US EPA

3154626 

Journal Article 

Development and Validation of a Novel Lateral Flow Immunoassay (LFIA) for the Rapid Screening of Paralytic Shellfish Toxins (PSTs) from Shellfish Extracts 

Jawaid, W; Campbell, K; Melville, K; Holmes, SJ; Rice, J; Elliott, CT 

2015 

Yes 

Analytical Chemistry
ISSN: 0003-2700
EISSN: 1520-6882 

American Chemical Society 

87 

10 

5324-5332 

English 

25893460 

10.1021/acs.analchem.5b00608 

WOS:000355057700043 

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. 

Ability testing; Finite difference method; Immunology; Metabolites; Molluscs; Toxic materials; Aqueous extraction; Data interpretation; Good correlations; Laboratory evaluation; Lateral flow immunoassays (LFIA); Paralytic shellfish toxins; Rigorous validation; Shellfish extracts; Shellfish; marine toxin; saxitoxin; analysis; animal; bivalve; chemistry; devices; economics; equipment design; immunoassay; limit of detection; oyster; reproducibility; shellfish; time; validation study; Animals; Bivalvia; Equipment Design; Immunoassay; Limit of Detection; Marine Toxins; Ostreidae; Reproducibility of Results; Saxitoxin; Shellfish; Time Factors