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(API System) 20E STRIP, Enterobacteriaceae

https://unicat.msf.org/cat/product/50411
STD SBIDAPIS20E

Valid Article

Former Code(s): SLASZBE0459 SLASMISC099 SLASZBD0099
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.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104080209 - Manual identification kits - anaerobes, pathogens - other
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
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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API 20E STRIPS, Enterobacteriaceae

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25 or 100 strips.

Definition

API 20 E is a standardized identification system for Enterobacteriaceae and other non-fastidious, Gram-negative rods which uses 20 miniaturized biochemical tests and a database.

Inoculation and reading are done manually, and identification is done with the software.

Specifications

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Components

Kit of 25 tests (20100) containing:

  • 25 API 20 E strips
  • 25 incubation boxes
  • 25 result sheets
  • 1 clip seal
  • 1 package insert

Kit of 100 tests (20160) containing:

  • 100 API 20 E strips
  • 100 incubation boxes
  • 100 result sheets
  • 1 clip seal
  • 1 package insert

Technical specifications

Strip with 20 microtubes containing dehydrated substrates. Oxidase test should be done separately. The microtubes are inoculated with baterial suspension. The colours changes occur during incubation, due to metabolism, spontaneously or by addition of reagents.

Packaging & Labelling

Kit of 25 or 100 tests.

To be Ordered Separately

  • API NaCl 0.85% medium, 5 ml
  • Mineral oil
  • API 20E reagent kit (NIT 1 + NIT 2, VP 1 + VP 2, TDA, JAMES)
  • Zn reagent
  • Oxidase
  • Pipettes or PSIpettes
  • Ampule rack and protector
  • APIWEB software

Instructions for use

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources. https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Bacteriology-Laboratory-Resources.aspx

For offline access, contact your laboratory advisor

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Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Store between 2°C and 8°C.
  • Do not use after expiry date.
  • Shelf life: 18 months.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.
  • Once aluminium pouch is opened, the strips may be kept for up to 10 months at 2°C-8°C with desiccant sachets.
  • Re-seal the pouch with the clip seal included in the kit.

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilize the cultures and all contaminated material. Contact your watsan referent for proper disposal.

MSF requirements

Reserved to bacteriology programmes.

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