Code - جامعة نزوى



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CHEM470

Clinical Chemistry

Spring 2016-2017

Course Syllabus

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|Doc. Ref. No. |Issue Version |Date |

|UoN-STC-CS |1 |June 2009 |

Course Syllabus

| | | | |

|COURSE NAME |: |Clinical Chemistry | |

| | | | |

|COURSE 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: |

| | |Conduct mathematical analysis related to the clinical chemistry laboratory |

| | |Evaluate the effectiveness of mandatory safety policies and procedures utilized in the clinical chemistry |

| | |laboratory. |

| | |Compare the properties and functions of biochemical analytes found in blood and body fluids |

| | |Evaluate laboratory results of biochemical analytes as to prediction of diagnosis and clinical condition of the|

| | |patient. |

| | |Examine factors contributing to pre-analytical, analytical and post-analytical variations in clinical chemistry|

| | |laboratory results. |

| | |Evaluate principles of manual and automated methodologies used in the clinical chemistry laboratory including |

| | |maintenance, function checks, and troubleshooting. |

| | | | |

|COURSE CONTENTS | |Principles of laboratory medicine | |

| | |Analytical techniques and instrumentation | |

| | |The analytes: Peptides, and Proteins | |

| | |The analytes Serum Enzymes | |

| | |The analytes: Tumor Markers and Cancer Genes | |

| | |The analytes: Kidney Function Tests—Creatinine, Urea, and Uric Acid | |

| | |The analytes: Carbohydrates | |

| | |The analytes: Lipids, Lipoproteins, Apolipoproteins, and Other Cardiac Risk Factors | |

| | |The analytes: Electrolytes and Blood Gases | |

| | |Diabetes | |

| | |Cardiovascular Disease | |

| | |Kidney Disease | |

| | |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 |: |Carl A. Burtis & David E. Bruns, Tietz Fundamentals of Clinical Chemistry and Molecular |Text Book |

| | |Diagnostics 7th edition, Saunders 2015. | |

| | |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, |Additional |

| | |MOSBY Learning 2012. |references |

TEACHING & ASSESSMENT PLAN

CHEM470: CLINICAL CHEMISTRY

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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-1 |

|Thursday |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: : sadri@unizwa.edu.om

11. Office hours : Day Time

|Sun, Mon, Wed |10:00 – 12:00 |

|Tue, Thu |09:00 – 11:00 |

12. Text Book & References :

|Text Book | |References |

|Carl A. Burtis & David E. Bruns, Tietz Fundamentals of Clinical Chemistry| |William J. Marshall, Stephen K. Bangert and Marta |

|and Molecular Diagnostics 7th edition, Saunders 2015. | |Lapsley, Clinical chemistry, 7th edition, MOSBY |

|John W. Ridley Essential of Clinical Laboratory Science, Delmer Cengage | |Learning 2012. |

|Learning, 2011 | | |

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 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. |

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: |

|copy the work of another student; |

|directly copy any part of another person’s work; |

|summarize another person’s work; |

|use or develop an idea or thesis derived from another person’s work; or |

|use experimental results or data obtained or gathered by another person. |

|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: |

|“Absentee Warning 1” has to be issued to student who has missed 5% of course contact hours. |

|“Absentee Warning 2” has to be issued to student who has missed 10% of course contact hours. |

|“Drop one Grade” has to be issued to student who has missed 15% of course contact hours. |

|“Barred from Examination” has to be issued to student who has missed 25% of course contact hours. |

17. Weekly Teaching & Assessment Plan:

|Week No| |Course Outcome |Assessment of Outcomes |

| |Topic | | |

|1 |Principles of laboratory medicine |The student shall be able to: |Homework, tutorials |

| | |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 | |

|2 |Principles of laboratory medicine |The student shall be able to: |Homework, tutorials |

| | |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 | |

|3 |Analytical techniques and |The student shall be able to: |Homework, tutorials, |

| |instrumentation |Apply Beer’s law to calculate the concentration of a substance in solution |Quiz, |

| | |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 | |

|4 |Analytical techniques and |Discuss clinical applications of Ion exchange, Affinity and Adsorption | |

| |instrumentation |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: |Homework, tutorials |

| | |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. | |

|6 |Serum Enzymes |The student shall be able to: |Homework, tutorials |

| | |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. | |

|7 |Tumor Markers and Cancer Genes |The student shall be able to: |In-semester exam |

| | |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. | |

|8 |Creatinine, Urea, and Uric Acid |The student shall be able to: |Homework, tutorials |

| | |State the clinical usefulness of measuring serum and urine creatinine. | |

| | |State the principle of the Jaffe reaction and list five interferences that | |

| | |affect this method. | |

| | |List and describe three enzymatic assays used to measure creatinine in serum. | |

| | |Describe “compensated assays” in relation to the measurement o creatinine. | |

| | |Explain the clinical usefulness and laboratory methods used to measure serum | |

| | |urea | |

| | |Discuss the clinical significance and the laboratory methods used to measure | |

| | |serum uric acid. | |

|9 |Spring break |

|10 |Carbohydrates |The student shall be able to: |Homework, tutorials |

| | |Compare glucose values in fasting whole-blood, capillary, and venous blood | |

| | |specimens; state the reasons or the discrepant values. | |

| | |describe the 72-hour fast test for diagnosing hypoglycemia. | |

| | |Describe the hexokinase method for measurement of glucose in blood | |

| | |Describe the glucose oxidase method for measurement of glucose in blood; | |

