What are the requirements for sampling swabs
What are the requirements for sampling swabs
Since the outbreak of the epidemic,
The virus sampling tube and nucleic acid test throat swab have been pushed to the cusp of the storm.
Many people worry that irregular sampling swabs will cause false positives or false negatives.
Because this will not only threaten personal safety but also cause great harm to society, the result will be very serious.
so the National Health Commission issue the “New Coronary Pneumonia Laboratory Testing Technical Guidelines (Third Edition)” in the specification requirements: (The original text is quote here)
China’s requirements for sampling swabs:
Pharyngeal swab: Use two plastic rod swabs with polypropylene fiber heads to wipe both pharyngeal tonsils and posterior pharyngeal wall at the same time,
and immerse the swab head in 3mL virus preservation solution (isotonic saline solution, tissue culture solution or Phosphate buffer solution),
discard the tail, and screw the cap tightly.
Have you see that the clear material requirements for swabs in my country’s guidelines require polypropylene fiber,
but the manufacturer that produces swabs needs to pay attention to not using wooden stick swabs and calcium alginate swabs.
Why What? Please look down
U.S. requirements for sampling swabs:
Let’s take a look at the requirements for sampling swabs use in the collection of nasal and pharynx samples in “InterimGuidelines for Collecting,
Handling, and Testing Clinical Specimens from Patients Under Investment (PUIs) for 2019NovelCoronavirus (2019-nCoV)” issued by the United States CDC.
The original text is: Use only synthetic fiber swabs with plastic shafts .
Do not use calcium alginate swabs or swabs with woodeen shafts,
as they may contain substance that inactivate some viruses and inhibit PCR testing.
Place swabs immediately into sterile tubes
The translation is: only synthetic fiber swabs with plastic rods can be use.
Calcium alginate swabs or wooden stick swabs cannot be used，
because they may contain substances that inactivate certain viruses and inhibit PCR detection.
to sum up:
We all know that the United States CDC has high requirements for the materials of medical devices,
and this time is no exception, and it explains why wooden stick swabs and calcium alginate swabs cannot be used.
China also has clear regulations on sampling swabs, so manufacturers must not be sloppy in this regard.
disposable sampling swabs
The difference between traditional fiber wound swabs:
Electron Microscope photograph of traditional fiber winded swab. Electron Microscope photograph of the nylon flocked swab.
With traditional fiber wound swabs a large percentage of the sample
collected remains entrapped in the fiber matrix of the tip.
It has been shown that the flocked swab release up to 95% of the sample
collected compared to 25% in a standard fiber tipped swab -especially
important if the sample size is particularly small.
Features:
⇒ Ergonomic and anatomic design
⇒ Superior sample elution
⇒ Rapid absorption
⇒ Increased assay sensitively
⇒ Simply collect, snap and ship
⇒ Quantitative volume transfer
⇒ Perpendicular nylon fibers
⇒ Certified free of inhibitors and interference
⇒ Highly suited to automation
| Part Number | Flocked Tip (mm) | Handle Dimension (mm) | Packaging | |||||
| Width | Thickness | Length | Diameter 1 | Diameter 2 | Molded Breakpoint Length from Tip | Overall Length | ||
| CY-96000 | 3 | 3 | 16 | 2.5 | Taper to 1.1 | 82.5 | 150 | 100 Swabs/Box50 Boxes/Case |
1. Utilizes unique “spray-on technology” and “electrostatic charge”.
2. Innovation nylon fibers technology.
3. The perpendicular nylon fibers act as a soft brush.
4. Capillary action between the nylon fiber strands facilitates strong hydraulic
uptake of liquid samples.
5. To limit interference and improve consistency the swab is manufactured from completely
inert components.
1. Collecting a large amount of the cells
2. Rapid elution and release of the specimen
3. Unique molded breakpoint design in swab handle
4. Free of any PCR inhibitors and interference
It is used for forensic, laboratory, a diagnostic company, the genetic testing company, drug company, etc.