While LIMS validation is commonly believed to be a United States FDA-mandated practice, it is sometimes not understood that countries outside of the United States, hoping to market products within the U.S. are also required to validate their systems. Wayne, Pennsylvania, USA—The Clinical and Laboratory Standards Institute has published Validation and Verification of Multiplex Nucleic Acid Assays —MM17. ... • Clinical and Laboratory Standards Institute 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. 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. To this end method validation and quality control data are evaluated automatically and relevant results color-coded for easy recognition. Diagnostic Methods in Clinical Laboratory Accredited by ISO 15189 213 A validation process like any other requires a series of planning, execution and control to ensure that the results come to fruition. 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. Download free 30-day trial now! The actual philosophy and method of performing instrument validation are described below using several performance items as examples. The clear layout of individual elements, combined with the comprehensive integrated help file, allows for intuitive handling at a fair price. This document was primarily developed for isolate sequencings, but included are other elements to consider for broader intended use and additional specimen types. It is used mainly for method comparisons. Easily calculate measurement uncertainty, as required by ISO 15189 / 17025, using the Nordtest or DEV-A04 method. Other Services Data Migration SOP Writing Process Automation Mock Audits. What is Method Validation? ASM Clinical Microbiology Procedures Handbook, 3rd edition Cumitech 31A: Verification and Validation of Procedures in the Clinical Microbiology Laboratory CLSI M52-P: Validation and Verification of ID and AST Systems (not yet published) Definitions (as used by CLIA / CLSI) Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne PA 19087-1898 USA, 2010. You might have heard Microsoft Excel isn't up to the job of statistical analysis. procedures. More advanced procedures like Deming regression and Passing-Bablok tell you the bias between methods, how medical decision points may be affected, and let you test if bias meets performance requirements. Chromatographic method validation is a critical step in many types of laboratories, whether your industry is pharmaceutical, food safety, chemical, or environmental. of method validation within their existing internal quality assurance programmes. The USP goes on to state that Method Validation typically evaluates the following analytical characteristics of a method … a. 9. What's New. A: I began conducting analytical method validation in the electronics chemical industry under an ISO quality system, and so many of those validation fundamentals readily transferred to validation under International Conference on Harmonization [ICH] guidance ICH Q2. Sum, Mean, Variance, SD, CV%, Skewness, Kurtosis, Dot plot – jittered, aligned, spread points and vary point symbol/color, Skeletal box plot, Tukey outlier box plot, Quantile box plot, Mean error bar plot, Mean confidence diamond plot, CDF plot with optional Kolmogorov-Smirnov confidence band, Normal Q-Q plot with optional Lilliefors confidence band, Shapiro-Wilk, Anderson-Darling, and Kolmogorov-Smirnov tests for normality, Mean estimate with t-based or Z-based confidence interval, Median with Thompson-Savur confidence interval, Hodges-Lehmann pseudo-median with Tukey confidence interval, Variance with X2-based confidence interval, Frequency table – frequency, cumulative frequency, relative frequency, cumulative relative frequency, Frequency bar plot with optional cumulative frequency line, Pearson X2 and Likelihood ratio G2 test for multinomial proportions, Proportion with Clopper-Pearson exact or Wilson score confidence interval, Side-by-side dot plots, mean plots, box plots by group, Z test for difference in means with known population SDs, Student’s independent samples t-test for difference between means, Welch’s t-test for difference between means with unequal variances, Wilcoxon-Mann-Whitney test for difference between means/medians, 1-way between-subjects ANOVA for equality of means, Welch’s ANOVA for equality of means with unequal variances, Kruskal-Wallis test for equality of mean/medians, Mean difference with t-based, Welch-Satterthwaite t-based, or Z-based confidence interval, Cohen’s and Hedge’s g standardized mean difference with non-central t-based confidence interval, Hodges-Lehmann location shift with Moses confidence interval, Multiple comparisons procedures: Student’s t (individual comparisons), Tukey-Kramer (all pairs), Dunnett (against control), Hsu (with