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Covid-19 virus detection IgM/IgG Antibodies Test Kit corona virus rapid test kit

China Covid-19 virus detection IgM/IgG Antibodies Test Kit corona virus rapid test kit

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Covid-19 virus detection IgM/IgG Antibodies Test Kit corona virus rapid test kit

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Payment Terms	L/C, D/A, D/P, T/T, Western Union, MoneyGram
Supply Ability	10000pieces/day
Delivery Time	7
Packaging Details	10 Test/Box; 25 Test/Box; 50 Test/Box; 100 Test/Box
name	2019-nCoV IgG/IgM Antibody Rapid Test Kit
PACKAGE	10 Test/Box; 25 Test/Box; 50 Test/Box; 100 Test/Box
Brand Name	OEM
Certification	CE
Place of Origin	China

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Product Specification


Payment Terms	L/C, D/A, D/P, T/T, Western Union, MoneyGram	Supply Ability	10000pieces/day
Delivery Time	7	Packaging Details	10 Test/Box; 25 Test/Box; 50 Test/Box; 100 Test/Box
name	2019-nCoV IgG/IgM Antibody Rapid Test Kit	PACKAGE	10 Test/Box; 25 Test/Box; 50 Test/Box; 100 Test/Box
Brand Name	OEM	Certification	CE
Place of Origin	China
High Light	rapid test kit ，antibody test kit

INTENDED USE

It is used for the qualitative detection of novel coronavirus IgG and IgM antibodies in human serum, plasma or whole blood in vitro.

Coronavirus is a large family that exists widely in nature. It is susceptible to humans and many animals. It is named for its corona-like fibroids on the surface of its virus particles.

The typical clinical symptoms of the new coronavirus (2019-nCoV) infection are fever,

fatigue, muscle soreness, and dry cough, which can progress to severe pneumonia,

respiratory failure, and even life-threatening.

Current evidence indicates that the new coronavirus is transmitted mainly through droplets, aerosols, and direct contact with secretions. After humans are infected with the new coronavirus (2019-nCoV), the human immune system will generate an immune response against the virus, producing specific antibodies. Detection of relevant antibodies can be used to screen for infection with the new coronavirus. Therefore, it is of great clinical significance to establish a simple, safe and reliable new method for laboratory diagnosis of coronavirus.

PRINCIPLE

This kit is based on the principle of colloidal gold technology.

After an appropriate amount of sample is added to the detection well, the sample moves under the action of the capillary. The new coronavirus IgG / IgM antibody in the sample will combine with the colloidal gold-labeled new coronavirus antigen to form a colloidal gold-antigen-antibody complex. The immune complex product is then chromatographed along the nitrocellulose membrane to the detection area (M), combined with the pre-coated monoclonal anti-human IgM to form a purple M line, showing that the new coronavirus IgM is positive. The immune complex continuously is chromatographed to the detection area (G ) and combined with pre-coated anti-human IgG to form a purple G-line, showing a new coronavirus IgG positive.

The quality control antibody-labeled colloidal gold particles are chromatographed to the quality control area (C) and combined with the pre-coated anti-quality control antibody to form a purple C line, indicating that the test is effective. If the QC line does not appear, the test result is invalid.

STORAGE AND STABILITY

The cassette is stable for 18months (while sealed in an aluminum foil pouch) if stored at 2 -30°C. The kit is effective in 1 hour after moving from aluminum foil pouch. The date of manufacture is detailed in the label.

Name	Composition
Cassette	It consists of a cartridge and a detection strip. The detection strip includes a sample pad, glass fiber (coated with colloidal gold-quality control antibody conjugate, colloidal gold-new coronavirus antigen conjugate), and nitrocellulose membrane (The detection area M is coated with mouse anti-human IgM, detection area G is coated with anti-human IgG antibody, quality control area is coated with anti-quality antibody), absorbent paper, PVC board
Buffer	Main component is phosphate buffered saline (PBS)

Note: Components of different batches can’t be mixed.

SAMPLE REQUIREMENTS

Clinical fresh non-hemolyzed serum, plasma or whole blood (EDTA anticoagulation) samples.

After sampling, the sample should be tested within 24h at room temperature. The sample should be stored for no more than 5 days in cold condition of 2-8°C and should be stored for no more than one month in cryopreservation condition of -18°C. The whole blood sample should be stored for no more than five days at 2-8°C if it can’t be tested within two hours after sampling.

