Celltrion DiaTrust™ COVID-19 Ag Rapid Test
The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a lateral flow immunochromatographic assay that has been authorized only for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers, not for any other viruses or pathogens.
It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Antigen Test Kit (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
As an intended Point-of-Care (POC) designated test with a 10 minute read processing time.
Features
- Lateral flow assay
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Rapid results are read at 15 minutes
- Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- For use under the Emergency Use Authorization (EUA) only
- For in vitro diagnostic use only
- For prescription use only
- For use with
nasopharyngeal swab specimens
Clinical Features
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Clinical sensitivity: 93.33% (28/30) (95% CI: 78.7%-98.2%)
- Clinical specificity: 99.03% (102/103) (95% CI: 94.7%-99.8%)
- Positive predictive value: 96.55% (28/29) (95% CI: 82.8%-99.4%)
- Negative predictive value: 98.08% (102/104) (95% CI: 93.3%-99.5%)
- Prevalence: 22.56%
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.
COVID-19 Antigen Test Components:
- 25 Test Devices
- 25 Sterile Swabs
- 25 Extraction Buffer
- 25 Filter Caps
- 1 Positive and 1 Negative Control Swabs
- 1 Package Insert
- 1 Instruction for Use
Procedure & Preparation
Specimen Collection
- Peel off the aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 10 times
- Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
- Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.
- Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
COVID-19 Antigen Rapid Test Kit Results Interpretation
Sample Results Interpretation
Read the result at 10 minutes. The test result should not be read after 15 minutes
|
Positive
|
Negative
|
Invalid
|
|
SARS-CoV-2 antigen present does not rule out co-infection with other pathogens. The color intensity in the test region will vary depending on the amount of SARS-CoV-2 antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.
|
Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions. It is recommended that these results be confirmed by a molecular testing method, if necessary for patient management.
|
Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.
|
Warning: The false positive, false negative, or invalid results may occur if the test is interpreted outside of the interpretation window.
‾‾‾
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection
of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Great quick service 
