Nucleic acid test antigen test swab sampling swab and sterilization is briefly introduced

We should all know whether to confirm the infection of the new coronavirus, in addition to nucleic acid, can also use antigen self-test, testing the sampling swab used for swab is a common medical device.

Nucleic acid test antigen test swab sampling swab introduction

Sampling swabs can be used to collect oral epidermal cells or nasal virus samples, and then the cells or samples are stored in the collection tube and transferred to the laboratory for testing, to achieve the detection of oral or nasal diseases in humans. Different from the swabs used in daily life, the sampling swab should ensure the sampling volume and release volume, and the selected material should not affect the subsequent testing. The swab is mainly composed of a sampling head and a medical ABS plastic rod, of which the material of the sampling head is closely related to the subsequent detection.

Flocked swabs made of nylon fiber by spray technology.

Sampling swab head should use Polyester (PE) synthetic fiber or Rayon (artificial fiber), can not use calcium alginate sponge or wooden stick swab (including bamboo swabs), the material of the swab head can not be cotton products, because the fiber of cotton is stronger adsorption of protein, not easy to elute to the subsequent preservation solution; and containing calcium alginate and wooden components of the wooden stick or bamboo swab broken and soaked In the preservation solution will also adsorb proteins, and even have an inhibitory effect on the subsequent PCR reaction.

Nucleic acid detection antigen detection swab sampling swab sterilization simple introduction

EO sterilization (ethylene oxide sterilization) or irradiation sterilization is commonly used for sampling swabs, but EO, as a carcinogen, is extremely hazardous to human health. For EO sterilized swabs, some people may worry about whether EO will remain on the swab and enter the body during testing. However, there is no need to worry, EO-sterilized swabs will go through 14 days of analysis, its EO residue testing qualified before leaving the factory, and in the process of circulation will also be naturally resolved, to reach our hands of the sampling swab its EO residue and will not have an impact on human health.

Why are there unsterilized non-sterile sampling swabs

For nucleic acid testing antigen detection swab sampling swab sterilization we have a simple understanding, however, many people responded why I see the swab packaging has "unsterilized" or "non-sterilized" mark, worried about the sampling swab " With bacteria", affecting the results of antigenic nucleic acid testing, such as "false positive" and so on; on the other hand, worried about the sampling process, the bacteria will be brought into the body, affecting health.

In fact, single-use samplers can currently apply for registration as Class II medical devices, but also as a class of medical devices (Class III is the highest level) in the regulatory department for the record.

     If as a Class II medical device, the factory must meet the sterility requirements, while a class of medical devices do not have the relevant requirements, can be "non-sterile", "not sterilized" state listed.

Medical device review experts said that "sterile" refers to the state of no viable microorganisms, labeled "sterile" medical devices after sterilization, the theoretical probability of the existence of viable microorganisms should not exceed 10-6, so in some particularly demanding use of the environment. Sterile" medical devices are required only in some particularly demanding environments.

Non-sterile sampling swabs can also be used safely

Although "non-sterile" and "non-sterile" medical devices do not have as low a theoretical probability of microbial survival as "sterile" medical devices, they must meet certain hygienic requirements as medical devices, including strict control of the number of microorganisms. Including strict control of the number of microorganisms, in order to be qualified to market. Therefore, the swabs applied for registration as a class I medical device also meet the quality acceptance criteria and can be used with confidence.