| | |Describe the chemical reaction used to assess lactate and pyruvate | |

| | |concentrations in blood; | |

| | |State the specimen collection and storage requirements for blood lactate and | |

| | |pyruvate analyses. | |

|11 |Lipids, Lipoproteins, Apolipoproteins,|The student shall be able to: |Homework, tutorials, |

| |and Other Cardiac Risk Factors |Compare clinical significance of the various classes of lipoproteins |Quiz |

| | |discuss enzymatic procedures used in the laboratory to measure cholesterol and | |

| | |triglyceride | |

| | |Apply the Friedewald formula to calculate LDL, cholesterol | |

| | |Describe high-sensitivity CRP and state its usefulness in predicting coronary | |

| | |heart disease events; state the laboratory technique used to detect hsCRP. | |

|12 |Electrolytes and Blood Gases |The student shall be able to: |In-semester exam |

| | |Describe the clinical significance, and method of laboratory analysis of | |

| | |Bicarbonate, Chloride, Potassium and Sodium | |

| | |Compare direct and indirect ion-selective electrode testing, | |

| | |Discuss the measurement of sweat chloride | |

| | |Describe the use of Coulometry-amperometry, Sweat testing, Osmometry, | |

| | |Tonometry, and Potentiometry in determination of electrolyte/blood gas | |

| | |Use formula to determine osmolality of urine and plasma | |

| | |explain the three approaches to determining oxygen saturation; | |

| | |List the analytical problems that arise in the analysis of pH, PO2, and PCO2 | |

| | |with inappropriate specimen collection or transport techniques | |

| | |describe the methods and calculations used to measure pH, PO2, and PCO2. | |

|13 |Diabetes |The student shall be able to: |Homework, tutorials |

| | |Summarize the role of the clinical laboratory in the diagnosis and short- and | |

| | |long-term management of diabetes mellitus. | |

| | |State the basic criteria for the diagnosis of diabetes mellitus | |

| | |Outline the procedure for administration and collection of an oral glucose | |

| | |tolerance test; | |

| | |Analyze and interpret the results of oral glucose tolerance test in the | |

| | |diagnosis of type 2 diabetes mellitus, impaired glucose tolerance, and | |

| | |gestational diabetes mellitus. | |

| | |Describe the assay of whole blood glucose used in a blood glucose meter; | |

| | |calculate the difference between whole blood and plasma glucose concentrations.| |

| | |List five variables that affect the accuracy and reproducibility of blood | |

| | |glucose meters; state how dehydration affects the reliability of a blood | |

| | |glucose meter. | |

| | |Describe a typical implanted sensor or monitoring blood glucose including assay| |

| | |method, calibration, and usefulness in a person with type 1 diabetes. | |

| | |Discuss the clinical significance of ketonemia and ketonuria in uncontrolled | |

| | |diabetes mellitus. | |

| | |Discuss three techniques used to determine glycated hemoglobin values | |

| | |Describe three semi-quantitative analyses o urinary albumin. | |

|14 |Kidney Disease |The student shall be able to: |Homework, tutorials |

| | |Describe the effect of disease on renal handling of electrolytes and water | |

| | |Describe glomerular filtration rate (GFR) and clearance in terms of clinical | |

| | |usefulness and effects of renal disease. | |

| | |Descibe markers used to assess clearance | |

| | |Use formula to determine GFR. | |

| | |Describe the proteins found in urine and their laboratory measurement for | |

| | |diagnosis of kidney diseases. | |

| | |Discuss the 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), Glomerular disease, | |

| | |Interstitial nephritis, Nephrotic syndrome,Pyelonephritis, Renal tubular | |

| | |acidosis (RTAs), Uremic syndrome, and Urinary tract obstruction | |

|15 |Liver Disease |The student shall be able to: |Homework, tutorials |

| | |List the enzymes synthesized in the liver, their subcellular location, | |

| | |tissue specificity, and mechanisms of enzyme release and clearance. | |

| | |Compare and contrast laboratory analyses used to distinguish between acute | |

| | |liver injury with chronic liver injury | |

| | |Describe laboratory tests used to diagnose the presence of hepatic virus. | |

| | |Describe 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 | |

| | |Calculate a MELD score and determine prognosis in cirrhosis. | |

| | |Describe hepatocellular carcinoma (HCC) including prevalence, risk actors, | |

| | |screening tests, and laboratory findings. | |

|16 |Cardiovascular Disease |The student shall be able to: |Homework, tutorials |

| | |Describe an ideal cardiac biomarker, including necessary characteristics, | |

| | |analytical considerations, and persistence in blood following an acute | |

| | |myocardial infarction (AMI). | |

| | |Compare troponin I and T, usefulness in diagnosing an AMI. | |

| | |List six proposed elements of the guidelines of the National Academy of | |

| | |Clinical Biochemistry or point-o -care testing (POCT) o cardiac biomarkers. | |

| | |describe clinical utility and laboratory analysis of Creatine kinase (CK), | |

| | |Natriuretic peptides (NPs), CK isoforms, NT-proBNP, Myoglobin, and Troponins | |

| | |List four preanalytical considerations that must be assessed by a clinical | |

| | |laboratory that uses NP assays. | |

|17-18 | | |FINAL EXAM |

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|Doc. Ref. No. |Issue Version |Date |

|UoN-STC-T&A |1 |June 2009 |

FACULTY

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Signature

Date :

HEAD OF DEPARTMENT

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Date :

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