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HEPATITIS C TEST, ser/pl/wb, 1 test (Bioline HCV 02FK16)

https://medicalguidelines.msf.org/en/node/286
https://unicat.msf.org/cat/product/74088
STD SSDTHCTE25T2

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).
W01050902 - Hepatitis viruses - 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.
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.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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HEPATITIS C TEST (Bioline HCV)

CAUTION

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

Definition

Rapid immunochromatographic test for the qualitative detection of antibodies specific to Hepatitis C in human serum, plasma or whole blood.

Specifications

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Components

  • 25 test devices
  • 1 vial of diluent (5ml), colour may slightly change according the batches
  • 25 sterile lancets
  • 25 capillary pipettes (10µl)
  • 25 alcohol swabs
  • instructions for use

Technical specifications

  • Two-step rapid test (20 minutes)
  • Sample type: serum, plasma or whole blood (venous or capillary)
  • Sample volume: 10µl
  • Membrane strip pre-coated with recombinant HCV capture antigen (core, NS3, NS4 and NS5)
  • Performance according to WHO Prequalification report (version August 2020):
    • Sensitivity: 100% (95% CI: 97.76 - 100%)
    • Specificity: 100% (95% CI: 98.85 - 100%)

Packaging & Labelling

Kit of 25 tests

To be Ordered Separately

  • For use with venous blood: venous blood collection materials and precision pipettes and tips
  • For use with capillary blood: safety lancets (see related items)

Instructions for use

Follow the 'instructions for use' (IFU).

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

Waste management

Incinerate the tests and used materials.

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