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(clinical chem. NycoCard II) CRP test, wb/ser/pl 1116807

https://msf.oodin.sh/cat/product/13268
STD ELAECCHT301

Valid Article

Former Code(s): ELAECCHT304 DDGTZBD0116 ELAE305
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.
14
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01021109 - C-reactive protein
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.
0208
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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(clinical chemistry NycoCard II) CRP TEST

Definition

NycoCard CRP is a immunochemichal assay for quantitative determination of C-reactive proteine, in capillary or venous blood, serum or plasma (with heparin, citrate, EDTA or no anti-coagulant). This measurement provides information for detection and evaluation of infection, inflammatory disorders and associated diseases. The standard rate is very stable in adults as in the newborn. There is no influence of the rate by pregnancy, steroid hormones, genetic polymorphism or micro-heterogeneity.

Specifications

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Components

  • Test device: 48 tests
  • R1/dilution liquid: 48 x 0.4 ml (borate buffer and detergent)
  • R2/conjugate: 3.5 ml (monoclonal anti-CRP antibodies and gold particles)
  • R3/washing solution: 3.0 ml (phosphate buffered NaCl solution and detergent)

Technical specifications

  • Solid phase, sandwich-format, immunometric assay
  • Analysis of blood sample (whole blood with or without anticoagulant, serum and plasma)
  • Measuring range: 8-200 mg/l for whole blood samples and 5-120 mg/l for serum and plasma samples

Packaging & Labelling

Box of 48 tests

To be Ordered Separately

  • Control kit (which is no longer included in the test): Afinion CRP Control ref. 1116785 (see related items)
  • Pipette (50 µl) and tips
  • Capillary tube holder
  • Nycocard reader II
  • Capillary tubes 5 µl

Instructions for use

Follow the instructions manual

Test performed on 50 µl sample (whole blood, serum or plasma)

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

  • Shelf life: 14 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Keep refrigerated between 2 and 8ºC, Protect from sunlight
  • Do not freeze
  • Opened kit:
    • Test device/R2-Conjugate/R3-Washing solution: Stable until expiry date at 2-8°C or 6 weeks at 15-25°C (refrigerate at the end of the working day).
    • R1/Dilution liquid: Stable until expiry date, refrigerated or at room temperature (2-25°C).

(Cf Introduction: Thermosensitive products)

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