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HEPATITIS B TEST HBsAg, wb, 1 test (Bioline HBsAg 01FK10W)

https://medicalguidelines.msf.org/en/node/286
https://unicat.msf.org/cat/product/73376
STD SSDTHBTE30T

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.
CT3+
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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HEPATITIS B TEST (Bioline HBsAg)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 30.

Definition

Rapid immunochromatographic test for the qualitative detection of hepatitis B surface antigen used for pretransfusional screening.

Specifications

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Components

  • 30 test devices
  • instructions for use

Technical specifications

  • Test device (30) single pouched
  • One-step rapid test (± 20 minutes)
  • Sample type: venous whole blood (not validated on capillary blood)
  • Sample volume: 100 µl
  • Analytical sensitivity on WHO International Biological reference preparation: 2.06IU/ml
  • According to WHO Prequalification report (version August 2020)
    • Sensitivity on serum: 100 % (95% CI: 98.1-100%)
    • Specificity on serum: 99.0% (95% CI:97.2-99.8%)
  • With internal control line
  • Without positive and negative external controls

Packaging & Labelling

Kit of 30 tests

Instructions for use

Follow the instructions in the leaflet.

IMPORTANT: After several complaints of false positive faint lines testing plasma on the Bioline HBsAg WB test received from several MSF field projects, MSF validated its use on venous whole blood only, regardless of the IFU claiming that plasma can be used.

Sample type: 100µl venous whole blood (not validated on capillary blood)

If you are considering the use of this test for another indication than pretransfusional screening (i.e. screening of chronic hepatitis B infection), additional testing should be performed to determine if the patient should be considered for antiretroviral therapy (i.e. HBeAg, HBV VL). It is recommended to consult your respective OC laboratory advisor and medical director before use outside pretransfusional screening.

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 40ºC
  • 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

Rapid test prequalified by WHO.

No need for cold chain.

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