Establishing Reference Value of Biochemical Parameters: A Must Before Ensuring Quality in Biochemistry Diagnostic Lab
Keywords:
Reference value, Quality control, Diagnostic lab
Abstract
Background: Quality assurance in a laboratory comprises of a set of factors which besides numerous preanalytical, analytical and post analytical variables also include effect of age and sex on various parameters. Present study was done to know the impact of these factors on various biochemical variables and reference values of the various biochemical parameters were set according to age and sex.Methodology: The present study was conducted on 200 apparently healthy individuals from Malwa belt of Punjab. The participants were divided according to age and sex. All the parameters were measured by standard lab protocols/methods.Result: In addition to various preanalytical, analytical & post analytical variables, some of the parameters showed significant variations according to age and sex. Serum creatinine, uric acid, AST, ALP and Calcium showed significant difference in males as compared to females (p<0.05). Parameters like Urea, Creatinine, uric acid, total protein and cholesterol showed significant difference in individuals who were more than 50 years when compared with individuals less than 50 years (p<0.05).Conclusion: These reference values will be used to compare the results of various biochemical parameters of patients coming to our tertiary care hospital. Also the setting of reference value should be done as a protocol before assuring quality control in the lab. But there is need for more elaborative studies and it should be comparable with the results from multiple laboratories that are using same methodology and instruments.References
1. Solbergm H. International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values: Approved Recommendation on the theory of reference values. Part 1. The Concept of Reference Values. J. Clin. Chem. Clin.Biochem. 1987;25: 337-342.
2. Grasbeck R, Saris NE. Establishment and use of normal values. Scand J Lab Invest 1969; 26:62-3
3. Soldberg HE. Establishment and use of reference values. In: Teitz text book of clinical chemistry, 2nd Ed. Burtis CA and Ashwood ER eds. Saundres, Philadelphia 1996; 356-86.
4. SujataWangkheimayum, Determination of reference values of some routine clinical biochemical parameters of apparently healthy North Indian subjects. J of Biochemistry Research 2013; 1(1):1-6.
5. G.A. Alemnji, J.Mbuagbaw, G. Teto, S. Nkengafac, E. Folefac ,N.Atems, B.Kwingwah, T.Asonganyi. Reference ranges for serum biochemical parameters among Healthy Cameroonians to support HIV Vaccine and Related Clinuicxal Trials.The oprn Clinicaql Chemistry 2010;3:66-71.
6. Stein M W. Clinical methods of enzymatic analysis,Academic Press,1965;117.
7. Talke H, Schubert GE. Enzymatic urea determination in the blood and serum in the warburg optical test.Klivische Wochenschrift 1965;43:174.
8. Fabiny DI, Ertingshausen G. Automated reaction rate method for determination of serum creatinine.Clin Chem.1971;17:696.
9. Fossati P, Prencipe L, Berti . Enzymic Creatinine Assay: A New Colorimetric Method Based on Hydrogen Peroxide Measurement G.Clin Cherm,1980;26:227.
10. Allain CC, Poon L S, Chan C S G, Richmond W Fu P C. Enzymatic determination of total serum cholesterol .Clin chem. 1974;12:403.
11. Trinder P,Ann Determination of Glucose in Blood Using Glucose Oxidase with an Alternative Oxygen Acceptor. Clin Biochem 1969;6:24.
12. Vnaden Berg A Mueller P, Biochem Z, Uber eine direct and eine indirect Diazo reaction of Bilirubin1916;77:90
13. Bowers GN, Mc Comb RB, Measurement of total alkaline phosphatase activity in human serum.Clin Chem 1975;21:1988-1995.
14. IFCC Methods for the Measurement of Catalytic Concentration of Enzymes Clin Chem.1977; 23:887.
15. Wroblewski F, La Due JS. Serum glutamic pyruvic transaminase in cardiac and hepatic disease.Pros Soc Exp Biol Med 1956;91:569.
16. Weichselaaum TE, Amer An accurate and rapid method for the determination of proteins in small amounts of blood serum and plasma. J Clin Path1946 ;16:40.
17. Rodkey FL Direct Spectrophotometric Determination of Albumin in Human Serum Clin chem. 1965;2: 478.
18. IFCC. Approved recommendation on the theory of reference values. Journal of Clinical Chemistry and Clinical Biochemistry 1981; 25(5): 337-342.
19. Ferre Masterrer, M, Fuentes, A.X. Puchal, An indirect reference limit estimated from patients results by three mathematical procedures. Clinica Chemica Acta 1999; 279(1-2): 97-105.
20. Rosen, FS., Cooper, M.D. and Wedgwood,R.J.The primary immunodeficiencies. New England Journal of Medicine 1984; 311: 235-242.
21. Erasmus RT., Ray U., Nathaniel K. and Dowes G. Reference ranges for serum creatinine and urea in elderly coastal Melanesians. Papua New Guinea Medical Journal 1997; 40(2): 89-91.
22. Reidenberg MM., Gu, Z-P., Lorenzo, B., Coutinho,E., Athayde, C., Frick, J., Alvarez, F., Brache, V.and Emuveyan, E.E. Differences in serum potassium concentrations in normal men in different geographic locations. Clinical Chemistry 1993; 39(1): 72-75.
