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Drucker Diagnostics Paralens Advance User Manual

Page 49

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7.4.1 Precision (continued)

In a separate precision study, intra- and inter-run
precision were assessed using a dual level QBC
Control (#424304). The controls were assayed on

multiple days at three sites using QBC AccuTubes
and the QBC Autoread Plus System. The results of
this study are presented in Table 7-2.

7-3

Table 7-2

.

AccuTube Precision Using QBC Control

Normal Level

Abnormal Level

Parameter

Site

Mean Value

Intra-run

Inter-run

Mean Value

Intra-run

Inter-run

% CV.

df

% CV.

df

% CV.

df

% CV.

df

HCT (%)

#1

33.67

1.28

28

0

14

28.47

0.94

26

0.66

14

#2

33.87

0.92

22

0

11

28.49

1.10

22

0

11

#3

34.75

0.51

24

0

12

29.34

0.82

24

0

12

HGB (g/dL)

#1

11.85

0.47

28

0.32

14

10.09

0.68

28

0

14

#2

11.96

0.56

22

0

11

10.24

0.43

22

0.21

11

#3

12.15

0.58

24

0

12

10.35

0.61

24

0

12

PLT (× 10

9

/L)

#1

386.89

5.15

28

5.09

14

141.05

6.03

28

4.14

14

#2

387.91

6.69

22

8.88

11

128.50

5.38

22

2.96

11

#3

330.37

4.50

24

1.09

12

129.38

4.74

24

2.70

12

WBC

(× 10

9

/L)

#1

9.55

9.07

28

6.70

14

19.06

9.05

28

0

14

#2

7.36

7.24

22

4.31

11

16.09

4.75

22

6.15

11

#3

7.69

8.11

24

2.78

12

15.51

5.47

24

3.83

12

GRAN (× 10

9

/L)

#1

6.15

9.30

28

5.76

14

10.29

8.28

28

0

14

#2

4.67

8.58

22

7.33

11

8.01

3.66

22

4.08

11

#3

4.94

8.39

24

3.61

12

8.27

4.73

24

3.18

12

LYMPH/MONO

(× 10

9

/L)

#1

3.40

12.05

28

8.95

14

8.77

11.32

28

0

14

#2

2.68

7.60

22

8.21

11

8.07

6.53

22

8.71

11

#3

2.74

11.86

24

4.13

12

7.24

9.09

24

5.49

12

Key to QBC Control Precision Table:
Intra-run precision = variability between duplicate tubes during the same run.
Inter-run precision = variability between two runs per day over multiple days.
df = degrees of freedom
0 = negative estimate (variance was negative)
Site #1 & Site #2 = POLs
Site #3 = BDPCD

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