CCHM 321: Clinical Chemistry 1│Lecture

2022-2023 3RD YEAR, 1ST SEMESTER Prof. Kimberly Ann Pulga, RMT, MPH

 Generated results are correlated to provide

Introduction to Clinical better diagnosis and monitor patient’s
Chemistry conditions
(Preliminary Term, 1st Topic)
 Results are compared to reference
Trans Outline:
Topic 1: Clinical Chemistry Topic 4: Regulatory
values/range
A. Definition Guidelines that Define the
B. Scope Practice  Considered/defined as:
C. Common Topic 5: Purpose of
Analytes Clinical Chemistry o Science
Topic 2: History of Clinical Laboratorian/Medical • links knowledge of gen chem,
Chemistry Technologist organic chem, and biochem
Topic 3: Typical Fluids Topic 6: Scope of Practice
used for Clinical Chemistry
with understanding of human
Tests physiology
o Service
• produces objective evidence
CLINICAL CHEMISTRY from medical decisions which
can be made because of
DEFINITION: different clinical chemistry
 Also known as: Chemical Pathology, tests and processes
Medical Biochemistry, Clinical o Industry
Biochemistry, Pure Chemistry • clinical labs are businesses
which are operated under
 A branch of Medical science that study
regulations and practices that
biochemical processes associated with health
guide the commerce in the
and disease.
Phil
 Deals with the measurement of constituents
in body fluids to facilitate diagnosis of  SCOPE:
disease and to monitor the effect of treatment.
 A quantitative science that is concerned with
measurement of amounts of biologically
important substances (called analytes) in
body fluids.
 Branch of laboratory medicine that focuses
primarily on the molecules (small ions which
are organic molecules) and even larger  Biochemistry
particles like proteins and even enzymes are o deals with the chemical processes
actually applied both in health and disease occurring in living things
states  Instrumentation
 A quantitative science – dealing with o machines and lab equipment are
numbers, measurements of different utilized; very important scientific
biological substances called analytes like discipline in CC
CSF, whole blood, peritoneal fluid, ascitic  Toxicology
fluid, and serum

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CCHM321 | BSMLS 2024 CLINICAL CHEMISTRY 1 TRANSCRIBER: CRUZ, A. M. A.
2022-2023 3RD YEAR, 1ST SEMESTER Prof. Kimberly Ann Pulga, RMT, MPH

o highlights drugs of abuse as well as patient; to locate the pain

TDM – therapeutic drug monitoring and understand what patient
 Endocrinology feels
o study of ductless glands, as well as  In ancient Greece, around 300 BC
physiology and dynamics of o Hippocrates, Father of Medicine
hormones o Urine examination to diagnose
 Analytical Chemistry disease
 Pharmacology o Hippocrates began to attribute
o study of drugs diseases to abnormalities of certain
 Immunology body fluids, particularly b
o focuses in immunity or defense examining urine to diagnose kidney
mechanism against foreign invasion diseases
 Computers  Method of choice – taste
 Note: includes automation patient’s urine and observe
its appearance
COMMON ANALYTES IN THE CLINICAL
CHEMISTRY LABORATORY:  In A.D 50, a Rufus of Ephesus described
hematuria
 Iron, Salts and Minerals o Rufus is a Greek physician
 Small Organic Molecules o Hematuria - presence of blood in
o Metabolites urine
o Therapeutic Drugs o Hematuria can be attributed to
o Toxicology
failure of kidneys
o Drugs of Abuse
 Friedrich Wohler
 Large Molecules
o physician and professor in
o Transport proteins
University of Gottingen
o Enzymes
o Disproved the vital force theory by
o Specific proteins
Berzelius
o Diabetes Marker
 Vital Force Theory, organic
 Note: CC2 will deal with the ff: therapeutic
drugs, toxicology, drugs of abuse, enzymes compounds must have their
origin in living organisms
HISTORY OF CLINICAL CHEMISTRY and consequently could
never be synthesized from
 Before 400 B.C., physicians in Egypt and inorganic material
Mesopotamia made diagnoses by performing (Berzelius)
o Auscultation o Synthesized a compound, urea by
 the action of listening to heating ammonium cyanate.
sounds from the heart, lungs, o Vital Force Theory – Organic
or other organs, typically compounds could be synthesized in
with a stethoscope, as a part the laboratory or in vitro and only
of medical diagnosis exclusive for living things/animals;
o Palpation
organic substances is to living
 uses touch to feel the body
during a physical things only
examination; apply light o Friedrich disproved Vital Force
pressure using fingers to Theory as in his classic experiment,
check and inspect the he was able to produce a compound

