CIE Flashcards

(77 cards)

1
Q
  • Healthcare facilities providing a wide range of
    laboratory procedures which aid the physicians in carrying out the diagnosis, treatment, and
    management of patients.
A

Clinical Laboratory

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2
Q

3 Phases of Laboratory Testing

A
  • Pre-pre-analytical - patient and client interaction
  • Pre-analytical - medtech
  • Analytical
  • Post-analytical
  • Post-post-analytical - client and result
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3
Q

Process or procedure that is performed by the
combined activities of Medical technologist and
machine

A

Semi-automation

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4
Q

First automated analyzer using a flow technique
called continuous flow analysis (CFA)

A

Autoanalyzer I

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5
Q

Autoanalyzer I inventor

A

Leonard Skeggs, PhD

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6
Q

It is an instrument or set of instruments that
standardize workflow in a clinical laboratory by
accepting, processing, and resulting specimens

A

Machine Automation

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7
Q

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.

A

Autoanalyzer

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8
Q

Uses instruments that only work with other pieces of equipment that
are manufactured by the same company

A

Closed
automation

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9
Q

Uses instruments that exist independently of each other and can interface with other pieces of equipment from different manufacturers.

A

Open automation

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10
Q

Each sample is analyzed in an individualized reaction chamber
where reagents are added separately

A

Discrete analysis

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11
Q

A dedicated channel is used for each
single test.

A

Single-channel
analysis

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12
Q

Several analyses are done at one
time using two or more channels for
the test.

A

Multiple-channel
analysis

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13
Q

Specimens are tested in or out of the order they are received based
on when required channels are available

A

Random access
analysis

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14
Q

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.

A

Assays

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15
Q

3 Basic approaches with Instrument

A
  1. Continuous flow
  2. Centrifugal analysis
  3. Discrete analysis
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16
Q
  • 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.
A

Continuous Flow Analysis (CFA)

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17
Q
  • 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.
A

Centrifugal Analysis

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18
Q

Centrifugal Analysis major advantage

A

Batch analysis

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19
Q
  • Each specimen in a batch — separate from every other specimen.
  • Keep sample separate throughout the testing process, dispensing precise amounts when required.
A

Discrete Analysis

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20
Q

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.

A

Discrete Analysis

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21
Q

Discrete Analysis e are high throughput machines that can analyze up to ___ samples in one go for single or multiple testing

A

75

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22
Q
  • 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
A

Direct reading Discrete Analyzer

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23
Q
  • 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.
A

Indirect reading Discrete Analyzer

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24
Q

platforms brought electronic data management to the
laboratory to manage the workflow and electronic
interfaces to the instruments.

A

LIS/LMS

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25
A system designed to increase the probability that each result reported is valid and can be used with confidence by the physician
Quality Control
26
How close a determination is to the actual or true value
Accuracy
27
The degree to which repeated analysis of the same materials approximate
Precision
28
* A measure of variability
Coefficient of Variation
29
* A method of instrument's CV is expressed as a percent and is calculated as ______________
CV(%)= (SD/ Mean) (100)
30
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
31
Inaccuracy expressed in bias
Systematic error
32
Imprecision expressed in CV
Random error
33
* 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
34
Confirmation that the requirements for specification were met thru the objective evidences
Validation
35
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)
36
* Documented collection of activities necessary to demonstrate that an instrument will function according to its operational specifications.
Operational Qualification (OQ)
37
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)
38
Comparative method to evaluate the systematic error on the basis of differences
Correlation
39
precision should be evaluated through ________________________ different samples within one run of that test
20 replicates of two to three
40
o The appropriate way to determine which method delivers the correct result is to compare to a _________________
reference method
41
this plot will calculate the average mean (bias) of the test method to the comparative method
Bland-Altman difference plot
42
o Use to establish the measuring interval that can be reported for the assay under evaluation.
Linearity/Reportable range
43
defined as range of analyte that a method can quantitatively report, allowing for dilution, , concentration, or other pre-treatment.
Clinically Reportable Range (CRR)
44
the likelihood that, given the absence of disease, a normal test result excludes disease. Relates to the negative predictive value
Diagnostic Specificity
45
– 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
46
chance of an individual having a given disease or condition if the test is abnormal
Positive predictive value
47
chance an individual does not have a given disease or condition if the test is within the reference interval
Negative predictive value
48
Formula for Predictive value of negative result
TN/(TN + FN) X 100%
49
Formula for Predictive value of positive result
TP/(TP + FP) X 100%
50
Formula for True -negative rate = diagnostic specificity
TN/(TN + FP) X 100%
51
Formula for True -positive rate = diagnostic sensitivity
TP/(TP + FN) = 100%
52
Formula for False -positive rate
100% – % specificity
53
* Contamination of a sample by the sample analyzed immediately preceding it
Carryover
54
is the branch of medicine concerning the study of blood, the blood-forming organs, and blood diseases
Hematology
55
* 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
56
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
57
3 Part hematology analyzer testing method is _______________________
Bioelectrical impedance technique
58
5 part hematology analyzer testing method are mostly using _____________________. It mainly combine with laser source, testing area and detector
light scattering detection technique
59
Cell passing an aperture which a current is flowing cause changes in electrical resistance that counted as voltage pulses.
Electrical impedance
60
It is an excellent method for determining five-part WBC differentials.
Flow cytometry
61
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)
62
Blood cells scatter light which are detected by a photodetector
Optical light scattering
63
Forward LS of Optical light scattering
measure cell size
64
90° angle of Optical light scattering
measure cell internal complexity/ granularity
65
Conductivity is determined using a ______________________ that provides information on the cell internal constituents.
high frequency electromagnetic probe
66
provide measurement of blood platelet levels in a fast and simple process
Coagulation Analyzer
67
could provide diagnostic prevention from potentially heart attack-inducing blood clots
A coagulation test
68
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
69
allows portions of the diluted blood sample to be analyzed for red blood cells and platelets.
Diluent
70
* A reagent system for substantially lysing red blood cells in a whole blood sample prior to leukocyte analysis
Lyse
71
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.
72
is a quantitative science that is concerned with measurement of amounts of biologically important substances (called analytes) in body fluids.
Clinical chemistry
73
“those analytical patient-testing activities provided within the institution but performed outside the physical facilities of the clinical laboratories
Point of Care Testing (POCT)
74
highly sophisticated, requiring only a single drop of blood, and are conveniently sized and portable
Glucometer
75
It is a requirement that manufacturers of equipment present evaluation data about the analytical performance of the instrument
Technical Evaluation
76
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
77
* Confirmation that the requirements for specification were met thru the objective evidences.
Validation