2019-NCoV IgM / IgG Detection Kit (Colloidal Gold-Based) Intended Use

Intended Use

This product is used to detect 2019-nCoV IgM/IgG antibodies in human serum, plasma, or whole blood. Only as a supplementary test indicator for suspected cases with a negative nucleic acid test result for 2019-nCoV, or in combination with nucleic acid testing for the diagnosis of suspected cases.

This product is used as an adjunctive diagnosis and emergency reserve for patients with pneumonia infected with 2019-nCoV infection

Test Method

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1. Prepare before experimentation
Remove reagents and samples and restore all reagents and samples to room temperature.
2. Experimental steps
(1) Open the foil bag. Remove the test strip and place horizontally.
(2) Add 10 μL of sample to the injection well of the test strip and add 2 drops (~60 μL) of sample buffer.
(3) Normal temperature reaction. After 10-15 minutes, the test results can be read. Results are invalid after 20 minutes.
(4) Concise operating procedures
Unpack, remove the test strip and place horizontally
↓
Add 10 μL of sample to the injection wells of the test strip
↓
Add 2 drops (~60 μL) of sample buffer to the sample wells
↓
React at room temperature for 10-15 minutes
Read the results with the naked eye.

Interpretation of test results

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Negative,Positive,Invalid

Test result graph:
(1) Invalid result: If there is no visible red line or only test
Line (T line) but no quality control line (C line), the result is
invalid, which needs to be retested.
(2) Negative result: If there is only a red control line
(C-line), indicating that there is no antibody or antibody in the sample
The antibody is below the detected level.
(3) Positive result: If there are two red lines (one red mass
control line and one red test line) or three red lines (one red
quality control line and two red test lines), the result is positive.

Company profile

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Zhongxiu Technology Co., Ltd. is a high-tech enterprise engaged in the research and development, production and operation of in vitro diagnostic products. The in vitro diagnostic products developed by the company cover POCT series, microbial series, biochemical series and immune series reagents and supporting instruments.
The company always adheres to the core concept of "fast and accurate, not living up to life", is committed to providing excellent products and services for the society, and contributes to the cause of human health.

Zhongxiu Qualifications

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White List

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Zhongxiu Science And Technology Co.,Ltd., founded in 2016, is located in Dingluan Industrial Zone, Changyuan City, Henan Province. The company covers an area of about 100 acres and the initial investment is about 200 million yuan. The company has a scientific and complete management system, a purification workshop of national standards, and a fully functional inspection center. On this basis, the company will continue to invest in research and development, accumulate technical strength, update manufacturing equipment, improve production technology, improve inspection technology, improve product quality, and provide customers with safe and effective in vitro diagnostic products.

Zhongxiu Science And Technology Co., Ltd. is a high-tech enterprise engaged in the research and development, production and operation of in vitro diagnostic products. The in vitro diagnostic products developed by the company cover POCT series, immune series, microbial series and other reagents and supporting instruments.

The company has always adhered to the core concept of “fast and accurate, living up to life”, committed to providing society with excellent products and services, and contributing to the cause of human health.