Use of patient sample for quality control of hematology analyzers: Is it a feasible option in resource-poor setting?

Abstract

Objectives: The operation of hematology analyzers (HAs) is assured by quality control (QC) procedures. For internal QC, the use of stable hematology control material is recommended; however, its use has various limitations such as prohibitive cost, limited shelf life, and logistics. The aims of this study were to determine the utility and efficacy of patient samples in regular QC and HAs. Material and Methods: The patient’s samples were used for duplicate testing, comparability testing, and replicate testing along with X̅B monitoring to determine the performance of primary HA MEK 1900. Results: Paired t-test and correlation results in duplicate test and Scatter plot, Bland–Altman plot, and Passing– Bablok regression results derived from comparability studies revealed acceptable results as per recommendations. In replicate testing, acceptable coefficients of variation were obtained for hemoglobin (Hb) (1.6%), platelet count (4.9%), red blood cell (RBC) count (1.1%), and white blood cell (WBC) count (1.9%). Discussion: In duplicate sample testing paired t-test revealed P > 0.05. In 97% of samples, the standard deviation (SD) was <±2SD for duplicate testing for Hb, platelet count, RBC count, and WBC count. In comparability testing, for Hb, platelet count, RBC count, and WBC count, the correlation coefficient values were close to 1 and comparable to similar published studies. Results for repeatability studies in our study are within acceptable limits as per recommendations. X̅B monitoring revealed results acceptable within the prescribed limits by the manufacturer. The experiments done and results obtained in our study favor the use of patient samples to perform IQC for HA; however, it does not replace the use of stable commercial quality control material. Conclusion: In small-scale laboratories in resource-poor settings, patient samples can be of some use in QC of HA.