INTRODUCTION:

A complete blood count (CBC) is a routine test performed by clinical laboratories as a supporting component frequently used in the diagnostic process of a disease^1-3. The CBC is an important tool in routine hematological studies of patients. The detection of anomalies in leukocytes, erythrocytes, and peripheral blood platelets aids in the clinical interpretation of patients' signs and symptoms. Modern automated analyzers enable for the objective and precise measurement of several hematological parameters, as opposed to manual approaches. Every day, innovative technologies are created to produce more dependable and accurate results⁴. Tests with haematology analyzers are becoming more efficient. In clinical laboratories, hematology testing frequently use an instrument called a hematology analyzer. A hematology analyzer provides blood test results quickly and accurately. The haematology analyser (Sysmex XN-1000) was one of the most common used. With the rapid development of technology, many hematology analyzers have been produced. Therefore, quality control of the latest instruments needs to be assessed to maintain the accuracy of the test results^5-7.

Dr. Soetomo General Academic Hospital is one of the tertiary hospitals in Indonesia, and the complete blood count examination in this hospital was performed using Sysmex XN-1000 instrument in the clinical pathology laboratory. The examination principle of this instrument used the flow cytometry method for leukocyte testing, impedance for RBC and platelet testing, and the Sodium Lauryl Sulfate (SLS) method for hemoglobin testing. The Sysmex XN-1000 in Indonesia is one of the hematology instruments that serves as the standard for complete blood count testing⁸. The laboratory test has three stages: pre-analytical, analytical, and post-analytical. The pre-analytical step is referred to as the initial preparation stage, as it impacts the quality of the sample generated and influences the subsequent work process. The pre-analytical stage includes the specimen collection process, where the use of the right tube for blood samples is one of the most influential pre-analytical factors, because each tube contains anticoagulants, such as Ethylenediaminetetraacetic Acid (EDTA), which is the recommended standard for routine blood tests^9-11.

HumaCount 5D CRP is an innovative complete hematology testing instrument that includes the examination of hemoglobin, leukocytes, erythrocytes, hematocrit, and platelets, along with the rapid and accurate measurement of C-reactive protein (CRP). CRP is an important biomarker for assessing inflammation in patients. The principle of hematology testing on this instrument uses the same methods as the Sysmex XN-1000 called flow cytometry for leukocyte testing, impedance for RBC and platelet testing, and colorimetry for hemoglobin testing¹². Many studies have been conducted to compare various hematological analyzer instruments, but the HumaCount 5D CRP has not been studied yet. This study aimed to analyze and compare the results of complete blood count values between the HumaCount 5D CRP and Sysmex XN-1000.

METHODS:

This study used primary data from patients who underwent a complete blood count examination in the clinical pathology laboratory of Dr. Soetomo General Academic Hospital from July 20, 2023, to August 31, 2023. The population in this study consisted of 172 patient samples of all ages, both men and women, who had a complete blood count test in the clinical pathology laboratory of Dr. Soetomo General Academic Hospital. This was a quantitative descriptive study conducted to determine the values of each variable. The patients’ blood samples were collected in EDTA tubes, after checked the patient's age according to the inclusion criteria, the volume of blood sample from each subject was 3ml, and checking the condition of the sample (whether there are clots or fibrin threads). A complete blood test was performed using both different instruments (HumaCount 5D CRP and Sysmex XN-1000). SPSS 24.0 was used to analyze the data on the entire result, and each group of parameters using the normality test, and further was adjusted using parametric and non-parametric tests using One-Way ANOVA. The data was presented with bland altman graphs.

RESULTS:

Figure 1 below showed the data distribution of each sample which showed that for the leukocyte parameter, 26 samples showed low results (<4,000/µL), 60 samples showed normal results (4,000-10,000/µL), and 86 samples showed high results (>10,000/µL). While for the erythrocyte parameter, 81 samples showed low results (<3,800,000/µL), 91 samples showed normal results (3,800,000-6,000,000/µL), and no samples showed high results (>6,000,000/µL). For the hemoglobin parameter, 72 samples showed low results (<11.6 g/dL), 100 samples showed normal results (11.6-16.6 g/dL), and no samples showed high results (>16.6 g/dL). For the hematocrit parameter, 114 samples showed low results (<36%), 58 samples showed normal results (36-54%), and no samples showed high results (>54%). For the platelets parameter, 32 samples showed low results (<150,000/µL), 116 samples showed normal results (150,000-400,000/µL), and 24 samples showed high results (>400,000/µL).

