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SICKLE CELL DISEASE TEST, wb, 1 test (Sickle Scan-CXJ020)

https://medicalguidelines.msf.org/en/node/327
https://unicat.msf.org/cat/product/76532
NST SSDTSCDI20T

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).
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.
W0106010109 - Sickle cell anemia
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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SICKLE CELL DISEASE TEST (Sickle SCAN)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 20.

Definition

The Sickle SCAN® test is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, S, and C using fingerstick or venipuncture whole blood samples.

Specifications

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Components

  • 20 Sickle Scan cartridges
  • 20 Capillary samplers
  • 20 Pre-treatment modules
  • 1 Buffer solution
  • 1 Package insert

Technical specifications

  • Technology: lateral flow assay
  • Format: Lateral flow cassette
  • Sample type: whole blood, venous or capillary
  • Detection limit: <10% for hemoglobins A, S and C
  • Sample volume: 5 µl
  • Time to result: 5 min

To be Ordered Separately

  • Safety lancets

Instructions for use

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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Storage

  • Store at 2°C-30°C.
  • Do not freeze
  • Shelf life: 24 months

MSF requirements

This SCD RDT is recommended as first line POC test in children presenting with signs and symptoms of suspect SCD in emergency settings, where transfusion is urgently required. Sickle Scan is the recommended test to avoid delays in transfusion.
A positive SCD test is enough to make a diagnosis (no electrophoresis required to confirm, unless required by national guidelines).

If SCD scan not available, Emmel test can be performed as first screening but confirmation electrophoresis is recommended when available.

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Description validated for the OCG referent (Roberto De La Tour) in February 2023