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Criticism to the Limulus Amebocyte Lysate Test as a Replacement Method to the Rabbit Pyrogen Test and Environmental Health Implications

Bachinski, Róber1; Saggioro, Enrico1; Caldeira, Cristiane2; Abreu, Clarice2; Presgrave, Octavio2; De Souza, Nádia Geisa3; Meyer, Armando1

doi: 10.1097/01.ede.0000392465.32109.f5
Abstracts: ISEE 22nd Annual Conference, Seoul, Korea, 28 August–1 September 2010: Ethics and Justice in Environmental Health Policy

1National School of Public Health (ENSP)/Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, RJ, Brazil; 2National Institute of Quality Control in Health (INCQS)/Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, RJ, Brazil; and 3Institute of Basic Sciences for Health (ICBS)/Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.

Abstracts published in Epidemiology have been reviewed by the societies at whose meetings the abstracts have been accepted for presentation. These abstracts have not undergone review by the Editorial Board of Epidemiology.


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This work intends to debate the acceptance of the limulus amebocyte lysate test as a complete alternative method to rabbit pyrogen test in detecting endotoxins.

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The work is based on literature review and analysis about ethic, methodological, and environmental questions.

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There is evidence that the extraction of hemolymph from Limulus polyphemus (horseshoe crabs) causes the death of about 30,000 crabs per year in the United States. That places the biomedical industry as one of the main causes of death of that arthropod. Added to that is our ignorance of the degree to which the phylogenetic scale of consciousness ceases. Therefore, we do not know about sentience of arthropod and other invertebrates. There are some evidences in the literature that horse shoe crabs eggs serve as intertidal migratory birds' food and a growing in Limulus death because of limulus amebocyte lysate kit production may be a factor of disturbance of theses birds' behavior. Five tests are already validated for the detection of pyrogen, possibly as replacement of the rabbit pyrogen test, which are based on the measurement of pro-inflammatory cytokines (interleukin-1β, interleukin-6). Four of these 5 tests use human blood and the other test uses human cell line (Mono Mac 6).

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There are several ethical advantages in using human blood, as human donors must be able to understand the research and give their consent to harmless donation. Because in vitro tests with human blood are potential complete replacement methods with no ethical consequences and without environmental disturbances, more studies for catch-up validation of those tests in different products from used in the validation study should be conducted and encouraged to be later incorporated to pharmacopoeias.

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