Biotechnologies in molecular diagnostics and fundamental of statistics

A.Y. 2020/2021
9
Max ECTS
84
Overall hours
SSD
BIO/12 MED/01 MED/05 MED/36
Language
Italian
Learning objectives
Acquire knowledge on the organization of the clinical diagnostic laboratory and of principles and methodologies associated to the most advanced diagnostic techniques.
Definition of diagnostic biomarker, characteristics of the main biomarkers currently used in clinical diagnostics of different human diseases and in clinical and traslational research.
Acquire the knowledge related to the basic principles of the main non-invasive diagnostic techniques (RX, TAC, Nuclear-based techniques, Ultrasound, MRI, Optical imaging) and the biomarkers assessed by using these procedures
Understand the potential of different imaging techniques and potential applications in clinical and preclinical / experimental settings.
Acquire basic knowledge on the relationship between scientific and statistical method with reference to the problems of measurement in biomedicine with the basics of the planning of experiments.
Expected learning outcomes
To know the limits and applicability of the different methods used in advanced clinical diagnostics. To be able to choose between different methodologies.
To apply the use of different biomarkers and diagnostic criteria related to different human diseases.
To understand the potential of different imaging techniques and potential applications in clinical and preclinical / experimental settings.
Knowing how to interpret the results of the different clinical diagnostic methods on a statistical basis. Knowing how to use the basic statistical methods for data analysis in biomedical research.
Course syllabus and organization

Single session

Responsible
Lesson period
First semester
TEACHING METHODS
The educational activity of the course will be provided as frontal teaching and distance teaching (in synchronous modality). The presence in the classroom will be possible in shifts in compliance with anti-covid regulations.
The methods and criteria for participating in the lessons in attendance, which require a reservation with a special app, will be published on the Ariel pages of the teaching and/or by the teaching secretary of the course.
In case of a new suspension of frontal lessons, all students will be asked to switch to synchronous distance learning. Each hour of the lesson will be divided into 45" formal teaching followed by 15" discussion / interaction / question time.
All lectures will be recorded and available to students on dedicated platforms (e.g. Ariel, TEAMS, etc.).
The lab sessions, while respecting the reported program, will be administrated remotely and the useful material will be available, also as registration provided by the teacher, on the dedicated platforms made available by the University.
Any notice regarding updates or also related to the evolution of the regulations imposed by Covid-19 will be published on the degree course Ariel website and on Ariel website of the individual courses as well as communicated by the teaching secretariat.

TEACHING RESOURCES
The program and reference material will not be changed. The latter will be made available on dedicated platforms (e.g. Ariel, TEAMS, etc.)

ASSESSMENT METHODS AND CRITERIA
Unless otherwise specified, the exams will be organized in the classroom and according to the reported learning methods. If the student will not be able to reach the exam center due to problems with COVID, other modalities may be considered (this applies only to exams scheduled until 31 December - 2020)
Prerequisites for admission
Students must have fulfilled all the prerequisite requirements indicated in the study plan: Biochemistry and Fundamentals of Human Biochemistry, Techniques in molecular and cellular biology, General Pathology and Immunology.
Assessment methods and Criteria
The exam consists of two written tests, both mandatory and performed on the same day.
The first written test, lasting 1 hour, consists of 60 questions (30 for clinical biochemistry and clinical molecular biology, and 15 for clinical pathology and 15 for diagnostic imaging ) which include:
1) multiple choice questions (70-80%);
2) short answer questions (30-20%);
Each question/exercise achieves 0.5 point.
The test is passed if the score total is equal to or greater than 18.
The second written test for the medical statistics part, lasting 1 hour, consists of 30 questions (20 for statistics and evaluation of the evidence in medicine and 10 for diagnostic imaging, which include:
1) open-answer questions with the analysis of statistical problems (50-60%);
2) multiple choice questions with brief explanation of the choice (40-50%);
Each question/exercise achieves 1 point. The test is passed if the score total is equal to or greater than 18.
Both tests aim to ensure that the student has theoretical knowledge on the main biochemistry and clinical diagnostics methodologies and knowledge of the principles underlying advanced diagnostic techniques, as well as the necessary basic statistical skills for observation and measurements in the presence of experimental uncertainty and the evaluation of scientific evidence from data analysis in biomedical research. The following evaluation parameters will be considered: correctness and completeness of the answers, and ,concerning open answers, the ability to organize the responce providing basic knowledge, critical reasoning skills and competence.

