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OTC Antigen Home Test | Celltrion DiaTrust COVID-19 Ag Home Test (25/box)

Item #:

  • $283.75

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Celltrion DiaTrust COVID-19 Ag Home Test

    • 25 tests per box.
    • Fast and simple to use.
    • Over-the-Counter (OTC) Home Test.
    • Results in 15 minutes.
    • FDA EUA.
    • For use with CPT codes 87426, 87426QW, 87811.

** In stock to ship immediately! **
** Need Expedited shipping? Call 888.562.5852 **
 

FACT SHEET (PATIENT)
FACT SHEET (HEALTHCARE PROVIDERS)
IFU (INSTRUCTIONS FOR USE)
PACKAGE INSERT


SUMMARY & EXPLANATION

Celltrion DiaTrust COVID-19 Ag Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and receptor binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2. 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.


MATERIALS SUPPLIED

25 test cassettes with test strip
25 extraction buffers
25 filter caps
25 swabs
1 Positive and 1 Negative Control Swabs
1 Instruction For Use


CLINICAL PERFORMANCE

ALL SUBJECTS

  • Positive Percentage Agreement: 86.7 % (95% CI: 73.8%-93.7%)
  • Negative Percentage Agreement: 99.8 % (95% CI: 98.7%-100.0%)


SYMPTOMATIC SUBJECTS

  • Positive Percentage Agreement: 86.1% (95% CI: 71.3% - 93.9%)
  • Negative Percentage Agreement: 99.4% (95% CI: 96.8% - 99.9%)


ASYMPTOMATIC SUBJECTS

  • Positive Percentage Agreement: 88.9 % (95% CI: 56.8%-98.0%)
  • Negative Percentage Agreemtn: 100.0% (95% CI: 98.6%-100.0%)

 

** In stock to ship immediately! **
** Need Expedited shipping? Call 888.562.5852 **



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

** No returns or refunds on Covid products **

FREE Shipping on all orders over $50* !!
** Web price only. Discounted or wholesale orders not eligible for free shipping.
** No returns or refunds on COVID-19 products. 

Items will ship FedEx Ground (or equivalent) unless other arrangements are made. Most orders will ship same day. We always make it a priority to get your order shipped as soon as possible.

** For expedited shipping please call 888-562-5852 to make arrangements. **

Order confirmation

Upon placing order you will receive an email order confirmation. This means that we have received the order and pre-authorized your credit card for the purchase. We will then make sure that the item(s) are immediately available to ship (within 3 business days – most items ship same or next day). Upon verifying this we will process the charge and fulfill the order for shipment. If the item you ordered is not available for immediate shipment we will notify you via email and/or phone to see how you would like to handle the order. If the item ordered is not available or on backorder we will void the pre-authorization and notify you via email.

Tracking Information

When the order ships you will be sent an email with the tracking number. Enter this information on the Track Your Order page to get the latest in-transit updates. Most items will get delivered within 1-4 business days.

Damages

Inspect all packages upon delivery. Should there be any damage to the package make note of it when signing for package receipt. If your item(s) do arrive damaged please take a photo and send it to returns@toxtests.com. We will process an insurance claim on your behalf.

Cancellations & Refunds

All orders cancelled after 48 hours are subject to a $20 administration fee regardless of whether or not your item(s) has shipped. If the order has already shipped, you (the buyer) will be responsible for all return shipping charges plus a 25% restocking fee. Refunds will only be issued to the credit card used for the initial purchase. Tests kits are packaged 25 per box and we do not accept returns for less than complete boxes. No refund requests are accepted after 30 days of purchase.

Returns are accepted only within 30 days of the purchase date. All returned items must be unopened. No returns will be accepted without prior approval and a Return Merchandise Approval (RMA) number. Contact us for the RMA number and the appropriate return address.

** No returns or refunds on COVID-19 products. 


                    

We guarantee you the best price online — to prove this, we will give you 30 days to find a better deal elsewhere. If you find one we will refund you the difference. We want you to be sure that you are getting the best deal on the items you order.

To request a partial refund simply email refund@toxtests.com and include a link to the item advertised online.

Limitations:

  • You must purchase item from our website before requesting partial refund.
  • Refunds can only be credited back to the credit card used for initial payment.
  • Special promotions such as rebates or buy one, get one free offers are not eligible.
  • The item must be in stock on competitors website.
  • Discounter or auction website are excluded (Ebay, etc.).
  • The price match guarantee applies only to item price and shipping charges. It excludes sales tax.

Listed below are the most common drug abbreviations, detection times, and cutoff levels used for point-of-care rapid drug and alcohol screening products. Please note that although most of the abbreviations are universal there are a few that differ slightly depending on the manufacturer of the test device (e.g. mAMP = MET; MOP = OPI300). Please contact us if you need clarification on anything.


