Validation of a Chemiluminescence Immunoassay for Measuring Amyloid-β in Human Blood Plasma

Abstract

The technical performance of immunological assays and their suitability for the intended use should be carefully validated before implementation in research, clinical studies or routine. We describe here the evaluation of a sandwich electrochemiluminescence immunoassay for measuring total Amyloid-β levels in human blood plasma as an example of a laboratory protocol for a partial "fit for purpose" assay performance validation. We tested two different assay protocols and addressed impact of sample dilution, parallelism, intra- and inter-assay variance, lower limit of quantification, lower limit of detection, and analytical spike recoveries.

Nanosensor-Driven Detection of Neuron-Derived Exosomal Aβ42 with Graphene Electrolyte-Gated Transistor for Alzheimer’s Disease Diagnosis

“…In recent years, a wealth of research endeavors to detect Aβ 42 in serum or plasma using enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence immunoassay, various ingenious biosensors, etc. Qin et al designed a graphite carbon nitride nanosheet-based electrochemical biosensor for the detection of Aβ 42 in serum.…”

“…As such, blood-based proteomic hallmarks are increasingly expected to propel crucial clinical solutions for AD, catalyzed by the restricted clinical applications of the CSF examination. In recent years, a wealth of research endeavors to detect Aβ 42 in serum or plasma using enzyme-linked immunosorbent assay (ELISA), 8 electrochemiluminescence immunoassay, 9 various ingenious biosensors, 10 etc. Qin et al 11 designed a graphite carbon nitride nanosheet-based electrochemical biosensor for the detection of Aβ 42 in serum.…”

Einfluss von prä-analytischen Entnahme- und Lagerungsbedingungen auf die Stabilität und Konzentration von Amyloid-ß-Peptiden in Blut

“…Mit der Methode des Elektrochemilumineszenz Immunmultiplex Assays (V-Plex Aß [6E10] von der Firma Meso Scale Discovery (MSD)), konnten Vogelgsang et al (2018c) einen Fit For Purpose Assay validieren, mit welchem die Möglichkeit besteht, detektierbare Aß-Peptidkonzentrationen im Blutplasma zu messen.…”