Comprehensive Protocols54 modules for method validation, quality control and general statistical functions in one program
Accreditation requirementsMeets requirements of international accreditation agencies following ISO 15189 / 17025 standards for clinical laboratories
CAP RequirementsMeets "College of American Pathologists" requirements for method-validations in the clinical laboratory
Quality ControlMeets all current requirements of the German Federal Medical Council for quality assurance in the clinical laboratory
CLSI EP-ProtocolsContains all relevant CLSI Evaluation Protocols for simple everyday implementation
Scientifically foundedImplements current guidelines from CLSI, CAP, ISO 15189, ISO 17025, RiliBÄK, DAkkS and EMA (European Medicines Agency)
Use in clinical trialsValidated according to GAMP-5 ("Good Automated Manufacturing Practice") and evaluated for 21 CFR Part 11 conformity
Integration with MS ExcelNo need to familiarize yourself with a new program: Work with Abacus 2.0 in the familiar Excel environment.
Comprehensive TrainingWe offer comprehensive webinar-based training for method-validations, quality assurance and general statistics.
Create powerful, validated statistical analyses in the clinical laboratory
The one-stop solution for all your statistical needs in the laboratory
Abacus 2.0 focuses on the statistical analysis of method validation and quality control data. For this purpose the software expands MS Excel's functions with a total of 54 modules in three categories:
Method Validation: Validation of quantitative, semi-quantitative and qualitative assays in clinical and analytical laboratories
Quality control functions: Includes, among others, estimation of measurement uncertainty according to Nordtest & DEV-A04, as well as summaries of peer-group comparisons
General statistics: Statistical functions for natural and life sciences (simple implementation of complex parametric and non-parametric functions for typical data analysis)
Method validation protocols are based on guidelines that are published by CLSI, CLIA '88, CAP, DIN, ISO 15189, ISO 17025 and EMA (European Medicines Agency). All parametric and non-parametric algorithms and method validation protocols adhere to current recommendations in the literature and have gone through a formal validation process.
Powerful method-validation statistics
According to ISO 15189 and ISO 17025 all analytical devices must be validated prior to implementation in the clinical laboratory. Methods, that have been validated by the manufacturer must, at the very least, undergo a verification of their precision and bias. Creating powerful statistics is easy with Abacus 2.0:
Method comparison: Compare new assays with validated ones by generating method comparison statistics, such as the Bland-Altman plot and Passing-Bablok regression analysis.
Precision & Bias: Use quality control samples to calculate CLSI precision data or perform simple precision evaluations, including trend-testing.
Analytical sensitivity: Calculate the LoD (limit of detection), following CLSI methods or estimate the LoQ(limit of quantitation) by measuring various sample concentrations.
Analytical Specificity: Estimate fixed-concentration drug interference or analyze concentration-dependant interference.
Assay linearity: Find the linear concentration range, using either the CLSI polynomial method or the CAP method for linearity and calibration verification.
Reference intervals: Estimate reference range limits with current methods that are recommended by CLSI and FACB.
Stability testing: Calculate analyte stability to optimize storage times and determine when left-over sample should be discarded.
ROC analysis: Correlate lab results with clinical disease. Find optimal cut-offs to maximize diagnostic sensitivity and specificity of your assay.
Abacus 2.0 was designed with reliability, simplicity and ease-of-use in mind and as a result does not require in-depth statistical knowledge by the user. To this end method validation and quality control data are evaluated automatically and relevant results color-coded for easy recognition.
Seamless integration with Excel: Use the familiar Excel environment for data entry and formatting - no need to familiarize yourself with a new platform.
High degree of automation: Features such as auto-complete, repeat-test function, report updates and automatic result interpretation take the tediousness out of data analysis.
Comprehensive and easy to understand documentation: Abacus 2.0 contains a built-in help file as well example data and example reports for all modules.
Internal databases for acceptance limits: Databases are freely editable and contain acceptance limits for the most common routine clinical chemistry, immunology and hematology parameters. New parameters can be added at any time.
Get started with Abacus 2.0 today and take the headache out of analyzing and summarizing method validation data.
