Description
Celltrion DiaTrust COVID-19 Ag Rapid Test
The covid-19 ag rapid test test is only available to CLIA accredited laboratories and is approved for use in patient care settings, i.e., Point of Care (POC). Celltrion DiaTrust does not distinguish between SARS-CoV and SARS-CoV-2. The antigen can be detected in human nasopharynx swap samples when the infection is in the acute phase.
Positive results confirm the presence of the virus-related antigens, although it is necessary to correlate with other diagnostic information and patient history to establish infection status. However, positive results do not exclude co-infection or bacterial infection with other viral antigens. The detected agent may not necessarily be the primary cause of the disease. Laboratories within the U.S. and its jurisdictions are needed to report all results to relevant public health authorities. On the other hand, negative results are considered presumptive, and if necessary, molecular assay-based confirmation can be performed for patient management. They do not exclude SARS-CoV-2 infection and can only serve as the primary grounds for patient management or treatment decisions.
Test Principle
The kit is developed to identify the SARS-CoV-2 antigen in nasopharynx swab samples from persons that health providers suspect of COVID19 within a week after onset of symptoms. It may also be used for individuals that health providers suspect of COVID-19 after multiple testing in 2-3 days with at least a day between each test. The kit does not require specimen transfer and has been approved for a direct specimen. In the device, there is a nitrocellulose membrane strip with a control-line and test line. The test line is pre-coated with SARS-CoV-2 monoclonal antibody to spot SARS-CoV-2 RBDs and nucleocapsid from spike proteins. On the other hand, goat anti-mouse IgG coats the control line that indicates whether the test was performed correctly.
Materials Provided
Each covid-19 ag rapid test device is packed in an aluminum pouch individually, with each box containing twenty-five tests. The device comes with a disposable test tube and 0.3-milliliter extraction buffer, a filter cap, sterilized swabs for sample collection, positive and negative swabs, and a reference instruction.
Specimen Storage and Stability
Testing of specimens collected from the nasopharynx should be instantaneous. However, if immediate testing is impossible, the specimen should be stored in an extraction buffer and stored for not more than 4 hours before testing. If testing is not possible after four hours, collect a new specimen for testing.
Quality Control
A positive control is necessary to validate that the covid-19 ag rapid test device is operating as intended and that the test procedures were accordingly. 0.1 micrograms of non-infectious RBD and nucleoprotein antigens are dried. They could be tested with each shipment and lot, for each new user, or as per the established quality control procedures for the respective laboratories. A sterile swab is used as a negative control, ascertaining that the device functions as intended. The swab should be tested with each shipment and lot, for each new user, or per the established quality control procedures for the respective laboratories.
Packing Information:
- I box of 25 tests
- 1 case of 24 boxes (600 tests)
- One pallet of 24 Cases (14,400 tests)
