Clinical Biochemistry
A.Y. 2025/2026
Learning objectives
The teaching aims to provide students with theoretical and practical knowledge for the understanding and use of current laboratory tests, through the knowledge of analytical principles, optimization processes and their interpretation.
Expected learning outcomes
At the end of the course, the student will acquire the knowledge of the analytical principles at the base of the most frequent laboratory tests, on the processes for the optimization of laboratory tests, on the current events in the market of national and international diagnostic producers. From a communicative point of view, the student will be able to explain and interpret the chemical-clinical examinations. The course will provide the basic principles to facilitate the future integration of Biologists in the field of Laboratory Medicine.
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
First semester
Course syllabus
Part I: sources of variability and interpretation of laboratory data.
· Pre-analytic phase. Main indications for requesting laboratory tests. Types of biological specimen. Main sources of pre-analytical variability related to the individual and collection, storage and processing of the biological sample. Unsuitable samples.
· Intra- and inter-individual biological variability.
· Analytical phase. Types of laboratory tests. Analytical variability. Main characteristics of measurement methods (precision, trueness, accuracy, linearity, sensitivity, specificity). Types of analytical errors. Analytical goals. Evaluation of the analytical performance of laboratory methods (mainly precision and accuracy). Standardization of measurements and metrological traceability.
· Validation of laboratory results: internal quality control procedures and external quality assessment programs (EQAS).
· Criteria for interpreting laboratory results: reference intervals, critical difference, decisional levels; the laboratory report.
· Diagnostic sensibility and specificity. ROC curve.
Part II: laboratory role in the diagnosis and monitoring of some relevant diseases. Most common laboratory tests.
· Biochemical-clinical aspects concerning the measurement of hemoglobin in blood and in other biological fluids. Complete blood count examination.
· Types of hemoglobins in blood, hemoglobin derivatives. Role of the laboratory in the diagnosis and characterization of hemoglobinopathies (thalassemias and hemoglobin variants). Techniques for the separation of hemoglobins in blood.
· Markers for the evaluation of iron metabolism alterations (iron, transferrin, transferrin receptor, ferritin, zinc-protoporphyrin).
· Lipoproteins, dyslipidemia, cardiovascular risk. Evaluation of lipid status (total and fractionated cholesterol, triglycerides). Biochemical markers of myocardial infarction (cardiac troponins).
· Laboratory role in the diagnosis and monitoring of dabetes mellitus (plasma glucose, OGTT, glycated hemoglobin and albumin, ketone bodies).
· Serum proteins: albumin, immunoglobulins, acute phase proteins. Electrophoresis of serum proteins. Monoclonal proteins: detection and characterization.
· Bilirubin and jaundice.
· Principles of clinical enzymology (LDH, AST, ALT, ALP, γGT, CK, colinesterase).
· Laboratory markers of kidney function (creatinine, GFR). Urine examination.
· Pre-analytic phase. Main indications for requesting laboratory tests. Types of biological specimen. Main sources of pre-analytical variability related to the individual and collection, storage and processing of the biological sample. Unsuitable samples.
· Intra- and inter-individual biological variability.
· Analytical phase. Types of laboratory tests. Analytical variability. Main characteristics of measurement methods (precision, trueness, accuracy, linearity, sensitivity, specificity). Types of analytical errors. Analytical goals. Evaluation of the analytical performance of laboratory methods (mainly precision and accuracy). Standardization of measurements and metrological traceability.
· Validation of laboratory results: internal quality control procedures and external quality assessment programs (EQAS).
· Criteria for interpreting laboratory results: reference intervals, critical difference, decisional levels; the laboratory report.
· Diagnostic sensibility and specificity. ROC curve.
Part II: laboratory role in the diagnosis and monitoring of some relevant diseases. Most common laboratory tests.
· Biochemical-clinical aspects concerning the measurement of hemoglobin in blood and in other biological fluids. Complete blood count examination.
· Types of hemoglobins in blood, hemoglobin derivatives. Role of the laboratory in the diagnosis and characterization of hemoglobinopathies (thalassemias and hemoglobin variants). Techniques for the separation of hemoglobins in blood.
· Markers for the evaluation of iron metabolism alterations (iron, transferrin, transferrin receptor, ferritin, zinc-protoporphyrin).
· Lipoproteins, dyslipidemia, cardiovascular risk. Evaluation of lipid status (total and fractionated cholesterol, triglycerides). Biochemical markers of myocardial infarction (cardiac troponins).
· Laboratory role in the diagnosis and monitoring of dabetes mellitus (plasma glucose, OGTT, glycated hemoglobin and albumin, ketone bodies).
· Serum proteins: albumin, immunoglobulins, acute phase proteins. Electrophoresis of serum proteins. Monoclonal proteins: detection and characterization.
· Bilirubin and jaundice.
· Principles of clinical enzymology (LDH, AST, ALT, ALP, γGT, CK, colinesterase).
· Laboratory markers of kidney function (creatinine, GFR). Urine examination.
Prerequisites for admission
It is advisable to have acquired basic knowledges of biochemistry, human anatomy and general physiology.
Teaching methods
The course is based on interactive lessons supported by projected materials. Students are stimulated to actively participate to the lecture/discussion in order to improve their critical spirit. This is achieved by carefully looking at the provided literature and by communicating their concepts in an adequate mode. The attendance to the lectures is strongly advised.
Teaching Resources
The presentations of all the lectures are available through MyAriel website. For the different topics, recommended readings from the recent scientific literature will be indicated.
Reference textbooks are the following:
1) Marcello Ciaccio. Elementi di Biochimica Clinica e medicina di laboratorio. EdiSES Università, Napoli,2020.
2) Mauro Panteghini. Interpretazione degli esami di laboratorio. Trattato Italiano di Medicina di Laboratorio. Volume VII. Piccin 2008.
3) Federici G. Medicina di laboratorio. MC GRAW HILL, 2008.
Reference textbooks are the following:
1) Marcello Ciaccio. Elementi di Biochimica Clinica e medicina di laboratorio. EdiSES Università, Napoli,2020.
2) Mauro Panteghini. Interpretazione degli esami di laboratorio. Trattato Italiano di Medicina di Laboratorio. Volume VII. Piccin 2008.
3) Federici G. Medicina di laboratorio. MC GRAW HILL, 2008.
Assessment methods and Criteria
Written exam with 3 open questions regarding the topics addressed during the lessons, to be completed in 90 min. The evaluation is based on the achievement of a good knowledge of the matter and on the completeness of answers to all the questions. The ability to present the topics clearly and logically will also be evaluated. The result of the exam is expressed in thirtieths and is the mean of the marks obtained in the individual questions. At least a passing grade in all three questions is required to pass the exam. The result of the exam is communicated through the dedicated University web-site. No pre-test or intermediate assays are planned.
BIO/12 - CLINICAL BIOCHEMISTRY AND MOLECULAR BIOLOGY - University credits: 6
Lessons: 48 hours
Professor:
Paleari Renata
Professor(s)