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lecture 2 (QC)

Pre-analytical variables can account for up to 75% of laboratory errors, highlighting the importance of accurate patient identification, preparation, and proper techniques during blood collection. Key factors affecting laboratory performance include accuracy, precision, specificity, and sensitivity, which are essential for reliable test results. Statistical measures such as mean, standard deviation, and coefficient of variation are used to assess and ensure the quality of laboratory testing.

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3 views

lecture 2 (QC)

Pre-analytical variables can account for up to 75% of laboratory errors, highlighting the importance of accurate patient identification, preparation, and proper techniques during blood collection. Key factors affecting laboratory performance include accuracy, precision, specificity, and sensitivity, which are essential for reliable test results. Statistical measures such as mean, standard deviation, and coefficient of variation are used to assess and ensure the quality of laboratory testing.

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yshunaa
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Effects of Pre-analytical Variables on the Quality of Laboratory Testing

It is clear that regardless of the advances of laboratory technology at the analytical stage,
improvements in preanalytical areas will remain to be a challenge because those variables
can account for up to 75% of laboratory errors.
Examples of possible preanalytical variables:
1. Patient Identification: It is important to identify a patient accurately so that blood is
collected from the correct person.
2. Patient Preparation: glucose and cholesterol, patients. Cortisol and
adrenocorticotropin have diurnal variations.
3. Selecting the Site:
4. Site Preparation:
5. Tourniquet Application and Time:
6. Proper Venipuncture Technique:
Avoid probing to find the vein.
Expired tubes should not be used, as they may have a decreased vacuum, as well as
potential changes in any additives in the tubes.
Blood from patients who are receiving anticoagulant therapy, such as heparin or
Coumadin, may take longer to clot.
Tubes should be allowed to clot at room temperature, upright in a test tube rack, with
the closures on the tubes.
Spinning the tube too soon may result in a gelatinous and/or fibrinous serum sample
that will require respinning.
7. Special Handling of Blood Specimens: Examples of specimens that need to be chilled
or transported on ice include adrenocorticotropic hormone (ACTH), angiotensin
converting enzyme (ACE), acetone, ammonia, catecholamines, free fatty acids, lactic
acid, pyruvate and renin
8. Stability for Whole Blood, Serum and Plasma: Once the serum has been removed or
separated from the red blood cells (in the case of a gel barrier tube), the sample will
be stable at room temperature for eight hours, and up to 48 hours at 2-4 degrees C.
After 48 hours, the serum specimen should be frozen at –20 degrees C in an aliquot
tube.

Common terms used when analysing laboratory performance


 Accuracy
The agreement between your value and the ‘true’ value.Determined absolutely by direct
comparison to a reference value.More commonly assessed by using an assayed control
serum, with accurate values assigned by the manufacturer.The closer your result to the target
value, the greater your accuracy.
 Precision
The reproducibility of your results (i.e. the agreement between replicate measurements)
The closer your results are to each other, for the same analyte, in the same serum, the better
your precision.There are 2 ways in which precision is assessed:
Within run performance (intra-assay precision)
Between run performance (inter-assay precision)
Poor accuracy relatively easy to solve
– Often a calibration problem
Poor precision more difficult
– A variety of causes
• Poor quality reagents
• Badly maintained instruments
• Inadequate training

 Specificity
The ability of a method to measure solely the component of interest.A lack of specificity will
affect accuracy.The test is measuring components other than the analyte of interest.
– Falsely elevated values may occur
• Structurally similar hormones
– FSH, LH, TSH & hCG all have an identical alpha-subunit
– Falsely low values may also occur
• Bromocresol Purple (BCP) method with bovine albumin
– The test does not measure the analyte 100%
– Bovine QC serum cannot be used with this method

 Sensitivity
The ability to detect small quantities of a measured component; Will affect both precision
and accuracy at the bottom end of the clinical range.How is sensitivity established? By
determining at what point an assay’s precision reaches an unacceptable level.
Basic QC Statistics
There are a number of statistical terms commonly used when assessing laboratory
performance;
Mean (͞x ), Standard Deviation (SD), Coefficient of Variation (CV),percent deviation(%
Dev.),standard deviation index(SDI),and the target score(TS).
• Mean (͞x), This is often used in clinical labs to identify the ‘true value’ of a set of data
points.
• Standard Deviation (SD)
• The SD of a set of results is a measure of how disperse the values are about the (͞x ),
i.e. it is a measure of precision. The SD is often used to establish limits or a range for
the acceptability of results. Most laboratories will adopt a 2SD range meaning a result
is deemed acceptable providing it falls within 2SD from the (͞x ). A low SD shows better
precision, less variability and therefore more accurate results. High standard
deviations equate to poor precision and greater variability between results.
 (xi - x) 2
SD = ( )
n -1
• Coefficient of Variation (CV)
A CV is a measure of variability and precision. This takes into consideration the
magnitude of the overall result and expresses the SD as a percentage of the mean.
This calculation will therefore allow comparison of precision at different
concentrations of patient testing.The lower the %CV the better the precision.

SD
CV = x 100%
Mean (x)

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