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CRYPTOCOCCUS TEST (CrAg LFA), ser/pl/wb/CSF, 1test CR2003

https://medicalguidelines.msf.org/en/node/289#id-.HIVinfectionandAIDSvEnglish-SecondaryprophylaxisSecondaryprophylaxis
https://unicat.msf.org/cat/product/19077
STD SSDTCRYP50T

Valid Article

Former Code(s): DDGTCRYP5T-
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.
W010506 - Mycology (infect. immunology/nat)
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.
1525
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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CRYPTOCOCCUS TEST (CrAg LFA)

CAUTION

The cryptococcus test is worded and codified by unit to make the order easier, but it is always packaged in kit of 50.

Definition

Rapid immunochromatographic test (Lateral Flow Assay, LFA) for the qualitative and semi-quantitative detection of Cryptococcus neoformans antigens in serum, plasma, whole blood or cerebro-spinal fluid (CSF).

Specifications

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Components

  • Lateral Flow Specimen Diluent (2.5 ml) - GLF025
  • Lateral Flow Titration Diluent (6.0 ml) - EI0010
  • CrAg Lateral Flow Test Strips (50 strips in vial with desiccant)
  • CrAg Positive Control (1 ml): solution with cryptococcal antigen - CB1020
  • Package insert

Technical specifications

  • Rapid test: +/- 15 min
  • Sample type: serum, plasma, whole blood and CSF
  • Sample volume: 40 µl
  • Positive control, titration and specimen diluents: colorless and odorless liquids

Packaging & Labelling

Kit of 50 tests

To be Ordered Separately

  • Automatic pipette with tips (40 μl and 80 μl)
  • Timer
  • Micro-tubes, test tubes, or a micro-titer plate

Instructions for use

Follow the instructions in the leaflet.

Complement to the staining with India ink.

Please consult the “Updated laboratory procedures, 2022” or “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/Home.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 20 and 25ºC
  • 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

(Cf Introduction: Thermosensitive products)

Waste management

Incinerate used strips and equipment.

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