The time-saving quality management tool
Simplify quality management with Abacus 2.0:
Comply with quality requirements: Reports include the name and logo of your institution, a time stamp, the software version number, the test protocol name and signature fields.
Save time: Reports can be printed, signed and filed immediately - no further formatting is required.
Generate confidence in your statistics: All statistical algorithms are validated according to GAMP-5 ("Good Automated Manufacturing Practice“) and verified for CFR Part 11 compliance.
Save time and increase efficiency by standardizing and simplifying the statistical analyses with Abacus 2.0 and focus on the more important everyday-processes in your laboratory.
Abacus 2.0 adds 54 statistical modules to MS Excel's functions. All functions are comprehensively documented in the help file and working examples are available for each module.
Method comparison experiments
Results of bias estimation experiments are presented with a Bland-Altman difference plot and a Passing-Bablok regression plot, which is in line with recommendations from CLSI and international accreditation bodies.
Intuitive dialogs, simple data-entry
Intuitive handling, intelligent design, optimal productivity. Abacus 2.0 works with easy-to-use intuitive dialog forms, which include an auto-complete function, to speed up data-entry.
Reference range calculations
Calculate reference ranges with parametric, non-parametric, robust and bootstrap methods, adhering to CLSI and NACB recommendations. Perform box-cox-, log- or root-transformations and verify manufacturers' reference ranges.
Measurement uncertainty
Easily calculate measurement uncertainty, as required by ISO 15189 / 17025, using the Nordtest or DEV-A04 method.
Precision & Bias according to CLSI
Simple and quick estimation of precision and bias according to CLSI recommendations (CLSI EP15-A3). Have Abacus 2.0 automatically calculate allowable error limits, using the most current algorithms.
Stability estimates
Single or multiple measurements: Abacus 2.0 simplifies the interpretation and interpolation of stability measurement results.
Passing-Bablok Regression
Analyze method comparison data with a Passing-Bablok regression analysis, including residual- and CUSUM plots.
References
Siemens Healthcare
We use Abacus for analysis of internal, as well as client data. Apart from its simple, intuitive handling, the program boasts an impressive amount of statistical functions, that cover much of what can be encountered during the dailiy routine within the laboratory. Moreover it makes allowance for national (RiliBÄK) as well as international standards (CLSI), which is a huge advantage not only for accredited laboratories and laboratories working internationally. On top of that, the package includes a comprehensive help function, which we use, among others, when preparing method validation experiments. In conclusion: Software created by users for users.
Andreas Ullrich, Support Manager
University Hospital Salzburg (SALK)
Our institute acquired Abacus as part of the preparations for the accreditation according to ISO 15189. Our goal was to carry out instrument- and method-comparisons, to establish target values and to perform method-validations (single-run precision, stability testing, linearity testing etc.) or even calculate reference ranges, in a standardized fashion and according to current guidelines. Abacus provided an enormous help with this and today we would not know what we would do without it.
Dr. Janne Cadamuro, Senior Physician, University Institute of Medical and Chemical Laboratory Diagnostics, Salzburg
Provincial Government, Department of Health, Lower Austria
I have been using Abacus ever since my training as a Chemical Pathologist at the University of Graz. It is unsurpassed in its class, especially in terms of ease-of-use, which makes it suitable and highly recommended for every-day-use. Of course there are more comprehensive and more powerful programs available on the market, however these usually require long familiarization periods, resulting in substantially higher costs. From my point of view, I can recommend the tool to anyone, who has to work with medical statistics, especially in the field of clinical chemistry. As a long-standing emergency physician at the University Clinic of Graz, a suitable analogy comes to mind: Not every patient, who requires an emergency physician, also requires a full anaesthetic on-site - usually less is sufficient. This is similar with statistical software.
Dr. Gerhard Höbarth, Public Health Officer
Institute for Laboratory Diagnostics Südharz Clinic Nordhausen gGmbH
We are very happy with Abacus. It is used mainly for method comparisons. Due to its relative ease-of-use, my colleagues manage very well with the program. The graphical representations are always well received at inspections. I am happy, we have this program.
