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Why trust DiaTrust?

It's as simple as ABC.

A. Simple Steps

Just four steps from start to finish, the DiaTrust™ system makes getting your results easy.

B. Rapid Results

Once you’ve completed the process, it’s just a 15-minute wait for the results to appear.

C. Reasonable Relief

DiaTrust™ is FDA EUA authorized to bring you back the ordinary life before pandemic.

0

Negative Percent Agreement

0

Positive Percent Agreement


Positive Percent Agreement: = 39/45*100 86.7%
Negative Percent Agreement: = 446/447*100 99.8%

The Celltrion DiaTrust™ COVID-19 Ag Home Test is for use under Emergency Use Authorization (EUA) only. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. & 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

Product Detail

Comfort's

in the details

(01)

Swab with softness

Our swab is a flock swab, with a softer tip that doesn't irritate your nasal passages.

(02)

Included in each kit

You’ll get the supplies for two tests: swabs, test devices, test tubes (extraction buffer) and filter caps. Test yourself and a family member at the same time, or take two tests in a designated timeframe for travel, work, and more.

(03)

No reading between
the lines

Red line only on the C line means negative.
Red lines on both the C line and T line means positive.
Results other than above means invalid.
※ C-line (Control Line)
※ T-line (Test Line)

We're FDA Emergency Use Authorized
for your assurance.

The Celltrion DiaTrust™ COVID-19 Ag Home Test is for use under Emergency Use Authorization (EUA) only. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. & 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

Download results

DiaTrust COVID-19 Ag Home Test IFU_Eng Download ↓
DiaTrust COVID-19 Ag Home Test IFU_ES Download ↓
DiaTrust COVID-19 Ag Home Test IFU for HCP Download ↓
DiaTrust COVID-19 Ag Home Test Fact Sheet for HCP Download ↓
DiaTrust COVID-19 Ag Home Test Box Labels Download ↓
DiaTrustCOVID-19 Ag Home Test Authorized Distributor List Download ↓

4 Steps

How to use.

(01)

Swab.

Swirl the swab in your nasal to collect a sample.

(02)

Mix.

Put the tip of the swab into the test tube, mix the sample and the buffer fluid thoroughly.

(03)

Drop.

Put the filter cap and dispense 3 drops into the sample well.

(04)

Results.

Read the result after 15 minutes.
Do not read results after 20 minutes.


Still have questions about the DiaTrust Rapid Antigen Test?

What is the Celltrion DiaTrust™ COVID-19 Ag Home Test?

Celltrion DiaTrust™ COVID-19 Ag Home Test is a type of test called an antigen test. Antigen test are designed to detect proteins from the SARS-COV-2 virus that causes COVID-19.

Who should use this test? When should it be taken?

This test is authorized for non-prescription home use with self-collected and adult-collected direct mid-turbinate swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
This test is also authorized for non-prescription home use with self-collected and adult-collected mid-turbinate swab samples from individual 14 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

What is Emergency Use Authorization (EUA)?

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

What are the known and potential risks and benefits of this test?

Potential risks include:
1) Possible discomfort during sample collection.
2) Possible incorrect test results.

Potential benefits include:
1) The results, along with other information, can help you and your healthcare provider make informed decisions about your care.
2) The results of this test may help limit the spread of COVID-19 to your family and others in your community.

What is serial testing?

Serial testing is when a single person is tested for COVID-19 more than once. Because antigen tests are less sensitive than other molecular COVID-19 tests and false results may occur, repeated testing may identify more individuals with COVID-19 infection than a single test. Repeated testing, it may identify COVID-19 infection more quickly and reduce the spread of infection. Additional testing with molecular COVID-19 test may be necessary, depending on your individual risk factors and test results. It is important that you work with your healthcare provider to help you understand the next steps you should take. Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.

Where can I purchase the product?

For individual use, Celltrion DiaTrust™ COVID-19 Ag Home Test may be found from your local retail stores.
To purchase bulk quantities or arrange periodic orders, please contact: DiaTrust@celltrion.com.

If I have other questions, who should I contact?

For additional help, please contact us by celltrionusa.CS@celltrion.com.

Other Products

Find information about the Celltrion COVID-19 Rapid Test Kit here:

Learn More
  • Notice
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Packaging for the Celltrion DiaTrust™ COVID-19 Ag Home Test may differ.
Despite the different packaging, both boxes shown below contain the official Celltrion DiaTrust™ COVID-19 Ag Home Test.