Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab

Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab

Yakibest.com: Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab : Industrial & Scientific
Celltrion DiaTrust COVID-19 Ag Home Test: Celltrion: the brand is innovative and keeps customer needs and satisfaction in mind. The range and variety of the products are briiliant.

What are celltrion diatrust covid-19 ag home test features?

  • Make sure this fits by entering your model number.
  • Shelf-life extension: our tests sold from amazon has 6 months longer shelf-life than the printed expiration date on the package. Fda granted 6 months shelf-life extension for the celltrion diatrust covid-19 ag home test, which extended the shelf life from 12 months to 18 months as of may 20th, 2022. The affected lot numbers can be found on fda’s website: https://www.fda.gov/media/159236/download
  • Fda eua-authorized home test (otc): celltrion diatrust covid-19 ag home test is an fda eua-authorized covid-19 rapid antigen at-home testing kit. Self-test in the comfort of your own home, and get the relief you need, fast. For use in individuals aged 14 years and older.
  • Two tests per kit: each kit contains supplies for two tests: swabs, test devices, test tubes (extraction buffer), filter caps, and an instructions for use manual. Test tubes and filter caps for two tests are enclosed in one inner package.
  • Rapid results and percentage: the test gives you results in just 15 minutes and is authorized for at-home use without submitting sample collection to labs. Our home test is capable of detecting covid-19 with 99.8% negative percent agreement and 86.7% positive percent agreement.
  • Simple steps: just four steps from start to finish. The diatrust system makes getting your results easy. Detailed instruction is enclosed with the product and video instruction is available on both our product page and website. Test yourself and a family member at the same time or take two tests in a designated timeframe for travel, work, and more.
  • Swab with softness: our products prioritize user comfort, utilizing flock swabs with a softer tip that doesn’t irritate your nasal passages.

Product guides and documents

Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab AMAZON

Yakibest.com: Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab : Industrial & Scientific

Looking for specific info?

Wasn’t this celltrion covid test recently recalled? Why is amazon still selling?

Hello, thank you for your question.
The celltrion diatrust covid-19 ag home test was not subject to the recall by the fda. The tests which were recalled were unauthorized celltrion diatrust covid-19 ag rapid tests from celltrion healthcare, which were not authorized for use in the us market.
Per the fda safety communication: ‘the celltrion diatrust covid-19 ag home test, from celltrion usa, inc., was authorized by the fda on october 21, 2021 for home use. These tests are not affected by this safety communication and can continue to be used. The celltrion diatrust covid-19 ag rapid test, from celltrion usa, inc., was authorized by the fda on april 16, 2021, for point-of-care use, such as in health clinics. These tests are not the subject of this safety communication and can continue to be used.’

How accurate is it?

In my experience, it was accurate. It let me know i was covid positive.

How deep should the sterile swab be inserted into the nostrils?

According to the product information, insert the entire soft end of the swab straight back into your nostril less than one inch (about 2 cm) or until resistance is felt.

1) how long is the shelf life of these tests? 2) where are they produced? 3) is the use of an app required for results (or, how are results obtained)?

1) *updated expiration* although the expiration date of the product can be found on the back of the box or on the back of the aluminum pouch for the test device and extraction buffer, please check on the fda website since the expiration date has been extended from 12 months to 18 months. Updated expiration dates can be found on the fda website by lot number here: https://www.fda.gov/media/159236/download
2) the test is made in south korea.
3) the use of the app is not required as the results can be directly read from the test. Please refer to the instructions of use for exact instructions on how to interpret the results.

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Isn’t it discouraged to use by the fda?

Fda recalled the different product (for poc, which is performed by healthcare provider), not this product.
– recalled product (for poc): celltrion diatrust covid19 ag ‘rapid’ test
– current product (for otc): celltrion diatrust covid-19 ag ‘home’ test

Is this product registered (authorized) by fda?

Fda issued an emergency use authorization (eua) for use of ‘celltrion diatrust covid-19 ag home test’ on october 21, 2021.
So, you can find the name of this product in fda’s eua list.

Https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2

What is the date of the product found on the back of the box or on the back of the aluminum pouch for the test device and extraction buffer?

12-15-22

Were these made in china?

They were produce in the republic of korea

How do i store unused celltrion diatrusttm covid-19 ag home tests?

According to the product information, an unopened test device should be stored at 2 – 30°c (36 – 86°f). It is stable until the expiration date marked on the label. Do not open the aluminum pouch until you are ready to use the test device. Use the test device immediately after opening the aluminum pouch. If the tests were refrigerated, keep them at room temperature for 30 minutes prior to use.

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What is the shelf life for this test?

Fda granted 18 months of shelf-life for the celltrion diatrusttm covid-19 ag home test as of may 20th, 2022. Shelf-life has been extended from 12 months to 18 months. The expiration date of your test may differ from what’s printed on the box and pouch. The affected lot numbers can be found on fda’s website at https://www.fda.gov/media/159236/download.