23. Jagarinec, N., Fleger, M., Surina, B., Vrhovsks, H.,Hebrung, N. and Predenkerokuvic, V. Pedriatic Reference Interval for 34 biochemical analytes in urban school children and aldolescent. Clinical Chemistry Laboratory Medicine 1998; 36(5): 327-337
24. Jannie W, Treuting JJ, Donald, C.C. Metabolic intermediates and inorganic ions. In:Clinincal diagnosis and management; 16th edition; Philadelphia; London and Toronto; WB Saunders company. 1979; pp 259-304.
25. Felding, P., Tryding, N., Hyltoft, P. et al. Effects of posture on concentrations of blood constituents in healthy adults: Practical application of blood specimen collection procedures recommended by the Scandinavian Committee on Reference Values. Scand. J. Clin. Lab. Invest.1980: 40; 615-621.
2. Grasbeck R, Saris NE. Establishment and use of normal values. Scand J Lab Invest 1969; 26:62-3
3. Soldberg HE. Establishment and use of reference values. In: Teitz text book of clinical chemistry, 2nd Ed. Burtis CA and Ashwood ER eds. Saundres, Philadelphia 1996; 356-86.
4. SujataWangkheimayum, Determination of reference values of some routine clinical biochemical parameters of apparently healthy North Indian subjects. J of Biochemistry Research 2013; 1(1):1-6.
5. G.A. Alemnji, J.Mbuagbaw, G. Teto, S. Nkengafac, E. Folefac ,N.Atems, B.Kwingwah, T.Asonganyi. Reference ranges for serum biochemical parameters among Healthy Cameroonians to support HIV Vaccine and Related Clinuicxal Trials.The oprn Clinicaql Chemistry 2010;3:66-71.
6. Stein M W. Clinical methods of enzymatic analysis,Academic Press,1965;117.
7. Talke H, Schubert GE. Enzymatic urea determination in the blood and serum in the warburg optical test.Klivische Wochenschrift 1965;43:174.
8. Fabiny DI, Ertingshausen G. Automated reaction rate method for determination of serum creatinine.Clin Chem.1971;17:696.
9. Fossati P, Prencipe L, Berti . Enzymic Creatinine Assay: A New Colorimetric Method Based on Hydrogen Peroxide Measurement G.Clin Cherm,1980;26:227.
10. Allain CC, Poon L S, Chan C S G, Richmond W Fu P C. Enzymatic determination of total serum cholesterol .Clin chem. 1974;12:403.
11. Trinder P,Ann Determination of Glucose in Blood Using Glucose Oxidase with an Alternative Oxygen Acceptor. Clin Biochem 1969;6:24.
12. Vnaden Berg A Mueller P, Biochem Z, Uber eine direct and eine indirect Diazo reaction of Bilirubin1916;77:90
13. Bowers GN, Mc Comb RB, Measurement of total alkaline phosphatase activity in human serum.Clin Chem 1975;21:1988-1995.
14. IFCC Methods for the Measurement of Catalytic Concentration of Enzymes Clin Chem.1977; 23:887.
15. Wroblewski F, La Due JS. Serum glutamic pyruvic transaminase in cardiac and hepatic disease.Pros Soc Exp Biol Med 1956;91:569.
16. Weichselaaum TE, Amer An accurate and rapid method for the determination of proteins in small amounts of blood serum and plasma. J Clin Path1946 ;16:40.
17. Rodkey FL Direct Spectrophotometric Determination of Albumin in Human Serum Clin chem. 1965;2: 478.
18. IFCC. Approved recommendation on the theory of reference values. Journal of Clinical Chemistry and Clinical Biochemistry 1981; 25(5): 337-342.
19. Ferre Masterrer, M, Fuentes, A.X. Puchal, An indirect reference limit estimated from patients results by three mathematical procedures. Clinica Chemica Acta 1999; 279(1-2): 97-105.
20. Rosen, FS., Cooper, M.D. and Wedgwood,R.J.The primary immunodeficiencies. New England Journal of Medicine 1984; 311: 235-242.
21. Erasmus RT., Ray U., Nathaniel K. and Dowes G. Reference ranges for serum creatinine and urea in elderly coastal Melanesians. Papua New Guinea Medical Journal 1997; 40(2): 89-91.
22. Reidenberg MM., Gu, Z-P., Lorenzo, B., Coutinho,E., Athayde, C., Frick, J., Alvarez, F., Brache, V.and Emuveyan, E.E. Differences in serum potassium concentrations in normal men in different geographic locations. Clinical Chemistry 1993; 39(1): 72-75.
23. Jagarinec, N., Fleger, M., Surina, B., Vrhovsks, H.,Hebrung, N. and Predenkerokuvic, V. Pedriatic Reference Interval for 34 biochemical analytes in urban school children and aldolescent. Clinical Chemistry Laboratory Medicine 1998; 36(5): 327-337
24. Jannie W, Treuting JJ, Donald, C.C. Metabolic intermediates and inorganic ions. In:Clinincal diagnosis and management; 16th edition; Philadelphia; London and Toronto; WB Saunders company. 1979; pp 259-304.
25. Felding, P., Tryding, N., Hyltoft, P. et al. Effects of posture on concentrations of blood constituents in healthy adults: Practical application of blood specimen collection procedures recommended by the Scandinavian Committee on Reference Values. Scand. J. Clin. Lab. Invest.1980: 40; 615-621.
Published
2016-08-17
Issue
Section
Original Article
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access at http://opcit.eprints.org/oacitation-biblio.html).
