medigraphic.com
ISSN 1025-0255 (Electronic)

2014, Number 4

<< Back Next >>

AMC 2014; 18 (4)

Stability of a control serum for total proteins used as a biochemical controller in clinical laboratories

Falcón AY, Quesada LL, Sosa MO, Fernández TS, Ruiz HZ, García CL

Language: Spanish
References: 34
Page: 401-414
PDF size: 240.49 Kb.


ABSTRACT

Background: one of the main ways to guarantee the quality in clinical labs is by using a control serum or controller. A problem we face is the lack of these products in the domestic market due to their high cost.
Objective: to evaluate the stability of an adult bovine serum for total proteins as a biochemical controller in clinical labs.
Method: a quasiexperiment was conducted during three years (January 2010-December 2012) through a probabilistic sampling. The stability in real time of the serum enriched with total proteins was evaluated during 12 months under two temperatures (refrigeration and freezing). The study was designed for three batches per month and three determinations per batch, for a total number of sample of the study (N=63).
Results: a liquid control serum for total proteins was obtained. The concentration of total proteins in the product obtained under refrigeration and freezing conditions kept stable for 12 months. The obtained product, when compared to the control serum from the company OLYMPUS, showed similar fluctuations regarding the concentration of total proteins.
Conclusions: a reference material was obtained as a stable controller for a period of 12 months.


REFERENCES

  1. Más Martín JC, Corral Almonte JF, Fernández Soto M, Vidal Vidal I, Araña FA, Zamora MJ, et al. Hematología. En: Más Martín JC, editor. Laboratorio Clínico. 2 ed. La Habana: Científico- Técnica; 1980. p. 414-83.

  2. Hernández Betancourt O, Fernández Torres S, Vázquez Reyes N, Quesada Leyva L, Falcón Almeida Y, Torres Romo U. Estabilidad de un suero control multienzimático utilizado como material de referencia en los laboratorios clínicos. Rev Cubana Inv Bio. 2012 Feb;31(2):226-42.

  3. Thielman K. Principios de Metodología de Bioquímica. La Habana: Organismos; 1973.

  4. Sonnenwith A, Jarret L, Grandwohl M. Métodos y diagnósticos del Laboratorio Clínico. T 1. La Habana: Científico Técnica; 1983.

  5. Frances F. A manual of laboratory and Diagnostic test. 4ta ed. Washington: JB Lippencott Company. Chemestry Studies; 1992.

  6. Pascual C, Torres W. Control de Calidad Bioquímica Clínica. Ciudad de la Habana: Ciencias Médicas; 1989.

  7. Guzel O, Guner EI. Requirements for quality and competence of medical laboratories, experience of a laboratory I. Clin Biochem [Internet]. 2009 Mar [citado 12 Abr 2014];42(4-5):[aprox. 5 p.]. Disponible en: http://preview.ncbi.nlm.nih.gov/pubmed/19863920

  8. Handbook Standards. Control and Linearity Reagents. Ginebra: SIGMA Diagnostics; 1994.

  9. Castillo de Sánchez ML, Fonseca-Yerena ME. Mejoría continúa de la calidad. Guía para los laboratorios de América Latina [Internet]. México DE: Editorial Médica Panamericana; 1995 [citado 12 Abr 2014]. Disponible en: http://redalyc.uaemex.mx/src/inicio/ArtPdfRed.jsp?iCve=57611572001

  10. Browing DM, Hill PG, Vázquez DA, Rodríguez Olaz'abal DA V'azquez de; World Health Organization. Health Laboratory Technology Unit. Preparation of stabilized liquid quality control serum to be used in clinical chemistry. Geneva: World Health Organization;1986.

  11. Burtis CA, Ashwood ER. Textbook of clinical chemistry. Philadelphia: WB Saunders Company; 2002.

  12. Meludle N. Olympus America Inc, two comparate center drive. Washington: America Inc; 2001.

  13. Loeb WF, Quinby FW. The Chemical Chemistry of Laboratory Animals. Philadelphia: Pergamon Press; 1990.

  14. Marijana M, Šimundic AM, Štefanovic M, Ferenec DR, Kvaternik M, Topic E, et al. A model for results comparison on two different biochemistry analyzers in laboratory accredited according to the ISO 15189. Bio Med [Internet]. 2009 [citado 12 Abr 2014];19(3):[aprox. 6 p.]. Disponible en: http://dx.doi.org/10.11613/BM.2009.027

  15. Hill P, Uldall A, Wilding P. Fundamento de la Evaluación Externa de Calidad. México: COLABIOCLI; 2000.

  16. Badrick T. The Quality Control System. Clin Biochem Rev. 2008 Aug;29 Suppl 1:S67-70.

  17. Guglielmone R, de Elías R, Kiener O, Collino C, Barzón S. Verificación de métodos en un laboratorio acreditado y planificación del control de calidad interno. Acta Bioquím Clín Latinoam [Internet]. 2011 [citado 12 Abr 2014];45(2):[aprox. 12 p.]. Disponible en: http://www.scielo.org.ar/pdf/abcl/v45n2/v45n2a12.pdf.

