Abstract
The goal of standardization for measurement of the catalytic concentration of enzymes is to achieve comparable results in human samples, independent of the reagent kits, instruments, and laboratory where the assay is performed. To pursue this objective, the IFCC has established reference systems for the most important clinical enzymes. These systems are based on the following requirements: a) reference methods, well described and evaluated extensively; b) suitable reference materials; and c) reference laboratories operating in a highly controlled manner. When these reference systems are used appropriately, the diagnostic industry can assign traceable values to commercial calibrators. Clinical laboratories that use procedures with validated calibrators to measure human specimens can now obtain values that are traceable to higher-order reference procedures. These reference systems constitute the structure of the traceability chain to which the routine methods can be linked via an appropriate calibration process, provided that they have a comparable specificity (i.e., they are measuring the same catalytic quantity).
| Original language | English |
|---|---|
| Pages (from-to) | 301-307 |
| Number of pages | 7 |
| Journal | Clinical Chemistry and Laboratory Medicine |
| Volume | 48 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 1 2010 |
Fingerprint
Keywords
- Calibration
- Enzymes
- IFCC reference methods
- Reference values
- Traceability
ASJC Scopus subject areas
- Clinical Biochemistry
- Biochemistry, medical
Cite this
Standardization in clinical enzymology : A challenge for the theory of metrological traceability. / Infusino, Ilenia; Schumann, Gerhard; Ceriotti, Ferruccio; Panteghini, Mauro.
In: Clinical Chemistry and Laboratory Medicine, Vol. 48, No. 3, 01.03.2010, p. 301-307.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Standardization in clinical enzymology
T2 - A challenge for the theory of metrological traceability
AU - Infusino, Ilenia
AU - Schumann, Gerhard
AU - Ceriotti, Ferruccio
AU - Panteghini, Mauro
PY - 2010/3/1
Y1 - 2010/3/1
N2 - The goal of standardization for measurement of the catalytic concentration of enzymes is to achieve comparable results in human samples, independent of the reagent kits, instruments, and laboratory where the assay is performed. To pursue this objective, the IFCC has established reference systems for the most important clinical enzymes. These systems are based on the following requirements: a) reference methods, well described and evaluated extensively; b) suitable reference materials; and c) reference laboratories operating in a highly controlled manner. When these reference systems are used appropriately, the diagnostic industry can assign traceable values to commercial calibrators. Clinical laboratories that use procedures with validated calibrators to measure human specimens can now obtain values that are traceable to higher-order reference procedures. These reference systems constitute the structure of the traceability chain to which the routine methods can be linked via an appropriate calibration process, provided that they have a comparable specificity (i.e., they are measuring the same catalytic quantity).
AB - The goal of standardization for measurement of the catalytic concentration of enzymes is to achieve comparable results in human samples, independent of the reagent kits, instruments, and laboratory where the assay is performed. To pursue this objective, the IFCC has established reference systems for the most important clinical enzymes. These systems are based on the following requirements: a) reference methods, well described and evaluated extensively; b) suitable reference materials; and c) reference laboratories operating in a highly controlled manner. When these reference systems are used appropriately, the diagnostic industry can assign traceable values to commercial calibrators. Clinical laboratories that use procedures with validated calibrators to measure human specimens can now obtain values that are traceable to higher-order reference procedures. These reference systems constitute the structure of the traceability chain to which the routine methods can be linked via an appropriate calibration process, provided that they have a comparable specificity (i.e., they are measuring the same catalytic quantity).
KW - Calibration
KW - Enzymes
KW - IFCC reference methods
KW - Reference values
KW - Traceability
UR - http://www.scopus.com/inward/record.url?scp=77249151647&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77249151647&partnerID=8YFLogxK
U2 - 10.1515/CCLM.2010.075
DO - 10.1515/CCLM.2010.075
M3 - Article
VL - 48
SP - 301
EP - 307
JO - Clinical Chemistry and Laboratory Medicine
JF - Clinical Chemistry and Laboratory Medicine
SN - 1434-6621
IS - 3
ER -