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Open Access Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay: An Interlaboratory Study

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Paralytic shellfish toxins (PSTs) in bivalve molluscs represent a public health risk and are controlled via compliance with a regulatory limit of 0.8 mg saxitoxin (STX)⋅2HCl equivalents per kilogram of shellfish meat (eq/kg). Shellfish industries would benefit from the use of rapid immunological screening tests for PSTs to be used for regulation, but to date none have been fully validated. An interlaboratory study involving 16 laboratories was performed to determine the suitability of the Neogen test to detect PSTs in mussels and oysters. Participants performed the standard protocol recommended by the manufacturer and a modified protocol with a conversion step to improve detection of gonyautoxin 1&4. The statistical analysis showed that the protocols had good homogeneity across all laboratories, with satisfactory repeatability, laboratory, and reproducibility variation near the regulatory level. The mean probability of detection (POD) at 0.8 mg STX⋅2HCl eq/kg using the standard protocol in mussels and oysters was 0.966 and 0.997, respectively, and 0.968 and 0.966 using the modified protocol. The estimated LOD in mussels was 0.316 mg STX⋅2HCl eq/kg with the standard and 0.682 mg STX⋅2HCl eq/kg with the modified protocol, and 0.710 and 0.734 mg STX⋅2HCl eq/kg for oysters, respectively. The Neogen test may be acceptable for regulatory purposes for oysters in accordance with European Commission directives in which the standard protocol provides, at the regulatory level, a probability of a negative response of 0.033 on 95% of occasions. Its use for mussels is less consistent at the regulatory level due to the wide prediction interval around the POD.
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Document Type: Research Article

Affiliations: 1: University of Tasmania, Institute for Marine and Antarctic Studies, Private Bag 129, Hobart, TAS 7001, Australia 2: South Australian Research and Development Institute, 2b Hartley Grv., Urrbrae, SA 5064, Australia 3: Queen’s University Belfast, School of Biological Sciences, Institute for Global Food Security, David Keir Building, Stranmillis Rd, Belfast, BT9 5AG, United Kingdom 4: Cawthron Institute, 98 Halifax St, Nelson 7010, New Zealand 5: University of Canberra, Institute for Applied Ecology, ACT 2617, Australia 6: IRTA, Carretera de Poble Nou, km 5.5, 43540 Sant Carles de la Ràpita, Spain 7: Agri-Food and Biosciences Institute, Veterinary Sciences Division, Belfast, United Kingdom 8: Wageningen University and Research, RIKILT, Wageningen, The Netherlands 9: Centre for Environment Fisheries and Aquaculture Science, Barrack Rd, The Nothe, Weymouth, Dorset DT4 8UB, United Kingdom 10: CER Groupe, Health Department, Rue du Point du Jour 8, 6900 Marloie, Belgium 11: Analytical Services Tasmania, 18 St Johns Ave, New Town, Hobart, TAS 7008, Australia 12: National Measurement Institute, 1/153 Bertie St, Port Melbourne, VIC 3207, Australia _contents"> National Measurement Institute, 1/153 Bertie St, Port Melbourne, VIC 3207, Australia 13: Cameron of Tasmania, 145–149 Arthur Hwy, Dunalley, TAS 7177, Australia 14: Advanced Analytical Australia Pty Ltd, 11 Julius Ave, North Ryde, NSW 2113, Australia 15: Spring Bay Seafoods, 488 Freestone Point Rd, Triabunna, TAS 7190, Australia 16: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Regulatory Science, College Park, MD

Publication date: March 1, 2018

This article was made available online on August 30, 2017 as a Fast Track article with title: "Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay: An Interlaboratory Study".

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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