. It is important to test before traveling or social gathering to prevent spreading the virus.

Certain countries accept rapid antigen screening for inbound travel. Make sure your test is accepted in the country you are travelling to so you can avoid any complications.

COVID-19 test kits can be used as proof to return to work/school. Check with your work/school if your test is accepted. 

Home test kits can be used to test family members or close contacts. Please read the product insert included with your kit for the authorized ages that can use the test and details on how to use your test kit for the specified ages.

Nasal swab tests involve inserting a swab into the nose to collect a sample either from the back (nasopharyngeal) or anterior portions of the nasal passage. They are commonly used because the virus tends to be present in higher quantities in the nasal passage, especially in the early stages of infection.

Saliva tests require a sample of saliva (oral fluid), which can be less invasive and more comfortable to collect than a nasal swab. However, the efficiency and accuracy of the test may vary. It is important to follow and read the instructions carefully provided with your kit for accurate results.

There are COVID-19 antigen test kits available for self-testing and on-site testing. PCR tests require a healthcare professional to administer and the collected test sample must be sent to a lab for analysis. 

Store COVID-19 test kits at 2-30°C (36-86°F) when not in use. The test device must remain in the sealed pouch until use. Do not use after the expiration date.

COVID-19 test kits should not be used on anyone under 2 years old. Children aged 2 and up should be tested by an adult. Children 14 and above may test themselves under adult supervision.

For questions or to report a problem, please call technical support at 1-888-339-9964 (MON-FRI 9AM – 5 PM EST) or email support@btnx.com.