Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay

An Interlaboratory Study

Juan José Dorantes-Aranda, Jessica Y.C. Tan, Gustaaf M. Hallegraeff, Katrina Campbell, Sarah C. Ugalde, D. Tim Harwood, Jill K. Bartlett, Mònica Campàs, Steven Crooks, Arjen Gerssen, Keith Harrison, Anne Catherine Huet, Timothy B. Jordan, Martina Koeberl, Tim Monaghan, Sam Murray, Rama Nimmagadda, Corinne Ooms, Rae K. Quinlan, Feng Shi & 3 others Andrew D. Turner, Betsy Jean Yakes, Alison R. Turnbull

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)469-479
Number of pages11
JournalJournal of AOAC International
Volume101
Issue number2
DOIs
Publication statusPublished - 1 Mar 2018

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Saxitoxin
Shellfish
saxitoxins
Ostreidae
Bivalvia
immunoassay
shellfish
immunoassays
Immunoassay
oysters
toxin
mussels
toxins
shellfish meat
gonyautoxins
Public risks
Molluscs
Immunologic Tests
Meats
Mollusca

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Dorantes-Aranda, J. J., Tan, J. Y. C., Hallegraeff, G. M., Campbell, K., Ugalde, S. C., Tim Harwood, D., ... Turnbull, A. R. (2018). Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay: An Interlaboratory Study. Journal of AOAC International, 101(2), 469-479. https://doi.org/10.5740/jaoacint.17-0221
Dorantes-Aranda, Juan José ; Tan, Jessica Y.C. ; Hallegraeff, Gustaaf M. ; Campbell, Katrina ; Ugalde, Sarah C. ; Tim Harwood, D. ; Bartlett, Jill K. ; Campàs, Mònica ; Crooks, Steven ; Gerssen, Arjen ; Harrison, Keith ; Huet, Anne Catherine ; Jordan, Timothy B. ; Koeberl, Martina ; Monaghan, Tim ; Murray, Sam ; Nimmagadda, Rama ; Ooms, Corinne ; Quinlan, Rae K. ; Shi, Feng ; Turner, Andrew D. ; Yakes, Betsy Jean ; Turnbull, Alison R. / Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay : An Interlaboratory Study. In: Journal of AOAC International. 2018 ; Vol. 101, No. 2. pp. 469-479.
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abstract = "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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Dorantes-Aranda, JJ, Tan, JYC, Hallegraeff, GM, Campbell, K, Ugalde, SC, Tim Harwood, D, Bartlett, JK, Campàs, M, Crooks, S, Gerssen, A, Harrison, K, Huet, AC, Jordan, TB, Koeberl, M, Monaghan, T, Murray, S, Nimmagadda, R, Ooms, C, Quinlan, RK, Shi, F, Turner, AD, Yakes, BJ & Turnbull, AR 2018, 'Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay: An Interlaboratory Study', Journal of AOAC International, vol. 101, no. 2, pp. 469-479. https://doi.org/10.5740/jaoacint.17-0221

Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay : An Interlaboratory Study. / Dorantes-Aranda, Juan José; Tan, Jessica Y.C.; Hallegraeff, Gustaaf M.; Campbell, Katrina; Ugalde, Sarah C.; Tim Harwood, D.; Bartlett, Jill K.; Campàs, Mònica; Crooks, Steven; Gerssen, Arjen; Harrison, Keith; Huet, Anne Catherine; Jordan, Timothy B.; Koeberl, Martina; Monaghan, Tim; Murray, Sam; Nimmagadda, Rama; Ooms, Corinne; Quinlan, Rae K.; Shi, Feng; Turner, Andrew D.; Yakes, Betsy Jean; Turnbull, Alison R.

In: Journal of AOAC International, Vol. 101, No. 2, 01.03.2018, p. 469-479.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Detection of Paralytic Shellfish Toxins in Mussels and Oysters Using the Qualitative Neogen Lateral-Flow Immunoassay

T2 - An Interlaboratory Study

AU - Dorantes-Aranda, Juan José

AU - Tan, Jessica Y.C.

AU - Hallegraeff, Gustaaf M.

AU - Campbell, Katrina

AU - Ugalde, Sarah C.

AU - Tim Harwood, D.

AU - Bartlett, Jill K.

AU - Campàs, Mònica

AU - Crooks, Steven

AU - Gerssen, Arjen

AU - Harrison, Keith

AU - Huet, Anne Catherine

AU - Jordan, Timothy B.

AU - Koeberl, Martina

AU - Monaghan, Tim

AU - Murray, Sam

AU - Nimmagadda, Rama

AU - Ooms, Corinne

AU - Quinlan, Rae K.

AU - Shi, Feng

AU - Turner, Andrew D.

AU - Yakes, Betsy Jean

AU - Turnbull, Alison R.

PY - 2018/3/1

Y1 - 2018/3/1

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KW - Dinoflagellida

KW - Immunoassay/methods

KW - Limit of Detection

KW - Marine Toxins/analysis

KW - Mytilus/chemistry

KW - Reagent Kits, Diagnostic

KW - Saxitoxin/analogs & derivatives

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