Analytical methodology validation for determining the bacterial endotoxin in the dialysis water by means of kinetic chromogenic technique
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Keywords

validation
endotoxin
water
renal dialysis

How to Cite

1.
Hilinski EG, Almodovar AAB, Silva FP de L e, Pinto T de JA, Bugno A. Analytical methodology validation for determining the bacterial endotoxin in the dialysis water by means of kinetic chromogenic technique. Rev Inst Adolfo Lutz [Internet]. 2018 Mar. 29 [cited 2024 May 16];77:1-4. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/34191

Abstract

The occurrence of endotoxin in the treated water for hemodialysis is an important indicator of quality, since high concentrations of endotoxin constitute the main source for causing chronic inflammation in patients undergoing dialysis. This study aims at validating the analytical method for determining quantitatively the bacterial endotoxin in hemodialysis water samples. The data from the kinetic chromogenic method were compared with the results obtained from the gel coagulation technique. The gel coagulation assays were performed in three samples of hemodialysis water, according to the Brazilian Pharmacopoeia. The validation of the kinetic chromogenic method was performed using the same samples through the portable test system. The geometric means of the concentrations of the endpoints obtained from the tests for confirming the LAL sensitivity and the interference by gel coagulation method showed a result of 0.125 EU/mL. The results obtained by the chromogenic method for recovering the product positive control varied from 89 to 186% and the coefficient of variation from 2.5 to 18.2%, demonstrating that the samples did not show interference. Equivalent results were obtained in both methods, therefore being viable the implementation of this methodology in the public health laboratories.

https://doi.org/10.53393/rial.2018.v77.34191
PDF (Português (Brasil))

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Copyright (c) 2018 Ellen Gameiro Hilinski, Adriana Aparecida Buzzo Almodovar, Fernando Pontes de Lima e Silva, Terezinha de Jesus Andreoli Pinto, Adriana Bugno

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