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Single-laboratory validation of the neogen qualitative lateral flow immunoassay for the detection of paralytic shellfish toxins in mussels and oysters


Turnbull, AR and Tan, JYC and Ugalde, SC and Hallegraeff, GM and Campbell, K and Harwood, DT and Dorantes Aranda, JJ, Single-laboratory validation of the neogen qualitative lateral flow immunoassay for the detection of paralytic shellfish toxins in mussels and oysters, Journal of AOAC International, 101, (2) Article 170135. ISSN 1060-3271 (2018) [Refereed Article]

Copyright Statement

Copyright 2017 AOAC International

DOI: doi:10.5740/jaoacint.17-0135


Detection of paralytic shellfish toxins (PSTs) in bivalve shellfish by analytical methods is complicated and costly, requiring specific expertise and equipment. Following extensive blooms of Alexandrium tamarense Group 1 in Tasmania, Australia, an investigation was made into commercially available screening test kits suitable for use with the toxin profiles found in affected bivalves. The qualitative Neogen rapid test kit, with a modified protocol to convert gonyautoxins GTX1&4 and GTX2&3 into neosaxitoxin and saxitoxin (STX), respectively, with higher cross-reactivities, was the best fit-for-purpose. This validation study of the test kit and the modified protocol was undertaken following AOAC INTERNATIONAL guidelines for the validation of qualitative binary chemistry methods. The validation used four different PST profiles representing natural profiles found in Australia and in Europe: two in a mussel matrix and two in an oyster matrix. The test kit was shown to have appropriate selectivity of the toxin analogs commonly found in bivalve shellfish. The matrix and probability of detection (POD) study showed that the rapid test kit used with the modified protocol was able to consistently detect PST at the bivalve regulatory level of 0.8 mg STX⋅2HCl eq/kg, with a POD estimated via the binomial logistic regression of 1.0 at 0.8 mg STX⋅2HCl eq/kg in all tested profiles in both matrixes. The POD at 0.4 mg STX⋅2HCl eq/kg was 0.75 and 0.46 for the two toxin profiles in an oyster matrix and 0.96 and 1.0 for the two toxin profiles in a mussel matrix. No significant differences in the PODs of the PSTs at the regulatory level were found between production lots of the test kits. The results suggest the method is suitable to undergo a collaborative validation study.

Item Details

Item Type:Refereed Article
Keywords:single lab validation, lateral flow, mussel, oyster, shellfish toxins, Alexandrium tamarense
Research Division:Biological Sciences
Research Group:Plant biology
Research Field:Phycology (incl. marine grasses)
Objective Division:Animal Production and Animal Primary Products
Objective Group:Fisheries - aquaculture
Objective Field:Fisheries - aquaculture not elsewhere classified
UTAS Author:Turnbull, AR (Dr Alison Turnbull)
UTAS Author:Ugalde, SC (Ms Sarah Ugalde)
UTAS Author:Hallegraeff, GM (Professor Gustaaf Hallegraeff)
UTAS Author:Dorantes Aranda, JJ (Dr Juan Dorantes Aranda)
ID Code:121091
Year Published:2018 (online first 2017)
Web of Science® Times Cited:7
Deposited By:Ecology and Biodiversity
Deposited On:2017-09-08
Last Modified:2020-06-16

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