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Table 3 Assay performance of the CytoBead CeliAK assay

From: Simultaneous detection of celiac disease-specific IgA antibodies and total IgA

Day

TG2autoAb (U/mL)

DG Ab (U/mL)

Total IgA (g/L)

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

Intra-assay variance

 

68.6

69.5

67.6

70.2

69.0

49.2

35.6

41.7

44.0

41.6

0.32

0.29

0.28

0.29

0.27

 SD

4.3

1.8

2.6

3.2

1.1

3.4

3.4

2.6

1.8

2.9

0.02

0.02

0.02

0.02

0.02

 CV %

6.3

2.6

3.8

4.5

1.5

6.9

9.5

6.2

4.0

6.9

6.2

6.9

7.1

6.8

7.4

Inter-assay variance days a–e

 

68.9

    

42.4

    

0.29

    

 SD

0.9

    

4.9

    

0.01

    

 CV %

1.4

    

11.5

    

6.4

    
  1. Autoantibodies (autoAb) to tissue transglutaminase type 2 (TG2) and deamidated gliadin (DG) as well total serum IgA were determined by CytoBead CeliAK in reference sera diluted 1–10. Intra-assay and inter-assay (8 times per run over 5 days) coefficients of variation (CV) were determined in accordance with the CLSI protocol EP15-A2
  2. AU arbitrary units, SD standard deviation