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Sekisui OSOM COVID-19 Antigen Rapid Test 40-Count EUA

$55000

Sekisui OSOM COVID-19 Antigen Rapid Test 40-Count EUA is backordered and will ship as soon as it is back in stock.

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Why you'll love it
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Point-of-care antigen test. detects SARS-CoV-2 nucleocapsid antigen in mid-turbinate nasal swabs
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Read at 15 minutes. results are interpreted at 15 minutes and should not be read after 30
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Built-in control line. confirms sufficient specimen volume and correct procedure
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CLIA settings only. for labs and POC sites with a waiver, compliance or accreditation certificate
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40 tests per kit. devices, buffer tubes and nasal swabs for each test are included

Specifications

DetectsSARS-CoV-2 nucleocapsid protein antigen
SpecimenDirect mid-turbinate nasal swab collected by a healthcare provider
Read time15 minutes (do not read after 30 minutes)
AuthorizationEUA, prescription use only, CLIA settings
AgeTested in individuals aged 5 and above
Kit size40 tests
Storage15 to 30 C (59 to 86 F)
Manufacturer cat. no.1066-40
Sekisui Diagnostics
Customers rate us 4.6/5 based on 260 reviews.

Shipping & Returns

Returns are accepted within 30 days for unopened, unused items in their original packaging. Customers are responsible for return shipping.

Please note that some items, including select medical and diagnostic products, are final sale and not eligible for return.

View our full policy for complete details.

Description

Sekisui OSOM COVID-19 Antigen Rapid Test, 40-count professional point-of-care kit

The OSOM COVID-19 Antigen Rapid Test from Sekisui Diagnostics is a lateral flow immunoassay that detects SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate nasal swab specimens. This 40-test kit includes a test device, buffer tube and sterile nasal swab for every test.

It is intended for healthcare professionals and operators proficient in point of care testing, in CLIA-certified laboratories and patient care settings holding a waiver, compliance or accreditation certificate. Results are interpreted at 15 minutes, and a built-in control line confirms sufficient specimen volume and correct technique.

Authorized under an Emergency Use Authorization for prescription use only, and not for at-home testing. Negative results are presumptive and may need molecular confirmation. Store at 15 to 30 C, and note that the test has only been evaluated in individuals aged 5 and above.

What's in the box
40xOSOM COVID-19 Antigen test devices
40xOSOM Antigen Buffer tubes (2 packs of 20)
40xSterile nasal swabs
1xInstructions for Use
1xQuick Reference Guide
A timer, gloves and disinfectant are needed but not included. The OSOM COVID-19 Antigen Control Kit (cat. 1068) is sold separately.

Frequently asked questions
Who can use this test?

It is for healthcare professionals or operators proficient in point of care testing, in laboratories certified under CLIA to perform waived, moderate or high complexity tests. It is not for at-home use and is for prescription use only.

What sample does it use?

Direct mid-turbinate nasal swab specimens collected by a healthcare provider. Other specimen types and viral transport media should not be used.

How long until I read the result?

Results are interpreted at 15 minutes. Do not read results after 30 minutes.

Is it FDA cleared?

No. Per the manufacturer's Instructions for Use, the test has not been FDA cleared or approved. It is authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.

What if the result is negative?

Negative results are presumptive. Confirmation with a molecular assay may be needed, and a negative result should not be the sole basis for treatment or infection control decisions. Serial testing is described in the Instructions for Use.

Can it be used on young children?

The manufacturer states the test should not be used on children under 5 years of age, as it has only been tested in individuals aged 5 and above.

Are control swabs included?

No. External controls are sold separately as the OSOM COVID-19 Antigen Control Kit (catalog 1068). The test device has a built-in control line.

How should the kit be stored?

Store between 15 and 30 C (59 to 86 F), and bring components to room temperature before use. Keep the device in its sealed pouch until use.