Evaluation of the automated coagulation analyzer CS-5100 and its utility in high throughput laboratories
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Franz Ratzinger
Abstract
Background: Automated analyzers are an important component of modern laboratories. As a representative of the newest generation of coagulation analyzers, the CS-5100 features several technical refinements including a pre-analytical assessment unit as well as multi-wavelength optical detection units. Therefore, the CS-5100 is supposed to rapidly and accurately perform a broad panel of coagulation tests. In the current study, the CS-5100 was evaluated regarding its precision and practicability in a clinical laboratory setting.
Methods: The CS-5100 was evaluated regarding its intra- and inter-assay precision using commercially available control samples. Results of patient samples, including hemolytic, icteric and lipemic specimens, measured on the CS-5100 were compared to reference analyzers, which are used in our accredited laboratory.
Results: The coefficients of variation, assessed in the intra- and inter-assay precision analyses were below 5% representatively for most parameters. Results, obtained by the CS-5100 showed predominantly a high comparability to used reference analyzers, with correlation coefficients ranging from 0.857 to 0.990. Only minor ranged systemic or proportional differences were found in Passing-Bablok regression between the CS-5100 and reference analyzers regarding most of the tested parameters. Lipemic samples had a tendency to deteriorate correlation coefficients, but an overall effect of the sample’s triglyceride level could be ruled out. In a routine setting, the analyzer reached a sample throughput rate of 160 tests per hour.
Conclusions: The CS-5100 is able to rapidly and precisely measure patient samples. No considerable influence on test comparability was found for elevated levels of free hemoglobin, bilirubin or triglycerides.
Acknowledgments
We are grateful that Siemens provide required reagents for measuring on the CS-5100.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research support played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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©2014 by Walter de Gruyter Berlin/Boston
Artikel in diesem Heft
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- Editorial
- Colorectal cancer and screening programs: not only analytical issues
- Reviews
- Laboratory diagnostics of inherited platelet disorders
- Reticulated platelets: analytical aspects and clinical utility
- Genetics and Molecular Diagnostics
- Advanced tools for BRCA1/2 mutational screening: comparison between two methods for large genomic rearrangements (LGRs) detection
- General Clinical Chemistry and Laboratory Medicine
- Establishing, harmonizing and analyzing critical values in a large academic health center
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- First fully automated immunoassay for anti-Müllerian hormone
- A multicenter evaluation of dysthyroxinemia in a defined patient cohort
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- Development of a new immunoassay for the detection of ethyl glucuronide (EtG) in meconium: validation with authentic specimens analyzed using LC-MS/MS. Preliminary results
- Optimizing centrifugation of coagulation samples in laboratory automation
- Evaluation of the automated coagulation analyzer CS-5100 and its utility in high throughput laboratories
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- Reference Values
- Faecal haemoglobin concentrations vary with sex and age, but data are not transferable across geography for colorectal cancer screening
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- Enhanced miR-182 transcription is a predictor of poor overall survival in colorectal adenocarcinoma patients
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- Further comments on “Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation”
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- Laboratory automation: how will you select the boarding assays?
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- The novel variant p.Ser465Leu in the PCSK9 gene does not account for the decreased LDLR activity in members of a FH family
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Colorectal cancer and screening programs: not only analytical issues
- Reviews
- Laboratory diagnostics of inherited platelet disorders
- Reticulated platelets: analytical aspects and clinical utility
- Genetics and Molecular Diagnostics
- Advanced tools for BRCA1/2 mutational screening: comparison between two methods for large genomic rearrangements (LGRs) detection
- General Clinical Chemistry and Laboratory Medicine
- Establishing, harmonizing and analyzing critical values in a large academic health center
- Standardization of DiaSorin and Roche automated third generation PTH assays with an International Standard: impact on clinical populations
- First fully automated immunoassay for anti-Müllerian hormone
- A multicenter evaluation of dysthyroxinemia in a defined patient cohort
- New biomarkers in diagnosis of early onset preeclampsia and imminent delivery prognosis
- Soluble Fms-like tyrosine kinase-1 to placental growth factor ratio in mid-pregnancy as a predictor of preterm preeclampsia in asymptomatic pregnant women
- Development of a new immunoassay for the detection of ethyl glucuronide (EtG) in meconium: validation with authentic specimens analyzed using LC-MS/MS. Preliminary results
- Optimizing centrifugation of coagulation samples in laboratory automation
- Evaluation of the automated coagulation analyzer CS-5100 and its utility in high throughput laboratories
- A new sampling device for faecal immunochemical testing: haemoglobin stability is still an open issue
- Reference Values
- Faecal haemoglobin concentrations vary with sex and age, but data are not transferable across geography for colorectal cancer screening
- Cancer Diagnostics
- Enhanced miR-182 transcription is a predictor of poor overall survival in colorectal adenocarcinoma patients
- Importance of promoter methylation of GATA4 and TP53 genes in endometrioid carcinoma of endometrium
- Frequent methylation of HOXA9 gene in tumor tissues and plasma samples from human hepatocellular carcinomas
- Letters to the Editor
- Further comments on “Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation”
- A questionnaire study among nurses: awareness of blood and urine sample collection procedures
- Measurement uncertainty and clinical interpretation of measurement results
- Laboratory automation: how will you select the boarding assays?
- Improvement and evaluation of a 1,2-dioleoylglycerol method for measuring pancreatic lipase catalytic activity in serum
- The novel variant p.Ser465Leu in the PCSK9 gene does not account for the decreased LDLR activity in members of a FH family
- 1,5 Anhydroglucitol serum concentration as a biomarker for screening gestational diabetes in early pregnancy
- A rare condition: IgE type monoclonal gammopathy of undetermined significance
- Laboratory analysis of intraosseous blood: bad to the bone?
