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CC BY-NC-ND 4.0 · J Lab Physicians 2020; 12(03): 191-195
DOI: 10.1055/s-0040-1721151
Original Article

Efficacy of Pooled Serum Internal Quality Control in Comparison with Commercial Internal Quality Control in Clinical Biochemistry Laboratory

Sweta Kulkarni
1   Department of Biochemistry, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed to be University), Pondicherry, India
,
Shema Alain Pierre
1   Department of Biochemistry, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed to be University), Pondicherry, India
,
Ramachandran Kaliaperumal
1   Department of Biochemistry, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed to be University), Pondicherry, India
› Author Affiliations Funding None.
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Abstract

Introduction With increasing automation in clinical laboratories, the requirements for quality control (QC) material have greatly increased in order to monitor performance. The constant use of commercial control material is not economically feasible for many countries because of nonavailability or the high-cost of those materials. Therefore, preparation and use of in-house QC serum will be a very cost-effective measure with respect to laboratory needs.

Materials and Methods In-house internal quality control from leftover serum samples of master health checkup subjects, which have been screened negative for HIV, HCV and HBsAg antibodies was pooled in a glass jar with ethanediol as preservative and kept in deep freezer at − 20°C. From the pooled serum, 100 microliter thirty aliquots were prepared. Every day along with commercial internal QC (IQC), one aliquot of pooled serum was analyzed for 30 days for the following parameters: plasma glucose, blood urea, serum creatinine, total cholesterol, triglycerides (TGL), high-density lipoprotein, calcium, total protein, albumin, total bilirubin, AST, ALT, ALP, amylase. After getting 30 values for each parameter, mean, standard deviation (SD) and CV% were calculated for both IQC commercial sample and pooled serum sample.

Results The mean, SD, and CV% of glucose, cholesterol, TGL, calcium, alanine aminotransaminase (ALT), aspartate aminotransferase (AST), amylase, and alkaline phosphatase (ALP) were statistically significant between pooled serum and commercial QC.

Conclusion In-house QC prepared from pooled serum is better than commercial internal QC. The biochemical parameters were stable in pooled serum due to less matrix effect; also, variation was less in pooled serum IQC.

Keywords

internal quality control - pooled serum - mean - standard deviation - CV%


Publication History

Article published online:
23 November 2020

© 2020. The Indian Association of Laboratory Physicians. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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  • References

  • 1 Kanagasabapathy AS, Swaminathan S, Selvakumar R. Quality control in clinical biochemistry. Indian J Clin Biochem 1996; 11 (01) 17-25
    CrossrefGoogle Scholar
  • 2 Kenning AO, Eaton RH. Practical guidelines for the preparation of quality control sera for use in clinical chemistry. Available at: https://apps.who.int/iris/handle/10665/259944. Accessed July 11, 2020
  • 3 Ohman S. Quality control for the clinical chemistry laboratory. Qual Assur 1997; 5 (02) 79-93
    PubMedGoogle Scholar
  • 4 Swaminathan S, Seshadri MS, Srikrishna G, Selvakumar R, Kanagasabapathy AS. Ethanediol stabilised quality control serum for measurement of zinc. Clin Chim Acta 1993; 215 (01) 119-121
    CrossrefPubMedGoogle Scholar
  • 5 Middle J. External quality assurance. Ann Clin Biochem 1998; 35 (Pt 4) 549-550, author reply 552–553
    CrossrefPubMedGoogle Scholar
  • 6 Zafar MN, Syed S. Economy and quality assessment of home made clinical chemistry reagents. J Pak Med Assoc 1992; 42 (04) 95-97
    PubMedGoogle Scholar
  • 7 Lalani R, Zafar MN, Khurshid M. Efficacy of internal and external quality control in chemical pathology. J Pak Med Assoc 1988; 38 (10) 255-259
    PubMedGoogle Scholar
  • 8 Jamtsho R. Stability of lyophilized human serum for use as quality control material in Bhutan Indian. J ClinBiochem. 2013; 28 (04) 418-421
    Google Scholar
  • 9 Premachandra P, Wood PL, Hill PG, Browning DM, Olazabal DA. Preparation and stability of low-cost liquid quality-control serum stabilized with ethanediol. Clin Chem 1987; 33 (06) 851-852
    CrossrefPubMedGoogle Scholar
  • 10 Khatri R, K C S. Shrestha P, Sinha JN. Implementing self sustained quality control procedures in a clinical laboratory. JNMA J Nepal Med Assoc 2013; 52 (189) 233-237
    CrossrefPubMedGoogle Scholar
  • 11 Kachhawa K, Kachhawa P, Varma M, Behera R, Agrawal D, Kumar S. Study of the stability of various biochemical analytes in samples stored at different predefined storage conditions at an accredited laboratory of India. J Lab Physicians 2017; 9 (01) 11-15
    Article in Thieme ConnectPubMedGoogle Scholar
  • 12 Czarnetzy EM, Richeal RJ, O’Malley JA. Temperature dependent changes with time in the alkaline phosphatase activity of commercial control serum. Clin Chem 1970; 16: 521-522
    Google Scholar
  • 13 Khan MAU, Khan FA. Low cost quality control human serum: method of preparation, validation of values and its comparison with the commercial control serum. J Pak Med Assoc 2004; 54 (07) 375-378
    PubMedGoogle Scholar