title: Development and Validation of a Novel Lateral Flow Immunoassay (LFIA) for the Rapid Screening of Paralytic Shellfish Toxins (PSTs) from Shellfish Extracts.
abstract: A single-step lateral flow immunoassay (LFIA) was developed and validated for the rapid screening of paralytic shellfish toxins (PSTs) from a variety of shellfish species, at concentrations relevant to regulatory limits of 800 μg STX-diHCl equivalents/kg shellfish meat. A simple aqueous extraction protocol was performed within several minutes from sample homogenate. The qualitative result was generated after a 5 min run time using a portable reader which removed subjectivity from data interpretation. The test was designed to generate noncompliant results with samples containing approximately 800 μg of STX-diHCl/kg. The cross-reactivities in relation to STX, expressed as mean ± SD, were as follows: NEO: 128.9% ± 29%; GTX1&4: 5.7% ± 1.5%; GTX2&3: 23.4% ± 10.4%; dcSTX: 55.6% ± 10.9%; dcNEO: 28.0% ± 8.9%; dcGTX2&3: 8.3% ± 2.7%; C1&C2: 3.1% ± 1.2%; GTX5: 23.3% ± 14.4% (n = 5 LFIA lots). There were no indications of matrix effects from the different samples evaluated (mussels, scallops, oysters, clams, cockles) nor interference from other shellfish toxins (domoic acid, okadaic acid group). Naturally contaminated sample evaluations showed no false negative results were generated from a variety of different samples and profiles (n = 23), in comparison to reference methods (MBA method 959.08, LC-FD method 2005.06). External laboratory evaluations of naturally contaminated samples (n = 39) indicated good correlation with reference methods (MBA, LC-FD). This is the first LFIA which has been shown, through rigorous validation, to have the ability to detect most major PSTs in a reliable manner and will be a huge benefit to both industry and regulators, who need to perform rapid and reliable testing to ensure shellfish are safe to eat.
authors.affiliation: †Neogen Europe Limited, The Dairy School, Auchincruive, Ayr, KA6 5HW, Scotland, U.K.|‡Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, David Keir Building, Stranmillis Road, Belfast, BT9 5AG, U.K.
authors.forename: Waqass
authors.initials: W
authors.lastname: Jawaid
authors.affiliation: ‡Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, David Keir Building, Stranmillis Road, Belfast, BT9 5AG, U.K.
authors.forename: Katrina
authors.initials: K
authors.lastname: Campbell
authors.affiliation: †Neogen Europe Limited, The Dairy School, Auchincruive, Ayr, KA6 5HW, Scotland, U.K.
authors.forename: Karrie
authors.initials: K
authors.lastname: Melville
authors.affiliation: †Neogen Europe Limited, The Dairy School, Auchincruive, Ayr, KA6 5HW, Scotland, U.K.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Holmes
authors.affiliation: §Neogen Corporation, 620 Lesher Place, Lansing, Michigan 48912, United States.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rice
authors.affiliation: ‡Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, David Keir Building, Stranmillis Road, Belfast, BT9 5AG, U.K.
authors.forename: Christopher T
authors.initials: CT
authors.lastname: Elliott
mesh_terms: D000818:Animals; D049872:Bivalvia / Q000737:chemistry*; D004867:Equipment Design; D007118:Immunoassay / Q000191:economics / Q000295:instrumentation*; D057230:Limit of Detection; D008387:Marine Toxins / Q000032:analysis*; D010125:Ostreidae / Q000737:chemistry; D015203:Reproducibility of Results; D012530:Saxitoxin / Q000032:analysis; D012758:Shellfish / Q000032:analysis*; D013997:Time Factors
chemical_list: D008387:Marine Toxins; D012530:Saxitoxin