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What should i do if my celltrion diatrusttm covid-19 ag home test result is negative?

According to the instructions, a negative test result indicates no antigens for covid-19 were detected. It is possible for this test to give a negative result that is incorrect (false negative) in some people with covid-19 and negative results are presumptive and may need to be confirmed with a molecular test. This means that you could possibly still have covid-19 even though the test is negative. If you receive a negative result, you should test again in 24-48 hours. If you test negative and continue to experience symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider immediately. Your healthcare provider may suggest you need another test to determine if you have contacted the virus causing covid-19. If you are concerned about your covid-19 infection status after testing or think you may need follow up testing, please contact your healthcare provider.

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How is the celltrion diatrusttm covid-19 ag home test different from a conventional lab-based pcr test?

According to the manual, molecular tests (also known as pcr tests) detect genetic material from the virus. Antigen tests, such as the celltrion diatrusttm covid-19 ag home test detect proteins from the virus that causes covid-19. Antigen tests are very specific for the covid-19 virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test is necessary and if you should continue isolating at home. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have covid-19.

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Why does the app say the test i just bought is not valid?

First, you can manually type the serialization number which is printed at the middle-left section of the test device.
If the app still says not valid after manual typing, please contact celltrion usa customer service (celltrionusa.cs@celltrion.com) for replacement.
Screen captured image (including invalid serial number) of the “invalid test” is required in order to be considered for product replacement.

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How do i get results in an electronic format, such as a pdf, to show airports and other officials?

You need to find a test that has a ‘proctor service’ who will observe via cell video you taking the test and the results. It’s usually a $20-25 usd cost for the video chat and documents. Most travel will not allow an unobserved test result as valid. There are tests on amazon that do offer proctor service (on/go brand) but you will likely have to check the products website for the service.

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Is this test approved for use for travel to jamaica and back into the us?

It depends on the latest travel policy.
For below answer by other user, correct information needs to be added.

Fda recalled the different product (for poc, which is performed by healthcare provider), not this product.
– recalled product (for poc): celltrion diatrust covid19 ag ‘rapid’ test
– current product (for otc): celltrion diatrust covid-19 ag ‘home’ test

Is this acceptable to meet airline requirements for returning to us after trip?

I traveled by plane with this product…

Is there a recall on these tests?

Hello, thank you for your question.
The celltrion diatrust covid-19 ag home test sold on amazon is not subject to any fda recalls. Amazon had mistakenly sent a recall notification in error. This was addressed by amazon on the same week, in the following email sent by the amazon.com team:

dear amazon customer,

you recently received the following recall notification in error:

https://www.fda.gov/medical-devices/medical-device-recalls/celltrion-usa-recalls-certain-point-care-celltrion-diatrust-covid-19-ag-rapid-tests-false-positive

due to this, we urge you to disregard the previous recall notification.

B09m7gkccb – celltrion diatrust covid-19 ag home test, 2 tests per pack, fda eua authorized multiple target otc test, result in 15 minutes without sending to a lab sold on amazon.com is not subject to recall by the fda or celltrion usa.

The safety and satisfaction of our customers is our highest priority. We regret any inconvenience this may cause you.

Sincerely,
customer service
amazon

Does this require a smartphone to use?

No. It is like a three inch piece of litmus paper inside a small plastic box. There is nothing technical about it

Should i collect the specimens from both sides of nostrils?

Yes. The instructions indicate that you should use the swab on one nostril and then the other.

Why does this test have so many false negatives? I bought it for my son and it falsely told me both times he was negative.

For the answer by other user, correct information is needed.

Fda recalled the different product (for poc, which is performed by healthcare provider), not this product.
– recalled product (for poc): celltrion diatrust covid19 ag ‘rapid’ test
– current product (for otc): celltrion diatrust covid-19 ag ‘home’ test

Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab AMAZON

Yakibest.com: Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab : Industrial & Scientific

What are our customers saying?

5Expert Score
There's a first time for everything

This test was phenomenal! I never needed one before. Unfortunately, my son & i got infected w/covid. I knew something was off when my son was sleeping more than usual. His temps were over 104 degrees. Thank god for the 1st responders who aided in helping my son & i otw to the hospital. We ended up at the e. R. Just for them to tell me my son tested positive for covid‍! So many are asymptomatic, so they’re not aware they are even infected w/covid & even if we got the jab. We followed all the cdc guidelines, or so i thought & were hardly around anyone. The one random time i decide we’re going to a place of worship outside of our local assembly (and because we had a ride going & coming), we end up with this sick illness! Life lesson learned here. This test was a big help to know where i stood after my son was healed. I thank god my poor baby recovered quickly, being he was exposed longer before it was confirmed. Thank god for the treatment we received & the resources we had at home. This test even has an app where you can report your test results & it was a good value for the money. The instructions are so simple that a 10 year old can understand them, lol. I will retest soon. I had preexisting health conditions, including w/my bronchial. So what few symptoms i experienced was sufficient enough for the test to read positive results w/the swab. That’s the only uncomfortable part lol.

