Recently, there have been many concerns about antigen testing on the Internet. One of them is that if the "disposable sampler" (sampling swab) used in antigen testing is a "non-sterile" or "non-sterile" product, use There will be risks from time to time. It is recommended that citizens disinfect the sampling swab with alcohol before conducting antigen testing at home.
Experts and industry insiders say such concerns are unnecessary as long as qualified products from formal channels are used. If citizens receive swabs that are suspected to be damaged or contaminated, please discard them directly according to relevant requirements.
Are there risks to using "non-sterile" "non-sterile" sampling swabs? Specifically, there are two main problems that netizens worry about: First, they are worried that the sampling swab will be "bacterial", which will affect the results of the antigen test, such as "false positives"; , the "bacteria" into the human body, affecting health.
Regarding the effect of "bacteria" sampling swabs on antigen test results, experts said that this is a misunderstanding caused by confusing bacteria and viruses.
You must know that the antigen test "looks" for the antibodies produced by the new coronavirus infected person. The display window of the reagent strip contains a protein that can recognize the antibody, like a dam, which intercepts the colloidal gold combined with the virus antibody, which is displayed in the display window. is red. Therefore, even if the sampling swab contains "bacteria", the kit will "ignore" it and focus on "finding" the antibodies produced by the new coronavirus infected person. Since the kit is not interfered by "bacteria", it will not affect the results of antigen detection.
For some people who think that "bacteria" sampling swabs will affect human health, experts say that this may be due to a lack of understanding of "sterile" products.
The person in charge of a medical device manufacturer told reporters that the single-use sampler can currently apply for registration as a second-class medical device, or it can be registered as a first-class medical device (the third-class is the highest level) in the regulatory department. If it is a Class II medical device, it must meet the sterility requirements when it leaves the factory, while a Class I medical device has no relevant requirements and can be listed in the state of "non-sterile" and "unsterilized".
In fact, if you understand what is "sterile", what is "non-sterile" and "unsterilized", you will not worry about whether the sampling swab should be "sterile".
Review experts said that "sterility" refers to the state of no viable microorganisms. Medical devices marked "sterile" have been sterilized, and the theoretical probability of the existence of viable microorganisms should not exceed 10 to the negative 6th power. Therefore, in some requirements "Sterile" medical devices are only required in particularly high usage environments.
Although "non-sterile" and "unsterilized" medical devices cannot be as strict as "sterile" medical devices, they are almost "uncontaminated", but they are not "stained". All medical devices must meet certain hygienic requirements, such as strict control of the number of microorganisms, before they can be qualified for the market.
The sampling head is the core component of the disposable sampling swab. Taking it as an example, the sampling head of the ordinary cotton swab can be made of medical absorbent cotton, polyester staple fiber, electrostatic flocking fabric and other materials. "Bacteria" medical absorbent cotton must comply with my country's pharmaceutical industry standard "Medical absorbent cotton", and the manufacturer must provide microbial limits for reference by medical institutions and other users.
In a fully competitive market environment, such a mechanism forces manufacturers to optimize their processes and processes, so that the microbial limit of the product is as close to "sterile" as possible, so as to be more competitive and safer for users.
As a disposable sanitary product, the "bacteria" of the disposable sampling swab is the number of microorganisms, and there are national mandatory standards that draw a "red line" that cannot be crossed.
Taking ordinary masks as an example, when leaving the factory, coliform bacteria and pathogenic pyogenic bacteria shall not be detected, the total number of fungal colonies shall not exceed 100cfu/gram, and the total number of bacterial colonies shall not exceed 200cfu/gram.
Therefore, as long as qualified sampling swabs from regular channels are used, there is no need to worry about "a large number of bacterial invasion" during antigen testing.
"In fact, in the vast majority of cases, it is very difficult and unnecessary to use a sterile product." Experts said that, for example, a person has a nosebleed and temporarily rolls up a tissue and plugs it. Nostrils, the tissue at this time is definitely not in a "sterile" state, and the use of tissue will not cause harm to human health because of some microorganisms it contains. In the same way, qualified "non-sterile" and "unsterilized" sampling swabs will not endanger human health.
