Analytical Performance Specifications

Dalenberg, Daniel A.; Schryver, Patricia G.; Klee, George G.

doi:10.1016/j.cll.2012.11.005

Cited by 9 publications

(4 citation statements)

References 14 publications

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“…Linearity on our comparative Roche biuret method (c502) was verified during our initial instrument validations (slope 1.001; data not shown). Linearity on the c502 TP assay is consistent with that observed in a separate, comprehensive analytical performance evaluation of the cobas 8000 system [29] .…”

Section: Discussionsupporting

confidence: 76%

“…It should be noted, however, that the clinical significance of TP differences at these inaccuracy specifications is negligible. Trueness of a Roche biuret TP assay (c701; within desirable bias limits of 1.2%) has previously been described [29] .…”

Section: Discussionmentioning

confidence: 94%

“…For example, intermediate (between-day) precision for TP on Roche c501/502 analyzers has been described as 1.7–2.5%CV [28] . An analytical performance characterization noted inter-assay precision on the Roche c701 TP assay to be 1.7–2.1%CV (for QC) and 1.5–2.4%CV (for serum) [29] .…”

Section: Discussionmentioning

confidence: 99%

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Clinical performance evaluation of total protein measurement by digital refractometry and characterization of non-protein solute interferences

Hunsaker

Wyness

Snow

et al. 2016

Practical Laboratory Medicine

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ObjectivesRefractometric methods to measure total protein (TP) in serum and plasma specimens have been replaced by automated biuret methods in virtually all routine clinical testing. A subset of laboratories, however, still report using refractometry to measure TP in conjunction with serum protein electrophoresis. The objective of this study was therefore to conduct a modern performance evaluation of a digital refractometer for TP measurement.Design and methodsPerformance evaluation of a MISCO Palm Abbe™ digital refractometer was conducted through device familiarization, carryover, precision, accuracy, linearity, analytical sensitivity, analytical specificity, and reference interval verification. Comparison assays included a manual refractometer and an automated biuret assay.ResultsCarryover risk was eliminated using a demineralized distilled water (ddH2O) wash step. Precision studies demonstrated overall imprecision of 2.2% CV (low TP pool) and 0.5% CV (high TP pool). Accuracy studies demonstrated correlation to both manual refractometry and the biuret method. An overall positive bias (+5.0%) was observed versus the biuret method. On average, outlier specimens had an increased triglyceride concentration. Linearity was verified using mixed dilutions of: a) low and high concentration patient pools, or b) albumin-spiked ddH2O and high concentration patient pool. Decreased recovery was observed using ddH2O dilutions at low TP concentrations. Significant interference was detected at high concentrations of glucose (>267 mg/dL) and triglycerides (>580 mg/dL). Current laboratory reference intervals for TP were verified.ConclusionsPerformance characteristics of this digital refractometer were validated in a clinical laboratory setting. Biuret method remains the preferred assay for TP measurement in routine clinical analyses.

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Section: Discussionsupporting

confidence: 76%

Section: Discussionmentioning

confidence: 94%

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Clinical performance evaluation of total protein measurement by digital refractometry and characterization of non-protein solute interferences

Hunsaker

Wyness

Snow

et al. 2016

Practical Laboratory Medicine

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“…The supernatant contained both HDL and sd-LDL particles, whose density fell between 1.044 and 1.063 g/mL. The concentration of supernatant-derived HDL-C and total cholesterol were determined using a Cobas 8000 modular analyzer (Roche ® Diagnostics) [65]. Since the supernatant only contained cholesterol from HDL and sd-LDL lipoproteins, the sd-LDL-C concentration was estimated by subtracting the HDL-C from the concentration of total cholesterol.…”

Section: Advanced Lipoprotein Precipitation Assaysmentioning

confidence: 99%

The Impact of the Mediterranean Diet and Lifestyle Intervention on Lipoprotein Subclass Profiles among Metabolic Syndrome Patients: Findings of a Randomized Controlled Trial

Candás-Estébanez,

Fernández-Cidón,

Corbella

et al. 2024

IJMS

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Metabolic syndrome (MetS) is associated with alterations of lipoprotein structure and function that can be characterized with advanced lipoprotein testing (ADLT). The effect of the Mediterranean diet (MedDiet) and weight loss on the lipoprotein subclass profile has been scarcely studied. Within the PREDIMED-Plus randomized controlled trial, a sub-study conducted at Bellvitge Hospital recruiting center evaluated the effects of a weight loss program based on an energy-reduced MedDiet (er-MedDiet) and physical activity (PA) promotion (intervention group) compared with energy-unrestricted MedDiet recommendations (control group) on ADLT-assessed lipoprotein subclasses. 202 patients with MetS (n = 107, intervention; n = 95, control) were included. Lipid profiles were determined, and ADLT was performed at baseline, 6, and 12 months. Linear mixed models were used to assess the effects of intervention on lipoprotein profiles. Compared to the control diet, at 12 months, the er-MedDiet+PA resulted in a significant additional 4.2 kg of body weight loss, a decrease in body mass index by 1.4 kg/m2, reduction in waist circumference by 2.2 cm, decreased triglycerides, LDL-cholesterol and non-HDL-cholesterol, and increased HDL-cholesterol. In er-MedDiet+PA participants, ADLT revealed a decrease in small dense-LDL-cholesterol (sd-LDL-C), intermediate-density lipoproteins, VLDL-triglyceride, and HDL-Triglyceride, and an increase in large LDL and large VLDL particles. In conclusion, compared to an ad libitum MedDiet (control group), er-MedDiet+PA decreased plasma triglycerides and the triglyceride content in HDL and VLDL particles, decreased sd-LDL-C, and increased large LDL particles, indicating beneficial changes against cardiovascular disease.

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Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals

Akbas

Schryver

Algeciras‐Schimnich

et al. 2014

Clinical Biochemistry

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Analytical Performance Specifications

Cited by 9 publications

References 14 publications

Clinical performance evaluation of total protein measurement by digital refractometry and characterization of non-protein solute interferences

Clinical performance evaluation of total protein measurement by digital refractometry and characterization of non-protein solute interferences

The Impact of the Mediterranean Diet and Lifestyle Intervention on Lipoprotein Subclass Profiles among Metabolic Syndrome Patients: Findings of a Randomized Controlled Trial

Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals

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