SARS-CoV-2 Antigen Rapid Test Kit
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%)
Features of Rapid Antigen Test Kit for COVID
- Easier: No special equipment needed; Easy to use; Intuitive visual interpretation.
- Rapid: Results in 10 minutes.
- Accurate: Results were validated by PCR and Clinical diagnosis.
- Diversity: Works with oropharyngeal swab, nasal swab and nasopharyngeal swab.
Before use, please read the instructions carefully and operate in strict accordance with the instructions:
- 1.Bring the pouch to room temperature before use.
- 2.Take out the cassette, put it on a horizontal table.
- 3.Add 3 drops of the processed sample vertically into the sample well and start the timer.
- 4.Observe the result after 10 minutes, the result is valid within 30 minutes, read results after 30 minutes is invalid.
- Positive: Both the detection 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.
IgM POSITIVE: Two lines appear.
Colored lines should be in the control line region (C) and IgM test line region. No line appears in IgG test line region.
IgG and IgM POSITIVE: Three lines appear.
Colored lines should be in the control line region(C), IgG line test region and IgM test line region. The color intensities of the lines do not have to match.
IgG POSITIVE: Two lines appear.
Colored lines should be in the control line region(C) and IgG test line region. No line appears in IgM test line region.
NOTE: The intensity of the color in the IgG and/or IgM test line region(s) will vary depending on the concentration of COVID-19 antibodies in the sample. Therefore, any shade of color in the IgG and/or IgM test line region(s) should be considered positive.
NEGATIVE: One colored line should be in the control line region (C). No line appears in IgG and IgM test line region(s).
INVALID: Control line fails to appear.
Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new cassette. If the problem persists, discontinue using the test kit and contact your local distributor.
Kit Components & Storage
Materials supplied:
*Test cassettes
*Droppers
*Package inserts
*Buffer bottle
Storage：
The kit can be stored at room temperature or refrigerated (2-30℃). The test cassette is stable before the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.
Product Introduction
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 goldlabeled 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 antimouse 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.
Test Procedure
Bring the pouch to room temperature before use.
Take out the cassette, put it on a horizontal table.
Add 3 drops of the processed sample vertically into the sample well and start the timer.
Observe the result after 10 minutes, the result is valid within 30 minutes, read results after 30 minutes is invalid.
Testing Results
Positive: The presence of the test line (T) and the control line (C) indicates positive result.
Negative: The presence of the only control line (C) and no test line (T) indicates a negative result.
Invalid: The control line (C) is not visible after performing the test, the result is considered invalid and it is recommended to be repeated after reading the instruction for use again.
Kit Components & Storage
Components
2. Desiccant
3. Swab
4. Sample treatment solution
5. Tube cap
Storage
About UNscience
UNscience, 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 sells 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.
HAuCl4 can gather together to form a gold particle of certain size under the effect of reductant (e.g., white phosphorus or ascorbic acid). Under the influence of electrostatic forces, it becomes a stable colloidal state, which named Colloidal gold.
GICA (Gold Immunochromatography Assay) is a novel immunolabelling technic which applies the colloidal gold as the tracer. The specific antigen/antibody was stripped fixed on the membrane, the reagent of colloidal gold (polyclonal antibody or monoclonal antibody) was absorbed on the conjugate pad. Sample will move forward by capillary action after added into the sample pad, and it will dissolve the labeling reagents of colloidal gold and then react with each other. Once the sample-colloidal gold compound moves to the antigen/antibody region, it will specifically combines with the fixed antigen/antibody and be intercepted to accumulate on the detection region, thus to produce a color reaction that can be observed by naked eyes. GICA has been developed into diagnostic strips and characterized by its convenience.