The final mark, will be expressed in thirtieths, resulting from the average of the score obtained in the first and second written tests rounded to the next larger integer.
The test results will be communicated via e-mail, through a verbal service.
Biotechnology in diagnostics
Course syllabus
Clinical Biochemistry:
Definition and purposes. Organization of the clinical diagnostic laboratory. Collection and storage of biological samples.
Sample preparation
Capillary zone electrophoresis (CZE): principles and applications
HPLC / nano HPLC: principles and applications.
Coating techniques of surfaces for CZE and ELISA applications
ELISA: principles and applications
Proteomics and metabolomics: principles
Mass spectrometry: principles
Mass spectrometry: applications

Clinical Pathology:
definition of biomarkers and their characteristics
metalloproteinases as biomarkers of bony pathologies
metalloproteinases as biomarkers of cardiovascular diseases
chemokines as pathology biomarkers
tumor biomarkers
introduction to osteoimmunology and osteoimmunology biomarkers
biomarkers of prosthetic infection
Teaching methods
The teachers will use: a) Frontal lessons (4 CFU); b): individual and / or small group experimental activity in disciplinary laboratory (1 CFU).
The teachers will use the Ariel platform to provide the teaching material which consists of: a) a copy of the presentations used in the lectures; b) handouts with the explanation of the experimental procedures to be addressed in the laboratory activity.
Attendance to lectures and disciplinary laboratory activities is mandatory.
Teaching Resources
Clinical Biochemistry:
Tietz: Fondamenti di Biochimica clinica
Clinical Pathology:
any in-depth analysis with reviews and articles provided in class and mentioned in the lessons
Statistics in biomedical experimentation
Course syllabus
Diagnostic Imaging
Non-invasive techniques: anatomical and functional studies, difference between structure and function, advantages and disadvantages, possible combinations.
Principles and applications of X-Ray based techniques: principles, imaging biomarkers, instrumentation, applications
Ultrasound imaging: principles and applications: principles, Doppler effect, imaging biomarkers, available instrumentation, applications
Principles and applications of nuclear imaging techniques: principles about radioactivity, radioactive decays, decay products, instrumentation available, uses in diagnostics and therapy
Principles and applications of Imaging with Magnetic Resonance: principles of the technique, available instrumentation, possible applications
Principles and applications of optical imging: Bioluminescence and fluorescence concept, available instrumentation, preclinical applications
Overview of molecular and cellular imaging: tracer concept, reporter genes for non-invasive imaging, cell labelling.

Foundations of Statistics
Statistics and Scientific Method
The problem of measurement: variables and scales
Data summaries: central tendency and variability indices (descriptive statistics).
Measurements: measurement errors (Accuracy and Precision).
Biological and analytical variability
Measurements and statistical models (statistical sampling)
Statistics as a measurement method: estimation (Statistical Inference 1)
Confidence intervals
Testing hypotheses on a statistical basis (Statistical Inference 2)
Association and dependence (the linear model)
Calibration of measurement methods and regression
Experimental design and Analysis of Variance
Concordance between measurement methods.
Diagnostic test 1: sensitivity, specificity and ROC.
Diagnostic test 2: predictive values and diagnostic likelihood ratios
Clinical Epidemiology: evaluation of the effectiveness of a diagnostic or therapeutic procedure
Bioprofiles from genomic analysis.
Teaching methods
The teachers will use frontal lessons and practical exercise activities (4 CFU).
The teachers will use the Ariel platform to provide the teaching material which consists of: a) a copy of the presentations used in the lectures; b) supplementary bibliographic material and programming code for statistical analyses.
Attendance to lectures and exercise activities is mandatory.
Teaching Resources
Any in-depth analysis with reviews and articles provided in class and mentioned in the lessons.
Biotechnology in diagnostics
BIO/12 - CLINICAL BIOCHEMISTRY AND MOLECULAR BIOLOGY - University credits: 0
MED/05 - CLINICAL PATHOLOGY - University credits: 0
Practicals: 16 hours
Lessons: 32 hours
Statistics in biomedical experimentation
MED/01 - MEDICAL STATISTICS - University credits: 0
MED/36 - IMAGING AND RADIOTHERAPY - University credits: 0
Practicals: 8 hours
Lessons: 28 hours