Figure 1. Data distribution chart.

The data presented in table 1 showed that the data obtained for the erythrocyte, hemoglobin, hematocrit, and platelet parameters were consistent (accordance) in both testing instruments, while for the leukocyte parameter, the data from both testing instruments showed inconsistency (discordance).

Table 1. Overall data distribution.

Parameter	Examination Instruments	N	Mean	SD	CV%
Leukocyte	SYSMEX XN-1000	172	13.27	11.92	89.83
Leukocyte	HUMACOUNT 5D CRP	172	12.04	11.20	93.02
Erythrocyte	SYSMEX XN-1000	172	3.88	0.72	18.56
Erythrocyte	HUMACOUNT 5D CRP	172	3,92	0.71	18.11
Hemoglobin	SYSMEX XN-1000	172	11.03	2.09	18.95
Hemoglobin	HUMACOUNT 5D CRP	172	11.08	2.11	19.04
Hematocrit	SYSMEX XN-1000	172	32.89	6.36	19.34
Hematocrit	HUMACOUNT 5D CRP	172	35.68	6.63	18.58
Platelet	SYSMEX XN-1000	172	261.20	139.65	53.46
Platelet	HUMACOUNT 5D CRP	172	274.13	141.55	51.64

Table 2. Data distribution of each variable.

Parameter	Group	Examination Instruments	N	Mean	Standard Deviation	CV%
Leukocyte	Low	SYSMEX XN-1000	26	2.68	0.89	33.21
	Normal		60	7.92	1.76	22.22
	High		86	20.20	13.44	66.53
	Low	HUMACOUNT 5D CRP	26	2.41	0.79	32.78
	Normal		60	7.11	1.66	23.35
	High		86	18.38	12.81	69.70
Erythrocyte	Low	SYSMEX XN-1000	81	3.24	0.40	12.35
	Normal	SYSMEX XN-1000	91	4.44	0.41	9.23
	Low	HUMACOUNT 5D CRP	81	3.36	0.41	12.20
	Normal	HUMACOUNT 5D CRP	91	4.41	0.53	12.02
Hemoglobin	Low	SYSMEX XN-1000	72	9.06	1.19	13.13
	Normal	SYSMEX XN-1000	100	12.45	1.31	10.52
	Low	HUMACOUNT 5D CRP	72	9.30	1.26	13.55
	Normal	HUMACOUNT 5D CRP	100	12.37	1.62	13.10
Hematocrit	Low	SYSMEX XN-1000	114	29.33	4.36	14.87
	Normal	SYSMEX XN-1000	58	39.89	2.93	7.35
	Low	HUMACOUNT 5D CRP	114	32.32	4.97	15.38
	Normal	HUMACOUNT 5D CRP	58	42.29	4.02	9.51
Platelet	Low	SYSMEX XN-1000	32	76.12	43.68	57.38
	Normal		116	263.43	66.01	25.06
	High		24	497.20	121.79	24.50
	Low	HUMACOUNT 5D CRP	32	85.00	50.48	59.39
	Normal		116	278.93	68.07	24.40
	High		24	503.12	133.33	26.50

The data presented in table 3 showed that for all variables, p>0.05, means that the data is normally distributed. Subsequently, a parametric test, called One Way ANOVA was conducted.

Table 3. The results of the normality test for the entire data.

