Test Information

STANDARD MOLECULAR NAAT (PCR OR TMA) COVID-19 TEST: Collection Sites’ nasal swab tests are used to detect the presence of COVID-19. The tip of a cotton swab is inserted into one nostril and rotated.

Potential risks include:

(i) possible discomfort or other complications that can happen during sample collection; and (ii) possible incorrect test result.

Potential benefits include:

(i) the results, along with other information can help your healthcare provider make informed recommendations about your care; and

(ii) the results of this test may help limit the spread of COVID-19 to your family and others in your community.

Upon obtaining the sample, it will be to an independent laboratory for processing. Test results will usually be available within two to four days, delays may occur during peak seasons or COVID outbreaks.

RAPID COVID-19 ANTIGEN TEST: Collection Sites’ nasal swab tests are used to detect the presence of COVID-19. The tip of a cotton swab is inserted into both nostrils. The swab is rotated in a circle around the entire inside edge of each nostril at least three times.

Potential risks include:

(i) possible discomfort or other complications that can happen during sample collection; and (ii) possible incorrect test result, or false negative results.

Potential benefits include:

(i) the results, along with other information can help your healthcare provider make informed recommendations about your care; and

(ii) the results of this test may help limit the spread of COVID-19 to your family and others in your community.

Upon obtaining the sample, it will be processed on site and the results will be provided to you, usually within an hour or less.

The Rapid COVID-19 Antigen Test used by Collection Sites has not been FDA cleared or approved. The test has been authorized by the FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

I also understand that Collection Sites participates in clinical research activities and that I may be asked to participate in these research activities. I further understand that my participation is 100% voluntary and that the care I receive from Collection Sites will not be impacted by my decision as to whether or not to participate in such clinical research activities.

RAPID ANTIBODY TEST

The COVID-19 antibody test measures the IgM and IgG “immunoglobin” or “antibody” in an individual’s blood for COVID. Approximately two drops of blood are required to perform the antibody test. The blood is obtained by administering a finger poke. You may experience slight discomfort during this process. In addition, there is a minor risk of infection at the site of the puncture. In the event of a suspected infection at the puncture site, clean the area, treat it with topical antibiotic and cover it with a band aid. If the site does not improve, consult your primary care physician.

Upon obtaining the sample, it is placed in a test cassette for processing. The test results are generally available within fifteen (15) minutes. Like all laboratory testing, there is a risk of an inaccurate result. While we feel confident in the testing data, this is a new test that has not yet been reviewed by the Food and Drug Administration and the results are not guaranteed.

The Food and Drug Administration requires any medical professional administering the COVID-19 qualitative screen test to ensure individuals receiving the test understand the following:

This antibody test being used has not been reviewed by the FDA Negative results do not rule out the SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with molecular diagnostics should be considered to rule out infection in these individuals.

Results from antibody testing should not be used as the sole basis of diagnose to exclude SARS-CoV-2 infection or to inform infection status.

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 receive a positive test result for COVID-19, we recommend that this result be confirmed using a nasal swab. You agree and acknowledge that your test results may be reported to various government agencies, including the county Health Department. The possible benefits of this test are that the results can help your medical provider make informed recommendations about your care, and the results may help to limit the spread of COVID-19 to your family and others in your community.