Performance Evaluation of the CRE2 Reagent from Siemens for Serum Creatinine Measurement
Laboratory Medicine Online
; : 6-11, 2019.
Article
de Ko
| WPRIM
| ID: wpr-719668
Bibliothèque responsable:
WPRO
ABSTRACT
BACKGROUND: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. METHODS: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. RESULTS: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. CONCLUSIONS: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.
Mots clés
Texte intégral:
1
Indice:
WPRIM
Sujet Principal:
Contrôle de qualité
/
Biais (épidémiologie)
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Appréciation des risques
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Créatinine
/
Prestations des soins de santé
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Diagnostic
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Indicateurs et réactifs
/
Maladies du rein
/
Méthodes
Type d'étude:
Diagnostic_studies
/
Etiology_studies
/
Guideline
/
Risk_factors_studies
langue:
Ko
Texte intégral:
Laboratory Medicine Online
Année:
2019
Type:
Article