As in the recent years will be coronavirus spread world wide range of popular, sly will be coronavirus mutation evolution, from the alpha delta and gram si to the nearest the Mick Dijon strain restructuring variant XE,
our great motherland at the expense of a great execution of dynamic reset, the national policy of nucleic acid effectively protect the safety of the lives of the people In outbreak centralization daily nucleic acid examination is necessary, believe that now everyone of nucleic acid tests at the root of small sampling swab familiar: the disposable use asepsis sampling swabs (commonly known as pharyngeal swab) this kind of product for its use of consumption is big, there are a lot of new medical equipment manufacturers for the production, the disposable use asepsis sampling swab usually want to accord with what standard
Disposable sterile sampling swabs generally have to comply with what standards?GB/T191-2008 packaging storage and transportation pictorial signs;
GB/T28281-2012 count sampling inspection procedures Part 1: batch-by-batch inspection sampling plan by receiving quality limit (AQL) retrieval;
YY/T0466.1-2016 medical devices for medical device labeling, marking and providing information on the symbols Part 1; General requirements;
GB15979-2002 sanitary standards for single-use sanitary products;
GB/T3923.1-2013 Tensile properties of textile fabrics Part 1: Determination of breaking strength and elongation at break (strip sample method);
ISO10993-7: 1995 Biological evaluation of medical devices part 7 ethylene oxide sterilization residues.
First of all, let's take a preliminary look at this epidemic state is flirting with the "old friend" of stabbing out calluses:.
The purpose of the sterile single-use sampling swab is to provide in sterile form for biological sample testing of human oral cavity parts.
Single-use sterile sampling swab structure and composition: sterile sampling swab by the push rod, set of rods, sample head composition.
We all know that the sampling swab is in direct contact with the sampling site, which is in direct contact with our human organs, and the material of the sampling head is closely related to the subsequent testing. Let's take a look at the National Health Commission's "Technical Guidelines for Laboratory Testing of New Coronary Pneumonia (Third Edition)" in the specification requirements.
1, sampling swab head: manufacturing sampling swab head should use PE synthetic fiber, polyester fiber, polypropylene fiber, rayon and other synthetic fibers.
(1) is not recommended for natural fibers such as cotton
Because the fibers of cotton have a strong adsorption of proteins and do not easily elute to the subsequent preservation solution;
(2) nylon type fibers are also not recommended
Because nylon-type fibers (similar to toothbrush bristles) do not absorb water well, resulting in insufficient sampling volume and affecting the detection rate.
(3) sampling swab head must not use calcium alginate sponge or wooden stick swab (including bamboo sticks).
Because the wooden stick or bamboo swab containing calcium alginate and wooden components soaked in preservation solution after breaking will also adsorb protein, and even inhibit the subsequent PCR reaction.
2. Sampling swab handles.
The material used to manufacture swab handles is recommended to use hollow polystyrene (PS) extruded tube, polypropylene (PP) injection indentation tube or ABS plastic (high strength, good toughness), regardless of the material used can not add calcium alginate type additives; not recommended to use wooden sticks or bamboo sticks.
Swab handle has a folding type, built-in type two.
(1) break type swab after sampling into the preservation tube from near the sampling head part of the break off and tighten the tube cover can be.
(2) The built-in swab can be placed directly into the preservation tube after sampling, and then the small hole built into the cap of the preservation tube can be tightened by aligning the cap with the top of the handle.
When comparing the two methods, the latter is relatively safe. The fracture swab, when used with a smaller size preservation tube, may cause the liquid inside the tube to spill out when it is broken, and full attention should be paid to the risk of contamination that may be caused by improper use of the product.
New crown nucleic acid testing disposable use sterile sampling swab inspection test items specification.
1) The surface of the sterile swab should be bright and clean, no impurities, odorless, the use of contact surface and surrounding should be rounded smooth, no burr, no plastic flow, no scratches, sampling head should feel soft, there should be no yellow spots, stains, foreign matter, mold.
Test method or instrument: visual inspection / 20X microscope;
2) connection strength: tensile testing machine fixture movement rate of 200mm / min; sampling head and one end of the connecting rod pull-off force should be not less than 2N.
We can see that the National Health Commission on the sampling swab material requirements are very strict, disposable sterile sampling swab should ensure that the sampling volume and release, the selected material can not have substances that affect the subsequent detection, which also explains why you can not use wooden stick swabs and calcium alginate swabs. The general public only view this sampling swab as an ordinary cotton swab, but we as a professional medical device manufacturers in this area of quality inspection and quality control must not be sloppy!
