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MALARIA HRP-2 TEST, wb, 1 test (Bioline P.f 05FK50)

https://medicalguidelines.msf.org/en/node/258
https://unicat.msf.org/cat/product/19097
STD SSDTMALF25T

Valid Article

Former Code(s): DDGTMALF31T
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.
W0105090401 - Plasmodium (malaria) - 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.
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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MALARIA HRP-2 TEST (Bioline)

CAUTION

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

Definition

Immunochromatographic rapid test for the qualitative detection of Pf HRP-II (Plasmodium falciparum specific "Histidine Rich Protein-II").

HRP2 based tests are used for the diagnosis of malaria caused by P. falciparum (P.falciparum >95%).

Specifications

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Components

  • 25 individually packed tests
  • 1 bottle of buffer
  • disposable specimen transfer device, lancets, alcohol swabs
  • package insert

Technical specifications

  • Rapid test (± 15 minutes) in 2 steps (application blood and application of buffer solution)
  • Sample type: whole blood (venous or capillary)
  • Sample volume: 5 µl
  • Test performance according to "WHO Product Testing Programme round 1 in 2009 and round 5 in 2014, see Prequalification report (January 2021):
    • Round 1: Detection rate (200 parasites/µl): 97.5%, false positive rate: 0.0 %
    • Round 5: Detection rate (200 parasites/µl): 95,0 %, false positive rate: 0.0 %

Packaging & Labelling

Kit of 25 tests.

Instructions for use

Can be carried out on whole blood by capillary or venous blood collected in EDTA or heparinized tube.

Giemsa stained thick and thin blood films remain the gold standard for malaria diagnosis when possible.

This test does not provide information about total parasitemia. The test detects only infection with Plasmodium falciparum.

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

Waste management

Incinerate the tests and the used materials.

MSF requirements

Different tests for malaria testing are proposed in this catalogue. To decide which one to choose, please refer to your laboratory or/and malaria advisor.

Malaria tests of different brands are not interchangeable because the testing procedures are different. Before start using a new test brand read the testing procedure carefully.

High detection rate. No need for additional equipment.

Note:

Due to current difficulties to procure quality-assured sources of pan pLDH tests, only HRP2 based tests or combo tests are available even for hyper- and holo-endemic areas with intense seasonal transmission. Please refer to your laboratory or/and malaria advisor to define the best option in your case remain the first choice for the time being.

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