best), Scheffe (all contrasts), Steel (non-parametric against control), Dwass-Steel-Critchlow-Fligner (non-parametric all pairs), Wilcoxon (non-parametric individual comparisons), Mean-Mean scatter plot for multiple comparisons, Bartlett, Levene, and Brown-Forsythe tests for homogeneity of variances, Difference plot with identity line and optional histogram of differences, Z-test for difference in means with known population SDs, Student’s paired samples t-test for difference between means, Wilcoxon signed ranks test for difference between means/medians, 1-way within-subject ANOVA for equality of means, Mean difference with t-based or Z-based confidence interval, Median difference with Thompson-Savur confidence interval, Hodges-Lehmann location shift with Tukey confidence interval, Pearson X2 test for independence / equality of proportions, Likelihood ratio G2 test for independence, Mosaic plot for association with color by category or residual, McNemar-Mosteller exact test for symmetry / marginal homogeneity, Score Z test for difference between proportions, Advanced models with simple, crossed, polynomial and factorial terms, with categorical explanatory variables coded as dummy variables, Transform X and Y variable in simple regression, Parameter estimates – beta, confidence intervals, VIF, standardized beta, Scatter plot with fit line and optional confidence bands, Main effect and interaction plots for categorical variables, Multiple comparisons of effect means: Student’s t (individual comparisons), Tukey-Kramer (all pairs), Dunnett (against control), Hsu (with best), Scheffe (all contrasts), F-test for lack of fit test for simple regression models, Save model variables back to the dataset: Fitted Y, Residuals, Standardized Residuals, Studentized Residuals, Leverage, Cook's Influence, Correlation matrix with color map on coefficients, Pearson r correlation coefficient with Fisher’s Z confidence interval, Spearman rs correlation coefficient with Fisher’s Z confidence interval, Kendall tau correlation coefficient with Samara-Randles confidence interval, Coefficient matrix with color map to reveal relationships, Classic Gabriel bi-plot with variables as vectors and observations as points, Gower-Hand bi-plot with variables and observations as points, Correlation mono-plot to show relationship between variables, Factor pattern / structure matrices with color map to reveal structure, 12 factor orthogonal/oblique rotations including Varimax, Oblimin, MSA (Measurement System Analysis) software, Sensitivity & Specificity analysis software, Statistical Process Control (SPC) statistical software, Excel Statistical Process Control (SPC) add-in, Principal Component analysis addin software, Multiple Regression analysis add-in software, Multiple Linear Regression statistical software, Excel statistical analysis addin software, Microsoft Excel 2007, 2010, 2013, 2016, 2019 and Office 365 (32- and 64-bit), Microsoft Windows Vista, 7, 8, 10, Server 2003, 2008, 2012, & 2016, Compare commutability of samples with prediction intervals, Test equality (no difference) or equivalence (difference within an allowable difference) at decision levels, Precision (SD or CV) and precision plots for each method, Proportion in positive agreement / negative agreement with Clopper-Pearson exact or Wilson score confidence intervals, Kappa and Weighted Kappa for chance-corrected agreement with Wald Z confidence interval, Generalized ESD outlier identification (Grubb’s test for more than one outlier), Difference plot of bias against assigned values with allowable bias bands, Test equality (no bias) or equivalence (bias within allowable bias), Weighted models for non-constant SD across the measuring interval, Adjust measuring interval to find linear range, Difference between linear and nonlinear fit with Hsieh-Liu confidence intervals, Test equality (no difference) or equivalence (difference within allowable nonlinearity), Difference plot of difference against assigned values with allowable nonlinearity band, Supports Emancipator-Kroll linearity and CLSI, Precision as variance, SD, or CV% with Exact, Satterthwaite, and MLS confidence, Abbreviated reproducibility/repeatability, and detailed intermediate precision components, Frequency density histogram of detection capability, LoB, and LoD, Partition by factor(s) for separate analysis of groups, Binomial test for proportion inside reference interval, Diagnostic performance for 1 test, up to 10 paired tests, or up to 10 independent tests/groups, Number of true positives (TP), true negatives (TN), false positives (FP), and false negatives (FN), Bi-histogram and dot-plot of positive/negative outcomes, Wilcoxon-Mann-Whitney area under curve with DeLong-DeLong-Clarke-Pearson confidence interval, Diagnostic