Name: evaluation of a point-of-care testing analyzer for measuring peripheral blood leukocytes
Uploaded: 2022-03-22T15:00:00
Description: Watch this Scientific Journal Video about Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes at JoVE.com

This study was supported by the Medical Scientific Research Foundation of Guangdong Province, China (A2019224). The funding groups agreed with the study design, data analysis, manuscript preparation, and decision to publish. No other funding was received for this study.

This study and the use of human blood samples were approved by the Ethics Committee of The First Affiliated Hospital of Guangzhou Medical University (GYYY-2016-73). All participants have given their written consent independently or through their parents (in the case of children).
1. Basic information of the study group
NOTE: Venous blood was collected from patients who visited the First Affiliated Hospital of Guangzhou Medical University (Hospital 1) ...

<ol>
	<li>Agbaria, A. H., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Diagnosis+of+inaccessible+infections+using+infrared+microscopy+of+white+blood+cells+and+machine+learning+algorithms.">Diagnosis of inaccessible infections using infrared microscopy of white blood cells and machine learning algorithms.</a> The Analyst. 145 (21), 6955-6967 (2020).</li><li>Mlinaric, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Autovalidation+and+automation+of+the+postanalytical+phase+of+routine+hematology+and+coagulation+analyses+in+a+university+hospital+laboratory.">Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory.</a> Clinical Chemistry and Laboratory Medicine. 56 (3), 454-462 (2018).</li><li>Genzen, J. R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Challenges+and+opportunities+in+implementing+total+laboratory+automation.">Challenges and opportunities in implementing total laboratory automation.</a> Clinical Chemistry. 64 (2), 259-264 (2018).</li><li>Kang, F., Li, W., Wang, W., Chen, B., Wang, Z. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+nationwide+multicenter+study+on+clinical+laboratory+construction+in+China.">A nationwide multicenter study on clinical laboratory construction in China.</a> Chinese Journal of Hospital Administration. 35 (10), 867-871 (2019).</li><li>Rawaf, S., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Lessons+on+the+COVID-19+pandemic,+for+and+by+primary+care+professionals+worldwide.">Lessons on the COVID-19 pandemic, for and by primary care professionals worldwide.</a> The European Journal of General Practice. 26 (1), 129-133 (2020).</li><li>Balla, M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=COVID-19,+Modern+pandemic:+a+systematic+review+from+front-line+health+care+providers'+perspective.">COVID-19, Modern pandemic: a systematic review from front-line health care providers' perspective.</a> Journal of Clinical Medicine Research. 12 (4), 215-229 (2020).</li><li>Cheng, B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Predictors+of+progression+from+moderate+to+severe+coronavirus+disease+2019:+a+retrospective+cohort.">Predictors of progression from moderate to severe coronavirus disease 2019: a retrospective cohort.</a> Clinical Microbiology and Infection. 26 (10), 1400-1405 (2020).</li><li>Budd, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Measurement+procedure+comparison+and+bias+estimation+using+patient+samples;+approved+guideline-third+edition.">Measurement procedure comparison and bias estimation using patient samples; approved guideline-third edition.</a> Clinical and Laboratory Standards Institute. 33 (11), (2013).</li><li>Wang, Y. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+trend+of+testing+instruments+in+grass-roots+hospitals.">Development trend of testing instruments in grass-roots hospitals.</a> Medical Equipment. 24 (03), 26-27 (2011).</li><li>Miesler, T., Wimschneider, C., Brem, A., Meinel, L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Frugal+innovation+for+point-of-care+diagnostics+controlling+outbreaks+and+epidemics.">Frugal innovation for point-of-care diagnostics controlling outbreaks and epidemics.</a> ACS Biomaterials Science &amp; Engineering. 6 (5), 2709-2725 (2020).</li><li>Vesper, H. W., Myers, G. L., Miller, W. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Current+practices+and+challenges+in+the+standardization+and+harmonization+of+clinical+laboratory+tests.">Current practices and challenges in the standardization and harmonization of clinical laboratory tests.</a> The American Journal of Clinical Nutrition. 104, 907-912 (2016).</li><li>Vaz Fragoso, C. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Epidemiology+of+lung+disease+in+older+persons.">Epidemiology of lung disease in older persons.</a> Linics in Geriatric Medicine. 33 (4), 491-501 (2017).</li><li>Qian, C., Xie, T. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Regional+differences+and+demographic+reasons+of+population+aging+in+Guangdong+Province.">Regional differences and demographic reasons of population aging in Guangdong Province.</a> Scientific Research on Aging. 5 (01), 46-56 (2017).</li><li>de Graaf, A. J., Hiemstra, S. W., Kemna, E. W. M., Krabbe, J. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Evaluation+of+a+POCT+device+for+C-reactive+protein,+hematocrit+and+leukocyte+differential.">Evaluation of a POCT device for C-reactive protein, hematocrit and leukocyte differential.</a> Clinical Chemistry and Laboratory Medicine. 55 (11), 251-253 (2017).</li><li>Chabot-Richards, D. S., George, T. I. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=White+blood+cell+counts:+reference+methodology.">White blood cell counts: reference methodology.</a> Clinics in Laboratory Medicine. 35 (1), 11-24 (2015).</li><li>Green, R., Wachsmann-Hogiu, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development,+history,+and+future+of+automated+cell+counters.">Development, history, and future of automated cell counters.</a> Clinics in Laboratory Medicine. 35 (1), 1-10 (2015).</li><li>Henry, B. M., de Oliveira, M. H. S., Benoit, S., Plebani, M., Lippi, G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Hematologic,+biochemical+and+immune+biomarker+abnormalities+associated+with+severe+illness+and+mortality+in+coronavirus+disease+2019+(COVID-19):+a+meta-analysis.">Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis.</a> Clinical Chemistry and Laboratory Medicine. 58 (7), 1021-1028 (2020).</li><li>Flanagan, B., Keber, B., Mumford, J., Lam, L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Hematologic+conditions:+leukocytosis+and+leukemia.">Hematologic conditions: leukocytosis and leukemia.</a> FP Essentials. 485, 17-23 (2019).</li></ol>

