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DENGUE NS1/IgM/IgG TEST (Dengue Duo),ser/pl/wb,1 test 11FK45

https://medicalguidelines.msf.org/en/node/287
https://unicat.msf.org/cat/product/19078
STD SSDTDENG10T

Valid Article

Former Code(s): DDGTDENG3T-
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.
W0105099007 - Dengue - rt & poc
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.
PM
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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DENGUE NS1/IgM/IgG TEST (Bioline Dengue Duo)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 10.

Definition

Rapid immunochromatographic test for the detection of the NS1 antigen and IgG /IgM antibodies specific to dengue virus in serum, plasma or venous whole blood.

This test consists of a combo-device containing two test cardridges, for simultaneous testing of NS1 and IgG/IgM.

Specifications

Note: there is only a test validated on whole blood, not on capillary blood. Contact your laboratory advisor in case of questions.

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Components

  • 10 test cassettes in individually sealed pouches with a desiccant; each test cassette contains:
  • Assay diluents for Dengue IgG/IgM test
  • Capillary pipette 10 µl for Dengue IgG/IgM test
  • Disposable dropper for Dengue NS1 Ag test
  • Instructions for use

Technical specifications

  • Time to result: 15-20min
  • Sample type: venous whole blood/serum/plamsa
  • Sample volume: 100µl for NS1 + 10µl for IgG/IgM
  • With internal control line
  • Without positive and negative external controls
  • Assay Buffer: 100mM Phosphate buffer (3ml), Sodium azide (0.01w/v%)

Packaging & Labelling

Box containing 10 tests

Instructions for use

Follow the instructions in the leaflet.

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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Precautions for Use

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

Storage

  • Store between 2 and 30°C
  • Do not freeze
  • Shelf life: 24 months
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

Waste management

Incinerate the tests and the used materials.

MSF requirements

Not to be used as individual diagnostic test in MSF programs due to limited performance. Contact your laboratory advisor in case of questions.

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