Details
Category: Volume 08 Issue 09 September 2020
Hits: 881

Title: External Quality Assessment of Haemoglobin Measurement: A Comparison of Different Analysers

Authors: Esther Wangui Mandania, MMLS, Juliette R. Ongus, Ph.D., Sarah Njoki Kaggia, MMed, Fatmah Abdallah, MMed

 DOI: https://dx.doi.org/10.18535/jmscr/v8i9.14

Abstract

The utilization of clinical laboratory test results in the diagnostic decision making process forms an essential aspect of clinical medicine. Inconsistent and unreliable laboratory test results may have severe effects on the health of the patient and society. The aim of this descriptive cross-sectional study was to evaluate the accuracy of most commonly used haemoglobin analysers in determining a standardised reference for low, normal and high haemoglobin values in blood and to compare the manual and automated methods of haemoglobin estimation. A total of 292 laboratories received three samples with low, normal and high haemoglobin concentrations for analysis, after which their results were evaluated for accuracy by comparing with the reference values. Accuracy of the analysers was evaluated using one-way analysis of variance while Coefficient of Variation was calculated as a measure of inter- method variability. Mean deviation from the expected mean of the references reflected the bias of each analyser. Overall 58.4 % (n=7/12), 17.6% (n=2/12) and 25% (4/12) gave accurate, underestimated and overestimated haemoglobin values respectively. Celltac, Humalyzer, Medonic, Mindray, Colourimeter, Hemocontrol and Sysmex produced results that were not significantly different from the reference values (P>0.05). Diaspect and Sahli underestimated while Hemocue, Urit and Mission overestimated Hb values (P<0.05). Automated methods were more precise than the manual methods with Coefficient of Variation for automated, semi-automated and manual methods being 7.08%, 7.04% and 34.26% respectively. With increasing reliance on the utilization of laboratory test outcomes for clinical decision- making, laboratories mustfrequently participate in External Quality Assessment in order to provide reliable results. Laboratories should embrace automation which gives more accurate and precise results.

Keywords: Haemoglobin, External Quality Assessment, Accuracy, Bias.

References

  1. Sah, S.P., Raj, G.A. and Prakash, M.B. Quality assurance programme in haematology at a teaching hospital in the eastern region of Nepal. Indian J Pathol Microbiol 1999;42 (2):145-149.
  2. World Health Organization. Overview of external quality assessment (EQA): module 10, content sheet 10-1. Geneva, Switzerland: WHO; 2011 Available at: http://www.who.int/ihr/training/laboratory_quality/10_ b_eqa _contents. pdf.
  1. Cheesbrough M. District Laboratory Practice in Tropical Countries, Part -2. Low price editions. United Kingdom: Cambridge University Press, 2000: 267-270.
  2. Peter T, Badrichani A, Wu E, Freeman R, Ncube B, Ariki F, et al. Challenges in implementing CD4 testing in resource-limited settings. Cytometry B Clin Cytom 2008;74B:S123–S130. https://doi.org/10.1002/cyto.b.20416.
  1. James D, Ames D, Lopez B, Still R, Simpson W, Twomey P. External quality assessment: best practice. J Clin Pathol 2014; 67:651–655.
  2. Carter JY, Lema OE, Wangai MW, Munafu CG, Rees PH, Nyamongo JA. Laboratory testing improves diagnosis and treatment outcomes in primary health care facilities. Afr J Lab Med 2012;1(1):8
  3. Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA. Laboratory medicine in Africa: a barrier to effective health care. Clin Infect Dis 2006;42:377–82. https://doi. org/10.1086/499363.
  4. WHO. Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. vitamin and mineral nutrition information system. Geneva, 2011.
  5. Morris SS, Ruel MT, Cohen RJ, Dewey KG, de la Brière B, Hassan MN. Precision, accuracy, and reliability of hemoglobin assessment with use of capillary blood. Am J ClinNutr 1999;69(6):1243–8.
  6. Barbara H, Anna P, Norma J.Basic Medical Laboratory Techniques. 4th Ed. Albany, NY; Delmar Publlishers, 2000:
  7. World Health Organization.Worldwide prevalence of anaemia 1993-2005:WHO Global Database on Anaemia. Geneva: World Health Organization; 2008. Available from:    [http://whqlibdoc.who.int/publications/2008/9789241596657_eng.pdf]
  8. Rauf M, Hanan A. Quality assurance considerations in chemical analysis. Qual Ass J 2009;12: 16-21.
  9. Agarwal R. Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors. Lab Medi2014;45: 80-88.
  10. Berkow L. Factors affecting hemoglobin measurement. J Clin Monit Comput 2013; 27(5):499–508. doi: 10.1007/s10877-013-9456-3.
  11. Medicare, Medicaid and CLIA programmes; regulations implementing the clinical laboratories improvement amendments of 1988 (CLIA) –FFCA. Final rule with comment period. Fed Regist 1992; 57(40):7002 – 186.
  12. American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology 2006;105:198–208
  13. Patil P, Thakare G,Patil, S. Variability and Accuracy of Sahli’s Method in Estimation of Haemoglobin Concentration. Natl J Integr Res Med 2013;4 (1):38–44.
  14. Kapil U, Tandon M, Pathak P, Dwivedi SN.Comparison of haemoglobin values obtained by Haemocue and Sahli’s methods. Ind J Public Health2002; 46 (1):28 -30.
  15. Robertson L, LewisD, Osei-Bimpong A. Utility of the Diaspect Haemoglobinometry System as Point- Of- Care Analyzer. J Near Patient Test Technol 2011; 10 (1):17–21.
  16. Mohanram M, Ramana-Rao GV, Sastry JG. A comparative study on prevalence of anaemia in women by cyanmethemoglobin and hemocue methods.Indian J Community Med 2002;27 (2):58-61.
  17. Bhaskaram P, Balakrishna N, Radhakrishna KV, Krishnaswamy K. Validation of haemoglobin estimation using hemocue. Indian J Pediat2003; 70:25-28.
  18. Sari M, De Pee S, Martini E, Herman S, Sugiatmi,BloemMW, Yip R. Estimating the prevalence of anaemia: a comparison of three methods. Bull World Health Organ 2001; 79(6):506 – 511.
  19. Rechner IJ, Twigg A, Davies AF,Imong S.Evaluation of the hemocue compared with the coulter STKS for measurement of neonatal haemoglobin. Arch Dis Child Fetal Neonatal Ed 2002; 86(3): F188 – 189.
  20. Neufeld L, Garcia-Guerra A, Sanchez-Francia D, Newton-Sanchez O, Ramirez-Villalobos MD,Rivera-Dommarco J. Haemoglobin measured by hemocue and a reference method in venous and capillary blood: a validation study. Salud Publica Mex 2002; 44:219 – 227.
  21. Jitthai S.A comparison of haemoglobin measurement between haemoglobinometer (POCT) and automated blood cell analyzer in hemodialysis patient. J Med Technol Assoc of Thai 2012; 40 (3):4332 - 4337.
  22. Fink NE, Fernandez Alberti A,Mazziota D.External assessment of analytic quality in haematology: a necessity in Latin America. Rev Panam Salud Publica 1997; 2(3):181-188.

Corresponding Author

Esther Wangui Mandania

Department of Medical Laboratory Sciences, Medical School, College of Health Sciences, Mount Kenya University