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2018, Number 1

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Rev Cubana Invest Bioméd 2018; 37 (1)

Accelerated stability study of the HemoCen Aerobic diagnostician

Brito GAI, Rodríguez MC, Zhurbenko R, Ortega SA

Language: Spanish
References: 30
Page: 11-21
PDF size: 243.39 Kb.


ABSTRACT

Introduction: Bacteremia is a serious complication of bacterial infections. Early diagnosis of the causative organism allows applying appropriate treatments in a shorter time interval. Hemocultures are clinical diagnosticians designed for this purpose.
Objective: Perform an accelerated stability study of a batch of HemoCen Aerobic hemoculture that allows planning its shelf designed in true conditions.
Methods: A batch of HemoCen Aerobic hemoculture was formulated at the National Bioproducts Center, BioCen, and aseptically packaged at the Biological Pharmaceutical Laboratories, LABIOFAM. An accelerated stability study was carried out by the Arrenhius Method. The bottles were stored for 120 days at 15 °C, 30 °C and 50 °C. Physicochemical, organoleptic and growth promotion capacity evaluations of Staphylococcus aureus ATCC 25923 were realized at 7, 15, 30, 60 and 120 days.
Results: The stability study demonstrated that the pH and the color of the medium progressively deteriorate over time as temperatures increase between 30 °C and 50 °C. Growth promotion of Staphylococcus aureus was favorable with recovery rates between 20 and 40 CFU bottle-1.
Conclusion: HemoCen Aerobic is functional with a satisfactory analytical performance, which recovery rates are consistent with the values reported in bacteremia of low magnitude. These results provide the basis for planning a shelf stability study under real conditions. A durability period of 2 years was estimated.


REFERENCES

  1. Martell Martorell L, Arencibia Núñez A. Infecciones intrahospitalarias en pacientes pediátricos con enfermedades hematológicas, 2006-2009. Rev Cubana Hematol Inmunol Hemoter. 2012;28(3):253-62.

  2. Nautiyal A, Madhav NS, Sharma RK, Ojha A, Bhargava S. Review on nosocomial infections. Carib J Sci Tech. 2015;3:781-8.

  3. Kumar G, Ahmad S, Taneja A, Patel J, Guddati AK, Nanchal R, et al. Severe sepsis in hematopoietic stem cell transplant recipients. Critical Care Med. 2015;43:41121.

  4. Oliveros Navarro A, Uribe N, Sierra P, Jaimes F, González JM. Bacteriemia por enterobacterias resistentes a carbapenems. Estudio transversal. Infectio.2015;19:606.

  5. Satlin MJ, Jenkins SG, Walsh TJ. The global challenge of carbapenemresistant Enterobacteriaceae in transplant recipients and patients with hematologic malignancies. Clin Infect Dis.2014;58:127483.

  6. Krause I, Ashkenazi S. Gastrointestinal Infections in Pregnancy and Neonates. En: Kurjak A, Chervenak FA. Textbook of Perinatal Medicine. Vol 2. 3a ed. New Delhi: Jaypee Brothers Medical; 2015.

  7. Manzur A, Ruiz MS, Fernández J, Bustos A, Amuchastegui R, Fonseca G, et al. Bacteriemia nosocomial en servicios de Cuidados Críticos y en Sala General. Actualizaciones en SIDA e Infectología. Buenos Aires. 2013;21(80):42-7.

  8. Cattani ME, Posse T, Hermes RL, Kaufman SC. Rapid identification of microorganisms by mass spectrometry in a blood culture system. Comparison of two procedures. Rev Arg Microbiol. 2015;47:1905.

  9. Dreyer AW. Blood Culture Systems: From Patient to Result. En: Azevedo L. Sepsis - An Ongoing and Significant Challenge. South Africa: InTech; 2012.

  10. Regulación No. 20-2004. Buenas Prácticas para la producción de Diagnosticadores. CECMED. Cuba; 2004.

  11. Kern WV. Usefulness of the CPG in the management of severe S. aureus infections. Enferm Infecc Microbiol Clin. 2015;33(9):577-8.

  12. Centre for infections. Standards Laboratory in conjunction with the Regional Food, Waterand Environmental. HPA Standard Method; 2008.

