LiliF™ GBN COVID-19 Antigen Rapid Kit
Description
Background Information
There are four genes in the Coronavirus family. Those are known to alpha, beta, gamma, and delta. Alpha and beta corona viruses can cause illness in both humans and animals, whereas others, such as gamma and delta coronaviruses, only infect animals. Reported illnesses have ranged from mild cold symptoms by Coronavirus 229E, NL63, OC43, or HKU1 to severe illness (e.g., pneumonia) by MERS-CoV and SARS-CoV. COVID-19 is a new coronavirus that has not previously identified. The new coronavirus
(COVID-19) belongs to beta and is one of the new infectious corona viruses that infects the human body as a pathogen of mass pneumonia that occurred in Wuhan, Hubei, China in December 2019. Common characteristics of people infected with coronavirus are fever, cough,shortness of breath and dyspnea. In more severe cases, it can cause
pneumonia, severe acute respiratory syndrome, kidney failure, and even death.
Principle
LiliF™ GBN COVID-19 Ag Rapid Kit is a lateral flow chromatographic immunoassay for the detection of SARS-CoV-2 specific antigens in human nasopharyngeal swab specimens. It is intended to be used by professionals as an aid in the diagnosis of infection with SARS-CoV-2 coronavirus, which causes COVID-19 disease. After applying the extracted swab specimen onto the hole of testing device, human’s sample first react with gold conjugated mouse monoclonal antibody to SARS-CoV-2 Nucelcapsid antibody and rabbit anti-chicken IgY antibody. After that, each reactant diffuses on the membrane to the another monoclonal antibody to SARS-CoV-2 Nucelcapsid antibody marked as test lines and the control line is coated with chicken IgY antibody. If positive, the test line turns to red color because antigen-antibody-gold conjugate complex is formed on the test lines. The control line is intended for procedural control and should always appear if the test procedure is performed correctly and the control line reagents are operated.
Intended Use
LiliF™ GBN COVID-19 Ag rapid kit is a chromatographic immunoassay for the qualitative test for the detection of COVID-19 antigens in nasopharyngeal swab specimen of the suspected patients. This kit should only be used as a diagnosis for screening purposes. In the case of positive results, confirmation tests through alternative diagnostic methods are required. After analyzing these test results and other clinical data, the Principal Investigator should perform a final diagnosis.
Kit Contents
| No. | Contents | 25 tests/kit |
|---|---|---|
| 1 | Test device | 25ea |
| 2 | Extraction Buffer tube | 25ea |
| 3 | Flocked swab | 25ea |
| 4 | IFU | 1ea |
Kit Methods
1) Ensure that specimen and test components are equilibrated to room temperature.
2) After pulling out the testing cassette from the closed pouch, place it on the flat position. And label the device with specimen’s ID or number.
3) Apply 3 drops (90 ~ 100ul) of specimen and extraction buffer mixture prepared for sample preparation method directly to the sample pad in the hole and ensure that the specimen and extraction buffer mixture are fully absorbed.
4) Wait for 15 min until the red line appears on the control line. Read and interpret the result at 15 min after applying this diluted sample.
5) Do not read test results after 15 minutes.
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