COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatography)

【Product Name】

COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatography)

【Size】1 Test,10 Tests,20 Tests,50 Tests

【Intend Use】

The New Coronavirus(COVID-19 )IgM/IgG Test Kit is a rapid chromatographic immunoassay for the qualitative detection of IgG & IgM antibody of WUHAN New Coronavirus in human whole blood ,serum ,or plasma, thus as an aid in the diagnosis of COVID-19 infections.

【Principle】

This kit uses immunochromatography. The test card contains: 1) colloidal gold-labeled recombinant new coronavirus antigen and quality control antibody gold markers; 2) two detection lines (G and M lines) and one quality Control line (C line) of nitrocellulose membrane. The M line is immobilized with a monoclonal anti-human IgM antibody for detecting a new coronavirus IgM antibody; the G line is immobilized with a reagent for detecting a new coronavirus IgG antibody; and the C line is immobilized with a quality control antibody.

When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains an IgM antibody, the antibody will bind to the colloidal gold-labeled new coronavirus antigen. The immune complex will be captured by the anti-human IgM antibody immobilized on the membrane to form a purple-red M line, showing that the new coronavirus IgM antibody is positive.

If the sample contains an IgG antibody, the antibody will bind to the colloidal gold-labeled new coronavirus antigen, and the immune complex will be captured by the reagent immobilized on the membrane to form a purple-red G line, indicating that the new coronavirus IgG antibody is positive.

If the test lines G and M are not colored, a negative result is displayed. The test card also contains a quality control line C. The fuchsia quality control line C should appear regardless of whether a test line appears. The quality control line is a color band of the quality control antibody immune complex. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.

【Reagent Components】

Each kit contains 1/10/20/50 test package. Each test package contains one IgM/IgG test card, one dropper pipette and one desiccant bag. The test card contains COVID-19 virus envelope protein particles conjugated gold particles and anti-human IgG, anti-human IgM antibody on the membrane.

【Storage and Expiry Date】

The original packaging should be stored at 4~ 30°C, to avoid light, keep dry and do not freeze.

The test kit is stable for 12 months in the sealed pouch.

【Specimen collection and Preparation】

1. The COVID-19 IgG/IgM Rapid Test Device is intended for use with human whole blood, serum or plasma specimens only.

2. Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.

3. Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, serum or plasma specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days after collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

4. Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.

5. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

【Direction for Use】

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing.

1.Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.

2.Place the test device on a clean and level surface.

For Serum or Plasma Specimens: using the provided 10uL disposable pipette, draw the specimen up to the Fill Line, and transfer 10ul serum/plasma to the specimen well of the test device, then add 2 drops of buffer and start the timer.

For Whole Blood (Venipuncture/Fingerstick) Specimens:

Using the provided 10uL disposable pipette, and transfer 1 drop of whole blood (approximately 20 µL) to the specimen well of the test device, then add 2 drops of buffer and start the timer.

Note: Specimens can also be applied using a micropipette.

3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

【Interpretation of Results】

IgG POSITIVE: *The colored line in the control line region (C) appears and a colored line appears in test line region IgG. The result is positive for COVID-19-IgG antibodies.

IgM POSITIVE: *The colored line in the control line region (C) appears and a colored line appears in test line region IgM. The result is positive for COVID-19-IgM antibodies and is indicative of primary COVID-19 infection.

IgG AND IgM POSITIVE: *The colored line in the control line region (C) appears and two-colored lines should appear in test line regions IgG and IgM. The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies.

NEGATIVE: The colored line in the control line region (C) appears.

No line appears in test line regions IgG or IgM.

INVALID: There is no line appear in the c region.

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 test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

【The limitations of the test kit】

1. This product can not be used as the only judgment standard, only as a reference for the comprehensive judgment of doctors.

2. This test paper can only show the qualitative level of IgM antibody produced by the human body after the new coronavirus (2019-ncov) infection in the sample, and cannot be used as the only diagnostic criterion.

3. This product belongs to colloidal gold immunochromatographic test paper, which has the inherent limitations of colloidal gold immunochromatographic method.

【Physical Performance of Products】

1. Phisical appearance: The components in this kit are neat and complete in appearance, no burrs, no damage, no pollution; the material is firmly attached; the label has clear writing and no damage.

2. Film strip width: Film strip width not less than 2.5 mm.

3. Travel speed: Not less than 10mm / min.

4. Negative/Positive coincident Rates: The test contained 5 IgG- positive human serum samples , and the test results showed that IgG was positive; IgM was negative; Comprising detecting IgM-positive human serum samples . 5 sticks, the detection result of IgM show positive; IgG negative; 10 healthy human samples were tested, and the test results were negative for both IgG and IgM.

5. Repeatability: Take any IgM positive sample and test it 10 times, IgM is positive; IgG is negative ; Take any one IgG- positive sample and test it 10 times, IgG is positive; IgM is negative .

6. Minimum detection limit: 1 : 8 dilution of a positive sample, the test result is positive.

7. Inter-batch difference: Extracted three batches novel coronavirus (COVID-19) IgM antibody detection kits, each batch of at least 10 parts of people, repeat positive samples detected at least 10 times . 3 batches of test results should be consistent. Take any one of the negative samples for 10 times and the results are all negative.

【Precautions】

1.For professional in vitro diagnostic use only. Do not use the kit beyond the expiration date.

2.Do not eat, drink or smoke in the area where the specimens or kits are handled.

3.Do not use the test if the pouch is damaged.

4.Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.

5.Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested.

6.The used test should be discarded according to local regulations.

【Symbols】

【Manufacturer Information】

BeiJing Abace Biology Co.,Ltd
No.22 Building, No.1 Jinghai 5th Road, Tongzhou District, Beijing, P.R.China
Production address:No.22 Building, No.1 Jinghai 5th Road, Tongzhou District, Beijing, P.R.China Zipcode:101111
Telephone: 400-008-6094
Website:www.abace-biology.com
Luxus Lebenswelt GmbH
Kochstr. 1, 47877, Willich, Germany

Datasheet

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