Flu SARS-CoV-2 Combo Home Test, 2 CT

General Questions

Does The OSOM Flu SARS-CoV-2 Combo Home Test Detect Newer Variants Of COVID-19?

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.

What Is The Age Range For The Test?

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.

Are There Any Limitations As To Who Can Use This Test?

Do not use on anyone under 2 years of age.

Is This Test Acceptable For Travel? Can It Be Used For Proof Of A Negative COVID-19 Test Result?

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

Who Do I Contact If I Have A Question About This Kit Or Encounter A Problem While Using It?

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 osomhometests@sekisui-dx.com

If There Is A Missing Component, What Do I Do?

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 techservices@sekisuidiagnostics.com

Where Do I Find The Kit Expiration Date?

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

Can I Still Use My Kit If It Has Expired?

No. Do not use kit past its expiration date.

What Is Serial Testing? What Are The Recommendations For Repeat Testing?

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.

Do I Need A Prescription For This Test?

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.

Where Is The Test Manufactured?

The test is manufactured in the US.

Can I Get A Free Test?

SEKISUI Diagnostics does not provide free of charge tests.

Can I Return The Test/Get Reimbursement?

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.

Sample Collection

Can I Swab My Throat/Ear etc. Include Instead Of Nasal Passage?

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

I Lost The Swab; Can I Use A Q-Tip Or A Swab From Another Manufacturer’s Kit Instead?

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

Will This Test Cause Any Pain?

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

I Collected A Swab From Only One Nostril And Have Already Placed It Into The Extraction Buffer – Can I Still Read And Interpret The Test Results?

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.

Performing the Test

I Think I Contaminated My Swab/Buffer/Test Device; Can I Still Use The Test?

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

If I Spilled Some Of The Buffer, What Should I Do?

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.

Resultados

I Waited Longer Than 15 Mins To Read The Result – Is It Still Valid?

Do not read test results after 30 minutes. Results read before 10 minutes or beyond 30 minutes may be inaccurate

What Does It Mean If The Test (T) Line Is Faint?

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