SNT Biotech Sterile Normal Saline, 0.85% Kit - Case of 600

SNT Biotech Sterile Normal Saline, 0.85% Kit - Case of 600

Manufacturer Name: Shenzhen Dakewe Bio-engineering Co., LTD

INTENDED USE:

SNT Biotech Sterile Normal Saline is intended for collection and transport of clinical specimens for pathogen diagnosis, which can be as alternative transport media to Viral Transport Media (VTM).

SUMMARY:

The preferred and most commonly method to detect severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) involves storage and refrigerated transport of respiratory specimens. This can be accomplished using viral transport media (VTM). In accordance with FDA’s guidance and existing studies, however, when the availability of viral transport media (VTM) is limited, normal saline can also be used [1, 2].

SNT Biotech Sterile Normal Saline, 0.85% Kit - is ready for use and requires no further preparation. SNT Biotech Sterile Normal Saline, 0.85% is packed both in bulk and in kit. The packaging in bulk is supplied in a vial filled with 2 or 3ml normal saline. And the packaging in kit also includes a sterile collection device.

IFU Document: 

Link to FDA’s Saline policy for registration and notification:

PRINCIPLE OF PROCEDURE:

SNT Biotech Sterile Normal Saline is mainly composed of 0.85% SNT Biotech Sterile Normal Saline and sterilized screw-cap tube. The SNT Biotech Sterile Normal Saline is isotonic and non-toxic to mammalian host cells. And as alternative transport media to Viral Transport Media (VTM), it can preserve the viability of clinical specimen at 4℃ for 72 hours without degradation [3, 4].

Swabs are available with different sizes and shapes of both shaft and tip for the different collection sites. Swabs are packed into medical grade paper pouch and be radiation sterile.

MATERIALS PROVIDED: 50 Kits per box, each box contains:

Saline Medium: The 1ml/3ml medium in the screw cap tube is designed for transport of the clinical specimens.

Swab: Nasopharyngeal swab or oropharyngeal swab 

Biohazard Bag: 6x9 Biohazard Bag with pocket

STORAGE:

The product must be stored in the original packaging at a temperature of 2℃ to 25 ℃ before use, and the shelf life is one year.

NOTE: Do not use after expiration date, which is clearly printed on the outer box and on the specimen transport tube label.

SWAB CHARACTERISTICS:

• The collection system uses nylon flocking swabs, which are non-toxic to microorganisms and can maximize the collection and release of specimens.
• The unique jet implanted nylon fiber technology increases the collection and release of specimens.
• The swab has a total length of 153mm, and the plastic rod has a unique breakable design.
• The fluff texture can collect more target analytes.
• There is no residual sample, speed up the processing of the specimen.
• Swabs are individually packaged for sterilization.

SKU: SNTB50006

SPECIMEN STORAGE:

Specimens for investigation should be collected and handled following published manuals and guidelines. To maintain optimum viability or the most accurate test results, transport the specimen to the laboratory as soon as possible.

For SNT Biotech Sterile Normal Saline, best recovery is obtained when specimens are refrigerated at 4°C following collection and while in transit. If there will be a delay of more than 72 hours before processing, specimens should be frozen at –70°C or colder and transported on dry ice. Repeated freezing and thawing of specimens should be avoided.

Proper specimen collection from the patient is extremely critical for successful isolation and identification of infectious organisms. For specific guidance regarding specimen collection procedures, consult published reference manuals.

DIRECTIONS FOR USE:

• Collect specimens with the swab at corresponding parts.
• Insert the swab into the tube with SNT Biotech Sterile Normal Saline.
• Snap off the swab shaft at the pre-scored line by bending it against the tube wall.
• Replace cup to tube and close tightly.
• Label with appropriate information as required.
• Transport the samples to the laboratory as soon as possible.

PRECAUTIONS:

• For in vitro diagnostic use only.
• Observe approved biohazard precautions and aseptic techniques. To be used only by adequately trained and qualified personnel.
• Do not immerse the swab in the SNT Biotech Sterile Normal Saline before sampling;
• Single-use device, only for transportation and preservation of clinical specimens, and not suitable for any other application than intended use.
• Sterilize all biohazard waste including specimens, containers and media after their use.
• Do not use if you observe the SNT Biotech Sterile Normal Saline out of expiry date, or leaking from the test tube.
• Strictly follow the sampling procedures when using this product to collect specimens, operate in a laboratory that fits the security level when testing specimens.
• Dispose of all containers in accordance with national regulations, including unused items and used items.

For bulk pricing or if you are a hospital, clinic, lab or reseller, Please contact us at 312-715-7101.