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Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 spike proteins in human nasopharyngeal swab specimen. Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen.
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Product Specification
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Sample Type |
NASOPHARYNGEAL SWAB SAMPLE (NPS) |
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Sample-to-answer time |
15 mins |
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FDA Status |
FOR USE UNDER THE EMERGENCY USE AUTHORIZATION (EUA) ONLY |
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Authorized Laboratories |
Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation (Waived, Moderate or High) |
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Contents |
25 test devices |
Intended Use
Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 spike proteins in human nasopharyngeal swab specimen. Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen.
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PRECAUTIONS AND WARNINGS
For use under Emergency Use Authorization Only.
For in vitro diagnostic use only.
For prescription use only.
Read all instructions completely and carefully and follow all instructions. Failure to follow all instructions may result in inaccurate test results.
This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
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 diagnostic tests 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 the authorization is revoked sooner.
Use appropriate precautions in the collection, handling and storage of patient samples. Refer to CDC Interim Guidelines for Collection, Handling and Transportation of clinical specimens from persons with Coronavirus Disease 2019 (COVID-19) at https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html, and to WHO’s Interim guidance for Laboratory testing for coronavirus disease (COVID-19) in suspected human cases at http://www.who.int/publications-detail/laboratory-testing-for-2019-novel-coronavirus-in-suspected-human-cases-20200117, as amended and supplemented. Refer to the WHO website for additional publications.
Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).
Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories.
This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
Do not use the test device beyond the expiration date.
Keep sealed until usage, and once opened use immediately.
Do not use the test device if the pouch is damaged or the device is seriously broken.
Do not re-use the device.
Handle all specimens safely as potentially infectious.
All samples, even after the extraction procedure, and reagents containing biological materials used for the assay must be considered as potentially able to transmit infectious agents; accordingly samples, reagents and the waste must be handled with utmost care and disposed of in compliance with the laboratory guidelines and the statutory provisions in force in each country.
This test is intended for assessment of coronavirus infection by detecting COVID-19 antigen, but should not be used as a sole criterion for the determination of SARS-CoV-2 infection. Other methods and clinical information (signs and symptoms) should be used and considered for diagnosis.
Discard Celltrion DiaTrust™ COVID-19 Ag Rapid Test in accordance with local, state and federal regulations or accreditation requirements.
Safety Precautions
Specimens may be infectious. Use Universal Precautions when performing this assay.
Use routine laboratory precautions. Do not eat, drink, or smoke in the area where samples are being handled and testing is being conducted. Avoid any contact between hands, eyes or mouth during sample collection and testing.
Wear personal protective equipment (PPE) in accordance with laboratory and institutional policies, such as laboratory coats, disposable gloves, and eye protection when handling patient samples.
Wash hands thoroughly after handling specimens and used cartridge.
Dispose of used test device in a biohazard waste container. Proper handling and disposal methods should be established according to local regulations.
Avoid splashing or aerosolization of samples or reagents as droplets are a means of transmission of SARS-CoV-2 virus. All drops and spills must be wiped up with an appropriate disinfectant such as a sodium hypochlorite solution with 0.5% active chlorine, and all soiled materials must be disposed of as infectious waste.
※ This test has not been FDA cleared or approved. This webpage is intended for U.S. audiences only. This webpage may contain information on products that are targeted to U.S. audiences, and could contain product details or information not approved in countries or regions outside U.S
- 100% Satisfaction
- Money Back Guaranteed
- 30 days return policy
Shipping:
- Please allow between 5-10 days for your order to arrive. If more than 20 days have passed please email us at support@diskatech.com to review the status of your order. Refunds will be handled through email if necessary.
Returns:
- Our policy lasts 30 days. If 30 days have gone by since your order was received, unfortunately, we can’t offer you a refund or exchange.
- To be eligible for a return, your item must be unused and in the same condition that you received it. It must also be in the original packaging.
- Additional non-returnable items:
- Gift cards
- Downloadable software products
- To complete your return, we require a receipt or proof of purchase.
- Please do not send your purchase back to the manufacturer.
- There are certain situations where only partial refunds are granted (if applicable)
- Book with obvious signs of use CD, DVD, VHS tape, software, video game, cassette tape, or vinyl record that has been opened Any item not in its original condition is damaged or missing parts for reasons not due to our error
- Any item that is returned more than 15 days after delivery
Refunds (if applicable)
- Once your return is received and inspected, we will send you an email to notify you that we have received your returned item. We will also notify you of the approval or rejection of your refund.
- If you are approved, then your refund will be processed, and a credit will automatically be applied to your credit card or original method of payment, within a certain amount of days.
- Late or missing refunds (if applicable)
- If you haven’t received a refund yet, first check your bank account again.
- Then contact your credit card company, it may take some time before your refund is officially posted.
- Next, contact your bank. There is often some processing time before a refund is posted. If you’ve done all of this and you still have not received your refund yet, please contact us at support@diskatech.com.
Sale items (if applicable)
- Only regular priced items may be refunded, unfortunately, sale items cannot be refunded.
Exchanges (if applicable)
- We only replace items if they are defective or damaged. If you need to exchange it for the same item, send us an email at support@diskatech.com and send your item to: 2509 Livenza Pl., Leander, TX 78641
Gifts
- If the item was marked as a gift when purchased and shipped directly to you, you’ll receive a gift credit for the value of your return. Once the returned item is received, a gift certificate will be mailed to you.
- If the item wasn’t marked as a gift when purchased, or the gift giver had the order shipped to themselves to give to you later, we will send a refund to the gift giver and he will find out about your return.
Shipping
- To return your product, you should mail your product to: 2509 Livenza Pl, Leander TX 78641
- You will be responsible for paying for your own shipping costs for returning your item. Shipping costs are non-refundable. If you receive a refund, the cost of return shipping will be deducted from your refund.
- Depending on where you live, the time it may take for your exchanged product to reach you may vary.
- If you are shipping an item over $75, you should consider using a trackable shipping service or purchasing shipping insurance. We don’t guarantee that we will receive your returned item.
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