Frequently Asked Questions

The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between October 2023 and January 2024. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

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.

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.

Serial testing should be performed in individuals with SARS-CoV-2 negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals. Consistent with serial testing recommendations for SARS-CoV-2, for multi- analyte tests, symptomatic individuals who test positive for influenza A or B on the initial test but test negative for SARS-CoV-2 should be tested again in 48 hours to evaluate for co-infection with SARS-CoV-2 infection.

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® Flu SARS-CoV-2 Combo Home Test 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.

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 strip.

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.

Do not read test results after 30 minutes. Results read before 10 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.