CIE Flashcards
- Healthcare facilities providing a wide range of
laboratory procedures which aid the physicians in carrying out the diagnosis, treatment, and
management of patients.
Clinical Laboratory
3 Phases of Laboratory Testing
- Pre-pre-analytical - patient and client interaction
- Pre-analytical - medtech
- Analytical
- Post-analytical
- Post-post-analytical - client and result
Process or procedure that is performed by the
combined activities of Medical technologist and
machine
Semi-automation
First automated analyzer using a flow technique
called continuous flow analysis (CFA)
Autoanalyzer I
Autoanalyzer I inventor
Leonard Skeggs, PhD
It is an instrument or set of instruments that
standardize workflow in a clinical laboratory by
accepting, processing, and resulting specimens
Machine Automation
A continuous flow analysis tests multiple samples at one time, while a sequential analysis tests one sample at a time and are resulted in the order they are tested.
Autoanalyzer
Uses instruments that only work with other pieces of equipment that
are manufactured by the same company
Closed
automation
Uses instruments that exist independently of each other and can interface with other pieces of equipment from different manufacturers.
Open automation
Each sample is analyzed in an individualized reaction chamber
where reagents are added separately
Discrete analysis
A dedicated channel is used for each
single test.
Single-channel
analysis
Several analyses are done at one
time using two or more channels for
the test.
Multiple-channel
analysis
Specimens are tested in or out of the order they are received based
on when required channels are available
Random access
analysis
Completes tests where there is a fixed time for the reaction to be finished (end-point test) ,or completes a continuous monitored
test where several data results are collected at specific time intervals.
Assays
3 Basic approaches with Instrument
- Continuous flow
- Centrifugal analysis
- Discrete analysis
- A sample is injected into a flowing carrier solution
passing rapidly through small-bore tubing. - The sample is mixed with a reagent, which reacts with
the sample to develop a color and determine the
sample concentration.
Continuous Flow Analysis (CFA)
- It uses the force generated by centrifugation to
transfer and then contain liquids in separate cuvettes
for measurement at the perimeter of a spinning rotor. - Most capable of running multiple samples, one test at
a time, in a batch.
Centrifugal Analysis
Centrifugal Analysis major advantage
Batch analysis
- Each specimen in a batch — separate from every other specimen.
- Keep sample separate throughout the testing process, dispensing precise amounts when required.
Discrete Analysis
Rotating individual cuvettes through the instrument instead of releasing the sample in a continuous stream cuts down on reagent waste and can produce hundreds of results per h.
Discrete Analysis
Discrete Analysis e are high throughput machines that can analyze up to ___ samples in one go for single or multiple testing
75
- Transfers via the robotic arm, the sample and
reagents direct to the cuvette where the optical
density will be read. - Benefits:
o Disposable, single use reaction cuvettes, no
clean-up of cuvettes
o Cheaper instrument purchase price
Direct reading Discrete Analyzer
- Initially transfers the sample and reagents to an intermediate reaction cuvette where the color
development progress’. - Once the sample color has saturated, optical density plateaus in the reaction cuvette, it is pumped through a common flow-through cell, used for all samples
where the optical density is measured.
Indirect reading Discrete Analyzer
platforms brought electronic data management to the
laboratory to manage the workflow and electronic
interfaces to the instruments.
LIS/LMS
A system designed to increase the probability that each result reported is valid and can be used with confidence by the physician
Quality Control
How close a determination is to the actual or true
value
Accuracy
The degree to which repeated analysis of the same materials approximate
Precision
- A measure of variability
Coefficient of Variation
- A method of instrument’s CV is expressed as a
percent and is calculated as ______________
CV(%)= (SD/ Mean) (100)
Quantifies the degree of dispersion of data points
about the mean and is used to set limits upon which
control result acceptability is determined
Standard Deviation
Inaccuracy expressed in bias
Systematic error
Imprecision expressed in CV
Random error
- Investigation and testing of the performance of
instrument/equipment in accordance with the agreed
program based on the manufacturer’s specification in
concordance with international and national
standards
Technical Evaluation
Confirmation that the requirements for specification
were met thru the objective evidences
Validation
A documented process that verifies that all aspects of
equipment that affect product quality adhere to the
approved specification and that the
equipment/instrument has been properly delivered
and correctly installed.
Installation Qualification (IQ)
- Documented collection of activities necessary to
demonstrate that an instrument will function
according to its operational specifications.
