CAEv–A program for computer aided evaluation

Bablok, W; Barembruch, R.; Stockmann, Wolfgang; Bräuer, Paula; Graber, P.; Michel, Raphaël; Vondersehmitt, D.

doi:10.1155/s1463924691000317

Cited by 18 publications

(10 citation statements)

References 2 publications

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“…The study was supported by CAEv, a program for "Computer Aided Evaluation" [13], which allows the definition of protocols, the sample and test requests for online (and offline) data capture, and statistical evaluation of the results. Data were validated by the evaluators and transferred electronically to the central study organisation at Roche Diagnostics in Mannheim, Germany.…”

Section: Methodsmentioning

confidence: 99%

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

Horowitz

Zaman

Blanckaert

et al. 2005

Journal of Analytical Methods in Chemistry

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MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.

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Section: Methodsmentioning

confidence: 99%

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

Horowitz

Zaman

Blanckaert

et al. 2005

Journal of Analytical Methods in Chemistry

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“…The approaches followed for data analysis and the reports for participants have been described in detail elsewhere (7,8). At the present time, about 200 Italian laboratories participate in this scheme for the CEA assay; 100 laboratories (75 Italian and 25 from other European countries) participate in the survey for the assay of CA 19-9, CA 125 and CA 15-3.…”

Section: Cnr Eqa Schemementioning

confidence: 99%

Tehnical reports

1992

Clinical Chemistry and Laboratory Medicine

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The analytical performance of the automated Enzymun Test System ES 300 and ES 600 (developed by Boehringer Mannheim) for the assay of the tumour markers CEA, CA 19-9, CA 125, and CA 15-3, was assessed from data collected in a multicentre collaborative study in which eleven laboratories were involved. Results of the 1990 cycle of the external quality assessment (EQA) scheme for tumour markers, supported by the Italian National Research Council (CNR), were also used in this evaluation. The within-assay and betweenassay precision was found to be 2.0 and 4.3 CV% for CEA, 2.9 and 6.8 CV% for CA 19-9, 3.6 and 9.4 CV% for CA 125, 2.9 and 6.0 CV% for CA 15-3. The between-lab variability of the four tumour markers on ES 300 and ES 600 systems was 9.4, 10.6, 11.9, 9.2 CV% for CEA, CA 19-9, CA 125 and CA 15-3 respectively. These values were comparable to or better than those obtained with the most precise manual kits used by laboratories participating in the 1990 EQA cycle. The agreement between the results from the Enzymun Test and those obtained using other method/kits was evaluated by assaying control samples previously circulated either in the CNR EQA or in the German EQA. The regression analysis indicates that for CEA, CA 125 and CA 15-3 assays the results produced by ES 300 and ES 600 are in good agreement with the consensus means of the EQAs; CA 19-9 results exhibit a worse correlation and are generally lower than the consensus mean. The linearity of the assays for the four tumour markers was checked by dilution tests performed by participants in the collaborative study; in all cases the dilution of the sample did not affect the values obtained. u CA 19-9, CA 125, and CA 15-3, we conducted a ) This work has been partially supported by: Progetto Final-. . " , . , . , . , ι , , izzato Biotecnologie e Biostrumentazione del Consiglio Na-multicentre collaborative study in which eleven labzionale delle Ricerche (C.N.R.) oratories paritipated. The results from this study were Eur.

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“…Processing and analysis of such large data volumes was made possible using computer aided evaluation (CAEv) software. This facilitated the definition of protocols, sample and test requests for on-line/off-line data capture, and the statistical evaluation of the results (8).…”

Section: Introductionmentioning

confidence: 99%

Multicentre performance evaluation of the E170 Module for MODULAR ANALYTICS

Bieglmayer¹,

Chan

Sokoll

et al. 2004

Clinical Chemistry and Laboratory Medicine (CCLM)

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The E170 module was evaluated at 13 sites in an international multicentre study. The objective of the study was to assess the analytical performance of 49 analytes, and to collect feedback on the system's reliability and practicability. The typical, within-run coefficients of variation (CVs) for most of the quantitative assays ranged between 1 and 2% while a range of 2-4% was achieved with the infectious disease methods. Total precision CVs were found to be within the manufacturer's expected performance ranges, demonstrating good concordance of the system's *Corresponding author: Dr. Albert Kunst, Roche Diagnostics GmbH, Centralized Diagnostics Clinical Trials, Sandhofer Straße 116, 68305 Mannheim, Germany Fax: q49-621-759-4175, E-mail: albert.kunst@roche.com measuring channels and a high reproducibility during the 2-4-week trial period. The functional sensitivity of 11 selected assays met the clinical requirements (e.g., thyreotroponin (TSH) 0.008 mU/l, troponin T 0.02 mg/ l, total prostate-specific antigen (PSA) 0.03 mg/l). The E170 showed no drift during an 8-hour period and no relevant reagent carryover. Accuracy was confirmed by ring trial experiments and method comparisons vs. Elecsys ᮋ 2010. The reliability and practicability of the system's hardware and software met with, or even exceeded, the evaluator's requirements. Workflow studies showed that E170 can cover the combined workload of various routine analysers in a variety of laboratory environment. Throughput and sample processing time requirements were achieved while personnel 'hands-on-time' could be reduced.

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CAEv–A program for computer aided evaluation

Cited by 18 publications

References 2 publications

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

Tehnical reports

Multicentre performance evaluation of the E170 Module for MODULAR ANALYTICS

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