  13. Regulación No. 23-2000. Requerimientos de los estudios de estabilidad para el registro de productos farmacéuticos nuevos y conocidos. Cuba; 2000.

  14. Guidelines for Assuring Quality of Medical Microbiological Culture Media. 2 ed. Australian Society for Microbiology; 2012.

  15. Rodríguez C, Mayo O. Paquete estadístico SmartVal. Versión 1. BioCen; 2011.

  16. Lupano CE. Modificaciones de componentes de los alimentos: cambios químicos y bioquímicos por procesamiento y almacenamiento. La Plata: Edulp; 2013.

  17. Barreiro JA, Sandoval AJ. Operaciones de conservación de alimentos por bajas temperaturas. Caracas: Equinoccio; 2006.

  18. Junco R, Rodríguez CM. Cultivo y crecimiento de los microorganismos. En: Llop A, Valdés-Dapena MM, Zuazo JL, eds. Microbiología y Parasitología Médicas Tomo I. La Habana: Ciencias Médicas; 2001.

  19. Macola S. Generalidades de la micología. En: Llop A, Valdés-Dapena MM, Zuazo JL, eds. Microbiología y Parasitología Médicas Tomo I. La Habana: Ciencias Médicas; 2001.

  20. Vetter EA, Torgerson CA, Feuker A, Hugnes JG, Harmsen WS, Schleck C, et al. Comparison of the BACTEC MYCO/F Lytic Bottle to the Isolater Tube, BACTEC Plus Aerobic F/Bottle and BACTEC Anaerobic Lytic/10 Bottle and Comparison of the BACTEC Plus Aerobic F/Bottle to the Isolater Tube for Recovery of Bacteria, Mycobacteria and Fungi from Blood. J Clin Microbiol. 2001;39(12):4380-6.

  21. Laboratorios MICROKIT, S.L. Estudios sobre la caducidad de los medios de cultivo preparados herméticos. Técnicas de laboratorio. Madrid, España; 2003. p. 686-91. Disponible en: http://dialnet.unirioja.es/servlet.

  22. Tortora GJ, Funke BR, Case CL. Metabolismo microbiano. Introducción a la Microbiología 9 ed. Buenos Aires: Médica Panamericana; 2007.

  23. Zhurbenko R, Someillan D, Ortega A, López Y, Blanco AM, Torres M, et al. Evaluación comparativa de dos medios para hemocultivos para el aislamiento de microorganismos aerobios. Salud i Ciencia. 2016 [citado 12 Dic 2016]. Disponible en: www.siicsalud.com; doi: http://dx.doi.org/10.21840/siic/153101

  24. Fallah M, Bahram S, Javadian SR. Fish peptone development using enzymatic hydrolysis of silver carp by-products as a nitrogen source in media. Food Sci Nut. 2015;3(2):153-7.

  25. Meli F, Lazzi C, Neviani E, Gatti M. Effect of protein hydrolysates on growth kinetics and aminopeptidase activities of Lactobacillus. Curr Microbiol. 2014;68(1):82-7.

  26. Hongfei Z, Fengling B, Fang Z, Walczak P, Xiangning J, Bolin Z, et al. Characterization of soybean protein hydrolysates able to promote the proliferation of Streptococcus thermophilus ST. J Food Sci. 2013;78(4):575-81.

  27. Zhurbenko R, Rodríguez C, Lobaina T, López OD, Viera DR. Peptona papaínica de corazón de vaca como fuente de nutrientes para los microorganismos. Salud i Ciencia. 2015;21(5):531-5.

  28. Lobaina T, Rodríguez C, Zhurbenko R. Caracterización de un extracto de Ipomoea batatas para ser utilizado en calidad de base nutritiva en medios de cultivo. Rev Cubana Med Trop. 2007;59(3).

  29. Britania HEMORAB. Hemocultivos con Resinas. Laboratorios Britania S.A. Caba: Argentina; 2011. Rev 03-31655.

  30. Zhurbenko R, Rodríguez C, Brito AI, Someillan D, Ortega A, López, et al. Validación del desempeño clínico del medio para hemocultivo de producción nacional HemoCen Aerobio. 8vo Congreso cubano de Microbiología y Parasitología. 5to Congreso Nacional de Medicina Tropical and 5to Symposium Internacional de infecciones HIV/SIDA en Cuba; 2014.




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