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Blood cell count

[Mennyiségi vérkép]

EPTIS Ringversuch Nr. 1256329 | Letze Änderung 2026-03-20 | URL: https://www.eptis.bam.de/pts1256329 https://www.eptis.bam.de/pts1256329

Name des Anbieters
Name des Anbieters QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd. QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd.
Ansässig in Hungary
Sprache(n) English, Hungarian
Anmerkungen The survey sample is not recommended for Abbott Cell Dyn 3200, 4000, Sapphire, Ruby devices. QualiCont has had accredited status as the QualiCont as a Proficiency Test Provider complies with the criteria of MSZ EN ISO/IEC 17043:2010 standard since 26 March 2014. The QualiCont has been accredited according to the MSZ EN ISO/IEC 17043:2023 standard since 18 December 2025. Our Company is a Proficiency Testing Provider Organisation accredited by NAH (National Accreditation Authority) under the NAH-8-0002/2023 registration number. As the result of the accreditation process performed by NAH, our Company has accredited status until 9 March 2028. QualiCont Nonprofit Kft. has been operating its quality management system since 2001. Our Company successfully passed the renewal audit on 6th May, 2025. The certificate is valid until 28 May 2028. Our Company has been assessed and certified as meeting the requirements of ISO 9001:2015 standard for the following activities: Planning, organization and management of proficiency testing (external quality assessment) and the related supporting services for in vitro medical diagnostic laboratories and investigators on other human and veterinary medicine.
Klassifizierung
Produktgruppen Health care / medical devices
Human test material
Prüfgebiete Medical analysis
Technische Einzelheiten
Prüfobjekt Prüfeigenschaft Prüfmethode
2 samples of 2 mL preserved, coagulation-inhibited blood Erythrocytes (RBC) Automated count of electrical pulses (impedance method)
Automated count of optical pulses
Haematocrit (centrifugated, PCV) Automated centrifugation method (Hemalog), high speed microhematocrit centrifuge: DIN, < 10 min
Automated centrifugation method (Hemalog), high speed microhematocrit centrifuge: DIN, > 10 min
Automated centrifugation method (Hemalog), not high speed centrifuge
Different length (32 or 90 mm) single-use capillary, high speed microhematocrit centrifuge: DIN, < 10 min
Different length (32 or 90 mm) single-use capillary, high speed microhematocrit centrifuge: DIN, > 10 min
Different length (32 or 90 mm) single-use capillary, not high speed centrifuge
Other mincromethods (Hedin, van Allen) high speed microhematcrit centrifuge: DIN, < 10 min
Other mincromethods (Hedin, van Allen) high speed microhematcrit centrifuge: DIN, > 10 min
Other mincromethods (Hedin, van Allen) not high speed centrifuge
Plasticine-sealed, 75 mm single-use capillary, high speed microhematocrit centrifuge: DIN, < 10 min
Plasticine-sealed, 75 mm single-use capillary, high speed microhematocrit centrifuge: DIN, > 10 min
Plasticine-sealed, 75 mm single-use capillary, not high speed centrifuge
Soldered, 75 mm single-use capillary, high speed microhematocrit centrifuge: DIN, < 10 min
Soldered, 75 mm single-use capillary, high speed microhematocrit centrifuge: DIN, > 10 min
Soldered, 75 mm single-use capillary, not high speed centrifuge: DIN, < 10 min
Wintrobe or other macromethod, high speed macrohematocrit centrifuge: DIN < 10 min
Wintrobe or other macromethod, high speed macrohematocrit centrifuge: DIN > 10 min
Wintrobe or other macromethod, not high speed centrifuge
Haematocrit (electronic) Automated count of electrical pulses (impedance method)
Automated count of optical pulses
Haemoglobin Cyanmethemoglobin, according to DIN 58931 standard
Other (modified) cyanmethemoglobin methods
Oxyhemoglobin
Sodium-dodecyl-sulphate (SDS)-, Sodium lauryl sulphate (SLS) method
Photometric, cyanide-free method
Leukocytes (WBC) count Automated count of electrical pulses (impedance method)
Automated count of optical pulses
Lyses of erythrocyten without washing solution
Lyses of erythrocyten with washing solution
MCV Electrical principle (impedance)
Optical principle
PLT - Platelet count Automated count of electrical pulses, parallel with the RBC count
Automated count of electrical pulses, after flotation
Automated count of optical pulses, parallel with the RBC count
Automated count of optical pulses, after hemolysis
MCH - Mean Corpuscular Haemoglobin Calculated value
MCHC - Mean Corpuscular Haemoglobin Concentration Calculated value
MPV - Mean Platelet Volume Electrical principle (impedance)
Optical principle (light scattering)
RDW-CV Calculated value
RDW-SD Calculated value
Mentzer-index Calculated value
Ringversuchsziele
Zielgruppe des Ringversuchs In vitro medical laboratories & general practitioners (adults & children)
Relevante Rechtsvorschriften oder Normen CLSI GP44-A4 – Procedures for Handling and Processing of Blood Specimens for Common Laboratory Tests ILAC_G8:09/2019 – Guidelines on Decision Rules and Statements of Conformity ISO 15189 – Medical laboratories – Requirements for quality and competence ISO/TS20658:2017 – Medical laboratories – Requirements for collection, transport, receipt and handling of samples VIM3 – Vocabulaire International de Métrologie WHO – Guidance on regulations for the Transport of Infectious Substances
Weitere Ziele validation of testing methods
Teilnehmerzahl
Anbieter unabhängig überprüft (akkreditiert, benannt, anerkannt)

Akkreditiert durch NAH (National Accreditation Authority) auf der Grundlage von ISO/IEC 17043:2010

Die Durchführung des Ringversuchs ist in Auftrag gegeben durch
Kosten
Teilnahmegebühr on demand
Regelmässig durchgeführt Ja (six times a year)
Der Ringversuch wird durchgeführt seit 1997
Kontaktdaten des Anbieters
Anbieter Kontaktperson
QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd.
Feketesas u. 19-21. I/7
6720 Szeged
Hungary

Telefon: +36 30 462 5864
Fax:
Web: http://www.qualicont.com/qc/index_en.html http://www.qualicont.com/qc/index_en.html
Ms. Eszter Mezey
Telefon: +36 30 462 5864
Fax:
E-Mail: mail@qualicont.com mail@qualicont.com
Haben Sie einen Fehler entdeckt? Bitte wenden Sie sich an den zuständigen EPTIS Koordinator für Hungary, Ms Eszter Mezey. Ms Eszter Mezey.
Haben Sie Fragen? Senden Sie uns eine E-Mail: eptis@bam.de.
Anwendungsversion: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5