Volume 21, Issue 4 (Winter 2024)                   Sci J Iran Blood Transfus Organ 2024, 21(4): 281-294 | Back to browse issues page


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Asiyabi S, Amini-Kafiabad S, Gholizadeh H R, Salek Moghaddam E, Abbasian A, Rafiee M H. Evaluation and Diagnostic Value of the Knowledge Enterprise Hemoglobinometer Compared to the Reference Method (Sysmex XT 2000i Automated Haematology Analyser) and the ComPoLab TM Hemoglobinometer. Sci J Iran Blood Transfus Organ 2024; 21 (4) :281-294
URL: http://bloodjournal.ir/article-1-1555-en.html
Abstract:   (430 Views)
A B S T R A C T
Background and Objectives
Hemoglobin screening is a mandatory prerequisite for blood donation, which is performed on all blood donors. Hemoglobinometer’s devices are among the conventional tools used for this screening in Blood Transfusion Centers. The objective of this study is to evaluate the quality control of a hemoglobinometer device developed by a knowledge-based company prior to its deployment in Blood Transfusion Centers.
Materials and Methods
This study utilized venous and capillary blood samples collected from donors at Blood Transfusion Centers in Tehran, Alborz, Qazvin and Fars provinces. The evaluation was conducted in two phases. In the first phase, a comparative evaluation of the studied hemoglobinometer was performed using the Sysmex XT 2000i Automated Haematology Analyzer as the reference standard, analyzing 135 blood samples. In the second phase, the device was evaluated against the CompoLab TM hemoglobinometer, curently used in Blood Transfusion Centers, with 194 samples. Statistical analysis including Bland-Altman, Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Accuracy and Intraclass Correlation (ICC) were conducted using R software version 4.4.1.
Results
The mean ± standard deviations of hemoglobin concentration measured by the reference and studied devices was 12.55 ± 2.32 g/dL and 12.42 ± 1.60 g/dL, respectively. Bland Altman analysis revealed no significant difference between the measurement obtained from the hemoglobinometer device and the reference method. The ICC demonestrated nearly perfect agreement between the two devices (0.80 < ICC< 0.89, 95% CI). A linear regression analysis was conducted to assess the correlation between the two devices. The analysis revealed a statistically significant correlation between two devices (R= 92, p< 0.0000001). The sensitivity, specificity, PPV, NPV, and accuracy of the studied device compared to the reference method were found reported to be 71.60%, 75.0%, 90.10%, 45.30%, and 72.40%, respectively.
Conclusions 
Based on the finding of the current study, comparative analysis between the studied hemoglobinometer and the reference method demonestrated that the device meets acceptable performance criteria for hemoglobin concentration measurement within the permissible range required for blood donation screening. Therefore the hemoglobinometer is suitable for implementaion in Blood Transfusion Centers as a reliable screening tool.
 
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Type of Study: Research | Subject: Blood Transfusion
Published: 2024/12/30