performance for 1 test, 2 paired tests, or 2 independent tests/groups, Sensitivity/Specificity with Clopper-Pearson exact or Wilson score confidence interval, Likelihood ratios with Miettinen-Nurminen score confidence interval, Predictive values with Mercado-Wald logit confidence interval, Difference between sensitivity/specificity with Newcombe or Tango score confidence intervals, McNemar-Mosteller exact, Fisher exact, and Score Z test for equality of sensitivity/specificity, Proportion difference (risk difference) with Newcombe score or Tango score confidence interval, Odds ratio with Binomial exact or Wilson score confidence interval, Proportion difference (risk difference) with Miettinen-Nurminen score, Newcombe score, or Tango score confidence interval, Proportion ratio (risk ratio) with Miettinen-Nurminen score or Newcombe confidence interval, Odds ratio with Hypergeometric exact or Miettinen-Nurminen score confidence interval, Vary points by color of based on a factor, Cronbach’s alpha (standardized and unstandardized). Reference intervals are essential for clinicians to interpret results and make a diagnosis. Laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) use rigorously validated methods and must substantiate that validation … Results from method validation can be used to judge the quality, reliability and consistency of analytical results. IV. Clinical Trials Custom Databases Database Testing Statistical Analysis Statistical Reporting. ANALYTICAL VALIDATION/VERIFICATION Laboratories are required to perform analytical validation or verification of each nonwaived test, method, or instrument system before use in patient testing, regardless of when it was first introduced by the laboratory, including instruments of the same make and model and temporary replacement (loaner) instruments. And if you get stuck we’re here for extra help - aiming to answer your queries within 24 hours. CLSI’s Clinical Laboratory Method Validation and Verification Solution Package focuses on such topics as interference, linearity, reference intervals, trueness, and precision, including related troubleshooting. • Clinical significance - leads to accurate medical decisions • Required by CLIA*, CAP, and The Joint Commission (*Clinical Laboratory Improvements Amendments of 1988) • Pass proficiency testing • Improvements over existing methodology • Assay validation requirements vary: Non-FDA approved > FDA approved > Waived tests Regardless of the organization, certain roles and responsibilities are generally applicable. All your data and results are kept in Excel workbooks, making it easy to collaborate and share them with colleagues, and meaning there's no locked-in file format. Laboratory Supervisor. The following is a review of how one educational program has incorporated the concepts of method validation into . 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. 21 CFR Part 11 Part 11 Training Part 11 Auditing Compliance Testing Software Assesments . In summary, the program is a valuable help, which we would not like to miss anymore. With the widest range of methods available in any software package, the ability to partition the intervals by factors such as sex, age, ethnicity, Analyse-it makes it easy to establish reference ranges or transfer them to a new measurement procedure. Analyze method comparison data with a Passing-Bablok regression analysis, including residual- and CUSUM plots. We use Abacus for analysis of internal, as well as client data. (v. 1.40.36.05), Qualitative - Known Diagnosis (CLSI EP12-A), Qualitative - Unknown Diagnosis (CLSI EP12-A), Limit of Quantitation - LoQ (CLSI EP17-A), Interference - Variable Conc. 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". The Association of Public Health Laboratoriesiv assembled There is a need to standardize how method validation is performed and evaluated across the different laboratories in Nova Scotia, as well as to ensure that clinical laboratory performance is comparable across these sites. After completing his medical studies in Pretoria/South Africa, Dr. Pum decided to specialize in Chemical Pathology. The method is typed and formatted into a written Standard Operating Procedure (SOP) document and assigned an identification number. However, it should be noted that the scope of GLP is designed System requirements are modest (PC with a 486 CPU, 8 MB RAM, and 10 MB hard drive space); the … This guide was first issued in 1998, and has over the years been one of the … Laboratory safety wear will include a lab coat and safety glasses. It’s essential to ensure the performance characteristics (precision, trueness, linearity, interferences, detection capability) of a measurement procedure meet the requirements for intended use. Measurement systems analysis (MSA) lets you determine all these important performance characteristics in one analysis. Certain IQ documentation would also apply to a qualified instrument that has been transported to another location or is being rein… Analytical Method Validation During Product Development CASSS CMC Strategy Forum 2018 Jacek Cieslak CDER/OPQ/OBP . CLSI document EP09-A2-IR (ISBN 1-56238-731-6). Telefon We provide your lab with the information needed to comply and keep up-to-date with the latest best practice guidelines and laboratory accreditation requirements. This procedure provides general guidance for approaching validation of Next Generation Sequencing (NGS) laboratory methods that establishes and documents the performance specifications of a test method. Mass spectrometry in the clinical laboratory: general principles and guidance; proposed guideline. "-Laura Araujo, Vice President, Quality, 4G Clinical. That's why we included extensive support for 11 CLSI protocols. The graphical representations are always well received at inspections. His experience in the field, combined with his skills in software-programming, enabled him to to find unique solutions in this area. zSubmit validation data and summary to Network Lab for approval. All the features from the Analyse-it Standard Edition are included so you can improve processes and The plan shall include the instrumental method(s) and sample preparation technique(s) to be used for a specific method. Wavelength Accuracy . Manufacturers (IVD companies) must establish performance during product development to feedback into the development process, for FDA 510k submissions and product marketing, and to support customers in the field. The validation procedure was based on several Clinical and Laboratory Standards Institute (CLSI) protocols, with the details given below in the Materials and Methods section. Purpose. Fig. Bland-Altman lets you see the agreement between methods and what effect the differences between methods might have on clinical interpretation. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition (Interim Revision). Planning: x Definition responsible for perfor ming the validation process. What's more, validation tests are run automatically after every change to the software so you can be confident We are very happy with Abacus. Proper validation and testing by the vendor should ensure the sponsor validation is simply a final check that everything is in place. This is in large part due to the absence of division specific clinical expertise in most lab sites outside of Central Zone. FDA, 2013. Additional assignments Goals Session Topic 2 Data analysis exercise Evaluate raw data using computer software. 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. 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. Clinical samples should be used to determine the clinical accuracy, clinical sensitivity, and clinical specificity. Planning: Definition responsible for performing the validation process. 1. Shortly thereafter he took on the position of Laboratory Director / Associate Vice President MRL Europe / Chief Scientific Officer worldwide operations. Abacus offers a variety of possibilites for method-validations (quantitative, qualitative etc. Abacus 2.0 adds 54 statistical modules to MS Excel's functions. the statistics are correct. We've conducted thousands of tests to put Analyse-it through its paces. Supports singlicate, duplicate, and replicate measurements, Reduce measuring interval to linear range, or partition into multiple intervals with different relationships (e.g. performing the testing, method validation will always be an integral part of the clinical laboratory and an essential skill for students to obtain in their educational programs. It also includes good graphical presentations and the possibility to add comments to reports. c. All laboratory method validation documentation is kept on file in the laboratory This consensus document presents the suggested guidelines developed by the Laboratory Technology Committee (LTC) of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for development, validation, and modification (methods comparability) of real-time PCR (rtPCR) assays. Rated best ROC curve software in Clinical Chemistry March 2003 vol. Validation. Due to its relative ease-of-use, my colleagues manage very well with the program. 