scholarly journals Validation Procedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices

2010 ◽  
Vol 93 (2) ◽  
pp. 442-450 ◽  
Author(s):  
Michael Abbott ◽  
Stephen Hayward ◽  
William Ross ◽  
Samuel Benrejeb Godefroy ◽  
Franz Ulberth ◽  
...  
Keyword(s):  
Best Practices ◽  
Method Validation ◽  
Validation Study ◽  
Food Allergen ◽  
Food Allergens ◽  
Elisa Method ◽  
Regulatory Authorities ◽  
Status Recognition ◽  
Future Work

Abstract This document provides supplemental guidance on specifications for the development and implementation of studies to validate the performance characteristics of quantitative ELISA methods for the determination of food allergens. It is intended as a companion document to other existing publications on method validation. The guidance is divided into two sections: information to be provided by the method developer on various characteristics of the method, and implementation of a multilaboratory validation study. Certain criteria included in the guidance are allergen-specific. Two food allergens, egg and milk, are used to demonstrate the criteria guidance. These recommendations will be the basis of the harmonized validation protocol for any food allergen ELISA method, whether proprietary or nonproprietary, that will be submitted to AOAC and/or regulatory authorities or other bodies for status recognition. Regulatory authorities may have their own particular requirements for data packages in addition to the guidance in this document. Future work planned for the implementation and validation of this guidance will include guidance specific to other priority allergens.

Determination of ochratoxin A in serum and urine of pigs

2012 ◽  
Vol 5 (4) ◽  
pp. 351-356 ◽  
Author(s):  
N. Perši ◽  
J. Pleadin ◽  
A. Vulić ◽  
I. Kmetić ◽  
B. Šimić
Keyword(s):  
Ochratoxin A ◽  
Method Validation ◽  
Screening Method ◽  
Enzyme Linked Immunosorbent Assay ◽  
Elisa Method ◽  
Relative Standard ◽  
Experimental Group ◽  
Simple Screening ◽  
Serum And Urine

The objective of the study was to determine ochratoxin A (OTA) concentrations in serum and urine of pigs during 30-day OTA treatment. OTA was administered orally to the experimental group (n=5) at a dose of 0.78 mg per animal per day, whereas control animals (n=5) were left untreated. OTA concentrations were determined using a validated enzyme-linked immunosorbent assay (ELISA). Method validation resulted in mean recoveries of 93-101% for serum and 98-106% for urine, with acceptable mean inter- and intraday relative standard deviations (<8% for urine and <7% for serum). The ELISA method can be effectively used as a simple screening method to determine OTA exposure in pigs during fattening. The maximum mean OTA concentration in serum was recorded on day 22 (8.75±2.93 ng/ml) and in urine on day 20 (43.56±35.76 ng/ml), indicating significant differences in OTA concentrations between these two matrices.

Gas Chromatographic-Electron Capture Detection Method for Determination of 29 Organochlorine Pesticides in Finished Drinking Water: Collaborative Study

1990 ◽  
Vol 73 (2) ◽  
pp. 276-286
Author(s):  
Viorica Lopez-Avila ◽  
Raymond Wesselman ◽  
Kenneth Edgell
Keyword(s):  
Gas Chromatography ◽  
Drinking Water ◽  
Method Validation ◽  
Electron Capture ◽  
Validation Study ◽  
Matrix Effects ◽  
Collaborative Study ◽  
Electron Capture Detection ◽  
Chlorinated Pesticides

Abstract A joint U.S. Environmental Protection Agency/AOAC interlaboratory method validation study was conducted on EPA Method 508, Determination of Chlorinated Pesticides in Water by Gas Chromatography with an Electron Capture Detector, to determine the mean recovery and precision for analyses of 29 pesticides in reagent water and finished drinking water. The study design was based on Youden's nonreplicate plan for collaborative tests of analytical methods. The waters were spiked with 29 pesticides at 6 concentration levels, as 3 Youden pairs. Eleven volunteer laboratories extracted the spiked test waters with methylene chloride, performed a solvent exchange with methyl ferf-butyl ether, and analyzed an aliquot of each extract by gas chromatography with electron capture detection. Results were analyzed using an EPA computer program, Interlaboratory Method Validation Study (IMVS), which measured recovery and precision for each of the 29 pesticides and compared the performance of the method between water types. Method 508 was judged acceptable for all analytes tested. Only 3 analytes (α-chlordane, 4,4′-DDE, and methoxychlor) exhibited practical significant matrix effects. The method has been adopted official first action.

Method Validation for Determination of Lignan Content in Fermented Sesame by Bioconversion

2017 ◽  
Vol 46 (5) ◽  
pp. 646-652
Author(s):  
Tae-Dong Jung ◽  
Jae-Min Kim ◽  
Sun-Il Choi ◽  
Seung-Hyun Choi ◽  
Bong-Yeon Cho ◽  
...  
Keyword(s):  
Method Validation

scholarly journals The Importance of Diet in Predicting the Remission of Urticaria—Determination of Allergen-Specific IgE

Medicina ◽  
2021 ◽  
Vol 57 (7) ◽  
pp. 679
Author(s):  
Monica Iuliana Ungureanu ◽  
Liliana Sachelarie ◽  
Radu Ciorap ◽  
Bogdan Aurelian Stana ◽  
Irina Croitoru ◽  
...  
Keyword(s):  
Predictive Value ◽  
Allergic Diseases ◽  
Specific Ige ◽  
Egg White ◽  
Food Allergens ◽  
Pediatric Hospital ◽  
Disease Remission ◽  
Specific Serum ◽  
Different Types

Background and Objectives: Different types of food introduced gradually in the diet will expose children to different food allergens, increasing the chance of developing allergic diseases. The aim of our study was to determine if allergen-specific IgE values can influence, depending on the diet, the prediction of remission of urticaria in children. Materials and Methods: This prospective study was conducted in 132 patients diagnosed over two years with urticaria, admitted to “Sf. Maria” Clinical Pediatric Hospital Iaşi. Total IgE assay was performed by ELISA, and determination of specific serum IgE by the CLA System Quanti Scan method (Innogenetics, Heiden, Germany). Data were gathered and statistical analysis was performed using statistical software SPSS, using descriptive and inferential statistics. Results: The determination of specific IgE to food allergens was performed on a total of 132 cases. The values of specific IgE were positive for one or more food allergens in 84 patients (63.64%). The most common allergens involved were: cow’s milk in 33.3% cases, egg white in 22.6% cases, and hazelnuts in 11.9% cases. The specific IgE values for the different types of food included in our study had a predictive value for disease remission. Conclusions: The determination of specific IgE confirms the presence of a particular food allergen and may have predictive value for the future development of an allergic manifestation.

Determination of Melatonin Hormone and Neurotransmitters in Cerebrospinal Fluid: Method Validation and Uncertainty Calculations

2018 ◽  
Vol 73 (6) ◽  
pp. 613-625
Author(s):  
Özge Yetgin Çetin ◽  
Hatice Karadeniz ◽  
Alper Karakaş ◽  
Serpil Yenisoy-Karakaş
Keyword(s):  
Cerebrospinal Fluid ◽  
Method Validation
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