TYPE OF COURSE UNIT	Elective Course
LEVEL OF COURSE UNIT	Master's Degree With Thesis
YEAR OF STUDY	-
SEMESTER	-
NUMBER OF ECTS CREDITS ALLOCATED	10
NAME OF LECTURER(S)	-
LEARNING OUTCOMES OF THE COURSE UNIT	At the end of this course, the students; 1) Know the methods related to diagnostic assay development and validation, and know how to prepare an experimental and statistical execution plan needed to carry out a diagnostic assay validation study. 2) Know how to analyze, evaluate and interpret the diagnostic assay validation results using informatics technologies and statistical analysis methods. 3) Know how to prepare the diagnostic assay validation results in report or presentation format using informatics technologies and statistical analysis methods.
MODE OF DELIVERY	Face to face
PRE-REQUISITES OF THE COURSE	No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT	Biostatistics
COURSE DEFINITION	In this course, referring to adsorption isotherms, diagnostic assay development is introduced and diagnostic assay validation is explained mentioning cutoff score (threshold), mean 2-standard-deviation method, receiver operating characteristic curve, Youden index, analytical sensitivity (limit of detection), sigmoid dose-response curve, probit analysis, curve fitting, analytical specificity, linear range, regression analysis, precision/reproducibility, coefficient of variation, robustness, accuracy, diagnostic sensitivity, and diagnostic specificity.
COURSE CONTENTS	WEEK TOPICS 1st Week Diagnostic assay development, adsorption isotherms, diagnostic assay validation 2nd Week Cutoff score (threshold) 3rd Week Mean 2-standard-deviation method 4th Week Receiver operating characteristic curve, Youden index 5th Week Analytical sensitivity (limit of detection) 6th Week Sigmoid dose-response curve 7th Week Probit analysis, curve fitting 8th Week Midterm Exam 9th Week Analytical specificity 10th Week Linear range, regression analysis 11th Week Precision/reproducibility, coefficient of variation 12th Week Robustness, accuracy 13th Week Diagnostic sensitivity 14th Week Diagnostic specificity
RECOMENDED OR REQUIRED READING	Jan S. Krouwer, 2002, Assay Development and Evaluation: A Manufacturer's Perspective, American Association for Clinical Chemistry Press
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS	Lecture,Discussion,Questions/Answers,Case Study,Project,Report Preparation,Presentation
ASSESSMENT METHODS AND CRITERIA	Quantity Percentage(%) Mid-term 1 35 Project 1 25 Total(%) 60 Contribution of In-term Studies to Overall Grade(%) 60 Contribution of Final Examination to Overall Grade(%) 40 Total(%) 100
ECTS WORKLOAD	Activities Number Hours Workload Midterm exam 1 2 2 Preparation for Quiz Individual or group work Preparation for Final exam 1 100 100 Course hours 13 3 39 Preparation for Midterm exam 1 90 90 Laboratory (including preparation) Final exam 1 2 2 Homework Project 1 70 70 Total Workload 303 Total Workload / 30 10,1 ECTS Credits of the Course 10
LANGUAGE OF INSTRUCTION	English
WORK PLACEMENT(S)	No