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Human Covid-19 Virus Detection Test Kit IgM/IgG Rapid Antibody Test Kit

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Human Covid-19 Virus Detection Test Kit IgM/IgG Rapid Antibody Test Kit

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Brand Name :	OEM
Certification :	CE
Price :	Negotiable
Payment Terms :	L/C, D/A, D/P, T/T, Western Union, MoneyGram
Supply Ability :	10000pieces/day
Delivery Time :	7

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Human Covid-19 Virus Detection Test Kit IgM/IgG Rapid Antibody Test Kit

2019-nCoV IgG/IgM Antibody Rapid Test Kit

(Colloidal gold Assay)

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.

PACKAGE

10 Test/Box; 25 Test/Box; 50 Test/Box; 100 Test/Box.

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.

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.

Human Covid-19 Virus Detection Test Kit IgM/IgG Rapid Antibody Test Kit

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Human Covid-19 Virus Detection Test Kit IgM/IgG Rapid Antibody Test Kit