5Expert Score
Incredibly simple and effective (i’ve tried 4 brands)

I did not know how much i’d like this brand until i tried a different one after. This test is incredibly simple and effective. I used a different brand where the cap would literally shoot off when trying to dispense the drops because you had to squeeze so hard, wasting 2 tests and making the third an incredibly stressful process. I had no issues with this brand.

5Expert Score
It worked, and quickly!

I tested positive earlier in the week, i wanted to see if i was still positive, i took this test and within the first 45 seconds of the 15 minute wait, i had a positive. It was very easy to see the bright red line. I use the app and the timer was convenient. However, i didn’t want to put all of my personal information in there, so i used dummy info.

5Expert Score
It had good results.

I didn’t like the results other tests gave me so i kept testing. I kept failing every day. Then i ran out of tests. So i bought this and three days later i finally got the result i needed. I’m not saying what the test results were just in case the man is watching. But i’m back to work as a result of my test because that’s what men do. You work if you want money. You don’t hide at home like some people i know. I know your reading this nick!

5Expert Score
A relief

Lingering symptoms, negative covid home tests, this was a great backup to have. Negative

5Expert Score
Covid test

Easy to use covid test. I would say the test process with this kits was slightly easier than the process used in the one’s sent by the government. This was the first test kit where i didn’t burn a test figuring out how it worked.

5Expert Score
Quick and easy

An inexpensive, quick, and easy to use at home test.

5Expert Score
Great product!

Easy to use with clear instructions

5Expert Score
It works it works easy .

Easy to set up .

5Expert Score
Run of the mill test

No issues, they are covid tests.

4Expert Score
Nostril tickler 5000

The packaging is great. It’s in a tray and there’s a holder to stand the serum vial up in. Easy to use and easy to repack away the unused one.

I don’t want to take stars away from the company but if my review was purely for the “swab,” i would give it 1. I’ve had numerous tests during this pandemic so i’ve used several types. My husband is getting over covid now and we mowed through all of the free tests from usps so i had to order more. I ordered these since they were cheaper and the video was appealing. But this swab is just awful! It feels like a feather. It feels like it’s whispering a secret into my nose. I barely made it through the first nostril because i was sneezing repeatedly. I’m no lightweight with this stuff either. You can’t even hold the stick tought because it’s flimsy. It’s like a cat toy. I have two boxes of these and i will use them but i will never buy these again. I am going back to the brand from usps – they are great.

4Expert Score
Quality test kit – lower price but lower quality materials

Quality test kit/product but i did notice the materials were of a slightly lower quality than other kits i’ve used (including those sent for free by the gov). Example: the plastic swab was a little bit more flimsy – still totally usable but definitely felt cheaper (hence the lower price). It does the job, i would order this kit again.

4Expert Score
I guess they work i am still alive

I guess they work i am still alive

4Expert Score
Directions not easy to understand

Print for directions was very small and directions were hard to understand and had to read them at least 3 times

4Expert Score
Bought the kit due to friend got covid. I tested negative so i’m happy

Easy to use and read. Let’s hope it’s accurate.

4Expert Score
It is what it is!

My husband’s employer requested him to test before going to a company meeting. It was an easy test however they don’t even tell you really how far to put it up your nose and for how long. Knowing how long the professionals do it and how far up they go is daunting when you’re doing it yourself. The diagram just shows that you go up inside the nose not far. His test was negative thankfully. We will put the other one away for the next time he has to test.

4Expert Score
What?!? 3 months until expiration?!? Should we get a fresher test kit than that?!?!

I can’t believe i’ve only have 3 months to use this….so much for being prepared……for only the next 12 weeks.

4Expert Score
Not the most comfortable test

We’ve had to use lots of tests, like everyone else, and this is my least favorite. The swab that goes up the nose is thin and flexible, so it tickles to almost pain as you spin it around in your nose. Then you sneeze and throw off the count. I would not buy this again unless it was my only option.

4Expert Score
The swab is weird!!!!

You can’t use these with kids!!! The swab is very thin and you are supposed to insert 2cm. It was difficult for me to do on myself.

I prefer the other kind of swab.

4Expert Score
Quick, easy , hopefully accurate

Quick, easy , hopefully accurate – available quickly!

Important information

Directions

Individuals aged 14 years and older

Legal Disclaimer

The Celltrion DiaTrust™ COVID-19 Ag Home Test is for use under Emergency Use Authorization (EUA) only. This test has not been FDA cleared or approved. This test has been authorized by FDA under 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 test 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. Please find more information in our privacy policy in the link here: http://diatrustcovid.com/assets/pdfs/privacy_policy_DiaTrust_Ver.1.01.pdf

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