Parameter	Examination Instruments	p-value
Leukocyte	SYSMEX XN-1000	0.087
Leukocyte	HUMACOUNT 5D CRP	0.085
Erythrocyte	SYSMEX XN-1000	0.200
Erythrocyte	HUMACOUNT 5D CRP	0.200
Hemoglobin	SYSMEX XN-1000	0.200
Hemoglobin	HUMACOUNT 5D CRP	0.200
Hematocrit	SYSMEX XN-1000	0.200
Hematocrit	HUMACOUNT 5D CRP	0.200
Platelet	SYSMEX XN-1000	0.071
Platelet	HUMACOUNT 5D CRP	0.061

The data presented in table 2 showed that the data obtained for the overall dataset were consistent for the low and normal leukocyte parameters, erythrocytes, hemoglobin, and hematocrit in both testing instruments. In contrast, the high leukocyte parameter showed inconsistent data. After sampling, a normality test was performed for the entire dataset and for each parameter using the Kolmogorov-Smirnov and Shapiro-Wilk tests.

Table 4 below showed that the results of the normality test mostly indicated that the data was not normally distributed. Therefore, a non-parametric test, called the Mann-Whitney test was conducted. For the normal leukocyte parameter, the data showed a normal distribution; therefore, a parametric test called the Independent T-Test was then conducted.

Table 4. Normality test results for each parameter.

Parameter	Group	Examination Instruments	p-value
Leukocyte	Low	SYSMEX XN-1000	0.014
	Normal		0.080
	High		0.000
	Low	HUMACOUNT 5D CRP	0.005
	Normal		0.443
	High		0.000
Erythrocyte	Low	SYSMEX XN-1000	0.000
	Normal	SYSMEX XN-1000	0.003
	Low	HUMACOUNT 5D CRP	0.000
	Normal	HUMACOUNT 5D CRP	0.003
Hemoglobin	Low	SYSMEX XN-1000	0.000
	Normal	SYSMEX XN-1000	0.001
	Low	HUMACOUNT 5D CRP	0.001
	Normal	HUMACOUNT 5D CRP	0.000
Hematocrit	Low	SYSMEX XN-1000	0.012
	Normal	SYSMEX XN-1000	0.002
	Low	HUMACOUNT 5D CRP	0.049
	Normal	HUMACOUNT 5D CRP	0.006
Platelet	Low	SYSMEX XN-1000	0.041
	Normal		0.042
	High		0.000
	Low	HUMACOUNT 5D CRP	0.162
	Normal		0.036
	High		0.012

The results of the parametric and non-parametric tests of each parameter were presented in table 5. The results of the parametric statistical test of all the parameters showed that most of the parameters showed no significant difference between the HumaCount 5D CRP hematology test instrument and the Sysmex XN-1000. These results were confirmed in the blant-altman test which showed the results within the standard deviation range. However, the hematocrit parameter results showed that there was a difference between the HumaCount 5D CRP hematology test instrument and the Sysmex XN-1000.

Table 5. Overall statistical test results.

Parameter	p-value
Leukocyte	0.325
Erythrocyte	0.626
Hemoglobin	0.818
Hematocrit	0.000
Platelet	0.394

Figure 2. Graph of Bland Altman on leukocyte, erythrocyte, hemoglobin, and platelet parameters

Figure 2 above showed the graph of Bland Altman on leukocyte, erythrocyte, hemoglobin, and platelet parameters. The results of parametric and non-parametric statistical tests for each group (low, normal, high) presented in table 6 showed that the results of most of the parameter groups showed no significant difference between the HumaCount 5D CRP hematology and the Sysmex XN-1000 test instruments. These results were confirmed in the blant-altman test which showed the results included in the standard deviation range. However, the results of the leukocyte parameters (normal and high), erythrocytes (low), and hematocrit (low and normal) showed that there was a difference between the HumaCount 5D CRP hematology and the Sysmex XN-1000 test instruments.

Table 6. Statistical test results for each parameter.

Parameter	Group	p-value
Leukocyte	Low	0.109
	Normal	0.010
	High	0.020
Erythrocyte	Low	0.015
Erythrocyte	Normal	0.825
Hemoglobin	Low	0.167
Hemoglobin	Normal	0.898
Hematocrit	Low	0.000
Hematocrit	Normal	0.000
Platelet	Low	0.472
	Normal	0.088
	High	0.695

Figure 3. Graph of Bland Altman on parameters of leukocytes (low), erythrocytes (normal), hemoglobin (low, normal), and platelets (low, normal, high).

