Multi-laboratory validation of the xMAP-Food Allergen Detection Assay: A multiplex, antibody-based assay for the simultaneous detection of food allergens.

The increasing prevalence of individuals with multiple food allergies and the need to distinguish between foods containing homologous, cross-reactive proteins have made the use of single-analyte antibody-based methods (e.g., ELISAs) sometimes insufficient.

Robustness Testing of the xMAP Food Allergen Detection Assay: A Multiplex Assay for the Simultaneous Detection of Food Allergens.

Abstract: The xMAP food allergen detection assay (xMAP FADA) can simultaneously detect 15 analytes (14 food allergens plus gluten) in one analysis. The xMAP FADA typically employs two antibody bead sets per analyte, providing built-in confirmation that is not available with other antibody-based assays. Before an analytical method can be used, its reliability must be assessed when conditions of the assay procedure are altered.

Extension of xMAP Food Allergen Detection Assay To Include Sesame.

An estimated 0.1 to 0.2% of the North American population is allergic to sesame, and deaths due to anaphylactic shock have been reported.

Single-Laboratory Validation of the Multiplex xMAP Food Allergen Detection Assay with Incurred Food Samples.

An xMAP Food Allergen Detection Assay (xMAP FADA) was developed to meet analytical needs when responding to complaints by individuals with multiple food allergies and to address potential ambiguities associated with cross-reactive proteins. A single-laboratory validation (SLV) was conducted to examine the reliability of the xMAP FADA to detect 15 analytes individually or as part of a mixture at more than six concentrations in four foods. The xMAP FADA reliably detected the analytes despite the incurred dark chocolate and incurred baked muffins displaying recoveries of 10-20% and <60%, respectively.

Cross-reactivity by botanicals used in dietary supplements and spices using the multiplex xMAP food allergen detection assay (xMAP FADA).

Food allergies affect some 15 million Americans. The only treatment for food allergies is a strict avoidance diet. To help ensure the reliability of food labels, analytical methods are employed; the most common being enzyme-linked immunosorbent assays (ELISAs).

Insights in regulated bioanalysis of human insulin and insulin analogs by immunoanalytical methods.

Despite the long and illustrious history of insulin and insulin analogs as important biotherapeutics, the regulated bioanalysis (in this article, regulated bioanalysis refers to the formalized process for generating bioanalytical data to support pharmacokinetic and toxicokinetic assessments intended for development of insulin and insulin analogs as biotherapeutics, as opposed to the analytical process used for measuring insulin as a biomarker) of these peptides remains a challenging endeavor for a number of reasons. Paramount is the fact that the therapeutic concentrations are often low in serum/plasma and not too dissimilar from the endogenous level, particularly in patients with insulin resistance, such as Type 2 diabetes mellitus. Accordingly, this perspective was written to provide helpful background information for the design and conduct of immunoassays to support regulated bioanalysis of insulin and insulin analogs.

Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs.

Regulatory recommendations for providing bioanalytical support for biological therapeutics have co-evolved with the increasing success of these unique pharmaceuticals. Immunoassays have been used to quantify biological macromolecules for more than 50 years. These assays rely on the use of antigen-specific antibodies.

Whole blood international normalization ratio measurements in children using near-patient monitors.

Purpose: To report a comparison of international normalization ratio (INR) measurements on four near-patient (point-of-care or bedside) whole blood INR monitors in children.

Patients And Methods: The INR results from 19 ambulatory pediatric subjects (30 hospital visits) receiving warfarin sodium were analyzed on four near-patient monitors and compared with plasma INR measurements on the laboratory CA-1000 Analyze. The instruments evaluated were CoaguChek, Hemochron Jr.