Professional Data Analysis according to DIN EN ISO 15189, DIN/IEC 17025, CLSI and CAP
Abacus 2.0 - Powerful Excel Add-In for Method Validations and Quality Control in the Clinical Laboratory

Abacus 2.0 - Powerful Method-Validation, Quality-Control and Statistics Add-In for Microsoft Excel

The simple, fast and efficient solution for all your statistical requirements in the laboratory!

Comprehensive Protocols 54 modules for method validation, quality control and general statistical functions in one program
Accreditation requirements Meets requirements of international accreditation agencies following ISO 15189 / 17025 standards for clinical laboratories
CAP Requirements Meets "College of American Pathologists" requirements for method-validations in the clinical laboratory
Quality Control Meets all current requirements of the German Federal Medical Council for quality assurance in the clinical laboratory
CLSI EP-Protocols Contains all relevant CLSI Evaluation Protocols for simple everyday implementation
Scientifically founded Implements current guidelines from CLSI, CAP, ISO 15189, ISO 17025, RiliBÄK, DAkkS and EMA (European Medicines Agency)
Use in clinical trials Validated according to GAMP-5 ("Good Automated Manufacturing Practice") and evaluated for 21 CFR Part 11 conformity
Integration with MS Excel No need to familiarize yourself with a new program: Work with Abacus 2.0 in the familiar Excel environment.
Comprehensive Training We 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. 

Simplifying statistical analyses with Abacus 2.0.
Method-validation statistics required by DIN EN ISO 15189, DIN EN ISO 17025. Bias, Precision, LoD, LoQ, linearity and many more.

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.

Intuitive interface, simple handling, reliable results

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.

Intuitive and simple interface. Seamless integration with MS Excel.
GAMP-5 validated statistical algorithms, verified for CFR Part 11 compliance.

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 Test Modules:

Precision & Bias
  • 20 x 1 Model
  • 5 x 4 Model
  • 20 x 1 plus 5 x 3 Model
  • n x 1 Model
  • CLSI EP-15A3
Precision
  • Simple
  • 1-Run (CLSI EP5-A2)
  • 2-Runs (CLSI EP5-A2)
Method Comparisons
  • Method Comparison (CLSI EP09-A3)
  • Multi-Instrument Comparison
  • Bland-Altman Plot
  • Semiquantitative Methods
  • Qualitative - Known Diagnosis (CLSI EP12-A)
  • Qualitative - Unknown Diagnosis (CLSI EP12-A)
  • Qualitative -  Three-Way (CLSI EP12-A)
Linearity
  • Linearity (CLSI EP6-A)
  • Linearity / Calibration Verification
Regression
  • Linear (weighted/unweighted)
  • Deming (known/unknown error)
  • Passing Bablok
  • Polynomial (2nd to 6th degree)
Analysis of Variance(ANOVA)
  • ANOVA-One-Way
  • ANOVA-Two-Way
  • Kruskal-Wallis
  • Friedman
Analytical Sensitivity
  • Limit of Detection - LoD  (CLSI EP17-A)
  • Limit of Detection - LoD (DIN32645)
  • Limit of Quantitation - LoQ (CLSI EP17-A)
  • PCR Methods
Analytical Specificity
  • Interference - Fixed Conc. (CLSI EP07-A)
  • Interference - Variable Conc. (CLSI EP07-A)
Quality Control
  • Internal Quality Assurance (RiliBÄK)
  • Intra-Laboratory Error Limits (RiliBÄK)
  • Measurement Uncertainty
  • Inter-Laboratory Comparisons
Descriptive Statistics
  • Box-Whisker Plot
  • Histogram
Correlation
  • Pearson Correlation
  • Spearman Correlation
  • Kendall's Tau
Comparison of Means
  • t-Test (One-Sample)
  • t-Test (Paired Samples)
  • t-Test (Unpaired Samples)
  • Sign-Test (One-Sample Test)
  • Wilcoxon Test
  • Mann-Whitney Test
Contingency Tables
  • Chi-Squared Test (2x2)
  • McNemar Test (2x2)
  • Cochran's Q-Test (kx2)
Reference Range (CLSI C28-A3c)
Stability Testing
Recovery
Carry-Over (normal/simple)
ROC Analysis
Two-Sample F-Test

Screenshots

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.

Marlies Bode & Uta Zinngrebe (Medical Technologists)
Transplant Center Cologne-Mehrheim

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
 

Licenses

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  • 12 months software maintenance
  • E-Mail Support
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  • Multi 5
  • License for 5 PC's
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  • Multi 10
  • License for 10 PC's
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  • 12 months software maintenance
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  • 1 free webinar
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  • Buy
  • Site License
  • Unlimited
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  • 12 months software maintenance
  • E-Mail Support
  • 1 free webinar
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* All prices exclude VAT

 

Prices for perpetual licenses can be found here.

 

Webinars

  • Module 1 - Basic Method Validation
  • 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

Dr. Joachim Pum | © Joachim Pum
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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