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CHOLERA TEST Ag O1/O139, stool, 1 test (Bioline 44FK30)

https://medicalguidelines.msf.org/en/node/800
https://unicat.msf.org/cat/product/71815
NST SSDTCHOL20T

Valid Article

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.
W0105011799 - Bacteriology - immunoassay 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.
CT30
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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CHOLERA TEST Ag O1/O139 (Bioline)

There is currently no cholera rapid test WHO prequalified or available as an MSF standard. It is possible to order the test as a nonstandard item only after validation by the medical director of your respective operational center. More information in the LWG communication of November 2017.

Please contact your laboratory advisor to receive the most updated information regarding the cholera rapid test to be ordered as a non-standard after validation of the medical director of your operational centre.

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged per 20 tests.

Definition

Rapid Polyclonal antibody-based co-agglutination test for the detection of Vibrio cholerae O1 and O139 antigen in stool samples in the context of an outbreak investigation.

Specifications

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Components

  • 20 Test devices with desiccant in individual foil pouches
  • Specimen collection tubes containing extraction buffer (20 x 1.2 ml/vial)
  • 20 Swabs for solid specimen collection
  • 20 Disposable droppers for liquid specimen collection
  • 20 Patient identification labels
  • 1 Instructions for use

Technical specifications

  • Time to result: 15 min
  • Specimen: Solid or liquid stool

Packaging & Labelling

Kit of 20 tests

Instructions for use

Follow the instructions on the leaflet and the protocol for the investigation of an epidemic.

  • Not to be used for individual diagnosis.
  • The test does not detect V. cholera non-O1/O139

Precautions for Use

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

Storage

  • Store between 1ºC and 30º C
  • Do not freeze
  • Shelf life: 24 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Not to be used beyond expiry date

Waste management

Incinerate the tests and the used materials.

MSF requirements

There is currently no cholera rapid test WHO prequalified or available as an MSF standard.

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