49 no. Abacus 2.0 - Powerful Method-Validation, Quality-Control and Statistics Add-In for Microsoft Excel. We appreciate the continuous development of the program and the possibility to have individual solutions integrated. constant / relative differences), Ordinary and Weighted linear regression average bias with confidence intervals, Deming and Weighted Deming regression average bias with Jacknife confidence intervals, Passing Bablok regression average bias with Passing-Bablok or Bootstrap confidence, Predict bias with confidence intervals at important decision levels, Scatter plot, with average bias, average bias confidence bands, identity line, and allowable difference band, Difference/relative difference/ratio plot against X or mean of methods with allowable difference band and histogram of differences, Bland-Altman limits of agreement with mean, median, and linear fit bias, Mountain plot with allowable difference band, Residual plot, raw and standardized, with histogram of residuals, CUSUM linearity plot and Kolmogorov-Smirnov linearity test, Unified analysis to examine performance characteristics of a method (bias, precision, linearity, interferences, and detection limits), Flexible balanced and unbalanced experiment design: up to 3 random nested factors, Variance function fit: 4 parameter function with turning point, Fit models: linear, polynomial (up to 5th order), forward stepwise polynomial, and best (2nd or 3rd) polynomial regression, Terminology depending on conditions of measurement: total / within, reproducibility / repeatability, or laboratory / repeatability, Variance function fit: constant variance, constant CV, mixed constant / proportional variance, and Sadler 3 parameter power, and 3 parameter alternative power functions, Limit of blank (LoB): of a blank material (parametric SD or non-parametric quantile), or using precision profile variance function, Limit of detection (LoD): pooled SD of non-blank materials, or using precision profile variance function, Limit of detection (LoD) using Probit regression, Limit of quantitation (LoQ) using precision profile variance function, Frequency distribution histogram with normal overlay and reference limits, Transform reference values with reciprocal, log, square and cube root, Box-Cox, Shapiro-Wilk or Anderson-Darling normality test of reference distribution, Robust bi-weight quantile for symmetric and skewed small samples, Various quantile computation methods (N+1)p, Np+1/2, and (N+1/3)p+1/3, Transfer existing reference interval using method comparison regression function, ROC curve plot: Sensitivity (TPF) vs 1-Specificity (FPF) with no discrimination line, Z test of area under curve is better than chance decision, Compare DeLong-DeLong-Clarke-Pearson difference in area under curves and test for equality (no difference), equivalence (difference negligible), or non-inferiority (not unacceptably worse than a standard test), Decision plot of accuracy over all possible decision thresholds: Sensitivity vs Specificity, Likelihood ratios, Predictive values, or Cost, Find optimal decision threshold based on cost of diagnosis/misdiagnosis. Where can I find more detailed protocols and statistical guidelines for method validation experiments? Reports were used for internal, as well as external audits (inspection by the Occupational Safety and Health Inspectorate) and accepted in all instances. It provides recommendations on how you, the applicant, can submit analytical . And the results to prove it? products by identifying solutions using hypothesis tests and model fitting techniques. ), allowing us to use it for all of our test systems. These suggested guidelines are presented with reference to the World Organisation for Animal … Method validation in clinical chemistry follows the established standards and procedures accepted by all disciplines of chemical metrology. A self-paced online learning program for clinical laboratorians who have some prior training in lab statistics. Samples and test solutions containing these compounds will be handled, stored, and disposed in accordance with applicable (your company) standard operating procedures, and all applicable state and federal regulations. There are some aspects of GLP that will be applicable to clinical sample analysis. Reproducibility was measured by testing replicate tissue sections from 43 FFPE breast tumor blocks across 3 sites following independent pathology review at each site. This overview focuses on the course RESPONSIBILITIES 3.1 Responsibilities for validating analytical methods within an ana-lytical laboratory vary from organization to organization. Analyse-it is developed for and is in use at thousands of ISO/IEC 17025 accredited testing and calibration laboratories, ISO 15189 accredited medical laboratories, CLIA '88 regulated medical laboratories, and IVD manufacturers for development, support, product labeling and FDA 510(k) submissions. Validation in the Analytical Laboratory Prove suitability for intended use hardware software System suitability testing and routine quality control (QC) Equipment qualification (components and systems) Analysis method analysis report IQ/OQ PQ Reviews • Primary • Secondary CLSI. 