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HEPATITIS B TEST HBsAg (Determine 2),ser/pl/wb,1 test 7D2943

https://medicalguidelines.msf.org/en/node/286
https://unicat.msf.org/cat/product/78566
STD SSDTHBTE10T2

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).
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
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.
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 HBsAg TEST (Determine 2)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 100.

Definition

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

Used for the screening of blood donors and patients for hepatitis B detection.

Specifications

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Technical specifications

  • Reagent strips attached by 10 (stripable)
  • One-step rapid test (± 20 minutes)
  • According WHO prequalification report, January 2020:
    • Sensitivity on serum: 100 % (98.2-100)
    • Specificity on serum/plasma: 100% (98.8-100)
  • With internal control
  • Without external positive and negative controls

Packaging & Labelling

Aluminium foil pack of 100 tests (= 10 cards), with zip closure

Instructions for use

Follow the instructions in the leaflet.

Provide an automatic pipette or disposable pipettes (MiniPets) and corresponding tips for the application of the 50 µl sample (see related articles below).

For serum or plasma samples (preferred sample types, see below):

  • No additional reagent is required
  • For plasma samples, use EDTA tubes

For whole blood samples:

  • Validated on venous and capillary blood
  • Chase buffer is mandatory, ref: 7D2243 or 7D2243R (see related articles)
  • For venous samples, use EDTA tubes
  • For capillary samples, use the specific EDTA capillary tubes, ref. 7D2222 or 7D2227 (see related articles)

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 2º and 30ºC
  • Do not freeze
  • Shelf life: 18 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.

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