The Celltrion DiaTrust ™ COVID-19 Ag Rapid Test is a rapid test based on a lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor-binding domains (RBD) of SARS-CoV-2 spike proteins. in a human nasopharyngeal swab specimen. The results are for the identification of the SARS-CoV-2 nucleocapsid and the RBD protein antigen.
- Sample type: NASOPHARYNGEAL HISO SAMPLE (NPS)
- Storage temperature: 2 – 30 ° C (36 – 86 ° F)
- Sample time to respond: 15 minutes
– 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%
- 25 test devices
- 25 swabs
- 25 extraction buffer
- 25 filter caps
- 1 positive control swab
- 1 negative control swab
- 1 quick reference instruction
POC Test Device Package
Test Device Bag for Point of Care Use (By laboratories certified under the CLIA that meet the requirements to perform tests of high or moderate complexity, or waived)
Precautions And Warnings
- Only for use under the authorization of emergency use.
- For in vitro diagnostic use only.
- For prescription use only.
- Read all instructions carefully and completely and follow all instructions. Failure to follow all instructions can result in inaccurate test results.
- This product has not been cleared or approved by the FDA but has been cleared by the FDA under an Emergency Use Authorization (EUA) for use by CLIA-certified laboratories that meet the requirements for performing high or moderate complexity tests. , or exonerated. This product is licensed for use at the point of care (POC), that is, inpatient care settings operating under a CLIA Certificate of Exemption, Certificate of Compliance, or Certificate of Accreditation.
- This product has been licensed only for the detection of SARS-CoV-2 proteins, not for other viruses or pathogens.
- The emergency use of this product is only authorized for the duration of the statement that circumstances exist that justify the authorization of the emergency use of in vitro diagnostic tests for the detection and/or diagnosis of COVID-19 under Section 564 (b ) (1) of the Federal Food, Drug, and Cosmetic Act, 21 USC § 360bbb-3 (b) (1) unless the statement is terminated or the authorization is revoked earlier.
- Take proper precautions in the collection, handling, and storage of patient specimens. See the CDC Interim Guidelines for the Collection, Handling, and Transportation of Clinical Specimens from People with Coronavirus Disease 2019 (COVID-19) at https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines- clinical-specimens. HTML, and to the WHO interim guidance for laboratory testing of coronavirus disease (COVID-19) in suspected human cases at http://www.who.int/publications-detail/laboratory-testing-for-2019 -novel-coronavirus-in -Suspicious-human-cases-20200117, amended and supplemented. See the WHO website for additional publications.
- Federal law restricts the sale of this device to or on the order of a licensed physician (the US only).
- Laboratories in the United States and its territories must report all results to the appropriate public health laboratories.
- This test has been licensed for the detection of SARS-CoV-2 proteins only, not for other viruses or pathogens.
- Do not use the test device after the expiration date.
- Keep sealed until use and, once opened, use immediately.
- Do not use the test device if the bag is damaged or if the device is badly torn.
- Do not reuse the device.
- Handle all samples safely as they are potentially infectious.
- All samples, even after the extraction procedure, and reagents containing biological materials used for the assay must be considered potentially capable of transmitting infectious agents; consequently, samples, reagents and waste must be handled with great care and disposed of in accordance with laboratory guidelines and the legal provisions in force in each country.
- This test is intended for the evaluation of coronavirus infection by detecting the COVID-19 antigen, but should not be used as the 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.
- Dispose of the Celltrion DiaTrust ™ COVID-19 Ag Rapid Test in accordance with local, state, and federal regulations or accreditation requirements.
- Samples can be infectious. Use universal precautions when performing this test.
- Use routine laboratory precautions. Do not eat, drink, or smoke in the area where samples are handled and tests are performed. Avoid any contact between hands, eyes, or mouth during specimen collection and analysis.
- Wear personal protective equipment (PPE) in accordance with institutional and laboratory policies, such as lab coats, disposable gloves, and eye protection when handling patient samples.
- Wash your hands thoroughly after handling the samples and the used cartridge.
- Dispose of the used test device in a biohazard waste container. Proper handling and disposal methods should be established in accordance with local regulations.
- Avoid splashing or spraying samples or reagents, as droplets are a means of transmission of the SARS-CoV-2 virus. All droplets and spills should be cleaned up with an appropriate disinfectant, such as sodium hypochlorite solution with 0.5% active chlorine, and all soiled materials should be disposed of as infectious waste.