| Course Type | Elective Course |
|---|
| Course Level | Master's Degree With Thesis |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 10 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- 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.
- Know how to analyze, evaluate and interpret the diagnostic assay validation results using informatics technologies and statistical analysis methods.
- 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 |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | Biostatistics |
|---|
| Course Description | 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 |
Analytical specificity |
|
9th Week |
Linear range, regression analysis |
|
10th Week |
Precision/reproducibility |
|
11th Week |
Coefficient of variation |
|
12th Week |
Robustness, accuracy |
|
13th Week |
Diagnostic sensitivity |
|
14th Week |
Diagnostic specificity |
|
| Recommended 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 Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
2 |
2 |
| Preparation for Quiz |
|
|
|
| Individual or group work |
|
|
|
| Preparation for Final exam |
1 |
95 |
95 |
| Course hours |
14 |
3 |
42 |
| Preparation for Midterm exam |
1 |
90 |
90 |
| Laboratory (including preparation) |
|
|
|
| Final exam |
1 |
2 |
2 |
| Homework |
|
|
|
| Project |
1 |
70 |
70 |
| Total Work Load | 301 |
| Total Work Load / 30 (h) | 10.03 |
| ECTS Credit of the Course | 10 |
|
| Language of Instruction | English |
|---|
| Work Placement(s) | No |
|---|