Figure 3 above showed the graph of Bland Altman on the parameters of leukocytes (low), erythrocytes (normal), hemoglobin (low, normal), and platelets (low, normal, high).

DISCUSSION:

The clinical laboratory is an essential component of health services because it plays a vital role in in-vitro diagnostics. The primary reason is that laboratory tests are required for screening, diagnosis, illness monitoring, and monitoring treatment. Given the significance of these laboratory tests, every laboratory is obliged to give exact, timely, and reliable findings^13-15. The complete blood count is very essential. A previous study found that a routine serial blood count determination during the full course of palliative radiotherapy had a substantial influence on RBC count¹⁶. This current study was conducted to compare the results of hematology examinations between the HumaCount 5D CRP and one of the current established instruments (the Sysmex XN-1000) on 5 parameters of hemoglobin, leukocytes, erythrocytes, hematocrit, and platelets.

The results of this study showed that the distribution of data on all parameters generally showed similar coefficient of variation (CV%) results, but the leukocyte parameters showed differences in CV% between the Sysmex XN-1000 leukocyte parameters (89.83%) and the HumaCount 5D CRP instrument (93.02%). This showed that the leukocyte parameters on the HumaCount 5D CRP instrument have more varied results compared to the Sysmex XN-1000 instrument.

The distribution results of each parameter level showed that most of the results have similar CV% results but there were differences in the high leukocyte parameters. The Sysmex XN-1000 instrument showed a high leukocyte CV% (66.53%), while the HumaCount 5D CRP instrument showed a high leukocyte CV% (69.70%). This result showed that the high leukocyte parameters according to the HumaCount 5D CRP instrument was more varied, compared to the Sysmex XN-1000 instrument.

Furthermore, the overall normality test on both instruments showed that all data parameters were normally distributed, therefore the parametric Independent T Test was carried out. However, the results of the normality test for each parameter level were different from the overall normality test of the data, showed that almost all levels of data parameters were not normally distributed, only the normal leukocyte parameter showed that the data was normally distributed. Therefore, all parameter levels used the Mann-Whitney non-parametric statistical test, except for the normal leukocyte parameter, the parametric Independent T Test was carried out.

The parametric test results on the overall data showed that the parameters of leukocytes, erythrocytes, hemoglobin, and platelets showed no significant difference between the two instruments (p>0.05). However, the results of hematocrit parameter showed a significant difference between the two instruments (p<0.05). Furthermore, the parametric and non-parametric tests from each group showed that the parameters of low leukocyte, normal erythrocytes, low and normal hemoglobin, low platelets, normal platelets, and high platelets have good results with p>0.05 which means that the data between the two instruments showed no significant difference. A previous study using two advanced hematology analyzers also reported that the results obtained from different automated CBC analyzers were similar⁴. Another study that compared the two hematological analyzers also reported that the two instruments have good correlation and consistency, and the two instruments can replace each other^17.However, our current study found that the results of the parameters of normal and high leukocyte, low erythrocytes, low and normal hematocrit have significant differences between the two instruments with p values of <0.05.

LIMITATION:

The sample was obtained by random sampling (not depicting a homogeneous population) where there were patients with various diseases and conditions which could cause the varies in distribution of the sample population.

CONCLUSION:

Compliance testing by comparing the latest innovative hematology instrument HumaCount 5D CRP with the established instrument Sysmex XN-1000 showed quite good results in overall results but there were still significant differences in several parameter levels. It is necessary to be aware of hematocrit parameter results if there is a discordance with the patient's clinical condition. Further study is needed using the prevalent data distribution at each level.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this study.

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Received on 04.12.2024 Revised on 13.04.2025

Accepted on 17.06.2025 Published on 01.12.2025

Available online from December 06, 2025

Research J. Pharmacy and Technology. 2025;18(12):6084-6090.

DOI: 10.52711/0974-360X.2025.00880

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