SWAB WIDTH VIRAL TRANSPORT MEDIUM FOR PATHOGENS
Ready-to-use devices, consisting of a nasal swab with a plastic rod and a test tube with screw cap containing liquid transport medium,stable at room temperature, suitable for collection, transport and storage of pathogens.
The standard dimensions of the devices make them suitable for both use with automatic instruments and for manual use. The liquid medium allows to dissolve the sample quickly and easily, obtaining a homogeneous solution ready for use e suitable to obtain several identical rates of sample to carry out various analyzes. The swabs are packaged in peel-packs, with easy opening, for optimal device protection. Devices produced in accordance with GMP (Good Manufacturing Practice), classified and certified as IVD. Swabs are sterile (ethylene oxide sterilization).
DISPOSABLE SAMPLING TUBE-I
Tube-I (inactivating) for sampling contains guanidine hydrochloride, tris, and glycine.
DISPOSABLE SAMPLING TUBE-N
Tube-N (non-inactivating) for sampling contains tris, bovine serum albumin BSA and glycine
Liquid Transport Medium is contained in a cylindrical test tube Ø16mm x 103mm in transparent material, to preserve sample and users safety. with screw cap.
Pre-labelled on test tube to allow a correct patient and sample identification. The difference in color of the medium allows a clear and immediate distinction between type N and type I tubes.
Swab tip that allows a better clinical sample collection and the follow immediate release into the liquid transport medium. The soft bud is more comfortable for patients, and has significant advantages for both conventional and molecular methods. It has a plastic shaft with “breakpoint” to allow the swab breaking into the test tube and the successive collection by the screw “capture” cap after the tube closing.
It allows to dispose of the swab together with the cap in a safer way. Available in • Fine tip: swabs, small dimensions, nasopharyngeal sampling.
INSTRUCTIONS FOR USE OF Viral Transport Medium
Open the blister pack from the head-narrow indication and aseptically remove the swab from the blister pack.
Take the sample from the patient according to the site of sampling:
Gently insert the swab head into the nasal palate, hold for a moment, and then slowly rotate to exit. Swab the other side of the nostril with another swab, dip the swab head into the cell preservation solution and discard the tail.
Wipe the bilateral pharyngeal tonsils and posterior pharyngeal wall with the swab, dip the swab head into the cell preservation solution, and discard the tail.
Unscrew the cap and insert the swab into the test tube, being careful not to spill the liquid medium contained inside
Break the swab in the test tube by placing the “breakpoint” indicated on the shaft of the swab against the edge of the test tube. Tilt it 180°, using moderate pressure. Discard the broken part of the shaft in accordance with current regulations for medical waste.
Firmly tighten the cap onto the test tube and shake gently. Label the test tube with the patient’s data and keep it at room temperature. Analyze the sample by performing standard clinical laboratory procedures.
– Overall Length 151 mm (6’’) – Tip / Puntale Ø 3 mm (0.12”) – Tip Length 20 mm (0.79”) – From the swab head to the breaking point: 8 cm
- Composition The fine tip is composed of nylon velvet, and the rod is made of ABS material.
- CE marked IVD – manufactured in compliance with EN ISO 13485:2016; EN ISO 14971:2012; EN ISO 13612:2002; EN ISO 18113:2011
- IVD marked sterile swabs and tubes with medium – manufactured in compliance with 98/79/EC Directive (Italian D.lgs 332 del 08/09/2000)
PRECAUTIONS FOR USE
1) The device must be suitable for both the selected transport medium and the defined sampling site;
2) Use only for the collection and transport of human biological samples for the detection of potential pathogens such as viruses, compatible with the type of device selected;
3) Do not deviate from the intended use;
4) Do not use the product if it is expired or the package is opened/damaged. Sterility guaranteed if unopened;
5) Use the device following aseptic procedures;
6) Single-use device; do not reuse. Reusing the device could contaminate the sample and/or the patient;
7) Keep the device away from flames and heat sources;
8) The shaft is breakable, exert moderate pressure during sample collection;
9) Store in a cool, dry place at a temperature between +2°C and +35°C;
10) Sample that cannot be analysed whithin 24 hrs from the sampling must be stored at 2°C-8°C and analyzed as soon as possible. If necessary, samples can be stored at -20°C (or lower temperature) for longer period before analysis. Allow the sample to reach room temperature before analysis.
11) After use, the device may contain infectious microorganisms. Use appropriate PPE and dispose of the test tube and swab according to current regulations for medical waste.
12) Keep out of flame or heat sources which might damage the product.
13) Keep out of reach of children.
14) Strictly follow the user’s instructions.