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Table 1 Prototype assay calibration performance summary using Quanterix standard for assay evaluation and clinical test batches

From: A digital enzyme-linked immunosorbent assay for ultrasensitive measurement of amyloid-β 1–42 peptide in human plasma with utility for studies of Alzheimer’s disease therapeutics

 

Concentrationa (pg/ml)

Theoretical concentration

0.023

0.069

0.206

0.617

1.85

5.6

16.7

50.0

 Run 1

 

0.096

0.199

0.616

1.85

5.56

16.9

49.9

 Run 2

−0.011

0.066

0.224

0.614

1.77

5.67

17.2

49.7

 Run 3

−0.032

0.135

0.281

0.613

1.78

5.56

17.4

49.5

 Run 4

−0.012

0.080

0.201

0.615

1.87

5.48

16.9

49.9

 Run 5

−0.074

0.103

0.218

0.602

1.85

5.54

16.9

49.9

 Run 6

0.061

0.088

0.194

0.620

1.85

5.48

17.0

49.8

 Run 7

 

0.066

0.202

0.627

1.82

5.56

16.8

49.9

 Run 8

 

0.234

0.323

0.525

2.11

5.23

17.5

49.8

 Run 9

 

0.214

0.240

0.583

1.82

5.43

17.8

49.2

N (total number of runs)

5

9

9

9

9

9

9

9

Inter-assay mean

−0.014

0.120

0.231

0.602

1.86

5.5

17.2

49.7

SD

0.049

0.063

0.044

0.031

0.099

0.121

0.350

0.237

CV%

−362

52.1

19.0

5.2

5.3

2.2

2.0

0.5

Inter-assay RE, %

−159

74.2

12.4

−2.5

0.4

−1.8

2.7

−0.5

  1. CV% Coefficient of variation percentage, RE Relative error
  2. In runs 6–8, calibration curves prepared using both Quanterix and Fujirebio standards were included
  3. aConcentrations were interpolated using the calibrator average enzymes per bead values against the fitted cubic curves