CHEM470
Clinical Chemistry
Spring 2016-2017
Course Syllabus
Doc. Ref. No. / Issue Version / DateUoN-STC-CS / 1 / June 2009
Course Syllabus
COURSE NAME / : / Clinical ChemistryCOURSE CODE / : / CHEM470
CREDIT / : / 3
CONTACT HOURS / : / 4
PREREQUISITE / : / BIOL334 – Biochemistry
Co-requisite
Course Description / This course involves the biochemical analysis of blood, urine, spinal fluid, and other body fluids with manual procedures and state of the art instrumentation. Emphasis is placed on the clinical significance of electrolytes, enzymes, lipids, and carbohydrates. Drug identification, endocrinology studies, and the serelogical detection are also included. Quality assurance, including quality control, is emphasized to ensure accuracy and validity of testing along with the utilization of laboratory Information System.
To enhance the student’s critical thinking skills, pre-analytical, analytical, and post analytical components are discussed and evaluated throughout the course.
Objectives / The objective of this course is to develop an understanding of biochemical basis of disease, correlate symptoms and signs with changes in biomolecules at cellular level. The student will be equipped with basic knowledge of spectrophotometry and use of spectrophotometric methods in analysis of human body fluids and blood for proteins, enzymes, carbohydrates, lipids, electrolytes and gases. The course will emphasize on good clinical practice and mandatory safety policies in clinical laboratory.
LEARNING OUTCOMES / : / At the end of this course, students shall be able to:
1. Conduct mathematical analysis related to the clinical chemistry laboratory
2. Evaluate the effectiveness of mandatory safety policies and procedures utilized in the clinical chemistry laboratory.
3. Compare the properties and functions of biochemical analytes found in blood and body fluids
4. Evaluate laboratory results of biochemical analytes as to prediction of diagnosis and clinical condition of the patient.
5. Examine factors contributing to pre-analytical, analytical and post-analytical variations in clinical chemistry laboratory results.
6. Evaluate principles of manual and automated methodologies used in the clinical chemistry laboratory including maintenance, function checks, and troubleshooting.
COURSE CONTENTS / 1. Principles of laboratory medicine
2. Analytical techniques and instrumentation
3. The analytes: Peptides, and Proteins
4. The analytes Serum Enzymes
5. The analytes: Tumor Markers and Cancer Genes
6. The analytes: Kidney Function Tests—Creatinine, Urea, and Uric Acid
7. The analytes: Carbohydrates
8. The analytes: Lipids, Lipoproteins, Apolipoproteins, and Other Cardiac Risk Factors
9. The analytes: Electrolytes and Blood Gases
10. Diabetes
11. Cardiovascular Disease
12. Kidney Disease
13. Liver Disease
LECTURES / : / Topic1 Principles of laboratory medicine / 3 hours
Details of topic 1
Clinical chemistry and laboratory medicine. Evidence based laboratory medicine. Quality assurance
Topic 2 Analytical techniques and instrumentation / 4 hours
Details of Topic 2
Optical techniques, electrochemistry, chromatography, mass spectrometry, Immunochemical techniques, Automation and Point-of-Care instrumentation
Topic 3 The analytes: Peptides, and Proteins / 3 hour
Details of topic 3
Protein sampling and analysis, acute-phase and negative acute phase response proteins. Clinical significance of plasma proteins, complement proteins, and immunoglobulin. Proteinuria and its analysis; CSF protein.
Topic 4 The analytes Serum Enzymes / 2 hour
Details of topic 4
Factors affecting enzyme activity and appearance in blood.
clinical significance and laboratory analysis of hydrolase, phosphotranferase lyase transferase and oxidoreductase found in blood as well as the important isoenzymes. serum enzymes that are related to future cardiovascular (CV) events.
Topic 5 The analytes: Tumor Markers and Cancer Genes / 3 hour
Details of topic 5
Classes of tumor markers, Clinical utility and their analysis. Marker distribution, Reference interval, Predictive value and Role in disease management. Oncogenes, proto-oncogenes, and tumor-suppressor genes their function, physiological effects in their alterations and analysis in the clinical laboratory.
Topic 6 The analytes: Kidney Function Tests—Creatinine, Urea, and Uric Acid / 2 hour
Details of topic 6
Clinical usefulness of measuring serum and urine creatinine. Jaffe reaction, enzymatic and other assays used to measure creatinine in serum. Clinical usefulness of measuring serum urea and uric acid. hypouricemia and hyperuricemia. Laboratory methods in analysis of urea and uric acid. Pathogenesis of gout and urinary tract uric acid stones.
Topic 7. The analytes: Carbohydrates / 2 hour
Details of topic 7
Glucose concentration and regulation in blood. hypoglycemia and its diagnosis. The hexokinase and glucose oxidase methods for measurement of glucose in blood. Estimation of lactate and pyruvate concentration in blood
Topic 8. The analytes: Lipids, Lipoproteins, Apolipoproteins, and Other Cardiac Risk Factors / 2 hour
Details of topic 8
Lipoprotein and apolipoproteins functions, and clinical significance; hyperlipidemia/dyslipoproteinemia. enzymatic procedures used in the laboratory to measure cholesterol and triglyceride. Assays used to assess HDL, Apolipoprotein A-I, and B-100, LDL, and Lipoprotein(a). Friedewald formula. Laboratory technique used to detect hsCRP.
