Performance standard-based validation study for local lymph node assay: 5-bromo-2-deoxyuridine-flow cytometry method.
Regul Toxicol Pharmacol
; 80: 183-94, 2016 Oct.
Article
en En
| MEDLINE
| ID: mdl-27318101
ABSTRACT
Local lymph node assay 5-bromo-2-deoxyuridine-flow cytometry method (LLNA BrdU-FCM) is a modified non-radioisotopic technique with the additional advantages of accommodating multiple endpoints with the introduction of FCM, and refinement and reduction of animal use by using a sophisticated prescreening scheme. Reliability and accuracy of the LLNA BrdU-FCM was determined according to OECD Test Guideline (TG) No. 429 (Skin Sensitization Local Lymph Node Assay) performance standards (PS), with the participation of four laboratories. Transferability was demonstrated through successfully producing stimulation index (SI) values for 25% hexyl cinnamic aldehyde (HCA) consistently greater than 3, a predetermined threshold, by all participating laboratories. Within- and between-laboratory reproducibility was shown using HCA and 2,4-dinitrochlorobenzene, in which EC2.7 values (the estimated concentrations eliciting an SI of 2.7, the threshold for LLNA BrdU-FCM) fell consistently within the acceptance ranges, 0.025-0.1% and 5-20%, respectively. Predictive capacity was tested using the final protocol version 1.3 for the 18 reference chemicals listed in OECD TG 429, of which results showed 84.6% sensitivity, 100% specificity, and 88.9% accuracy compared with the original LLNA. The data presented are considered to meet the performance criteria for the PS, and its predictive capacity was also sufficiently validated.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Acroleína
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Bromodesoxiuridina
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Ensayo del Nódulo Linfático Local
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Dinitroclorobenceno
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Ensayos de Aptitud de Laboratorios
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Citometría de Flujo
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Ganglios Linfáticos
Tipo de estudio:
Clinical_trials
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Guideline
/
Prognostic_studies
Límite:
Animals
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Female
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Humans
País/Región como asunto:
Asia
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Año:
2016
Tipo del documento:
Article