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Table 10 Comparison of prototype digital enzyme-linked immunosorbent assay (Simoa) amyloid-β 1–42 peptide assay with the Quanterix commercial Simoa assay in the context of use as a pharmacodynamic marker in β-site amyloid precursor protein cleaving enzyme 1 inhibitor clinical trials

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

ELISA

LLOQ (pg/ml; ±20%)

Mean baseline (pg/ml) (SD)

Maximum percentage reduction (SD)

Maximum quantifiable percentage reduction (±20%)

Quanterix commercial Aβ1–42 assay performance

 Aβ1–42 peptide calibrator

    

  Quanterix

0.274 (0.220–0.329)a

17.1 (2.16)b

64 (5)c

98 (96.5–98.7)

  Fujirebio

0.824 (0.659–0.989)a

39.6 (4.93)b

64 (5)c

98 (95.4–98.3)

Prototype Simoa Aβ1–42 assay performance

 Aβ1–42 peptide calibrator

    

  Quanterix

1.2 (0.96–1.44)

18.7 (2.04)d

75 (3)e

94 (92.3–94.9)

  Fujirebio

2.8 (2.24–3.36)

44.35 (4.99)d

79 (3)e

94 (92.4–94.9)

  1. Aβ amyloid-β, ELISA Enzyme-linked immunosorbent assay, LLOQ Lower limit of quantification
  2. Note: Quanterix assay data show the maximum reduction of signal observed in I4O-MC-BACA and the assay’s maximum quantifiable percentage reduction limit for the Quanterix commercial assay. Prototype Simoa assay data show results for the same parameters when using the newly developed Simoa assay
  3. aLLOQ based on lowest standard with replicate performance <20% coefficient of variation
  4. bBaseline values are calculated from study I4O-MC-BACA (not shown)
  5. cMaximum percentage reduction calculated from 35-mg dose group of study I4O-MC-BACA (not shown)
  6. dMean baseline values are calculated from study I4O-MC-BACA (Table 3)
  7. eMaximum percentage reduction calculated from 35-mg dose group of study I4O-MC-BACA (Table 5)
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Alzheimer's Research & Therapy

ISSN: 1758-9193