OSOM^® COVID-19 Antigen Home Test

SEKISUI Diagnostics is constantly monitoring the CDC website to track variants of concern (VoC). When a variant emerges, the impact of SARS-CoV-2 variants on the performance of the OSOM COVID-19 Antigen Test will be evaluated. To date, the test has demonstrated the ability to detect all variants tested. We will ensure that any impacts on product performance caused by variants of concern are communicated to our customers.

This test is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 or older or adult collected anterior nasal swab samples from individuals aged 2 years or older.

Yes, the test can be used regardless of vaccination status.

Do not use on anyone under 2 years of age.

Please consult your state health department and visit the CDC website for pre and post travel requirements and documentation.

If you have questions regarding the use of this product, or if you want to report a problem with the test, please contact SEKISUI Diagnostics Technical Services at (800) 491-6220 or

[email protected].

If you have questions regarding the use of this product, or if you want to report a problem with the test, please contact SEKISUI Diagnostics Technical Services at (800) 491-6220 or

[email protected]

The test kit expiration date is indicated on the test kit box, under the lot number and next to the hourglass symbol.

No. Do not use kit past its expiration date.

Yes. This test is authorized for individuals with symptoms of COVID-19 and for individuals without symptoms or other epidemiological reasons to suspect COVID-19.

Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at: add link to documentation page.

Serial testing should be performed in all individuals with negative results; individuals with symptoms of COVID-19 and initial negative results should be tested again after 48 hours. Individuals without symptoms of COVID-19, and with initial negative results, should be tested again after 48 hours and, if the 2nd test is also negative, a 3rd time after an additional 48 hours. You may need to purchase additional tests to perform this serial (repeat) testing.

This test is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 or older or adult collected anterior nasal swab samples from individuals aged 2 years or older.

The test is manufactured in the US.

SEKISUI Diagnostics does not provide free of charge tests.

No, the OSOM® COVID-19 Antigen Home Test kit cannot be returned for refund and imbursement. Sekisui Diagnostics does not provide reimbursement for the test.

No, only nasal swab samples are validated for use with the test.

No, only the swabs provided in the test kit are acceptable for use with the test.

Instructions on how to collect an anterior nasal swab sample can be found: https://www.cdc.gov/coronavirus/2019-ncov/testing/How-To-Collect-Anterior-Nasal-Specimen-for-COVID-19.pdf

No- the test should not cause more than discomfort during sample collection.

The test is validated using nasal swab sample collected from both nostrils. Recollect the nasal swab sample and repeat test. Repeat testing using a new patient sample, new antigen buffer tube and new test device.

No, the test needs to be repeated. Repeat testing using a new patient sample, new antigen buffer tube and new test device.

Use a new buffer tube. If the test needs to be repeated, repeat using a new patient sample, new antigen buffer tube and new test device. Adding less than the required amount of sample may cause an invalid result.

Repeat the test. Repeat testing using a new patient sample, new antigen buffer tube and new test device. Adding less than the required amount of sample may cause an invalid result.

Do not read test results after 30 minutes. Results read before 15 minutes or beyond 30 minutes may be inaccurate.

Any faint visible pink/purple Test (T) line with the Control (C) should be read as positive.