Topic 9. The analytes: Electrolytes and Blood Gases / 3 hours
Details of topic 9
Clinical significance, and laboratory analysis of Bicarbonate, Potassium, Chloride and Sodium. Electrolyte/blood gas determination by Coulometry-amperometry, Sweat testing, Osmometry, Tonometry, and Potentiometry.
Topic 10. Diabetes / 2 hour
Details of topic 10
oral glucose tolerance test. assay of whole blood and plasma glucose concentrations. accuracy and reproducibility of blood glucose meters. measurement of glycated hemoglobin and its use in diagnosis of diabetes. semi-quantitative analyses of urinary albumin.
Topic 11. Kidney Disease / 2 hours
Details of topic 11
markers used to determine GFR. laboratory methods used to assess Acute kidney injury (AKI), Acute nephritic syndrome, Acute tubular necrosis (ATN), Chronic kidney disease (CKD), Diabetes insipidus (DI), End-stage renal disease (ESRD) ,Renal tubular acidosis (RTAs), Uremic syndrome and Urinary tract obstruction
12. Liver Disease / (2 hour)
Details of topic 12
causes and consequences of Disordered hemostasis, Liver enzyme release, Jaundice, and Portal hypertension. laboratory tests used to diagnose the presence of viral hepatitis. Laboratory findings in Acute alcoholic hepatitis, Alcoholic liver disease, Autoimmune hepatitis, Cholestatic hepatitis, Cholestatic liver diseases, Cirrhosis, Drug-induced liver injury (DILI), Ischemic hepatitis, Primary biliary cirrhosis (PBC), Primary sclerosing cholangitis (PSC), Toxic hepatitis. Calculating MELD scores.
13. Cardiovascular Disease / 2 hours
Details of topic 13
Laboratory analysis of Creatine kinase (CK), Natriuretic peptides (NPs), CK isoforms, NT-proBNP, Myoglobin, and Troponins in diagnosing an AMI
Total / (30 hours)
ASSESSMENTS / : / Course Work / In-semester exams 30%, Quizzes 10%, and Practical 20%
Final Examination / 40%
REFERENCES / : / 1. Carl A. Burtis & David E. Bruns, Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics 7th edition, Saunders 2015.
2. John W. Ridley Essential of Clinical Laboratory Science, Delmer Cengage Learning, 2011 / Text Book
William J. Marshall, Stephen K. Bangert and Marta Lapsley, Clinical chemistry, 7th edition, MOSBY Learning 2012. / Additional references
TEACHING & ASSESSMENT PLAN
CHEM470: CLINICAL CHEMISTRY
TEACHING & ASSESSMENT PLAN
1. College: Pharmacy and Nursing
2. Department: School of Pharmacy
3. Semester: Spring 2016-2017
4. Course Code: CHEM470
5. Course Name: Clinical Chemistry
6. Timetable : Day Time Class Room
Tuesday / 11:00 - 11:50 / 5B-1Thursday / 11:00 - 11:50 / 2A-1
Thursday / 14:00 – 15:50 / 6 – 6B
7. Faculty Name : Dr. Sadri Abdullah Said
8. Office No : 33-11
9. Telephone Ext. : 423
10. E-mail: :
11. Office hours : Day Time
Sun, Mon, Wed / 10:00 – 12:00Tue, Thu / 09:00 – 11:00
12. Text Book & References :
Text Book / References1. Carl A. Burtis & David E. Bruns, Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics 7th edition, Saunders 2015.
2. John W. Ridley Essential of Clinical Laboratory Science, Delmer Cengage Learning, 2011 / William J. Marshall, Stephen K. Bangert and Marta Lapsley, Clinical chemistry, 7th edition, MOSBY Learning 2012.
13. Course Description
This course involves the biochemical analysis of blood, urine, spinal fluid, and other body fluids with manual procedures and state of the art instrumentation. Emphasis is placed on the clinical significance of electrolytes, enzymes, lipids, and carbohydrates. Drug identification, endocrinology studies, and the serelogical detection are also included. Quality assurance, including quality control, is emphasized to ensure accuracy and validity of testing along with the utilization of laboratory Information System. To enhance the student’s critical thinking skills, pre-analytical, analytical, and post analytical components are discussed and evaluated throughout the course..13. Learning Outcomes
At the end of the course the student shall be able to,
1. / Conduct mathematical analysis related to the clinical chemistry laboratory2. / Evaluate the effectiveness of mandatory safety policies and procedures utilized in the clinical chemistry laboratory.
3. / Compare the properties and functions of biochemical analytes found in blood and body fluids
4. / Evaluate laboratory results of biochemical analytes as to prediction of diagnosis and clinical condition of the patient.