The sample needs to be restored to room temperature before testing. Cryopreserved

samples need to be completely melted, rewarmed, mixed evenly before use, avoid

freezing and thawing repeatedly.

TEST PROCEDURE

1. Please read the manual of the kit before operation.

2. If the sample is stored refrigerated or frozen, please allow the sample to fully melt at room temperature (20-30 ° C), and mix the sample upside down before use.

3. Before starting the test, remove the test strip from the aluminum foil bag, lay it flat on the table, and mark the sample number.

4. Use a sample gun or a dropper to draw 10ul of the sample to be tested (serum, plasma or whole blood sample) into the sample well on the test card. Immediately add 2 drops (70-90ul) of the sample dilution solution to the sample well, and avoid significant bubbles during operation.

5. Count and read the results within 15 minutes at room temperature.

Please strictly control the reaction time and read the result within 15 minutes.

Interpretation of test results

The test results are divided into three cases: negative, positive or invalid. The specific interpretation methods are as follows:

M line	G line	C line	Result
No color	No color	Color rendering	Negative, no new coronavirus antibodies detected
Color rendering	No color	Color rendering	Positive, new coronavirus IgM antibody detected, no new coronavirus IgG antibody detected
No color	Color rendering	Color rendering	Positive, new coronavirus IgG antibody detected, new coronavirus IgM antibody not detected
Color rendering	Color rendering	Color rendering	Positive, Simultaneous detection of novel coronavirus IgM and IgG antibodies
Color rendering	No color	No color	Invalid test, need to re-measure
No color	Color rendering	No color	Invalid test, need to re-measure
Color rendering	Color rendering	No color	Invalid test, need to re-measure

LIMITATIONS OF THE TEST

1. This reagent is a qualitative test and cannot be used for quantitative determination of antibody content.

2. This reagent is used for the detection of human whole blood, serum or plasma samples. It cannot be used for the detection of saliva, urine or other body fluids.

3. The test results of this product are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms / signs, medical history, other laboratory tests, treatment response, and epidemiology.

4. In the early stage of infection, if the virus-specific IgM antibody is not produced or the titer is very low, it will lead to negative results. If a virus infection is suspected, the patient should be reminded to check again within 10-20 days and take a second sample, which should be the same as the first sample. Simultaneously test under conditions to determine if there is a seroconversion or a virus-specific IgG or IgM antibody titer that is significantly

higher in the first infection.

5. The interpretation of positive results should be further determined in conjunction with clinical symptoms and other etiological methods (nucleic acid and sequencing).

6. Negative results indicate that no new coronavirus IgM / IgG antibodies have been detected, but if the new coronavirus IgM / IgG antibody content in the sample is below the minimum detection limit of the kit, negative results may also be obtained.

PRODUCT PERFORMANCE

Appearance: The appearance of the reagent should be neat and tidy, and the text symbol should be clearly marked. There is no leakage. The test strip is intact.The positive rate, precision, and minimum detection limit of this product meet therequirements of quality standards, and the product quality is stable during the validity period. Hepatitis B virus surface antigen antibody, Hepatitis C virus antibody, Hepatitis E virus IgM antibody, Hepatitis A virus IgM antibody, Syphilis antibody, HIV antibody, Rheumatoid factor, Antinuclear antibody, Coxsackie virus A16 IgM antibodies, adenovirus IgM antibodies, respiratory syncytial virus IgM antibodies, influenza A virus antibodies, EV71 virus IgM antibodies, Mycoplasma pneumoniae IgM antibodies, anti-mitochondrial antibody (AMA) positive samples, and high-concentration

non-specific IgG (serum total IgG) will not cause interference with this product.

NOTES

This product is for in vitro diagnostic use only.

The operation steps cannot be omitted or simplified.

The positive samples detected by this kit need to be confirmed by other methods.

Disinfect or treat all samples and reagents as potential sources of contamination in accordance with local regulations.

INDEX OF SYMBOLS

Company Details

Bronze Gleitlager

Bronze Sleeve Bushings

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Graphite Plugged Bushings

from Quality China Factory

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Business Type:

Manufacturer,Distributor/Wholesaler,Trading Company 
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Year Established:

2013 
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Total Annual:

5000000-6.000.000
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Employee Number:

200~300 
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