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UNIVERSAL TRANSPORT MEDIUM+SWAB, 3ml, synth. mini tip

https://unicat.msf.org/cat/product/35785
STD STSSTRTUUTM1

Valid Article

Former Code(s): SLASZNL0161 SLASTMUV1--
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
16
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
A1102 - Sample collection swabs with transport medium
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT25
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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UNIVERSAL & VIRAL TRANSPORT MEDIUM + SWAB

Definition

Kit containing Universal / Viral Transport Medium and 1 swab for the collection and transport of specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.

Specifications

  • 3 ml of UTM medium in screw-cap tube
  • One swab with synthetic tip and plastic handle with breaking point

Different presentations depending your ESC:

  • Option 1: Supplied togehter, in kit or in bulk (STSSTRTTUUTM1)
  • Option 2: Supplied toghether in bulk UTM (STSSTRTUUTM6) and swabs (STSSSWAB8PS)

Caution

In the exceptional situation that the references above are not available, alternative sources may be proposed. All specifications below should be met:

  • Swab
    • Swab with polysester/Rayon/Nylon tip, ideally flocked (not cotton!)
    • Mini-tip, suitable for nasopharyngeal sample collection (for COVID)
    • 1 swab/patient
    • Plastic flexible stick/handle
    • Sterile
  • Viral transport medium
    • 1,2 or 3 ml Viral transport medium isotonic to mammalian host cells, supplemented with antibiotics to inhibit growth of competing bacteria and yeast.
    • Note that for analysis using the GeneXpert SARS-CoV-2 cartridge only the 3ml volume has been validated.
    • Should not contain Guanidine Thiocyanate (= toxic)

Both to comply with CLSI standard M40-A

Technical specifications

  • Medium Composition
    • Hanks' Balanced Salts
    • bovine serum albumin
    • L-cysteine, gelatin
    • sucrose
    • L-glutamic acid
    • HEPES buffer
    • vancomycin
    • amphotericin B
    • colistin
    • phenol red
  • Mini-tip swabs are suitable for nasopharyngeal sample collection (whereas swabs with standard tips are for oropharyngeal sample collection)

Instructions for use

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

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Storage

  • Temperature between 2 and 25°C.
  • Do not overheat or freeze prior to use
  • The product must be stored in its original packaging
  • Shelf life: 16 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

MSF requirements

Sample collection and storage of the sample during transport to the laboratory, for suspiscions of viruses, chlamydiae, mycoplasmas or ureaplasmas.

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