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.