On June 5, 2020, the new product novel coronavirus IgM/IgG antibody test kit (colloidal gold method) developed by Jinan Deheng Medical Technology Co., Ltd. passed the EU CE certification, met the compliance requirements of EU medical device related directives, and obtained the EU market access qualification. The "CE" mark is a safety certification mark that is considered a passport for manufacturers to open and enter the European market. CE stands for Unification of Europe. In the EU market, the "CE" mark is a mandatory certification mark. Whether it is a product produced by internal enterprises in the EU or products produced in other countries, in order to circulate freely in the EU market, it is necessary to attach the "CE" mark to indicate that the product meets the basic requirements of the EU's "New Methods for Technical Coordination and Standardization" directive. This is a mandatory requirement of EU law for products. On April 25, the Ministry of Commerce, the General Administration of Customs, and the State Administration of Market Supervision and Administration issued a notice on further strengthening the supervision of the export quality of epidemic prevention materials: since April 26, export enterprises whose products have obtained foreign standard certification or registered novel coronavirus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must submit a written statement at the time of customs declaration, promising that the products meet the quality standards and safety requirements of the importing country (region), and the customs will release them based on the list of manufacturers that have obtained foreign standard certification or registration provided by the Ministry of Commerce (the website of the China Chamber of Commerce for the Import and Export of Pharmaceutical and Health Products is updated dynamically, and the medical industry calls it the export "white list").
On July 4, 2020, the product and company successfully entered the list of medical material production enterprises that have obtained foreign standard certification or registration issued by the China Chamber of Commerce for Import and Export of Healthcare Products.
Deheng Medical Diagnostic Warfare products have successfully passed the EU CE certification and been included in the Ministry of Commerce's "white list". They have opened up all links for exporting to Europe and supporting the fight against the epidemic.
Deheng Medicine strives to defend public life and health with precise diagnosis!
Novel coronavirus IgM/IgG antibody detection kit (colloidal gold method)
Packaging specifications:
1 person/box, 25 people/box, 50 people/box
Intended use:
This reagent is used for qualitative detection of novel coronavirus IgM/IgG antibodies in human serum, plasma and whole blood samples.
Verification principle:
This kit uses the indirect method principle of colloidal gold immunochromatography to detect novel coronavirus IgM/IgG antibodies in human serum, plasma and whole blood samples.
Add blood samples and sample diluents dropwise to the sampling well of the reagent kit, and the sample solution moves along the reagent card through chromatography.
If the sample contains novel coronavirus IgG antibody and/or IgM antibody, it will bind with colloidal gold labeled novel coronavirus antigen, pre coated anti human IgG antibody and/or anti human IgM antibody respectively, forming a complex in the detection area, showing a red precipitation line (M or G); The unconjugated colloidal gold complex was chromatographed to the quality control line (C) and showed a red precipitate line when combined with pre coated sheep anti mouse antibodies.
If the sample does not contain novel coronavirus IgG antibody and/or novel coronavirus IgM antibody, there is no corresponding red precipitation line in the detection area.
Test significance:
After infection, the body gradually produces antibodies, with IgM (immunoglobulin M) antibodies appearing first, followed by IgG (immunoglobulin G) antibodies. After entering the recovery period, the antibody will reach its peak, and the titer of the antibody can increase to at least four times higher than in the acute phase. Antibodies can be maintained for a long time after disease recovery, so antibody testing can not only be used to diagnose infection, but also for restorative diagnosis.
After the outbreak of the disease, antibody testing of all close contacts in a certain area can investigate the transmission rate, latent infection rate, and antibody levels of the population, which is of great significance for future disease prevention and control.
Product advantages:
1) Fast, this product only takes about 10 minutes to complete testing.
2) The detection operation is simple and only takes 15 minutes μ Dropping whole blood from the fingertip into the testing well can detect samples infected for 3-7 days.
3) No instrument required, can be read directly with the naked eye. A positive result for the antibody test indicates that the patient is currently infected or has previously been infected.
4) Widely applicable, it can be used for monitoring the resumption of work and school resumption in current enterprises, as well as for home self-test, community epidemic prevention monitoring and other application scenarios.
Knowledge LinkEU CE certification
The Ministry of Commerce's export "whitelist"
