Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes

Huiqing Zhu; Zhifeng Huang; Huimin Huang; Caiyou Wang; Liting Wu; Runpei Lin; Baoqing Sun

doi:10.3791/63364

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Method Article

Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes

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DOI:

10.3791/63364

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March 22nd, 2022

Huiqing Zhu^*¹ , Zhifeng Huang^*¹ , Huimin Huang¹ , Caiyou Wang² , Liting Wu¹ , Runpei Lin¹ , Baoqing Sun¹

¹National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, ²Laboratory Department, Fifth affiliated (Zhuhai) Hospital of Zunyi Medical University

^* These authors contributed equally

Summary

A protocol to measure peripheral blood leukocytes using a POCT card-based leukocyte analyzer is presented here. Same blood samples were tested by two automated hematology analyzers to evaluate the consistency and accuracy of the results. The results showed that the evaluated analyzer had a good correlation with the reference system.

Abstract

White blood cell (WBC) is an important indicator of inflammation in the body, and it can help distinguish between bacterial and viral infections. At present, most primary medical institutions in China have a poor percentage of adoption of blood-testing technology, and a hematology detection system with a high price to performance ratio and easy operation is urgently needed in primary healthcare centers. This paper introduces the principle and operation procedures of a point-of-care testing (POCT) card-based leukocyte analyzer (evaluated system), which was used to detect WBC indexes such as neutrophils, lymphocytes, and intermediate group cells (including eosinophils, basophils, and monocytes) in whole blood. The results from the evaluated system were compared to those from two commercial automatic hematology analyzers (reference system). The correlation and consistency between the evaluated system and the commercial reference systems were analyzed. The results showed that WBC count and number of granulocytes detected by the evaluated and reference systems showed a strong positive correlation (r_s = 0.972 and 0.973, respectively), while the number of lymphocytes showed a relatively low correlation (r_s = 0.851). A Bland-Altman plot showed that the major difference between the values detected by the evaluated system and the reference systems is within 95% limits of agreement (LoA), indicating that the two systems are in good agreement. In conclusion, the evaluated system has an excellent correlation, robust consistency, and a reliable comparison with the results of the widely used automatic hematology analyzers. It is ideal for WBC detection in primary medical institutions where a full-automatic five-category hematology analyzer is unavailable, especially during the COVID-19 normalized prevention and control period.

Introduction

White blood cell (WBC)count or differential is an important indicator to reflect the inflammation of the body, which can distinguish bacterial infection from viral infection. WBC analysis is also helpful to guide the follow-up diagnosis and treatment¹. At present, the five-classification fully automatic hematology analyzer has been widely used in large and medium-sized medical units, because it is automatic, has high efficiency, yields accurate and reliable results, and effectively reduces the work intensity of laboratory technicians. It plays an important role in clinical examination²^,³