Drug Test Strip Abbreviations, Drug Test Detection Times and Cut-off Levels

Celltrion DiaTrust COVID-19 Ag Home Test

    • 25 tests per box.
    • Fast and simple to use.
    • Over-the-Counter (OTC) Home Test.
    • Results in 15 minutes.
    • FDA EUA.
    • For use with CPT codes 87426, 87426QW, 87811.

** In stock to ship immediately! **
** Need Expedited shipping? Call 888.562.5852 **
 

FACT SHEET (PATIENT)
FACT SHEET (HEALTHCARE PROVIDERS)
IFU (INSTRUCTIONS FOR USE)
PACKAGE INSERT


SUMMARY & EXPLANATION

Celltrion DiaTrust COVID-19 Ag Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and receptor binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2. 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.


MATERIALS SUPPLIED

25 test cassettes with test strip
25 extraction buffers
25 filter caps
25 swabs
1 Positive and 1 Negative Control Swabs
1 Instruction For Use


CLINICAL PERFORMANCE

ALL SUBJECTS

  • Positive Percentage Agreement: 86.7 % (95% CI: 73.8%-93.7%)
  • Negative Percentage Agreement: 99.8 % (95% CI: 98.7%-100.0%)


SYMPTOMATIC SUBJECTS

  • Positive Percentage Agreement: 86.1% (95% CI: 71.3% - 93.9%)
  • Negative Percentage Agreement: 99.4% (95% CI: 96.8% - 99.9%)


ASYMPTOMATIC SUBJECTS

  • Positive Percentage Agreement: 88.9 % (95% CI: 56.8%-98.0%)
  • Negative Percentage Agreemtn: 100.0% (95% CI: 98.6%-100.0%)

 

** In stock to ship immediately! **
** Need Expedited shipping? Call 888.562.5852 **



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

** No returns or refunds on Covid products **

FREE Shipping on all orders over $50* !!
** Web price only. Discounted or wholesale orders not eligible for free shipping.
** No returns or refunds on COVID-19 products. 

Items will ship FedEx Ground (or equivalent) unless other arrangements are made. Most orders will ship same day. We always make it a priority to get your order shipped as soon as possible.

** For expedited shipping please call 888-562-5852 to make arrangements. **

Order confirmation

Upon placing order you will receive an email order confirmation. This means that we have received the order and pre-authorized your credit card for the purchase. We will then make sure that the item(s) are immediately available to ship (within 3 business days – most items ship same or next day). Upon verifying this we will process the charge and fulfill the order for shipment. If the item you ordered is not available for immediate shipment we will notify you via email and/or phone to see how you would like to handle the order. If the item ordered is not available or on backorder we will void the pre-authorization and notify you via email.

Tracking Information

When the order ships you will be sent an email with the tracking number. Enter this information on the Track Your Order page to get the latest in-transit updates. Most items will get delivered within 1-4 business days.

Damages

Inspect all packages upon delivery. Should there be any damage to the package make note of it when signing for package receipt. If your item(s) do arrive damaged please take a photo and send it to returns@toxtests.com. We will process an insurance claim on your behalf.

Cancellations & Refunds

All orders cancelled after 48 hours are subject to a $20 administration fee regardless of whether or not your item(s) has shipped. If the order has already shipped, you (the buyer) will be responsible for all return shipping charges plus a 25% restocking fee. Refunds will only be issued to the credit card used for the initial purchase. Tests kits are packaged 25 per box and we do not accept returns for less than complete boxes. No refund requests are accepted after 30 days of purchase.

Returns are accepted only within 30 days of the purchase date. All returned items must be unopened. No returns will be accepted without prior approval and a Return Merchandise Approval (RMA) number. Contact us for the RMA number and the appropriate return address.

** No returns or refunds on COVID-19 products. 


                    

We guarantee you the best price online — to prove this, we will give you 30 days to find a better deal elsewhere. If you find one we will refund you the difference. We want you to be sure that you are getting the best deal on the items you order.

To request a partial refund simply email refund@toxtests.com and include a link to the item advertised online.

Limitations:

  • You must purchase item from our website before requesting partial refund.
  • Refunds can only be credited back to the credit card used for initial payment.
  • Special promotions such as rebates or buy one, get one free offers are not eligible.
  • The item must be in stock on competitors website.
  • Discounter or auction website are excluded (Ebay, etc.).
  • The price match guarantee applies only to item price and shipping charges. It excludes sales tax.

Listed below are the most common drug abbreviations, detection times, and cutoff levels used for point-of-care rapid drug and alcohol screening products. Please note that although most of the abbreviations are universal there are a few that differ slightly depending on the manufacturer of the test device (e.g. mAMP = MET; MOP = OPI300). Please contact us if you need clarification on anything.


Drug Test Strip Abbreviations, Drug Test Detection Times and Cut-off Levels

Product Reviews


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