Table 3 Proportion of patients who are misclassified when laboratory testing for diabetes is repeated (American Diabetes Association criteria).

From: Impact of analytical and biological variations on classification of diabetes using fasting plasma glucose, oral glucose tolerance test and HbA1c

Tests

True classification

Classification after repeated tests

Without bias (%)

With positive bias (%)

With negative bias (%)

Fasting Plasma Glucose Biological variation: 5.7% Analytical variation: 2.5%

Normal (<5.6 mmol/L)

Normal

91.5

70.5

98.7

Impaired

8.5

29.4

1.3

Diabetes

0

0

0

Impaired (5.6–6.9 mmol/L)

Normal

25.3

6.1

54.3

Impaired

71.6

81.3

45.3

Diabetes

3.1

12.6

0.5

Diabetes (≥7 mmol/L)

Normal

0

0

0.1

Impaired

10.5

2.4

24.1

Diabetes

89.5

97.6

75.8

OGTT Biological variation: 16.7% Analytical variation: 2.5%

Normal (<7.8 mmol/L)

Normal

91.5

85.5

95.4

Impaired

8.5

14.4

4.6

Diabetes

0

0.1

0

Impaired (7.8–11.0 mmol/L)

Normal

26.9

17.4

37.8

Impaired

61.7

62.7

56.1

Diabetes

11.4

19.9

6.1

Diabetes (≥11.1 mmol/L)

Normal

1

0.5

1.8

Impaired

15.9

10.3

22.1

Diabetes

83.1

89.2

76.1

HbA1c Biological variation: 1.8% Analytical variation: 2%

Normal (<5.7%)

Normal

86.8

66.3

98.1

Pre-diabetes

13.2

33.7

1.9

Diabetes

0

0

0

Pre-diabetes (5.7–6.4%)

Normal

17.2

4.9

44.3

Pre-diabetes

80.6

88.3

55.4

Diabetes

2.2

6.8

0.3

Diabetes (≥6.5%)

Normal

0

0

0

Pre-diabetes

10.3

3

25.1

Diabetes

89.7

97

74.9

HbA1c Biological variation: 1.8% Analytical variation: 3.5%

Normal (<5.7%)

Normal

81.3

64.2

94.3

Pre-diabetes

18.7

35.8

5.7

Diabetes

0

0

0

Pre-diabetes (5.7–6.4%)

Normal

22.3

10.1

44.4

Pre-diabetes

73.7

80.2

54.6

Diabetes

4

9.7

1

Diabetes (≥6.5%)

Normal

0

0

0.1

Pre-diabetes

12.9

5.9

24.9

Diabetes

87.1

94.1

75

  1. A between-laboratory positive bias of +7% and +2.5% were introduced for the fasting plasma glucose/oral glucose tolerance test, and HbA1c, respectively. A between-laboratory negative bias of −6% and −3% were introduced for the fasting plasma glucose/oral glucose tolerance test, and HbA1c, respectively.