Petra Willomitzer, Quality Manager
Bioscientia Institute for Medical Diagnostics GmbH
We have been using Abacus in all our regional laboratories for a number of years. Owing to its integration into the familiar Excel environment, the software is easy to use, generally resulting in very short familiarization periods, also for staff less adept at statistics. The spectrum of testing protocols and statistical functions, combined with the fact that the program is validated according to current GAMP-5 guidelines, enables virtually unlimited use in all departments, including our Clinical Trials department. Added to this is the standardized presentation of the results with graphs and tables, which have passed all internal and external audits (accreditation, Bureau of Standards, clinical trials sponsors) in our laboratories so far. By implementing this software, we were able to not only save a considerable amount of time, but also to standardize method-validations and various quality control processes in our laboratories. In light of our consistently positive experiences, we can recommend Abacus without reservations.
PD Dr. med. Markus Nauck, CEO and Medical Director
Medical Laboratory Limbach Hannover
Easy-to-use and easy-to-understand software, comprehensive help file. A highly user-friendly software, also for people with limited Excel skills, as much is self-explanatory and calculations are carried out with simple clicks and predefined, but also freely editable criteria with a minimum amount of time-expenditure. Reports were used for internal, as well as external audits (inspection by the Occupational Safety and Health Inspectorate) and accepted in all instances. Although SOP documents must still be maintained for the accreditation, this can be done with considerably less effort. Abacus offers a variety of possibilites for method-validations (quantitative, qualitative etc.), allowing us to use it for all of our test systems. It also includes good graphical presentations and the possibility to add comments to reports. Compared to our previous system, we estimate a time saving of at least 70%, and now have a standardized process for all departments using Abacus.
The Transplant Center Cologne has been successfully using the Excel-Adin "Abacus" routinely for a number of years. We also use the software for quality control purposes in our nephrology laboratory for the evaluation and documentation of mandatory quality control testing. Apart from that the software also offers a multitude of statistical functions, which we use for scientific questions and to validate new methods. The clear layout of individual elements, combined with the comprehensive integrated help file, allows for intuitive handling at a fair price. We appreciate the continuous development of the program and the possibility to have individual solutions integrated. In summary, the program is a valuable help, which we would not like to miss anymore.
OA Dr. med. Wolfgang Arns, Director Transplant Center
Verification of Precision & Bias with CLSI EP15-A3 and 5x4 model
Method comparisons with Passing-Bablok regression and Bland-Altman plots
Multi-instrument comparisons
Comparison of semiquantitative methods
Comparison of qualitative methods
Duration: approx. 3 hours
Price: 850,00 € *
Module 2 - Advanced method validation
Linearity, confirmation of analytical measurement range
Limit of detection / limit of quantitation
Determination of reference ranges
Stability measurements
Carry-over
Duration: approx. 3 hours
Price: 850,00 € *
* All prices exclude VAT
About the author
Joachim Pum, MBChB, MMed, FC Path
After completing his medical studies in Pretoria/South Africa, Dr. Pum decided to specialize in Chemical Pathology. In 2002 he moved to Europe with his family, where he worked for Medical Research Laboratories International (later "PPD Global Central Labs"), a clinical trials laboratory in Brussels/Belgium. In 2003 his specialist degree was accepted by the Royal College of Pathologists in London and he was admitted to the Specialist Register of the General Medical Council. Shortly thereafter he took on the position of Laboratory Director / Associate Vice President MRL Europe / Chief Scientific Officer worldwide operations. In 2006 he decided to move to Germany with his family to join a local laboratory in Jena (Bioscientia), where he currently has the position of Medical Director.
Ever since he began working as a pathologist, he recognized the need for process optimization within the laboratory. His special focus has always been quality assurance and continuous quality improvement. His experience in the field, combined with his skills in software-programming, enabled him to to find unique solutions in this area. Apart from numerous publications he also completed his doctoral thesis on "Establishing a software program for internal quality assurance in the laboratory" in 2012, for which he was awarded "magna cum laude".
His long-standing commitment to quality assurance and quality improvement finally lead to the release of the award-winning software "Abacus 2.0", which is validated according to the GAMP-5 standard since 2015 and is marketed internationally by LABanalytics GmbH.
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