title: Validation of the RIDASCREEN(®)FAST Milk Kit.
abstract: The RIDASCREEN(®)FAST Milk test is a sandwich ELISA for the rapid quantification of milk proteins in various foods. The specific antibodies target casein and β-lactoglobulin. Samples are extracted and can then be analyzed in less than 40 min. The calibration curve covers a range from 2.5 to 67.5 mg/kg milk protein. The assay was validated with cookies, infant formula, chocolate dessert, ice cream, and sausages. All negative samples were found well below the LOQ of 2.5 mg/kg. Recoveries of the spiked samples were mostly in the range of 80-120%. The LOD of the ELISA was found below 1 mg/kg. The analysis of 39 different substances of interest revealed that no cross-reactivity above the LOQ occurred. Ruggedness testing proved that variations in incubation temperature, reagent volume, incubation time, extraction temperature, and extraction time had no significant influence. The stability at 4-8°C of three independent lots was investigated and found to exceed 18 months. Very good lot-to-lot consistency and no significant loss of the analytical capacity over the shelf life were observed. Incurred cookies and chocolate dessert samples were prepared and analyzed by an independent laboratory; mean recoveries of 94.4 and 102.2% and mean SDs of 10.9 and 6.3%, respectively, were found. For the 0 mg/kg level for both materials, all samples tested returned values of <2.5 mg/kg. Therefore, the analytical performance claims of the manufacturer were confirmed.
authors.affiliation: R-Biopharm AG, An der neuen Bergstrasse 17, D-64297 Darmstadt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Weiss
authors.forename: Markus
authors.initials: M
authors.lastname: Lacorn
authors.forename: Jonathan
authors.initials: J
authors.lastname: Flannery
authors.forename: M Joseph
authors.initials: MJ
authors.lastname: Benzinger
authors.forename: Patrick
authors.initials: P
authors.lastname: Bird
authors.forename: Erin S
authors.initials: ES
authors.lastname: Crowley
authors.forename: Dave
authors.initials: D
authors.lastname: Goins
authors.forename: James R
authors.initials: JR
authors.lastname: Agin
authors.affiliation: FAOACI, Foreign Fellow of Pakistan Academy of Science, Ottawa, Ontario, Canada.
authors.forename: Sarwar
authors.initials: S
authors.lastname: Gilani
authors.affiliation: Merieux NutriSciences, 113 Route De Paris, 69160 Tassin La Demi Lune, France.
authors.forename: Bert
authors.initials: B
authors.lastname: Poepping
authors.affiliation: U.S. Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Garber
mesh_terms: D000818:Animals; D002364:Caseins / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay; D005504:Food Analysis; D007782:Lactoglobulins / Q000032:analysis*; D008892:Milk / Q000737:chemistry*
chemical_list: D002364:Caseins; D007782:Lactoglobulins