COVID-19 IgM/IgG test kit

Product Name

COVID-19 IgM/IgG test kit (Colloidal Gold)

Specifications

25 tests/box

Intended Use

This kit is used for the qualitative determination of COVID-19 IgM/IgG antibodies in human serum, plasma and venous whole blood samples in vitro, as an auxiliary diagnosis of COVID-19 infection for hospitals and home use.

€675.00
Out of stock

If you are representing Government, Public Institution, Doctors Associations and want to order more tests please write us an email at [email protected]

Detection principle

Steps
1. Collect blood/serum/plasma sample.
2. Add blood/serum/plasma sample to sample well.
3. Place 2-3 drops of buffer in sample well.
4. Read results after 15 minutes.

This kit uses colloidal gold immunochromatography. Testing COVID-19 IgG antibody and COVID-19 IgM antibody in human serum, plasma and whole blood samples.

The blood samples diluent containing COVID-19 IgG antibody and/or COVID-19 IgM antibody chromatography to colloidal gold binding pad, recombinant with colloidal gold marked COVID-19 antigen antibody, forming colloidal gold - antigen complex, chromatography to test area, combining to precoated anti-human IgG antibody and/or anti-human IgM antibody respectively, forming complexes in the test area and presenting red precipitation line.

Unbound rabbit IgG colloidal gold bond chromatography to quality control line (C) combined with precoated sheep anti-rabbit IgG antibody presented a red precipitation line.

If the samples do not contain COVID-19 IgG antibody and/or COVID-19 IgM antibody, there is no corresponding red precipitation line existed in the test area. A red precipitation line appears on the quality control line (C) no matter if there is COVID-19 IgG antibody and/or COVID-19 IgM antibody in the sample or not.

Components

Do not mix use the Components from different lot number

Storage and Stablity

1. Store at 2~30°C for 18 months in a cool place, no direct sunlight and no freeze preservation. The test card and sample diluent should be used up in 1 hour after opening the package (opening temperature 10~30°C, humidity 5%~95%).

2. The date of production and the term of use are labeled.

Specimen collection and preparation

1. This kit is suitable for serum, (EDTA anticoagulation, heparin anticoagulation, sodium citrate anticoagulant 1:9) plasma and venous whole blood samples. Fresh samples are recommended.

2. Sample collection:Referring to the“national clinical laboratory operation regulations” venous blood collection ,If it cannot be tested in time, the sample can be stored in refrigerator at 2~8 °C. The separated serum and plasma samples should be stored at 2~8 °C within 7 days,and -20 °C for more than 7 days. -20 °C can be preserved for 3 months. Samples can be frozen and melted 3 times. Whole blood samples cannot be stored at 2~8°C for more than 7 days. Restore to room temperature before test.

Test Procedure

1. Restore the test card to room temperature, tear off the seal of the aluminum foil bag, remove the test card from the aluminum foil bag and lay it flat on the operating table.

2. 10 μl of serum/plasma / 15 μl of whole blood samples to be measured should be absorbed with a proper range pipper and added to the sample hole. Then two drops of diluent (about 80 μl) should be added to the sample hole of the test card. Avoid producing obvious bubbles when absorbing and adding samples.

3. The timer keeps time and the results are interpreted in 10 minutes.

Interpretation of Results

1. Positive result:
a. Positive result of COVID-19 IgG: red precipitation line appeared in both quality control area C and test area (test line T1), while no red precipitation line appeared in test area (test line T2).
b. Positive result of COVID-19 IgM: red precipitation line appeared in both quality control area C and test area (test line T2), while no red precipitation line appeared in test area (test line T1).
c. Double positive result of COVID-19 IgG/IgM: red precipitation line appeared in both quality control area C and test area (test line T1 and T2)

2. Negative result:
Red precipitation line appeared in quality control area C, while no red precipitation line appeared in test area (test line T1/T2).

3. Invalid result:
No precipitation line appeared in quality control area C.
The test results are interpreted as following graphs:

Limitations of Procedure

1. This reagent is only for the in vitro detection of plasma and of human serum, plasma and venous whole blood samples.

2. Operation must be strictly operated according to the operation rules and careful operate to get the correct result. Any modification to the operation procedure may affect the result.

3. Unreasonable sample collection, transfer and processing, and low concentration of the measured substance in the sample may lead to false negative results.

