Results in 3 minutes? Only 8 minutes?

This new crown virus self-test "artifact" can not believe

A few days ago, the reader broke the news that a kit called self-testing for the new crown virus appeared on the Internet, which is called "3 minutes to read the results and the whole test is only 8 minutes". So, are these kits formal and effective? In this connection, the reporter launched an investigation yesterday.

Chongqing Evening News-Upstream News Reporter Wen Han Photography Report

Wechat:

I can test at home

"If you feel coughing, dizzy, uncertain, and worried, don't worry about yourself, you can test it at home. This is a test reagent. You can try it without going to the hospital. It is very safe." The words come from a circle of friends of Weishang, and the picture is a reagent with a mosaic.

The micro-business said that she sells the new coronavirus detection reagent that can read the results in 3 minutes and detect only 8 minutes in the whole process. Introduction of publicity materials: This reagent can provide fast and convenient on-site detection methods for suspected patients with new coronary pneumonia, asymptomatic patients, close contacts, and negative nucleic acid tests, and assist disease control departments and medical institutions to take timely and effective prevention and control measures. It can better meet the needs of rapid detection and control of epidemic scenes in various countries, and help prevent and control the new crown pneumonia epidemic globally.

claim:

EU registration for foreign sales

The reagent is priced at 260 yuan each, 20 per box, and the whole box is sold. "If you want to buy a box, you can give your internal staff a price of 200 yuan. I am a member of the company and I test it for free every week." Weishang also provided a video of the use to reporters, which involved alcohol disinfection, blood collection, waiting Testing and other procedures. She said that currently the reagent is mainly sold abroad and registered in the European Union, and has already qualified for EU market access.

survey:

No registration record found

According to China's relevant laws and regulations, medical device registration certificate is required for the listing of medical devices. Basic information of medical devices can be checked by the State Drug Administration. However, a new coronavirus IgM / IgG antibody rapid detection kit (colloidal gold method) sold by Weshang for a biomedical technology company in Jiangsu, the reporter searched the medical device product (registration) of the State Drug Administration, and no registration record was found. In response, the reporter asked whether the WeChat reagent is a regular product, and she did not respond positively.

In addition, the reporter noticed that, in addition to the WeChat, in some online platforms, some merchants are selling kits. The common point is that copywriting ads are more obscure, and the product information displayed is mostly incomplete.

A total of 5 colloidal gold assay kits approved in China

According to the reporter's understanding, the most accurate way to check for the new crown virus is to conduct nucleic acid testing through regular medical institutions. The colloidal gold method can only be used as a supplement to nucleic acid detection. The colloidal gold method is more commonly used in pregnancy testing equipment.

According to the official website of the State Food and Drug Administration, as of March 19, the State Food and Drug Administration approved a total of 5 antibody detection kit products using colloidal gold, which are:

1.New coronavirus (2019-nCoV) IgM antibody detection kit (colloidal gold method) (Guangdong Hexin Health Technology Co., Ltd. National Machinery Note 20203400199)

2. New coronavirus (2019-nCoV) IgM / IgG antibody detection kit (colloidal gold method) (Nanjing Nuoweizan Medical Technology Co., Ltd. National Machinery Note 20203400239)

3. Novel coronavirus (2019-nCoV) antibody detection kit (colloidal gold method) (Guangzhou Wanfu Biotechnology Co., Ltd. National Machinery Note 20203400176)

4.New coronavirus (2019-nCoV) antibody detection kit (colloidal gold method) (Innotek (Tangshan) Biotechnology Co., Ltd. National Machinery Note 20203400177)

5.New coronavirus (2019-nCoV) IgM / IgG antibody detection kit (colloidal gold method) (Zhuhai Lizhu Reagent Co., Ltd. National Machinery Injection Standard 20203400240)

SFDA: Not applicable for general population screening

The kit products found by reporters on the Internet platform are not among them. In addition, the State Food and Drug Administration has also clarified the use of such kit products: it is only used as a supplementary detection indicator for new suspected cases of negative coronavirus nucleic acid detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases, and cannot be used as a new coronavirus infection The basis for the diagnosis and exclusion of pneumonia is not suitable for screening in the general population, and is only used by medical institutions.

Relevant persons of the Municipal Drug Administration also reminded the public that the use of kit products that have not passed the approval of the National Drug Administration or informal channels cannot guarantee the accuracy rate. Improper blood collection may also pose an infection risk. It is recommended that the public be cautious in purchasing relevant self-test products .