Validation of an immunoassay for detection and quantitation of a genetically modified soybean in food and food fractions using reference materials: interlaboratory study

J AOAC Int. 2000 Jul-Aug;83(4):919-27.

Abstract

An immunoassay for detection of a specific genetically modified soybean (Roundup-Ready) was validated on dried soybean powder in an interlaboratory study. Different percentages of genetically modified soybeans in nonmodified soybean matrix were evaluated in a blind study. Thirty-eight laboratories from 13 countries participated. The immunoassay was evaluated for 2 endpoints: (1) To give a semiquantitative result, i.e., determination of a given sample above or below a given threshold, or (2) to compute a quantitative result, i.e., percentage of genetically modified soybeans in the sample. Semiquantitative results showed that a given sample which contained <2% genetically modified soybeans was identified as below 2% with a 99% confidence level. Quantitative use of the assay resulted in a repeatability (r) and reproducibility (R) that were computed to be RSDr = 7% and RSDR = 10%, respectively, for a sample containing 2% genetically modified soybeans. Application of this method depends on availability of appropriate reference materials for a specific food matrix. Only matrix-matched reference materials can be used for analysis of food or food fractions.

MeSH terms

  • Antibodies, Monoclonal
  • Calibration
  • Food Analysis / methods*
  • Genetic Engineering*
  • Glycine max / chemistry
  • Glycine max / genetics*
  • Immunoassay*
  • International Cooperation
  • Laboratories
  • Logistic Models
  • Quality Control
  • Reagent Kits, Diagnostic
  • Reference Standards
  • Sensitivity and Specificity

Substances

  • Antibodies, Monoclonal
  • Reagent Kits, Diagnostic