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BACKGROUND: External quality assessment provides an essential tool for medical laboratories which enables participants
to evaluate both assay performances and established quality standards. Croatian Centre for Quality Assessment in Croatia
provides quality assessment for biochemistry assays through corresponding module in every round of the scheme. The
performance of each laboratory is evaluated using previously established allowable limits of deviation from consensus mean of
comparison. In the last three rounds of the quality assessment scheme certified referent values based on reference methods has
been assigned for 17 analytes. Reference values give the opportunity to access trueness of laboratory measurements
procedures, especially when multiple instruments, reagents and calibrators are used. We compared the deviation of consensus
overall mean from reference value for each of those 17 analytes and calculated the percentage of laboratories that met the
criteria of allowable limits when both reference value and consensus overall mean were set as a target value.
MATERIALS AND METHODS: The data reported RESULTS: Average biases of consensus overall means vs.
during three biochemistry rounds have been reviewed. reference values ranged from 0,69% (Na) to 9,15% (CK).
The biases of target values were calculated using The percentage of laboratories that met the allowable limits of
formula: performance ranged from 66,3 – 100% when consensus
overall mean was set as a target value, whereas
The number of laboratories that met the allowable limits the range is 51,1-100% when using reference value as target
of performance (ALP) criteria was calculated first by value. Table 1. summarizes the results of laboratories’
defining minimum and maximum values allowed performances according to different choice of target value.
and then
Table 1: Results of data evaluating when consensus overall mean and
counting the number of laboratories that fulfilled the reference value are set as a target value. Pink shaded are results with
criteria. largest differences in performance status.
N Consensus Bias ± ALP – ± ALP – N Consensus Bias ± ALP – ± ALP – N Consensus Bias(%) ± ALP – ± ALP –
ANALYTE ALP(%) mean (%) consensus reference mean (%) consensus reference mean consensus reference
(reference mean (%) value (%) (reference mean (%) value (%) (reference mean (%) value (%)
value) value) value)
ALT 12 177 36 (35) 2,86 93.8 92.7 177 143 (140) 2,14 97.2 96.6 181 43 (42) 2,38 95.6 94.5
AST 15 177 38 (42) -9,52 97 64 177 184 (196) -6,12 97.7 93.2 181 43 (46) -6,52 96.0 85.0
Calcium 5 98 2,39 (2,43) -1,65 93.9 91.8 98 3,36 (3,35) 0,30 95.9 96.9 99 2,33(2,32) 0,43 92.9 92.9
Chloride 4 88 107 (110) -2,73 93.2 79.5 86 134 (137) -2,19 93.0 79.1 91 111 (114) -2,63 94.5 81.3
Cholesterol 10 177 4 (3,9) 2,56 99.4 97.7 176 6,0 (6,0) 0,00 98.3 97.7 179 4,1 (4,0) 2,50 99.4 99.4
CK 12 105 63 (71) -11,27 87.6 60 105 305 (323) -5,57 92.4 85.7 104 101 (113) -10,62 97.1 57.7
Creatinine 8 178 83 (82) 1,22 66.3 68.5 177 252 (262) -3,82 84.2 80.2 182 84 (79) 6,33 67.6 51.1
GGT 12 175 38 (42) -9,52 96 90.3 177 146 (149) -2,01 98.3 97.2 181 37 (42) -11,90 97.8 81.2
Glucose 5 178 4,5 (4,5) 0,00 94.4 94.4 178 10,8 (10,9) -0,92 92.1 92.7 182 4,5 (4,3) 4,65 96.7 83.0
LD 12 109 140 (143) -2,10 97.3 95.4 110 305 (310) -1,61 100.0 99.1 108 144 (149) -3,36 98.1 97.2
Magnesium 15 62 0,92 (0,91) 1,10 95.2 98.4 62 1,50 (1,51) -0,66 98.4 98.4 60 0,80 (0,79) 1,27 100.0 100.0
Potassium 5 176 3,9 (4,0) -2,5 96.0 99.4 176 5,9 (6,0) 1,67 93.7 98.3 179 3,8 (3,8) 0,00 96.6 96.6
Protein 5 156 62 (62) 0,00 96.8 96.8 155 101 (103) -1,94 89.7 97.7 157 68 (68) 0,00 94.9 94.9
Sodium 3 176 135 (136) -0,74 98.3 98.3 176 166 (167) -0,60 88.6 94.3 179 137 (138) -0,72 97.2 96.6
Triglycerides 15 178 1,1 (1,2) -8,33 98.9 99.4 176 4,6 (4,9) -6,12 98.3 98.9 179 1,0 (1,0) 0,00 98.9 98.9
Urea 10 177 4,5 (4,7) -4,26 100 98.9 177 12,5 (12,6) -0,79 98.3 98.3 181 4,7 (4,5) 4,44 97.2 95.6
Uric acid 12 176 305 (299) 2,01 98.3 97.7 175 666 (648) 2,78 98.3 97.1 179 306 (298) 2,68 97.8 98.3
N – number of results; ALP - allowable limit of performance; ±ALP – consensus mean (reference vale) – percentage of results within allowable limits of performance when consensus mean (reference value) is
set as a target value ; Bias - deviation of consensus overall mean from target value (B= (consensus-target)/target x 100; ALT –Alanine- aminotransferase; AST-Aspartate-aminotransferase; CK – Creatine-
kinase; GGT-γ-glutamil transferase; LD-Lactate dehydrogenase
CONCLUSIONS:
Deviations from target values were higher when reference values were set as target value and the extent of deviation depends on
the analyte and the value.