EPTIS
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Urine chemistry, qualitative

[Vizelet rutin, kvalitatív]

EPTIS factsheet 1255810 | Last revision 2024-11-26 | URL: https://www.eptis.bam.de/pts1255810 https://www.eptis.bam.de/pts1255810

PT provider
PT provider QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd. QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd.
Based in Hungary
Language(s) English, Hungarian
Remarks The test samples are basically intended for semi-quantitative urine chemistry with diagnostic test strips. The results displayed on the test strip should be reported. In proficiency testing, different results may be obtained from a given sample based on the sensitivity and specificity of the different test strips, and this is taken into account in the target values and the acceptable range. Therefore, the test strip results should be reported regardless of the sediment test results! In daily routine work, a correct result is reported for human samples, i.e. after the sediment test, the false positive or false negative result of the test strip for cellular elements should be adjusted if necessary. If two sets of samples are required for the determination, please order double amount!
Keywords
Product groups Health care / medical devices
Human test material
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
2 samples of 10 mL liquid human urine each Ascorbic acid Test strip
Bilirubin Test strip
Erythrocyte (RBC) Test strip
Microscopic examination/urinary sediment
Glucose Test strip
HCG Test strip
Agglutination test
Ketone bodies Test strip
Leucocyte (WBC) Test strip
Microscopic examination/urinary sediment
Microalbumin Test strip
Nitrite Test strip
PH Test strip
Potentiometry (glass electrode)
Specific gravity Test strip
Areometer/urometer
Protein Test strip
Qualitative determination with sulfosalicilic acid
Qualitative determination with acetic acid-boiling method
Urobilinogen Test strip
Ehrlich reagent
Erythrocyte (RBC) in the sediment Microscopic analysis
Instrumental analysis
Flow cytometric method
Leucocyte (WBC) in the sediment Microscopic analysis
Instrumental analysis
Flow cytometric method
Crytals in the sediment Microscopic analysis
Instrumental analysis
Flow cytometric method
Bacterium in the sediment Microscopic analysis
Instrumental analysis
Flow cytometric method
Epithelial cells in the sediment Microscopic analysis
Instrumental analysis
Flow cytometric method
Cylinders in the sediment Microscopic analysis
Instrumental analysis
Flow cytometric method
Aims of the PT scheme
Target group of participants In vitro medical laboratories & general practitioners (adults & children)
Linked to specific legislation / standards CLSI GP16-A3 – Urinalysis 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 The EFLM European Urinalysis Guideline 2023
Additional, subsidiary aims validation of testing methods
Number of participants
Accredited or otherwise reviewed by a 3rd party

Accredited by NAH (National Accreditation Authority) on the basis of ISO/IEC 17043:2010

Operation is commissioned / requested by
Fees and frequency
Participation fee on demand
Regularly operated Yes (four times a year)
Year of first operation 1997
Contact details of the PT provider
Provider Contact person
QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd.
Feketesas u. 19-21. I/7
6720 Szeged
Hungary

Phone: +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
Phone: +36 30 462 5864
Fax:
Email: mail@qualicont.com mail@qualicont.com
If you find any mistakes please contact the responsible EPTIS coordinator in Hungary, Ms Eszter Mezey. Ms Eszter Mezey.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5