5 / Examine factors contributing to pre-analytical, analytical and post-analytical variations in clinical chemistry laboratory results.
6 / Evaluate principles of manual and automated methodologies used in the clinical chemistry laboratory including maintenance, function checks, and troubleshooting.
14. Assessment Policy
Assessment process takes direct and indirect measurements to ensure that learning outcomes and program objectives have been achieved. The assessment includes assignments, quizzes, tests, projects and discussions. The type of assessment is indicated in the weekly plan table and the assessment details are as follows:
Assessment Details:
Assessment / Percentage %Quizzes / 10%
Mid term Tests / 30%
Practical / 20%
Final Exam / 40%
15. Plagiarism policy
As per the University Policy UoN-STC-CR-1-2009, the following actions(not limited to), without proper attribution (quoting and/or referencing), will attract stringent penalties:1. copy the work of another student;
2. directly copy any part of another person’s work;
3. summarize another person’s work;
4. use or develop an idea or thesis derived from another person’s work; or
5. use experimental results or data obtained or gathered by another person.
6. cheat during an exam
16. Attendance policy
As per the University Absentee Regulations Uon-RR-AP-1-2009, Absentee warning notice will be issued to the student according to:1. “Absentee Warning 1” has to be issued to student who has missed 5% of course contact hours.
2. “Absentee Warning 2” has to be issued to student who has missed 10% of course contact hours.
3. “Drop one Grade” has to be issued to student who has missed 15% of course contact hours.
4. “Barred from Examination” has to be issued to student who has missed 25% of course contact hours.
17. Weekly Teaching & Assessment Plan:
Week No / Topic / Course Outcome / Assessment of Outcomes1 / Principles of laboratory medicine / The student shall be able to:
List and explain reasons or performing a laboratory test.
Describe the field of laboratory medicine, including subdisciplines,
Define Evidence-based laboratory medicine
Compare accuracy and precision and how to measure them
Discuss the term clinical significance and relate it to the reporting of laboratory results
Describe how Levey-Jennings chart would indicate deterioration or changes in reagents or equipment
Compare the use of F-test and T-test / Homework, tutorials
2 / Principles of laboratory medicine / The student shall be able to:
Discuss the meaning of standard deviation and coefficient of variation
List the three categories of errors that may routinely occur in performance of laboratory test
Compare and contrast sensitivity and specificity
- / Homework, tutorials
3 / Analytical techniques and instrumentation / - The student shall be able to:
Apply Beer’s law to calculate the concentration of a substance in solution
Discuss clinical laboratory applications of and
Explain the basic concepts of photometry, fluorescence, chemiluminescence, nephelometry and turbidimetry as well as their clinical laboratory applications.;
State the principles and clinical applications of Voltammetry/Amperometry, Coulometry, Conductometry and Potentiometry
List four examples of biosensors and state their uses in the clinical laboratory;
Compare clinical uses of Capillary Microchip, Disc Two-dimensional and Isoelectric focusing electrophoresis / Homework, tutorials, Quiz,
4 / Analytical techniques and instrumentation / Discuss clinical applications of Ion exchange, Affinity and Adsorption chromatography
Describe clinical applications of mass spectrometry including the hyphenated-MS techniques
Compare clinical uses of various kinds of immunoassay techniques
Discuss advantage and quality control issues in the use of point-of -care testing (POCT).
5 / Peptides, and Proteins / The student shall be able to:
Compare plasma and serum with regard to protein concentration.
List the acute-phase response proteins and the negative acute phase response proteins.
Classify clinical significance plasma proteins and explain how they are affected by disease,
Discuss the complement proteins, including their clinical significance, abundance, pathway involvement, and disease associations.
Discuss types and clinical significance of immunoglobulins
Explain the presence of protein in urine and describe four types o proteinuria; describe how protein is analyzed in urine.
Explain the presence of protein in CSF and the significance of increased CSF protein. / Homework, tutorials
6 / Serum Enzymes / The student shall be able to:
List the actors that affect enzyme activity and appearance in blood.
describe clinical significance and method of laboratory analysis, of 5′-Nucleotidase Amylase
Alanine aminotrans erase Aspartate aminotrans erase Aldolase Creatine kinase, Alkaline phosphatase γ-Glutamyltrans erase Lactate dehydrogenase Serum cholinesterase Lipase Tartrate-resistant acid phosphatase
Discuss clinical significance and methods of laboratory analysis used to assess the isoenzymes
Describe two serum enzymes that are related to future cardiovascular (CV) events. / Homework, tutorials
7 / Tumor Markers and Cancer Genes / The student shall be able to:
Discuss clinical utility of tumor marker including the concerns associated with their use in cancer assessment.
describe Marker distribution and Reference interval, Predictive values
discuss analytical methodology used to assess various tumor markers
Compare clinical significance of oncogenes, proto-oncogenes, and tumor-suppressor genes and how these genes are assessed in the clinical laboratory. / In-semester exam