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Control Preparation Ofsera1

Control Preparation Ofsera1

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Published by: sulieman omar on Apr 28, 2010
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Preparation of control sera
 Types and Sources of Control Materials.  Serum collection and screening for infectious diseases.  Preparation of different control levels.  Analysis of Control Materials.  Calculation.  Summary comments
04/27/10 Majid Mohammed Ali 2

Quality Control for Quantitative Tests

Preparation of control sera
Majid Mohammed Ali M.Sc Clinical Chemistry

Sources for Control Materials
Commercial product. Diagnostic samples (qualitative QC). “Homemade” or “In-house”. Obtained from:
Another laboratory . EQA provider.


Majid Mohammed Ali


Quantitative QC Materials
• Calibrator:

• a solution which has a known amount of analyte weighed in or has a value determined by repetitive testing using a reference or definitive test method • Control: • material or preparation used to monitor the stability of the test system within predetermined limits


Majid Mohammed Ali


Control solutions- control materials The International Federation of Clinical Chemistry defines a control solution or control material as a "specimen or solution which is analyzed solely for quality control purposes, not for calibration" .
04/27/10 Majid Mohammed Ali 6

Control solutions- control materials We use the term control material or control product to refer to a control solution that is available, usually commercially, in liquid, frozen, or lyophylized form, packaged in small bottles suitable for use on a daily basis.
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Control Material


Majid Mohammed Ali


Types of Control Materials Types of Control Materials
 Assayed mean calculated by the manufacturer must verify in the laboratory  Unassayed less expensive must perform data analysis  “Homemade” or “In-house” pooled sera collected in the laboratory characterized preserved in small quantities for daily use
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Assayed versus Unassayed controls
 Control products are available as assayed or Unassayed materials.  Assayed control materials generally come with an assay sheet of expected values for analytes assayed by various methods and instrument systems.  These assay sheets usually list, for each constituent present, expected mean values as well as expected ranges.
04/27/10 Majid Mohammed Ali 10

“Homemade” or “In-house” pooled sera
pooled sera collected from: pooled sera collected in the laboratory. pooled sera collected in the blood bank. pooled sera collected from animals.
04/27/10 Majid Mohammed Ali 11

In-house pooled sera preparation

Collection. Screening for infectious diseases (HIV 0,1,2, HBsAg, HCV, Syphilis). Freezing to -70 °C( 24 Hr).
04/27/10 Majid Mohammed Ali 12

Analyte levels Constituent levels of quality control materials should be chosen at medical decision concentrations and/or at critical method performance limits such as upper and lower linearity limits.
04/27/10 Majid Mohammed Ali 13

Analyte levels
Two or three different concentrations are often needed for each analyte.  Choosing control materials at critical concentrations will allow the analyst to estimate the random error at critical levels of the method .


Majid Mohammed Ali


levels of quality control materials
Transfer the cooled container to room temperature. Put it upside down on clean dry beaker. Separate to three plasma fraction from the freeze pooled sera. Separated pooled sera fraction stabilized with ethanediol.
04/27/10 Majid Mohammed Ali 15

Analysis of Control Materials Analysis of Control Materials
 Need data set of at least 20 reading to each parameter.  Make sure any procedural variation is represented: different operators different times of day Different instruments.  Determine the degree of variability in the data to establish acceptable range. 04/27/10 Majid Mohammed Ali 16

oCalculate mean. o Standard deviation. o Coefficient of variation. oDetermine target ranges.


