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COVID-19 15-min TESTS - set 25 tests US DOM_1
Great test to DETECT COVID-19 CORONA VIRUS in 15 minutes!
The accuracy of this kit is around 92%, the most advanced one

One box contains 25 cassette and 1 bottle red cap buffer.

COVID-19(SARS-CoV-2)IgM Antibody Test Kit (Colloidal Gold Immunochromatography Assay)

【Product name】 COVID-19(SARS-CoV-2)IgM Antibody Test Kit (Colloidal Gold Immunochromatography Assay)

【Packing specification】 Cassette: 25pcs/box

【Intended Use】
COVID-19(SARS-CoV-2)IgM Test is used for qualitative detection of novel coronavirus IgG/IgM antibodies in human serum, plasma and whole blood. After infection with the novel coronavirus, the common signs include respiratory symptoms, fever, cough, wheezing and dyspnea, etc. In more severe cases, the infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and even death. Coronaviruses can be expelled from the body through respiratory secretions, transmitted by oral fluids, sneezing, contact, and by airborne droplets.

【Principle】
COVID-19 ( SARS-CoV-2 ) IgM Test is the colloidal gold labeled rabbit IgG and the novel coronavirus (SARS-CoV-2) antigen, while the nitrocellulose membrane is coated with anti-human IgG and sheep anti-rabbit IgG combined to form a band. The principle of colloidal gold immunochromatography indirect method is used to detect the novel coronavirus (SARS-CoV-2) IgG/IgM antibody in human serum. 【Composition】
1. COVID-19(SARS-CoV-2)IgM Antibody test cassette(Contains 1 desiccant, 1 pcs test device)
2. Buffer: 1 bottle
3. Instruction: 1pcs

【Storage and Expiry date】

⚫ The kit should be stored at room temperature (4-30°C).
⚫ Keep in a dry place away from light.
⚫ Do not freeze the test kit.
⚫ Expiry date: 24 months.

【Production date】See the package
【Specimen】
⚫ COVID-19(SARS-CoV-2)IgM Test can be performed used on Whole Blood/ Serum/ Plasma.
⚫ Testing should be performed immediately after specimen collection.
⚫ Use only clear non-hemolyzed specimens.

【Test Procedure】
Read the instructions carefully before use and bring tests, buffer and specimens were restored to room temperature.
1. 10 uL of serum/plasma/whole blood was absorbed and added to the sample hole (S)
2. Add 1 drop of sample diluent to the test card sample hole (S).
3. Wait for the colored line(s) to appear. The result should be read at 10-15 minutes. Do not interpret the result after 30 minutes.

Interpretation of Result
Positive:1. Two or three distinct lines appear. One line should always appear in the control line region (C), and another one or two apparent colored line(s) should appear in the test line region(s) (T1 and T2).
2. If a line appears on the quality control line, a line appears on the test line T1, and no sline appears on the test line
2. The test results of this product are for reference only, not as the sole basis for diagnosis and treatment, and should be confirmed in combination with clinical symptoms or other conventional testing methods.
3. The negative result may be due to the lower antibody concentration than the analytical sensitivity of the product.


【Warnings and precautions】
1. For in vitro diagnostic use only. Operation should be carried out in strict accordance with the instructions, do not use expired or damaged products.
2. Only the diluent in the package can be used, and diluent in different batches cannot be mixed.
3. Do not use tap water, purified water and distilled water as negative controls.
4. The test device should be used within 1 hour after unsealing. If the ambient temperature is higher than 30°C or more humid, use immediately after tearing.
5. If there is no liquid migration in the test window within 30 seconds after adding the detection solution, add another 1 drop of detection solution.
6. Pay attention to the possibility of virus infection when collecting specimens, wear disposable gloves, masks, etc., after washing hands. 7. The test device is disposable. The test device and specimen after use shall be regarded as medical waste with biological infection risk and properly disposed of according to relevant national regulations.
3. Insert the Detection Strip into the microplate well/EP tube;
4. Standing for 10 minutes and read the result.

Reading of Test Results
The presence of two lines (line T and line C) indicates a positive result; a single control line indicates a negative result. If the control line does not appear, the result is invalid and the sample need to be retested.

Quality Control
The control line (line C) is internal quality control. The test result is invalid if there is no control line.
[Interpretation of Results]
1. Negative results cannot exclude Novel Coronavirus infection, and it is possible that the false negative results are caused by the high dilution ratio.
2. The color depth of the test results cannot be used as the basis for determining the total content of Novel Coronavirus IgM antibody. [Limitations of Detection Method]
1. The product is only used for the detection of Novel Coronavirus antibody in the human whole blood / serum / plasma sample.
2. The detection results of the reagents are just used for reference, cannot be used as the only basis, the clinical management of patients should be combined with their symptoms/signs, medical history, other laboratory tests and treatment response.

[Performance Indexes]
1. Positive reference product coincidence rate: The positive reference product coincidence rate should be 100%.
2. Negative reference product coincidence rate: The negative reference product coincidence rate should be 100%.
3. Repeatability: Test the repeatable reference product 10 times, the reaction results should be consistent, the color development should be uniform, and all are positive.
4. Specificity: There was no cross-reactivity in positive sample with common respiratory pathogens (Legionella pneumophila, Mycoplasma pneumonia, Rickettsia q, Rickettsia pneumonia, Chlamydia pneumonia, adenovirus, respiratory syncytial virus, influenza A virus, influenza B virus, and parainfluenza virus Types 1, 2, and 3) [Precautions]
1. This product is only used for in vitro diagnosis, one-time use.
2. Please read the test results within the specific time to avoid wrong medical interpretation.
3. Please properly handle the used Strip and do not throw them away at will.
4. When the content of Novel Coronavirus IgM antibody in the sample is very high, the line C may be weakened, which is a normal phenomenon.
5. The kit is only used for medical institutions. To carry out laboratory testing of novel coronaviruses, it should meet the requirements of the local "Technical Guide for Novel Coronavirus Laboratory Testing" and do a good job of biosafety.

[Reference]
1. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study.
2. Identification and neuroprotective evaluation of a potential c-Jun N-terminal kinase 3 inhibitors through structure-based virtual screening and in-vitro assay.
3. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China.
4. Diagnosis and treatment recommendations for pediatric respiratory infection caused by the 2019 novel coronavirus.
6. Ji, W., Wang, W., Zhao, X., Zai, J. and Li, X., 2020. Homologous recombination within the spike glycoprotein of the newly identified coronavirus may boost cross‐species transmission from snake to human. Journal of medical virology.
7. Zhang, N., Wang, L., Deng, X., Liang, R., Su, M., He, C., Hu, L., Su, Y., Ren, J., Yu, F. and Du, L., Recent advances in the detection of respiratory virus infection in humans. Journal of Medical Virology.

Our Price: $285.00

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COVID-19 15-min TESTS - set 25 tests US DOM

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