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Quality Control in Serology
Quality Control in Serology
Dr.T.V.Rao MD
DR.T.V.RAO MD
Routinely collect and analyze data from every test run or procedure
Allows for immediate corrective action
DR.T.V.RAO MD
DEFINITIONS
Quality Control - QC refers to the measures that must be
included during each assay run to verify that the test is working properly.
Quality Assurance
- QA is defined as the overall program that ensures that the final results reported by the laboratory are correct.
The aim of quality control is simply to ensure that the results generated by the test are correct. However, quality assurance is concerned with much more: that the right test is carried out on the right specimen, and that the right result and right interpretation is delivered to the right person at the right time
DR.T.V.RAO MD
DEFINITIONS
Quality Assessment - quality assessment (also
known as proficiency testing) is a means to determine the quality of the results generated by the laboratory. Quality assessment is a challenge to the effectiveness of the QA and QC programs.
DR.T.V.RAO MD
DESIGNING A QC PROGRAM
Establish written policies and procedures Corrective action procedures
Equipment
Information Management
Occurrence Management
Assessment
Process Improvement
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Customer Service
Patient/Client Prep Sample Collection Reporting Data and Lab Management Safety Customer Service Personnel Competency Test Evaluations
Record Keeping
Quality Control
Testing
Sample Transport
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COLLECTION OF SPECIMEN
There must be a system for the orderly and efficient requesting of tests; collection and identification of specimens; and transporting, preparation, and storage of specimens. Nothing is more important than having an adequate amount of an appropriate specimen in good condition for examination. If each specimen is not properly collected, labeled, and handled, or is not representative, the laboratory may do more harm than good by testing it.
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Epidemiological tools
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are now available and every day new ones are added to an already impressive list. Every laboratory must define a policy for conducting these tests because some may be expensive, all require certain reagents (sera or antigens etc.) which have limited shelf life, and all require standardised techniques which must be documented in SOPM.
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CONTROL SERA
Source
Some control sera are available commercially. Small volumes are generally available as components in kits but are intended to be used only with a single kit. A few may be available in larger quantities.
Preparation
Sera to be used as controls should be kept sterile to avoid deterioration. In general each procedure should have a normal control serum (negative), a strong positive control serum, and another positive control serum which is reactive at the critical concentration (borderline positive). With some tests, controls with a low concentration of analyze should be included. Controls recommended by the manufacturer of a particular test should always be used and additional control sera can be included if a test involves special problems.
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STORAGE
Sera to be used as controls should be standardized against international reference materials when they are available. "Standards" included in commercial kits are not calibrated with each other and often are not interchangeable. These should be stored in aliquotes in frozen forms. Repeated
freezing and thawing should be DR.T.V.RAO MD avoided.
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WHAT IS CLINICAL SPECIFICITY The clinical specificity of a method is evaluated by testing negative samples and samples containing substances which might cause interference. Closely related or cross-reacting substances frequently found in clinical specimens should be included .
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Discard
S/Co Ratio
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12 10 8 6
4
2 0 1024 2048 4096 8192 16384 32768 65536 2 4 8 16 32 64 128 256 512 131072 262144 524288
Doubling Dilutions
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EVALUATION ON PRECISION
The precision of a quantitative or Semiquantitative test must be evaluated in light of the precision required for the clinical application of the test results. Many factors affect precision, but one that is frequently overlooked in serologic tests is the size of the dilution increments. If all other variables are held constant, serologic tests tend to become less precise as the size of the dilution increment increases. For example, it should be expected that a test based on a four fold dilution would be less precise than the same test with a twofold dilution.
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ERRORS IN MEASUREMENT
True value - this is an ideal concept which cannot be achieved. Accepted true value - the value approximating the true value, the difference between the two values is negligible. Error - the discrepancy between the result of a measurement and the true (or accepted true value).
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ANTIBODY TEST
Flocculation test (RPR) control procedures required Nonreactive serum control Weakly reactive serum control Reactive serum control
Expected results
No clumping Clumping of graded activity Clumping of graded activity
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ANTIBODY TEST
Antibody test
No clumping Clumping
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ANTIBODY TEST
Antibody test
Direct agglutination (Widal test, STA for Brucellosis)
Control procedures required Antigen control Negative control serum Positive control serum Expected results No clumping No clumping Clumping
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ANTIBODY TEST
Antibody test Passive haemagglutination (ASO) Control procedures required Streptolysin control Red cell control Expected results Hemolysis No hemolysis
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ANTIGEN TEST
Antigen test Coagglutination test (Haemolytic streptococci meningitis antigens) Control material
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Control material
Pneumococci Haemolytic streptococci H.influenzae type b Acinetobacter anitratum Expected result Capsular swelling No reaction Capsular swelling No reaction
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DESIGNING A QC PROGRAM
Establish written policies and procedures Corrective action procedures Train all staff Design forms Assure complete documentation and review
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QUALITATIVE QC
Quality control is performed for both, system is somewhat different Controls available Blood Bank/Serology/Micro RPR/TPHA Dipstick technology Pregnancy
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different operators
different times of day Determine the degree of variability in the data to establish acceptable range
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MEASUREMENT OF VARIABILITY
A certain
Variability is affected by operator technique, environmental conditions, and the performance characteristics of the assay method. The goal is to differentiate between variability due to chance from that due to error.
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SOURCES OF ERROR
Input data required - such as standards used, calibration values, and values of physical constants.
Inherent characteristics of the quantity being measured - e.g. CFT and HAI titer.
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RANDOM ERROR
An error which varies in an unpredictable manner, in magnitude and sign, when a large number of measurements of the same quantity are made under effectively identical conditions. Random errors create a characteristic spread of results for any test method and cannot be accounted for by applying corrections. Random errors are difficult to eliminate but repetition reduces the influences of random errors. Examples of random errors include errors in pipetting and changes in incubation period. Random errors can be minimized by training, supervision and adherence to standard operating procedures.
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SOURCES OF ERROR
Input data required - such as standards used, calibration values, and values of physical constants. Inherent characteristics of the quantity being measured - e.g. CFT and HAI titer. Instruments used - accuracy, repeatability. Observer fallibility - reading errors, blunders, equipment selection, analysis and computation errors. Environment - any external influences affecting the measurement. Theory assumed - validity of mathematical methods and approximations. DR.T.V.RAO MD 51
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MONITORING QC DATA
Use Levey-Jennings chart
Plot control values each run, make decision regarding acceptability of run
Monitor over time to evaluate the precision and accuracy of repeated measurements Review charts at defined intervals, take necessary action, and document
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