[Production Filing Certificate Number] Su Yang Food and Drug Administration Medical Device Production Filing No. 20210006

[Product Filing Certificate Number] Su Yang Equipment No. 20210038

[Product Technical Requirements Number] Su Yang Equipment No. 20210038

[Product Name] Single-use viral sampling tube

【Specifications and Model】

Types: non-inactivated, inactivated, and VTM

Specifications: 1 ml, 2 ml, 3 ml, 3.5 ml, 4 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, 10 ml, 15 ml, 100 ml

[Product Performance, Main Structural Components, or Ingredients]

Comprises a tube body, lid, preservation solution, and accompanying swab; a biosafety bag is available as an optional accessory. Not supplied sterile.

【Scope of Application】 Used for the collection, transportation, and storage of samples, among other applications.

【Main Ingredients】

The composition of VTM preservation solution includes several or multiple components, such as Hank’s balanced salt solution, phenol red, bovine serum albumin, polymyxin B, and cryoprotectants.

The composition of the non-inactivated preservation solution includes sodium chloride, magnesium sulfate, potassium chloride, magnesium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, hydroxyethylpiperazine ethanesulfonic acid, cysteine, glutamic acid, streptomycin, penicillin, phenol red, glucose, water, and other components, either singly or in combination.

The composition of the inactivation preservation solution includes, as major components, balanced salts, EDTA chelating agent, guanidinium salts, anionic surfactants, cationic surfactants, phenol, 8-hydroxyquinoline, dithiothreitol (DTT), proteinase K, and several other components, either individually or in combination.

[Storage Conditions and Shelf Life] The sampling tube should be stored at 4–25°C; the shelf life is 12 months.

[Sample Requirements]

Collected samples shall be transported at 2–8°C and submitted for testing immediately; the total transport and storage time shall not exceed 48 hours.

【Instructions for Use】

1. Prior to sampling, label the sampling tube with the relevant sample information.

2. Depending on the specific sampling requirements, collect a sample from the nasopharyngeal region using a sampling swab;

3. The specific sampling method is as follows:

a) Nasal swab: Gently insert the swab tip into the nasal cavity to the nasopalatine area, hold it in place for a few seconds, then slowly rotate and withdraw. Use a second swab to sample the other nostril, immerse the swab tip in the collection solution, and discard the tail end.

b) Pharyngeal swab: Use the swab to gently wipe both palatine tonsils and the posterior pharyngeal wall, then immerse the swab tip in the collection solution, discarding the handle.

4. Quickly place the swab into the sampling tube;

5. Break off the portion of the sampling swab that extends above the sampling tube, then tightly screw on the tube cap.

6. Newly collected clinical samples shall be transported to the laboratory within 48 hours at 2–8°C.

【Limitations of the Testing Method】

1. Contamination of samples after collection can affect the final test results;

2. Failure to store samples at the prescribed temperature will affect the final test results;

【Product Performance Specifications】

1. Appearance: The sampling tube shall be clean, free of impurities and visible defects; the sampling solution shall be a clear red liquid or a colorless, transparent liquid. The label shall be intact, neatly and securely affixed, with clear and accurate text and symbols.

2. pH: At 20–25°C, the pH of the sampling solution should be 7.0–8.2.

3. Fill Volume: The fill volume of the sampling solution shall be no less than ±10% of the labeled volume.

4. Stability: The product shall maintain stable physical and chemical properties for at least one month beyond its expiration date.

 

Comprises a tube body, lid, preservation solution, and accompanying swab; a biosafety bag is available as an optional accessory. Not supplied sterile.