Validation Study of BioSystems® Y15 Histamine Dehydrogenase Kit for the Detection of Histamine in Fish and Fishery Products: AOAC Performance Tested MethodSM 072001.
Journal
Journal of AOAC International
ISSN: 1944-7922
Titre abrégé: J AOAC Int
Pays: England
ID NLM: 9215446
Informations de publication
Date de publication:
12 Jun 2021
12 Jun 2021
Historique:
received:
23
09
2020
accepted:
23
09
2020
pubmed:
29
12
2020
medline:
29
6
2021
entrez:
28
12
2020
Statut:
ppublish
Résumé
BioSystems has developed a histamine kit for automated procedure, through the use of a Y15 analyzer, for quantification of histamine in fish and fishery products. Validate the method under the specific guidelines of the AOAC Research Institute Performance Tested MethodSM (PTM) program. Samples are extracted with boiling water. The enzymatic method is based on histamine dehydrogenase that catalyzes the oxidation of histamine in the presence of an electron mediator that reduces a dye that is measured at 420 nm. The increase of absorbance is proportional to the histamine concentration. Dispensing of reagents and sample, absorbance readings, calibration, and calculation of results are performed automatically in the analyzer BioSystems Y15. The linearity ranges from 0 to 200 mg/kg (r2 > 0.99). The LOQ is 10 mg/kg in all the matrixes. Recoveries range from 75 to 107% at concentrations from 5 to 200 mg/kg, with repeatability precision values between 0.8 and 5.5%. Comparisons with the HPLC reference method shows a good correlation. Cross-reactivity of the assay is negligible for all biogenic amines tested except for agmatine (6.3%). Product consistency was verified by validating lot-to-lot variations and variations within the same lot. Shelf life was verified by real-time stability testing during 40 months at 2-8°C. No differences in histamine detection were observed in robustness testing, in which minor changes are introduced to the assay protocol. The automated, simple, and rapid BioSystems Y15 Histamine Dehydrogenase Kit has been successfully validated. The method is qualified for PTM certification No. 072001.
Sections du résumé
BACKGROUND
BACKGROUND
BioSystems has developed a histamine kit for automated procedure, through the use of a Y15 analyzer, for quantification of histamine in fish and fishery products.
OBJECTIVE
OBJECTIVE
Validate the method under the specific guidelines of the AOAC Research Institute Performance Tested MethodSM (PTM) program.
METHOD
METHODS
Samples are extracted with boiling water. The enzymatic method is based on histamine dehydrogenase that catalyzes the oxidation of histamine in the presence of an electron mediator that reduces a dye that is measured at 420 nm. The increase of absorbance is proportional to the histamine concentration. Dispensing of reagents and sample, absorbance readings, calibration, and calculation of results are performed automatically in the analyzer BioSystems Y15.
RESULTS
RESULTS
The linearity ranges from 0 to 200 mg/kg (r2 > 0.99). The LOQ is 10 mg/kg in all the matrixes. Recoveries range from 75 to 107% at concentrations from 5 to 200 mg/kg, with repeatability precision values between 0.8 and 5.5%. Comparisons with the HPLC reference method shows a good correlation. Cross-reactivity of the assay is negligible for all biogenic amines tested except for agmatine (6.3%). Product consistency was verified by validating lot-to-lot variations and variations within the same lot. Shelf life was verified by real-time stability testing during 40 months at 2-8°C. No differences in histamine detection were observed in robustness testing, in which minor changes are introduced to the assay protocol.
CONCLUSIONS
CONCLUSIONS
The automated, simple, and rapid BioSystems Y15 Histamine Dehydrogenase Kit has been successfully validated.
HIGHLIGHTS
CONCLUSIONS
The method is qualified for PTM certification No. 072001.
Identifiants
pubmed: 33367653
pii: 5923287
doi: 10.1093/jaoacint/qsaa139
pmc: PMC8372101
doi:
Substances chimiques
Histamine
820484N8I3
Oxidoreductases Acting on CH-NH Group Donors
EC 1.5.-
histamine dehydrogenase
EC 1.5.99.-
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
693-711Informations de copyright
© AOAC INTERNATIONAL 2020.
Références
Toxicon. 2010 Aug 15;56(2):231-43
pubmed: 20152850
Food Sci Biotechnol. 2017 Dec 13;26(6):1463-1474
pubmed: 30263683
J Food Sci Technol. 2016 May;53(5):2210-8
pubmed: 27407186
Anal Biochem. 2005 Nov 15;346(2):320-6
pubmed: 16236240
Agents Actions. 1984 Jun;14(5-6):633-6
pubmed: 6475660