4. The test results of this kit cannot be used as the only standard for clinical diagnosis, which should be combined with other test results and clinical manifestations to make a judgment.

5. Limited by the sensitivity of the analysis, negative results cannot completely exclude the possibility of infection with COVID-19.

If the test results are negative while clinical symptoms exist, it is recommended to use other clinical methods for testing.

6. This reagent is a colloidal gold detection reagent, which is only used for the initial screening and cannot be used as a diagnostic result.

Performance Characteristics

1. Negative coincidence rate: the reference for testing negative enterprises (N1-N10), 10 copies shall be negative.

2. Positive coincidence rate: the reference for positive enterprises (P1-P10), P1-P4 should be IgM positive and IgG positive, P5-P7 should be IgM positive and IgG negative, P8-P10 should be IgM negative and IgG positive.

3. Minimum test limitation: test the enterprise sensitivity reference S1~S4(diluted by the enterprise sensitivity reference S in accordance with 1:32, 1:64, 1:256 and 1:512). It is required that S1 and S2 should be positive for IgM and IgG, while S3 and S4 should be negative.

4. Batch repeatability: use the same batch kits to test negative enterprise repetitive reference products C1 and repetitive positive reference C2 (IgM and IgG are all positive) respectively. Each sample was tested 5 times in parallel, where C1 test results should be negative and C line color is consistent, and C2 test results should be IgM positive and IgG positive with consistent color
display.

5. Inter-batch repeatability: three consecutive batch number kits were used to test the enterprise's repeatable negative reference C1 and repeatable positive reference C2(both IgM and IgG were positive), and each sample was tested 5 times in parallel, and the C2 test results were all positive IgM and positive IgG.

Warnings and Precautions

1. This kit is for in vitro diagnosis only. Please do not use expired products.

2. Do not swallow the reagent or contact with the skin, eyes and mucous membranes,Once contact, the pollution part should be flushed with water.

3. After the test card is taken out of the aluminum foil bag, the experiment should be carried out as soon as possible to avoid being placed in the air for too long, resulting in damp.

4. Protective measures should be taken during the collection, disposal, storage, mixing and determination of samples, and all clinical samples, used reagents and waste should be treated as infectious after the test.

Reference

1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011; 81: 85-164.

2. Masters PS, Perlman S. Coronaviridae. In: Knipe DM, Howley PM, eds. Fields virology. 6th ed. Lippincott Williams & Wilkins, 2013: 825-58.

3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016; 24: 490-502.

4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17: 181-192.

Essential information

Registrant / manufacturer:Xiamen AmonMed Biotechnology Co.,Ltd.

Registered address:Unit 503, 120 Xinyuan Road, Haicang District, Xiamen, Fujian China.

Tell:0592-6081739

Name of after-sales service unit:Xiamen AmonMed Biotechnology Co.,Ltd.

Tell:0592-6081739

Production address:Unit 1203, 120 Xinyuan Road, Haicang District, Xiamen, Fujian China.

Production license number:The production permit of Fujian food drug supervision equipment No. is 20180411

Certificates

Manufacturing information

Xiamen AmonMed Biotechnology Co. Ltd. is a subordinate enterprise of the Chinese Academy of Sciences and specialises in manufacturing, research and development of medical testing equipment. After a new type of coronavirus appeared in China at the start of this year, our Company was ordered by the concerned Chinese governmental departments to develop research equipment and schemes to detect that new type of coronavirus (COVID-19). Thereafter, we presented special products and equipment IgM/IgG, i.e. antibody detection test.

The item we offer is the only trial product tested and used in Leishenshan Hospital in the distress area of Wuhan.

Then it was quickly approved for manufacturing and promotion. Leishenshan Hospital is a temporary hospital built by the Chinese Government over a ten-day period in order to settle the challenges of treatment of infected people and to detect infected employees in the area of distress – Wuhan. Our test products are based on the up-to-the-minute nanotechnologies and rare-earth metals, thus allowing to get quick results. As a consequence, the medical staff significantly reduce their contacts with patients, thus decreasing the probability of infection.

Contact us

If you are representing Government , Public Institution , Doctors Associations or any other Group of people and want to order more tests please write us an email with the exact number of tests you would like and we will try to do our best to provide you as fast as possible.

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