This kit adopts the sandwich method and the technical principle of colloidal gold immunochromatography to qualitative determine the SARS-CoV-2 antigen. During the test, the sample is dropped into the sample well, and chromatography is performed under the capillary effect. The SARS-CoV-2 antigen in the sample combined with the colloidal gold-labeled SARS-CoV-2 monoclonal antibody I, and then spread to the test area. It is captured by another coated antibody (SARS-CoV-2 monoclonal antibody II), to form a complex and gather in the test area (T line). The quality control area is coated with the goat anti-mouse antibody, and the colloidal gold-labeled antibody is captured to form a complex and aggregate in the quality control area (C line). If the C line does not show color, it indicates that the result is invalid, and this sample needs to be tested again
Product Features
When the Ct value ≤ 37 the sensitivity was 92.414% (95%CI: 86.832%, 96.152%) and specificity was 99.569% (95%CI: 97.589%, 99.918%). when the Ct value ≤ 30 the sensitivity was 95.413% (95%CI: 86.619%, 98.494%) and specificity was 99.327% (95%CI: 97.589%, 99.918%).
Procedure is simple and time saving.
All necessary reagents provided & no equipment needed.
Obtain CE certification.
Suitable for large scale rapid screening.
Test Procedure
Before use, please read the instructions carefully and operate in
strict accordance with the instructions:
Bring the pouch to room temperature before use.
Take out the cassette, put it on a horizontal table.
Add 4 drops of the processed sample vertically into the sample well and start the timer.
Observe the result after 15 minutes, the result is valid within 30 minutes, read results after 30 minutes is invalid.
Testing Results
Positive: Both the test line (T line) and the quality control line (C line) appear colors.
Negative: The test line (T line) does not appear color, only the quality control line (C line) appears color.
Invalid: The quality control line (C line) does not appear color, which means that the test is invalid and the test should be repeated.
The kit can be stored at 2-30℃ for 18 months. Do not use after the expiration date.
About UNscience
UNscience (https://www.uni-science.com), a wholly owned subsidiary of Elabscience, specializes in the research and development, production and sale of in-vitro diagnostic reagents. Certified with ISO 13485 and other documents, UNscience sell its products all over the world.
The company has 100,000 grade GMP purification workshop and quality management system, three major technical platforms (Colloidal Gold Immunochromatographic Platform, Fluorescence Immunochromatographic Platform, and Pathological Diagnosis Antibody Platform). UNscience has the independent research and development and production capacity of core raw materials, and has successfully developed 27 POCT immunochromatographic quantitative detection products (colloidal gold and fluorescence), mainly covering cardiovascular and cerebrovascular diseases, kidney diseases, diabetes, infectious diseases, reproductive health, health examination and other.
Asked: I have a question about SARS-CoV-2 Antigen Rapid Test Kit (Cat.No: CP04009).
Does the product also support inspection of the Delta variant?
Thank you very much.
Reply
A
Y**iSubmitted [ Aug 18 2021 ]
Answered: Dear Yuichiro san,thanks for your inquiry.
SARS-CoV-2 Antigen Rapid Test Kit (Cat.No: CP04009).Yes,this product can detect the Delta variant.
Best regards,
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