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. We also use the software for quality control purposes in our nephrology laboratory for the evaluation and documentation of mandatory quality control testing. Festnetz: +49 (012345) 6578679 3 Outline 1. In fact, there is an informal cooperation between the U.S. FDA and its Chinese counterpart, the Chinese FDA (or, CFDA) to ensure system conformance. Laboratory validation of a clinical metagenomic sequencing assay for pathogen detection in cerebrospinal fluid Steve Miller,1,2,10 Samia N. Naccache,1,2,3,10 Erik Samayoa,1 Kevin Messacar,4 Shaun Arevalo,1,2 Scot Federman,1,2 Doug Stryke,1,2 Elizabeth Pham,1 Becky Fung,1 William J. Bolosky,5 Danielle Ingebrigtsen,1 Walter Lorizio,1 Sandra M. Paff,1 John A. Leake,6 Rick Pesano,6 Roberta … Materials and Methods. Method Validation Seminar June 06 © 2006 LGC Limited 4 Method performance parameters Providing evidence that the method produces results that are fit-for-purpose They may, for instance, be used to assign validation acceptance criteria. The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics: Second edition (2014) Quick links: Overview of the guide; Downloads; Citing the guide ; Supplementary guidance on method validation topics; Providing comments and feedback; Previous versions; Introduction. From the beginning of the project to completion, using one application saves me probably a day's worth of time. Kontaktieren Sie uns über das Kontaktformular, Professional Data Analysis according to DIN EN ISO 15189, DIN/IEC 17025, CLSI and CAP, 54 modules for method validation, quality control and general statistical functions in one program, Meets requirements of international accreditation agencies following ISO 15189 / 17025 standards for clinical laboratories, Meets "College of American Pathologists" requirements for method-validations in the clinical laboratory, Meets all current requirements of the German Federal Medical Council for quality assurance in the clinical laboratory, Contains all relevant CLSI Evaluation Protocols for simple everyday implementation, Implements current guidelines from CLSI, CAP, ISO 15189, ISO 17025, RiliBÄK, DAkkS and EMA (European Medicines Agency), Validated according to GAMP-5 ("Good Automated Manufacturing Practice") and evaluated for 21 CFR Part 11 conformity. The validation of a qualitative method requires much lesser effort, than the validation of a quantitative method. That's right. The new SOP will be added to the laboratory Master List. Instead, Analyse-it handles all of the calculations internally, using reliable algorithms and IEEE 754 double laboratories that perform the analysis or evaluation of clinical trial samples, some clinical laboratories have applied the principles of Good Laboratory Practice (GLP). Methods, that have been validated by the manufacturer must, at the very least, undergo a verification of their precision and bias. 1 Emission Lines of a Deuterium Lamp. Explore how the test differentiates between positive and negative cases and explore optimum decision thresholds factoring in the costs of misdiagnosis. 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. floating point precision. Of 21 positive surplus clinical specimens included in this validation, we were able to species identify 14 (66.7%) as follows: A. castellanii (n = 6), A. hatchetti (n = 2), A. polyphaga (n = 2), A. lenticulata (n = 2), A. quina (n = 1), and A. griffini (n = 1). Guidelines for Submitting Samples and Analytical Data for Methods . CAP for verification and validation of microbiological procedures. We offer comprehensive webinar-based training for method-validations, quality assurance and general statistics. This presentation reflects the views of the author and should not be used in place of regulations, published FDA guidances or discussions with the Agency. FDA Disclaimer . Skip to content. Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. Molecular Biology, Clinical Laboratory, Virga Jesse Hospital, Hasselt, Belgium Real-time polymerase chain reaction (PCR) is a frequently used technique in molecular diagnostics. 3.2. There's virtually no learning curve, and the intuitive user interface and logical task-based workflow makes sense to The Transplant Center Cologne has been successfully using the Excel-Adin "Abacus" routinely for a number of years. 433-439, The third is a transfer validation protocol to be used when methods are transferred between laboratories. When introducing a new measurement procedure you want to see how it stacks-up against your existing procedure or evaluate its performance against the gold-standard. Manufacturer must, at the University of Graz between positive and negative cases and optimum! 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