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CCHM321 | BSMLS 2024 CLINICAL CHEMISTRY 1 TRANSCRIBER: CRUZ, A. M. A.
2022-2023 3RD YEAR, 1ST SEMESTER Prof. Kimberly Ann Pulga, RMT, MPH

o called urea which is an organic  CAP – College of American

substance formed from heated Pathologists and AACC –
ammonium cyanate which is an American Association of
inorganic substance Clinical Chemistry
o Hence, organic matter can be made  1950
out of an inorganic substance o Discoverer: Levey and Jennings
 1836  Shewhart QC chart
o first clinical textbook was published  Clinical methods for several
 1918 to 1920 enzymes which are
o Discoverer: Otto Folin organspecific
 Clinical methods for  Method for blood
phosphorus & magnesium triglycerides
 Various urine analytes  Levy and Jennings –
determination prominent in field of CC due
 Relationship of NPN to renal to Shewhart QC chart – to
function better tract quality control
- NPN – non-protein and quality assurance
nitrogen o Discoverer: Technicon Corporation
 Folin-Ciocalteau reagent for  Autoanalyzer with FP
CHONs determination principle
o 1920 – several methods were - FP – flame
discovered for determining urine photometry
analytes  1960 (has rapid dev of technology for CC
 1930 especially in instrumentation) – to present
o Discoverer: Beckman Company o Discoverer: Perkin Elmer
 Clinical methods for various  Introduced AAS
enzymes - atomic absorption
 Refractometer spectrophotometer –
 pH meter for determination of
o methods were developed for clinical calcium and
determination of various enzymes magnesium
like alkaline phosphatase/ALP, acid o Discoverer: Becton Dickinson
phosphatase/AC, lipase, serum,  Introduced disposable
blood ammonia needle & syringe
o refractometer was first used o Discoverer: IBM
o pH meter – to measure alkalinity or  Introduced disk storage for
computers
acidity of fluid
o Discoverer: DuPont
 1940
 First CC random-access
o Photoelectric colorimeters
analyzer
 Colorimeters – to read o Laser and first mechanical pipette
certain color reactions;
(known as auto diluter) were
chemistry analysis
developed and put into use
o Vacuum collection tubes
o Establishment of CAP and ACCC

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CCHM321 | BSMLS 2024 CLINICAL CHEMISTRY 1 TRANSCRIBER: CRUZ, A. M. A.
2022-2023 3RD YEAR, 1ST SEMESTER
FLUIDS TYPICALLY USED FOR
CLINCIAL CHEMISTRY TESTS
 Blood, Urine, Cerebrospinal Fluid, Amniotic
Fluid, Saliva, Synovial Fluid, Pleural Fluid,
Pericardial Fluid, and Peritoneal Fluid
 Serum – commonly used sample
REGULATORY GUIDELINES THAT
DEFINE THE PRACTICE OF CLINICAL
CHEMISTRY
 Clinical Laboratory Improvement
Amendments (CLIA) OF 1988
o Quality standards for all clinical
laboratories to ensure accuracy,
reliability and timeliness of patient
test results regardless of where the
test was performed
o Defines clinical laboratories
broadly.
o Two Levels of Regulation:
 Waived Tests
- simple laboratory
examinations and
procedures that are
cleared by the U.S. Food
and Drug Administration
(FDA) for home use.
- e.g. pregnancy test,
other rapid test kits,
urine dipstick test
 Nonwaived Tests
- moderately and highly
complex tests as defined
by the requirements for
operator skill, reagent
preparation, and
automation and the
difficulty of
interpretation of results.
- needs the professional’s
knowledge, skill,
reagents, and machines
to perform this kind of
test, they are regulated
under guidelines that
CCHM321 | BSMLS 2024 CLINICAL CHEMISTRY 1 TRANSCRIBER: CRUZ, A. M. A.
Prof. Kimberly Ann Pulga, RMT, MPH
cover the quality
standards for the
proficiency testing; e.g.
tests in lab like lipid
profile, measurements of
HDL/LDL
 Occupational Safety and Health Act (OSHA)
o Defines clinical laboratories broadly
o Regulations include guidelines for
operating safety equipment and
identifying, handling and storing
chemical hazards.
PURPOSE OF CLINCIAL CHEMISTRY
LABORATORIAN/ MEDICAL
TECHNOLOGIST
 Perform analytical procedures that yields
accurate and precise information, aiding in
patient diagnosis and treatment.
 Correctly use basic supplies and equipment.
 Possesses an understanding of fundamental
concepts critical to any analytic procedure.
SCOPE OF PRACTICE: GENERAL
SERVICES PROVIDED BY CLINICAL
LABORATORY SCIENTISTS / MEDICAL
TECHNOLOGISTS
 Assuring reliable test results that contribute
to the prevention, diagnosis, prognosis, and
treatment of physiological and pathological
conditions. This assurance requires:
o Producing accurate test results
o Correlating and interpreting test
data.
o Assessing and improving existing
laboratory methods.
o Designing, evaluating, and
implementing new methods.
 Designing and implementing cost-effective
administrative procedure for laboratories,
including their services and personnel.
 Designing, implementing, and evaluating
processes for education and continued
education of laboratory personnel.
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2022-2023 3RD YEAR, 1ST SEMESTER Prof. Kimberly Ann Pulga, RMT, MPH

 Developing and monitoring a quality

assurance system to include:
o Quality control of services
o Competence assurance of personnel.
 Promoting an awareness and understanding
of the services they render to the consumer,
the public, and other health-care
professionals
REFERENCES
o Arneson, W., Brickel, J., (2007) Clinical
Chemistry, A Laboratory Perspective (pp.
1-5)
o Bishop, M. L., Fody, E. P., & Schoeff, L.
E. (2018). Clinical Chemistry: Principles,
Techniques, and Correlations. 8th ed.
Philadelphia: Wolters Kluwer
Health/Lippincott Williams & Wilkins.
o Reed, R. (2017) Clinical Chemistry
Learning Guides by Abbott Diagnostics
(pp. 6 to 16)

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CCHM321 | BSMLS 2024 CLINICAL CHEMISTRY 1 TRANSCRIBER: CRUZ, A. M. A.