Process Control - Quality Control For Qualitative and Semiquantitative Procedures

Process control—

quality control for qualitative

and
semiquantitative procedures
Dr Abdulaziz Aloliqi
Objectives
• At the end of this lecture, student will be able to:
1. Overview
2. Quality control materials
3. Quality control of stains
4. Quality control of microbiological media
5. Summary
Overview
• Qualitative and semiquantitative examinations
• Qualitative examinations are those that measure the presence or absence of a substance, or
evaluate cellular characteristics such as morphology. The results are not expressed in numerical
terms, but in descriptive or qualitative terms such as “positive”, “negative”, “reactive”,
“nonreactive”, “normal” or “abnormal”.
• Examples of qualitative examinations include microscopic examinations for cell morphology or
presence of parasitic organisms, serologic procedures for presence or absence of antigens and
antibodies, some microbiological procedures and some molecular techniques.
Overview
• Semiquantitative examinations are similar to qualitative examinations; testing does not measure the
precise quantity of a substance. The difference is that results of these tests are expressed as an estimate of
how much of a measured substance is present. This estimate is sometimes reported as a number.
Therefore, test results for semiquantitative tests may be shown as “trace amount”, “1+, 2+ or 3+”, or
positive at 1:160 (titre or dilution). Examples of semiquantitative examinations are urine dipsticks, tablet
tests for ketones and serological agglutination procedures.
• Some microscopic examinations are considered semiquantitative because results are reported as estimates
of the number of cells seen per low-power field or high-power field. For example, a urine microscopic
examination might report 0–5 red blood cells seen per high-power field.
• If QC results are not acceptable, do not report patient results.

Quality control materials
• Qualitative and semiquantitative examinations include tests that utilize
a variety of control materials. These controls may be built-in (on-
board or procedural) controls, traditional controls that mimic patient
samples, or stock cultures for use with microbiological examinations.
• Built-in controls are those that are integrated into the design of a test
system such as a test kit device. Usually, the device is marked with
designated areas where coloured lines, bars or dots should appear to
indicate success or failure of positive and negative controls, and these
controls are performed automatically with each test.
• Examples of test kits with built-in controls are rapid tests that detect the presence of
antigens or antibodies, such as those for infectious disease (human immunodeficiency
virus [HIV], influenza, lyme disease, streptococcal infection, infectious
mononucleosis), drugs of abuse, pregnancy or faecal occult blood.
• QC in microbiology requires use of live control organisms with predictable
reactions to verify that stains, reagents and media are working correctly. They must
carefully maintained in the form of stock and working cultures. For each reaction,
organisms with both positive and negative results should be tested.
• Some laboratories may choose to use isolates from their own laboratories for QC.
If so, they should be monitored closely to verify that reactions tested are sustained
over time.
Quality control of microbiological media
• The quality of media used in the microbiology laboratory is crucial to achieving
optimal and reliable results.
• In all cases, in-house and purchased media should be carefully checked for:
• Sterility — incubate overnight before use
• Appearance — check for turbidity, dryness, evenness of layer, abnormal colour
• pH
• ability to support growth — using stock organisms
• ability to yield the appropriate biochemical results — using stock organisms.
Quality control of microbiological media
• Use of control organisms for verification:
• The laboratory must maintain suffi cient stock organisms to check all its media and
test systems. Some examples of important stock organisms, and the media checked,
include:
• Escherichia coli (ATCC 25922): MacConkey or eosin methylene blue (EMB), some antimicrobial
susceptibility testing.
• Staphylococcus aureus (ATCC 25923): blood agar, mannitol salt and some antimicrobial
susceptibility tests.
• Neisseria gonorrhoeae (ATCC 49226): chocolate agar and Thayer–Martin agar.
Summary
• Qualitative and semiquantitative examinations are those that give non-numerical results. Qualitative
examinations measure the presence or absence of a substance, or evaluate cellular characteristics such as
morphology. Semiquantitative examinations provide an estimate of how much of the measured substance is
present.
• Qualitative and semiquantitative testing must be monitored by QC processes. These processes should use
controls that mimic patient samples as much as possible. Quality controls that check kits, reagents, stains
and microbiological media and ensure that they work as expected must be used whenever they are
available.
• The laboratory must establish a QC programme for all of its qualitative and semiquantitative tests. In
establishing this programme, set policies, train staff and assign responsibilities, and ensure that all resources
needed are available. Make sure that recording of all QC data is complete, and that appropriate review of
the information is carried out by the quality manager and the laboratory director.

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Process control—

quality control for qualitative

• If QC results are not acceptable, do not report patient results.

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