Metrological traceability of values for catalytic concentration of enzymes assigned to a calibration material

Canalías, Francesca; Camprubí, Sandra; Sánchez, Mariana López; Gella, F. Javier

doi:10.1515/cclm.2006.058

Cited by 9 publications

(3 citation statements)

References 6 publications

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“…Since the measurement results are procedure-dependent, the comparability of measurement results obtained by different routine procedures can best be ensured by the calibration of these routine procedures using validated calibrants, which carry values traceable to the International System of Units (SI) using a reference measurement procedure (1)(2)(3)(4). Since the measurement results are procedure-dependent, the comparability of measurement results obtained by different routine procedures can best be ensured by the calibration of these routine procedures using validated calibrants, which carry values traceable to the International System of Units (SI) using a reference measurement procedure (1)(2)(3)(4).…”

Section: Introductionmentioning

confidence: 99%

Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase

Toussaint

Emons

Schimmel

et al. 2010

Clinical Chemistry and Laboratory Medicine

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Section: Introductionmentioning

confidence: 99%

Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase

Toussaint

Emons

Schimmel

et al. 2010

Clinical Chemistry and Laboratory Medicine

Self Cite

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“…[ 15 ] For most manufacturers, the detailed information of the procedure to assign the values of routine calibrators is not provided; therefore, the laboratories cannot know if the traceability chain has been maintained. The traceability standards in the in vitro diagnostic instruments directive (Directive 98/79/EC) as well as ISO17511 and ISO18153[ 16 ] are all relevant to diagnostic equipment manufacturers.…”

Section: Discussionmentioning

confidence: 99%

Inductively Coupled Plasma Mass Spectrometry as a Reference Method to Evaluate Serum Calcium Measurement Bias and the Commutability of Processed Materials during Routine Measurements

Zhao

Yin

et al. 2018

Chinese Medical Journal

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Background:Measuring total serum calcium is important for the diagnosis of diseases. Currently, results from commercial kits for calcium measurement are variable. Generally, the performance of serum calcium measurements is monitored by external quality assessment (EQA) or proficiency testing schemes. However, the commutability of the EQA samples and calibrators is often unknown, which limits the effectiveness of EQA schemes. The aim of this study was to evaluate the bias of serum calcium measurements and the commutability of processed materials.Methods:Inductively coupled plasma mass spectrometry was applied as a comparative method, and 14 routine methods were chosen as test methods. Forty-eight serum samples from individual patients and 25 processed materials were quantified. A scatter plot was generated from patient samples, and 95% prediction intervals were calculated to evaluate the commutability of the processed materials and measurement bias at three concentration levels was used to determine the accuracy of routine assays.Results:All assays showed high precision (total coefficient of variation [CV] <2.26%) and correlation coefficients (r > 0.99). For all assays, the mean bias for the 48 patient samples ranged from −0.13 mmol/L to 0.00 mmol/L (−5.61–0.01%), and the ranges for the three concentrations were −0.10–0.04 mmol/L (−5.71–2.35%), −0.14–−0.01 mmol/L (−5.80–−0.30%), and −0.19–0.04 mmol/L (−6.24–1.22%). The EQA samples, calibrators, and animal sera exhibited matrix effects in some assays; human serum pools were commutable in all assays; certificate reference materials were commutable in most assays, and only GBW09152 exhibited a matrix effect in one assay; and aqueous reference materials exhibited matrix effects in most assays.Conclusions:Biases for most assays were within the acceptable range, although the accuracy of some assays needs improvement. Human serum pools prepared from patient samples were commutable, and the other tested materials exhibited a matrix effect.

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“…Routine measurement systems using validated calibrators should ensure that the values are traceable to the IFCC primary procedures. 9 Calibrators with matrix effects should be used with matched reagents and analysers. 10 This is called the homogeneous system.…”

Section: Introductionmentioning

confidence: 99%

Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of γ-glutamyltransferase catalytic concentration measurements in China

Xia

Tong²,

Wang³

et al. 2010

Ann Clin Biochem

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Background: The in vitro directive of the European Union requires traceability to the international recommended reference procedures. The application of the reference procedures is necessary in order to evaluate the accuracy of gglutamyltransferase (GGT) assays of routine measurement systems in China. Methods: Five frozen patient-pooled serum samples were assigned values by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference procedure in order to evaluate the traceability of the results of GGT catalytic activity from six homogeneous systems. One of the serum samples was used to calibrate seven non-homogeneous systems.Results: All of the homogeneous systems, except the Dade system (Dade Bering Inc, IL, USA), achieved traceability within the measurement range. The Roche and Hitachi systems were better than the other systems. After calibration, the variance of the non-homogeneous systems decreased dramatically from between 14.50% and 25.23% to between 1.25% and 3.09% and the bias decreased from between 211.4% and 24.1% to between 0.5% and 3.5%. Conclusion: Manufacturers in China should ensure that their calibration systems correspond to the IFCC reference procedures. Fresh frozen pooled patient serum assigned by reference laboratories can be used to calibrate nonhomogeneous systems in order to achieve traceability.

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Metrological traceability of values for catalytic concentration of enzymes assigned to a calibration material

Cited by 9 publications

References 6 publications

Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase

Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase

Inductively Coupled Plasma Mass Spectrometry as a Reference Method to Evaluate Serum Calcium Measurement Bias and the Commutability of Processed Materials during Routine Measurements

Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of γ-glutamyltransferase catalytic concentration measurements in China

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