With the advancement of modern laboratory medicine, it is now typical to see several detection technologies utilized in the same or different laboratories to identify the same clinical marker. As a result, more emphasis should be placed on the consistency of test results to assist clinics in making accurate interpretations and judgments of test results. According to the investigation, the total value of laboratory equipment in tertiary hospitals and independent laboratories is substantially higher than that in primary ho...

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. However, most primary medical institutions, such as community healthcare centers and private clinics, have a low adoption rate of a hematology analyzer. According to a nationwide multicenter study on clinical laboratory construction in China, the laboratory construction of primary medical institutions is insufficient, as evidenced by the small size of laboratories, the insufficient talents transmission, and the spread of science and technology to the countryside, amongst other factors4.
Since December 2019, COVID-19 began to spread all over the world and developed into a global pandemic. In the 'post-epidemic era', a series of national policies have been proposed to implement the normalized prevention and control measures of epidemic situations. The laboratory of primary medical institutions plays an important role in grassroots diagnosis and treatment and disease prevention and control. It is the first line of defense and control in epidemic situations, and it is critical to COVID-19 prevention and control5. Some studies have shown that the detection of peripheral blood lymphocytes and neutrophils will contribute to COVID-19 patient screening, diagnosis, and treatment, and that the neutrophil/lymphocyte ratio can also be used as clinical early warning indicators of severe and critical COVID-196,7. Moreover, leukocyte detection has the benefit of providing a quick report. Primary medical and health institutions can extensively carry out leukocyte detection to help detect and screen suspected infections in time.
POCT card-based leukocyte analyzer (evaluated system; see Table of Materials) is a three-classification blood cell analyzer based on the gold standard "Coulter principle". The evaluated system provides quantitative analysis results of one WBC histogram and seven blood parameters including WBC count, number of granulocytes (Gran#), percentage of granulocytes (Gran%), number of lymphocytes (Lym#), percentage of lymphocytes (Lym%), number of intermediate cells (Mid#), and percentage of the intermediate cells (Mid%). It adopts the card-based innovative technology and has advantages such as the availability of single-person detection kit, absence of liquid waste, fast detection in 30 s, being free from routine maintenance, and user-friendly operation. Therefore, it is particularly well-suited to primary medical institutions. This study aims to evaluate the clinical detection performance of POCT card-based leukocyte analyzer by comparing against two fully automatic commercial hematology analyzers (reference system 1 and reference system 2; see Table of Materials) from laboratories of two large-scale public hospitals.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>Blood cell detection module</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>Blood lancet</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>Hemolytic reagent</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>IBM SPSS Statistics 25</td>
			<td>International Business Machines Corp., Armonk, NY</td>
			<td></td>
			<td>Software for data analysis</td>
		</tr>
		<tr>
			<td>MedCalc 11.4.2.0</td>
			<td>2021 MedCalc Software Ltd</td>
			<td></td>
			<td>Software for data analysis</td>
		</tr>
		<tr>
			<td>Microsoft Excel 2019</td>
			<td>Microsoft</td>
			<td></td>
			<td>Software for data analysis</td>
		</tr>
		<tr>
			<td>Point-of-care testing (POCT) card-based leukocyte analyzer</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td>CX-2000</td>
			<td>Evaluated system</td>
		</tr>
		<tr>
			<td>Quantitative pipette with capillary tube inside</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>Siemens fully automatic hematology analyzer and its related reagents and consumables</td>
			<td>Siemens Healthcare Diagnostics Inc.</td>
			<td>ADVIA 2120i</td>
			<td>Reference system 2</td>
		</tr>
		<tr>
			<td>UniCel DxH 800 Coulter Cellular Analysis System and its related reagents and consumables</td>
			<td>Beckman Coulter, Inc.</td>
			<td>DxH 800</td>
			<td>Reference system 1</td>
		</tr>
	</tbody>
</table>

evaluation of a point-of-care testing analyzer for measuring peripheral blood leukocytes

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 (rs = 0.972 and 0.973, respectively), while the number of lymphocytes showed a relatively low correlation (rs = 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.

Sample data 
A total of 1066 patients were enrolled in two research centers, including Hospital 1 (n = 532) and Hospital 2 (n = 534). The patient characteristics are shown in Table 1. The percentage of males is 49.9% and the median age is 52 (32, 66) years. Patients enrolled in the study were comprised of inpatients (51.1%), outpatients (39.0%), and physical examination patients (8.4%). The samples tested were from patients who visited the internal medicine departments (30.6%), surg...

Watch this Scientific Journal Video about Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes at JoVE.com

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

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.

White blood cell (WBC) is an important indicator of inflammation in the body, and it can help distinguish between bacterial and viral infections. At ...

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