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This SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) uses the sandwich immunocapture method and colloidal gold immunochromatography to qualitatively determine the presence of SARS-CoV-2 antigens in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.
Certified with ISO 13485， CE and other documents
Suitable for: point-of-care use, community, remote regions
Sensitivity: 96.330% (95%CI: 90.870%, 98.991%)
Specificity: 99.569% (95%CI: 97.622%, 99.989%)
Before use, please read the instructions carefully and operate in strict accordance with the instructions:
The colloidal gold labeled reagent coated on conjugate pad is SARS-CoV-2 monoclonal antibody I.
T Line: SARS-CoV-2 monoclonal antibody II.
C Line: Goat anti-mouse IgG (polyclonal).
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay) are not suitable for new virus/positive patients (no positive results) and are generally used at the onset of infection and symptoms (1-7 days)
The test reagent is stored at 2~30 ℃, and the validity period is tentatively set for 18 months.
See the label for the production date and expiration date.
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.
C****lSubmitted [ Aug 17 2021 ]
Asked: Hello If the T line shows up but very pale, what does it mean? Thank you
adminSubmitted [ Aug 17 2021 ]
Answered: The light shade of the T line is mostly caused by the high concerntration of mucin in the sample. For the mucus box in the sample and other factors that will interfere with the results, we use the filter plug of the diluent and the filter of the sample pad to effectively intercept most interfering substance, but these approaches does not rule out the influence of individual unknown factors on the interpretation of results.