New crown antigen detection self-test sampling swabs must be sterile and sterile?
New crown antigen testing self-test sampling swabs must be sterile? "Non-sterile sterilization" to alcohol disinfection before use?
Recently, there are many concerns about antigen testing on the Internet, one of the views that antigen testing to use the "single-use sampler" (sampling swab) if it is "non-sterile" "not sterile "products, the use of risk, it is recommended that the public home before the antigen test, first disinfected with alcohol sampling swabs.
Experts and industry insiders have said that as long as the use of qualified products from regular channels, such concerns are not necessary. If the public receives a sample swab that is suspected to be damaged or contaminated, please discard it directly in accordance with the relevant requirements.
The use of "non-sterile" "non-sterile" sampling swabs risk? The netizens are worried about two specific problems: First, they are worried about the sampling swabs "with bacteria", affecting the results of antigen testing, such as "false positive"; second, they are worried about the sampling swabs "with bacteria ", in the sampling process, the "bacteria" into the body, affecting health.
For the "bacteria" sampling swabs affect the antigen test results, experts said that this is confused bacteria and viruses after the misunderstanding.
To know, the antigen test "to find" is the new coronavirus infection produced by the antibodies, the display window of the reagent strip contains a protein that can recognize the antibodies, like a dam, intercepting the colloidal gold combined with antibodies to the virus, so that the display window is red. Therefore, even if the sample swab is "bacterial", the kit will "ignore" it and concentrate on "finding" the antibodies produced by the new coronavirus infected person. Since the kit is not interfered by the "bacteria", it will not affect the results of the antigen test.
For some people think that "with bacteria" sampling swabs will affect human health, experts say that this may be due to the lack of understanding of "sterile" products.
The person in charge of a medical device manufacturer said that single-use samplers can currently apply for registration as Class II medical devices, but also as a class of medical devices (Class III for the highest level) in the regulatory department for the record. If as a class II medical device, the factory must meet the requirements of sterility, while a medical device does not have the relevant requirements, can be "non-sterile" "not sterile" state listed.
In fact, to understand what is "sterile", what is "non-sterile" "not sterile", will not be entangled sampling swabs to "sterile The problem of "sterility".
"Sterile" refers to the state of no viable microorganisms, the medical device labeled "sterile" is sterilized, the theoretical probability of the existence of viable microorganisms should not exceed 10 to the minus 6, so in some particularly demanding use environment, only need "sterile" medical devices.
Although "non-sterile" "unsterile" medical devices can not be as stringent as "sterile" medical devices almost "sterile ", but also not so much as to "hide dirt". All medical devices must meet certain hygiene requirements, such as strict control of the number of microorganisms, in order to qualify for the market.
Sampling head is the core component of the disposable sampling swab, for example, the sampling head of the ordinary type swab type swab available medical skim cotton, polyester short fiber, electrostatic flocking fabric and other materials made, if the use of "non-sterile" medical skim cotton, must comply with China's pharmaceutical industry standards "medical skim cotton", the manufacturer must provide microbiological The manufacturer must provide microbiological limits for the reference of medical institutions and other users.
In a fully competitive market environment, such a mechanism to force manufacturers to optimize the process and process, so that the product microbial limit as close to "sterile", will be more competitive, for users, will also be safer.
Disposable sampling swabs as a single-use sanitary products, the "bacteria" is the number of microorganisms, by the national mandatory standards delineated the "red line" shall not be exceeded.
Therefore, as long as the use of qualified sampling swabs from the regular channels, there is no need to worry about antigen detection when there is a "large number of bacterial invasion".
"In fact, the vast majority of cases, to use a sterile product, it is very difficult and unnecessary." Experts said, to use an analogy, a person has a nosebleed, temporary take the paper towel rolled up to plug the nostrils, at this time the paper towel is certainly not "sterile" state, the use of paper towels will not be because of some microorganisms with the human health harm. Similarly, qualified "non-sterile" "non-sterile" sampling swabs, more than human health risks