  18. CECMED. Regulación No. 24-00. Requisitos de los estudios de estabilidad para el registro de nuevos ingredientes farmacéuticos activos. La Habana: CECMED; 2000.

  19. Bradford MM. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem. 1976 May 7;72:248-54.

  20. Barón López FJ, Téllez Montiel F. Apuntes de bioestadísticas: Tercer ciclo en Ciencias de la Salud y Medicina [Internet]. Málaga: Universidad de Málaga; 2004 [citado 12 Abr 2014]. Disponible en:http://www.bioestadistica.uma.es/baron/apuntes/ficheros/cap01.pdf

  21. Sigarroa A. Biometría y diseño experimental. La Habana: Pueblo y Educación; 1985.

  22. Voet D, Voet JG. Biochemistry. 4th ed. New York: John Wiley & Sons; 2010.

  23. Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications for the imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J Clin Chem Clin Biochem [Internet]. 1992 May [citado 12 Abr 2014];30(5):[aprox. 7 p.]. Disponible en:http://preview.ncbi.nlm.nih.gov/pubmed/?term=Proposed+quality+specifications+for+the+imprecision+and+inaccuracy+of+analytical+systems+ for+clinical+chemistry.

  24. Schiele GF JM, Lessinger J. Henny Harmonisation des pratiques: application à la mesure d'activités enzymatiques utilisées en prévention, dépistage, diagnostic et surveillance thérapeutique. Anna Bio Clin. 2001;59(3):291-7.

  25. Infusino I, Panteghini M. Panteghini M. Traceability in clinical enzymology. Clin Biochem Rev [Internet]. 2007 [citado 12 May 2014];28(4):[aprox. 6 p.]. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2282404/pdf/cbr28_4p155.pdf

  26. Westergard JO, Richterich R, Klinische C, Karger B. Clinical chemistry. New York: Academic Press; 2003.

  27. Lessinger JSF, Vialle A, Férard G, Myara A, Guéchot J, Imbert-Bismut F, et al. Le calibrage en enzymologie clinique: principe, conditions d'application et resultants. Anna Bio Clin [Internet]. 2002 [citado 12 Abr 2014];60(3):[aprox. 6 p.]. Disponible en: http://www.jle.com/fr/revues/bio_rech/abc/e-docs/00/00/C4/95/article.phtml

  28. Gulderen Y. ISO 15189 Accreditation: Requirements for quality and competence of medic

  29. Goldstein D, Harris H. Expression of alkaline phosphatase loci in mammalian tissues. Proc Nat Acad Sci USA. 1980 May;77(5):2857–60.

  30. Franzini C. Ethylene glycol-stabilized haemolysates as control material in haemoglobinometry. Clin Chim Acta. 1983 Dec 15;135(2):175-9.

  31. Pazhang MKK, Ranjbar B, Hosseinkhani S. Effects of water-miscible solvents and polyhydroxy compounds on the structure and enzymatic activity of thermolysin. J Biotechnol. 2006 Dec 15;127(1):45-53.

  32. Nascimento C, Lino PR, Ramos L, Almeida AJ, de Almeida IT, Leandro P. Polyol additives modulate the in vitro stability and activity of recombinant human phenylalanine hydroxylase. Appl Biochem Biotechnol. 2010 Sep;162(1):192-207.

  33. Feng S. Effects of glycerol on the compaction and stability of the wild type and mutated rabbit muscle creatine kinase. Proteins. 2008;71(2):844-54.

  34. Toussaint B, Emons H, Schimmel HG, Bossert-Reuther S, Canalias F, Ceriotti F, et al. Traceability of values for catalytic activity concentration of enzymes: a certified reference material for aspartate transaminase. Clin Chem Lab Med. 2010 Jun;48(6):795-803.al laboratories, experience of a laboratory II. Clin Biochem. 2009 Mar;42(4-5):279-83.




2020     |     www.medigraphic.com