Commutability of the CRM 470 C-reactive protein value in the Dade Behring N High Sensitivity CRP assay.
Clin Chem Lab Med
; 41(2): 177-82, 2003 Feb.
Article
in En
| MEDLINE
| ID: mdl-12667004
ABSTRACT
Certified Reference Material 470 (CRM 470) demonstrates commutability with both the manufacturer's calibrator and with dilutions of serum pools in the Dade Behring N High Sensitivity assay for C-reactive protein (CRP). Both regression and back calibration show similar nonlinearity for all materials, largely due to the method of calibration curve fitting used in this assay. Significant differences in values among the currently available commercial assays can be largely overcome by using appropriate calibration curve fitting and the recommended value transfer protocol, which includes a minimum of two assay runs on each of at least 3 separate days, with weight correction of all reconstitutions and dilutions. An initial weight-corrected dilution should be made each day because of the relatively high level of CRP in CRM 470. In our opinion, the degree of nonlinearity, imprecision, and differences in values in currently available assays renders the use of fixed clinical decision cut-points questionable for high-sensitivity CRP. An alternative approach is suggested.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
C-Reactive Protein
/
Chemistry, Clinical
/
Nephelometry and Turbidimetry
Type of study:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
Limits:
Humans
Language:
En
Journal:
Clin Chem Lab Med
Journal subject:
QUIMICA CLINICA
/
TECNICAS E PROCEDIMENTOS DE LABORATORIO
Year:
2003
Document type:
Article
Affiliation country:
United States