Operational Qualification (OQ)
Documented collection of activities necessary to
demonstrate that an instrument consistently
performs according to the specification defined by the user and its appropriate for the intended use
Performance Qualification (PQ)
Comparative method to evaluate the systematic
error on the basis of differences
Correlation
precision should be evaluated through ________________________ different samples
within one run of that test
20 replicates of two to three
o The appropriate way to determine which
method delivers the correct result is to compare
to a _________________
reference method
this plot will calculate the average mean
(bias) of the test method to the
comparative method
Bland-Altman difference plot
o Use to establish the measuring interval that can be reported for the assay under evaluation.
Linearity/Reportable range
defined as range of analyte that a method can
quantitatively report, allowing for dilution, ,
concentration, or other pre-treatment.
Clinically Reportable Range (CRR)
the likelihood that, given
the absence of disease, a normal test result
excludes disease. Relates to the negative
predictive value
Diagnostic Specificity
– the likelihood that, given
the presence of disease, an abnormal test result
predicts the disease. Relates to the positive
predictive value of a test
Diagnostic Sensitivity
chance of an individual
having a given disease or condition if the test is
abnormal
Positive predictive value
chance an individual
does not have a given disease or condition if the
test is within the reference interval
Negative predictive value
Formula for Predictive value of negative result
TN/(TN + FN) X 100%
Formula for Predictive value of positive result
TP/(TP + FP) X 100%
Formula for True
-negative rate = diagnostic specificity
TN/(TN + FP) X 100%
Formula for True
-positive rate = diagnostic sensitivity
TP/(TP + FN) = 100%
Formula for False
-positive rate
100% – % specificity
- Contamination of a sample by the sample analyzed
immediately preceding it
Carryover
is the branch of medicine concerning the
study of blood, the blood-forming organs, and blood
diseases
Hematology
- performs routine hematology testing (CBC), limited
coagulation, and various body fluid testing and
analysis. - The testing utilizes the latest technologies to provide
the most accurate results
Hematology Section
also known as blood
cell analyzer.
* The blood cell analyzer machine in the market they
fully automated which can analyze blood sample from
an EDTA tube and the microtainer
Hematology Analyzer
3 Part hematology analyzer testing method is _______________________
Bioelectrical impedance technique
5 part hematology analyzer testing method are mostly using _____________________. It
mainly combine with laser source, testing area and
detector
light scattering detection technique
Cell passing an aperture which a current is flowing
cause changes in electrical resistance that counted as
voltage pulses.
Electrical impedance
It is an excellent method for determining five-part
WBC differentials.
Flow cytometry
The intensity of the forward scatter indicates the cell volume. The side scatter provides information about
the internal cell structure and its content, such as
nucleus and granules. The side fluorescence indicates the amount of nucleic acids present in the cell.
Fluorescent (flow cytometry)
Blood cells scatter light which are detected by a
photodetector
Optical light scattering
Forward LS of Optical light scattering
measure cell size
90° angle of Optical light scattering
measure cell internal complexity/
granularity
Conductivity is determined using a ______________________ that provides information on
the cell internal constituents.
high frequency
electromagnetic probe
provide measurement of blood platelet levels in a fast and simple process
Coagulation Analyzer
could provide diagnostic
prevention from potentially heart attack-inducing
blood clots
A coagulation test
can be used to measure a
coagulation pathway speed, as well as thrombin and
thromboplastin levels in as low as a few minutes
A coagulation analyzer
allows portions of the diluted blood
sample to be analyzed for red blood cells and
platelets.
Diluent
- A reagent system for substantially lysing red blood
cells in a whole blood sample prior to leukocyte
analysis
Lyse
A final acidic media, ranging from about pH 4 to about 6, is used to ____________________ and continuously remove ________________________
stabilize the white blood cells
red blood cell fragments.
is a quantitative science that is
concerned with measurement of amounts of biologically
important substances (called analytes) in body fluids.
Clinical chemistry
“those analytical patient-testing activities provided within the institution but
performed outside the physical facilities of the clinical laboratories
Point of Care Testing (POCT)
highly sophisticated, requiring only a single drop of blood, and are conveniently sized and portable
Glucometer
It is a requirement that manufacturers of equipment
present evaluation data about the analytical performance of
the instrument
Technical Evaluation
Investigation and testing of the performance of
instrument/equipment in accordance with the agreed
program based on the manufacturer’s specification in
concordance with international and national
standards
Technical Evaluation
- Confirmation that the requirements for specification
were met thru the objective evidences.
Validation
