Instrumentation, Techniques and Methods in the Clinical Laboratory

Code:

MI074178

Acronym:

ITMLAC

Keywords
Classification	Keyword
OFICIAL	Physical Sciences

Instance: 2021/2022 - 1S

Active?	Yes
Web Page:	https://moodle.up.pt/course/view.php?id=2025
Responsible unit:	Applied Chemistry Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	30	Official Curriculum	4	-	3	52	81

Teaching language

Suitable for English-speaking students
Obs.: Nota: as aulas serão lecionadas maioritariamente em português. No entanto, aos outros estudantes serão indicados materiais de estudo em inglês, dado um apoio adicional no processo de aprendizagem e a avaliação será feita em inglês.

Objectives

To provide the students with an integrated overview of the basic principles of operation of laboratory equipment, instrumental techniques and analytical methodologies most commonly used in Clinical Laboratories (including the "Bioanalytical" area).
The ultimate goal is the students become superiorly skilled on the more technical/technological aspects of the entire laboratory activity, particularly in terms of proper and efficient use of laboratory equipment, with deep knowledge of their basic principles of operation, and the development, implementation, validation and control of analytical procedures/ methodologies.
This curricular unit should be regarded as "nuclear" for those students intending a future laboratory activity as analysts in the biomedical field.
As transversal competences, this curricular unit aims to contribute to the development of the following: a) cognitive: analytical, critical, reflective and creative thinking; b) methodological: time management, problem-solving, learning strategies and digital skills; c) social: interpersonal communication and teamwork.

Learning outcomes and competences

It is intended that students become properly trained to carry out the typical activities of a Clinical Laboratory, particularly in the area of clinical/toxicology chemistry, being especially well prepared for the operation and/or supervision of the operation with the main equipment, the development and validation of analytical methods and quality control procedures. The training provided is also particularly relevant for professional practice upstream, ie in IVD companies (equipment, reagents, etc.) and the competent authorities. The program also includes a component that will be useful for professional working at Community Pharmacy, while addressing the issue of PCOT (point of care testing), with its specific techniques and analytical systems.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

Previous knowledge in the area of Instrumental Methods of Analysis and Biostatistics is important. And, of course, knowledge in the areas of Clinical Biochemistry and Hematology.

Program

Theoretical component
Introduction – The Clinical Laboratory: organization, objectives, activities. Legislation on Clinical Laboratories. Professional and scientific organizations.
Part 1 – Laboratory terminology. Analytical methodologies: Development and validation of analytical methods (specificity, sensitivity, accuracy, precision, etc.). (Pharmaceutical) Bioanalytical methods: ICH Guidelines on bioanalytical methods. Basic laboratory statistics (descriptive statistics, comparative statistics, trend evaluation, and correlative statistics). Quality control. The reagents and the equipment for the clinical laboratory as “in vitro diagnostic medical devices” (IVDs). Essential requirements of IVDs: analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, interferences, limits of detection. Traceability. The «CE» marking of conformity.
Part 2 – Instrumental 8analytical) techniques - basic principles of operation and examples of use in the Clinical Laboratory: flame atomic emission photometry; flame atomic absorption spectrophotometry; UV/Vis molecular absorption spectrophotometry; densitometry; reflectance photometry; luminescence techniques (fluorescence; chemiluminescence and electrochemiluminescence); turbidimetry and nephelometry; potentiometry/ion selective electrodes; electrophoresis; capillary electrophoresis; chromatographic systems: instrumentation, main mechanisms of separation and main types of detectors (UV/Vis, fluorimetric, electrochemical). LC/MS; ICP-MS; particle counters; radiation counters; flow cytometry. Systems of “near patient testing”/“point of care testing”. Instruments and methods for “dry chemistry”.
Part 3 – Automation. Historical perspective and technological developments. General aspects of automation: automatic and automated equipment, focused automation and total automation, advantages and disadvantages of laboratory automation. Pre- and post-analytical automation. Automatic robotized analyzers and automation based on flow systems. The modern Automatic Analysers (for Clinical Chemistry, Haematology, Microbiology, Immunology and Endocrinology). 

Theoretical-practical component
Most of the theoretical-practical classes will be reserved for the discussion of the topics presented in the theoretical classes, solve concepts application exercises and case studies.
At the beginning of the semester, there will be a distribution of topics to be deepened by the students (individually or in groups of two), who should, at the end of the semester, make a presentation of that topic to their colleagues.
This component of the curricular unit may also include some laboratory work designed to highlight the basic principles of instrumentation operation, including analytical automation, and to carry out procedures for the application of concepts, namely those referring to Part 1 of the theoretical component (development and validation of analytical methods). It may also include visits(s) to large clinical laboratories so that students can have a more clear view of ​​the reality being studied.

Mandatory literature

Richard A. McPherson; Henry.s clinical diagnosis and management by laboratory methods. ISBN: 978-1-4377-0974-2

Complementary Bibliography

Michael L. Bishop, Edward P. Fody, Larry E. Schoeff; Clinical Chemistry: Principles, Techniques, and Correlations, LWW, 2013. ISBN: 978-1451118698
Ward-Cook Kory M.; Clinical diagnostic technology. ISBN: 1-59425-034-0
Turgeon Mary Louise; Linné & Ringsrud99s clinical laboratory science. ISBN: 978-0-323-03412-8

Teaching methods and learning activities

The teaching component of the CU is mainly based on lectures and tutorials. The lectures ("theoretical classes") are essentially expository talks, using PowerPoint presentations. The tutorials (“theoretical-practical classes”) are discussion classes (with and between students), with extensive use of web resources (videos in particular). Some of these classes (end of the semester) are reserved for presentations by students of specific topics (selected at the beginning of the semester). This component is also subject to evaluation. Laboratory classes, when they exist, will be essentially demonstrative, aimed to explain in a practical way certain concepts and show students the typical operation of a Clinical Laboratory, with its main equipment/instruments.

keywords

Physical sciences > Chemistry > Instrumental analysis
Physical sciences > Chemistry > Analytical chemistry > Clinical chemistry
Natural sciences > Biological sciences > Biology > Clinical biology

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	80,00
Apresentação/discussão de um trabalho científico	20,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	30,00
Frequência das aulas	48,00
Apresentação/discussão de um trabalho científico	6,00
Total:	84,00

Eligibility for exams

Attendance to theoretical-practical classes is mandatory, as established in the FFUP Assessment Rules. Regarding theoretical classes, there is no obligation of attendance, except in those dedicated to presenting and discussing specific topics by the students.

Calculation formula of final grade

Final classification: the weighted average of the distributed evaluation and the final exam, with weights of 20% and 80%, respectively.
Distributed evaluation: Corresponds to the evaluation of the theoretical-practical component – study and presentation of specific topics by the student.
Final exam: It consists of a written test and an oral test. The oral test is only for students who obtained a grade between 8.0 and 9.5 in the written test. The other students are excused.
Note: Regardless of the grade in the written test, students who by law are exempt from attending classes (and therefore cannot be subject to distributed assessment) will be required to take this oral test of the final exam.

Examinations or Special Assignments

Some classes will be reserved for the presentation of specific topics by the students (individually or in groups of two). At the beginning of the semester, students will choose the topic they will present. Another group of students (two) can be asked also to prepare themselves to conduct an in-depth discussion (asking questions to colleagues) during the presentation of each specific theme.

Special assessment (TE, DA, ...)

According to the rules in force, approved by the FFUP Pedagogical Council.

Classification improvement

Students who want to improve the final classification may do so by improving the grade obtained in the written test of the final exam.