(619) 904-7695 sales@mymsupply.com
Celltrion DiaTrust™

COVID-19 Ag
A Home Test

DiaTrust™

Fast and precise result

in 15 mins.

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.

Direct mid-turbinate swab samples

Non-prescription home use (OTC)

Storage Temperature

2 – 30°C (36 – 86°F)

 

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%)

Contents

  • Kit components
  • Test cassette with test strip
  • 1 Extraction buffer is provided in the sealed test tube.

Precautions and warnings

  • For in vitro diagnostic use only
  • This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA).
  • 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.
  • All the results within the United States and its territories are required to be reported to the appropriate public health authorities.
  • This product 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.
  • Test samples immediately after collection.
  • Do not use the test device if the pouch is damaged or open.
  • Do not re-use the device.
  • This test is intended for diagnosis 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 laboratory tests and clinical information (signs and symptoms) should be used and considered for diagnosis.
  • Inadequate or inappropriate sample collection may yield false test results.
  • To obtain accurate results, the test must be performed as indicated in the Instructions for Use
  • Results should be read within 15 minutes. If the test is read before 15 minutes or after 20 minutes, false negative or false positive results may occur.
  • Inadequate or improper nasal swab sample collection may result in false negative test results.
  • Do not touch the swab head when handling the swab.
  • Do not ingest.
  • Keep out of reach of children.
  • Avoid contact with skin and eyes.
  • If contact with the body occurs, rinse with water. If irritation persists, seek medical advice.
  • Discard Celltrion DiaTrust™ COVID-19 Ag Home Test in accordance with local, state and federal regulations or accreditation requirements.

Limitations

  • Do not use this test for individuals under 14 years of age. The swab included in the kit is designed for collection of samples from adults and additional safety measures are needed for safe collection in children under 14 years of age.
  • Testing for asymptomatic individuals should be performed at least twice over three days, with at least twenty-four hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.
  • 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 a COVID-19.
  • 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
  • This test detects both viable (live) and non-viable SARS-CoV-2. Test performance depends on the amount of virus (antigens) in the sample and may or may not correlate with viral culture results performed on the same sample.
  • A negative test result may occur if the level of antigens in a sample is below the detection limit of the test or if the sample was collected or transported improperly.
  • Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
  • Test results must be evaluated in conjunction with other clinical data available to the physician.
  • Positive test results do not rule out co-infections with other pathogens.
  • Negative test results are not intended to rule in other non-SARS-CoV-2 viral or bacterial infections.
  • Negative results should be treated as presumptive and confirmed with an FDA-authorized molecular assay, if necessary, for clinical management.
  • Performance of nasal swabs collected from patients without symptoms or other epidemiological reasons to suspect COVID-19 infection or for serial screening, when tested twice over two to three days with at least 24 but not more than 48 hours between tests has not yet been determined; a study to support use will be completed.
  • If the differentiation of specific coronaviruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.
  • The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after seven days are more likely to be negative compared to RT-PCR.
  • The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between March and July of 2021. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
  • The Celltrion DiaTrust™ COVID-19 Ag Home Test does not differentiate between SARS-CoV and SARS-CoV-2.

English

(619) 904-7695

Location

8684 Avenida de la Fuente, Suite 14, San Diego, CA 92154

Spanish

(619) 710-8083

Email

sales@mymsupply.com

Are you interested in our products? Want to buy it? Is easy!

The COVID-19 rapid test is available now for prompt international shipping, contact MYM Supply to place an order or request additional information. Call (619) 710.0126 in San Diego CA.