Majid Mohammed Ali


Calculation of Mean Calculation of Mean

X +X +X (X ) =
1 2


... + X n


X = Mean X1 = First result X2 = Second result Xn = Last result in series

n – Total number of Mohammed Ali Majid results


Calculation of Mean to glucose results Calculation of Mean to glucose results
1. 2. 3. 4. 5. 6. 192 mg/dL 194 mg/dL 196 mg/dL 196 mg/dL 160 mg/dL 196 mg/dL

7. 200 mg/dL 8. 200 mg/dL 9. 202 mg/dL 10. 255 mg/dL 11. 204 mg/dL 12. 208 mg/dL 13. 212 mg/dL
Majid Mohammed Ali 19


Calculation of Mean to glucose results Calculation of Mean to glucose results
1) 192 mg/dL 2) 194 mg/dL 3) 196 mg/dL 4) 196 mg/dL 5) 196 mg/dL 6) 200 mg/dL 7) 200 mg/dL 8) 202 mg/dL 9) 204 mg/dL 10)208 mg/dL 11)212 mg/dL Sum = 2,200 mg/dL

• Mean = the calculated average of the values • The sum of the values (X1 + X2 + X3 … X11) divided by the number (n) of observations • The mean of these 11 observations is (2200 ÷ 11) = 200 mg/dL


Majid Mohammed Ali


Calculation of Variance Calculation of Variance
Variance is a measure of variability about the mean. It is calculated as the average squared deviation from the mean. the sum of the deviations from the mean, squared, divided by the number of observations (corrected for degrees of freedom)
04/27/10 Majid Mohammed Ali 21

Calculation of Variance (S2) Calculation of Variance (S2)

∑ (X − X ) = mg 2 /dl 2 S = N −1
2 2


Majid Mohammed Ali


Calculation of Standard Deviation Calculation of Standard Deviation
 The standard deviation (SD) is the square root of the variance it is the square root of the average squared deviation from the mean  SD is commonly used (rather than the variance) since it has the same units as the mean and the original observations  SD is the principle calculation used in the laboratory to measure dispersion of a group of values around a mean.


Majid Mohammed Ali


Calculation of Standard Deviation Calculation of Standard Deviation


(x − x ) N −1


= mg/dl

04/27/10 Majid Mohammed Ali 24

Standard Deviation and Probability Standard Deviation and Probability
• For a set of data with a normal distribution, a value will fall within a range of:
– +/- 1 SD 68.2% of the time – +/- 2 SD 95.5% of the time – +/- 3 SD 99.7% of the time

68.2% 95.5% 99.7%
-3s2s +3s -1s Mean +1s +2s


Majid Mohammed Ali


Standard Deviation and Probability Standard Deviation and Probability
 In general, laboratories use the +/- 2 SD criteria for the limits of the acceptable range for a test  When the QC measurement falls within that range, there is 95.5% confidence that the measurement is correct  Only 4.5% of the time will a value fall outside of that range due to chance; more likely it will be due to error
04/27/10 Majid Mohammed Ali 26

Calculation of Calculation of Coefficient of Variation Coefficient of Variation
• The coefficient of variation (CV) is the standard deviation (SD) expressed as a percentage of the mean • Ideally should be less than 5%

SD CV = x 100 mean


Majid Mohammed Ali


Range Range
o Range refers to the difference or spread between the highest and lowest observations. o It is the simplest measure of dispersion. o It makes no assumption about the shape of the distribution or the central tendency of the data. o Calculated from the mean ± 2sd.
04/27/10 Majid Mohammed Ali 28

Summary comments • The selection of appropriate control materials requires consideration of many factors and should be part of the planning process for the selection and implementation of SQC. • Compromises may have to be made in order to limit the number of control materials used.
04/27/10 Majid Mohammed Ali 29

Summary comments

• There is no right or wrong way to choose control materials for a given method, just as there is no perfect control which behaves exactly the same as a fresh human sample. • Control materials being used should be reassessed yearly.
04/27/10 Majid Mohammed Ali 30

Summary comments • Selection of appropriate control materials is a balancing act in which cost, stability, ease of use, performance due to matrix effects, and constituent levels must be considered and weighted for each laboratory’s own application and use.
04/27/10 Majid Mohammed Ali 31

Questions ???
04/27/10 Majid Mohammed Ali 32


Majid Mohammed Ali



Majid Mohammed Ali



Majid Mohammed Ali


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