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P2‐037: Development and analytical validation of a novel assay for measurement of total tau in human CSF
Author(s) -
Dunty Jill,
Berisha Flora,
Dzantiev Leonid,
Simon Adam,
Gleason Carol,
Wong Oitak Allen,
Mbwana Mwanatumu,
Hapip Sara,
Ning Qian,
Braffett Franklin,
Robles Sarah,
Green George,
Neely Robert,
Soares Holly,
Wilbur James,
Oberoi Pankaj,
Stewart David,
Rhyne Paul
Publication year - 2012
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2012.05.740
Subject(s) - reproducibility , chromatography , dilution , matrix (chemical analysis) , cerebrospinal fluid , immunoassay , accuracy and precision , linearity , consistency (knowledge bases) , chemistry , biomedical engineering , computer science , mathematics , medicine , statistics , antibody , engineering , immunology , pathology , physics , artificial intelligence , electronic engineering , thermodynamics
sure differences in A b 1-42 levels between normal and AD samples. The results show an average LLOD (66 runs, 3 lots) of 0.35 pg/mL with a quantitative range of 3 to 2000 pg/mL. The precision, accuracy, and total error were determined from human CSF control samples with typical interand intra-plate precision < 12% CV. Dilution linearity and spike recovery testing demonstrated minimal matrix effects at 1:8 dilution of CSF and accurate quantitation of A b 1-42 peptide over the range of the assay. The assay exhibited tolerance of CSF contamination with hemolyzed blood and showed no significant cross-reactivity to closely related A b peptides, suggesting the assay was highly specific for A b 1-42. Conclusions: A new assay was developed and analytically validated to measure A b 1-42 in human CSF. The A b 1-42 assay had good analytical performance characteristics, inter-lot consistency, and the ability to distinguish A b 1-42 levels between normal and ADCSF samples. This assay will support ongoing efforts to standardize AD biomarker testing.