References
1. Chandra A, Achary T, Vohra K, Aravind M, Singh A, Yadav K. Validation of new invasive digital hemoglobinometer for hemoglobin estimation as point-of-care device among pregnant women in a facility setting India. Indian Journal of Community Health 2024; 36(2): 272-7. [DOI:10.47203/IJCH.2024.v36i02.018]
2. Amini Kafiabad S, Akbari N, Hariri M, Javadzadeh Shahshahani H, Hasanzadeh A, Nakhaee S. Comparison of hemoglobin color scale diagnostic value with photometric method in blood donor selection in Isfahan blood transfusion organization. Sci J Iran Blood Transfus Organ 2012; 9(3) :315-22. [Article in Farsi]
3. Deyhim M, Razjou F, Maghsudlu M, Aghaie B, Attarchi Z, Sharifi S. Comparative evaluation of hemoglobin measurement by automated cell blood counter and by hemoglobin strip in female blood donors. Sci J Iran Blood Transfus Organ 2008; 5(2): 125-31. [Article in Farsi]
4. Chaudhary R, Dubey A, Sonker A. Techniques used for the screening of hemoglobin levels in blood donors: current insights and future directions. J Blood Med 2017; 8: 75-88. [DOI:10.2147/JBM.S103788] [PMID] []
5. Iranian Blood Transfusion Organization. Iranian National Standards for Blood Transfusion. 3rd ed. Teimoozadeh press; 2016. p. 200.
6. Saxena S, Wong E. Heterogeneity of common hematologic parameters among racial, ethnic, and gender subgroups. Arch Pathol Lab Med 1990; 114(7): 715-9.
7. Radtke H, Polat G, Kalus U, Salama A, Kiesewetter H. Hemoglobin screening in prospective blood donors: comparison of different blood samples and different quantitative methods. Transfus Apher Sci 2005; 33(1): 31-5. [DOI:10.1016/j.transci.2004.11.004] [PMID]
8. Ranjan V, Rana R, Kant R, Khillan K. Comparison of Two Techniques Used for the Evaluation of Point-of-Care Methodology for Testing Hemoglobin in Blood Donors. Global Journal of Transfusion Medicine 2021; 6(2): 193-7. [DOI:10.4103/gjtm.gjtm_47_21]
9. Gaddam Harikrishna JP, Araveti Y, Boddapati A. Evaluation of three hemoglobin estimation methods for screening blood donors: An experience in a south Indian Hospital. Journal of Research in Applied and Basic Medical Sciences 2022; 8(1): 1-7. [DOI:10.52547/rabms.8.1.1]
10. Statute of Iranian Blood Transfusion Organization. Islamic Council Approval. 1984. Article 2. Tehran, Iran.
11. Mansournia MA, Waters R, Nazemipour M, Bland M, Altman DG. Bland-Altman methods for comparing methods of measurement and response to criticisms. Global Epidemiology 2021; 3: 100045. [DOI:10.1016/j.gloepi.2020.100045] [PMID] []
12. Peng F, Zhang N, Chen C, Wu F, Wang W. Ensemble Extreme Learning Machine Method for Hemoglobin Estimation Based on PhotoPlethysmoGraphic Signals. Sensors 2024; 24(6): 1736. [DOI:10.3390/s24061736] [PMID] []
13. WHO. HIV assays: operational characteristics. Report 16, Rapid assays; 2009. Available from: https://iris.who.int/handle/10665/44042.
14. Rout D, Sachdev S, Marwaha N. Evaluation of new non-invasive & conventional invasive methods of haemoglobin estimation in blood donors. Indian J Med Res 2019; 149(6): 755-62. [DOI:10.4103/ijmr.IJMR_301_17] [PMID] []
15. Gómez-Simón A, Navarro-Núñez L, Pérez-Ceballos E, Lozano ML, Candela MJ, Cascales A, et al. Evaluation of four rapid methods for hemoglobin screening of whole blood donors in mobile collection settings. Transfus Apher Sci 2007; 36(3): 235-42. [DOI:10.1016/j.transci.2007.01.010] [PMID]
16. Goldman M, Uzicanin S, Yi QL, Acker J, Ramirez Arcos S. Validation and implementation of a new hemoglobinometer for donor screening at Canadian Blood Services. Transfusion 2012; 52(7pt2): 1607-13. [DOI:10.1111/j.1537-2995.2012.03757.x] [PMID]
17. Pinto M, Barjas-Castro ML, Nascimento S, Falconi MA, Zulli R, Castro V. The new noninvasive occlusion spectroscopy hemoglobin measurement method: a reliable and easy anemia screening test for blood donors. Transfusion 2013; 53(4): 766-9. [DOI:10.1111/j.1537-2995.2012.03784.x] [PMID]
18. Rudolf-Oliveira RCM, Gonçalves KT, Martignago ML, Mengatto V, Gaspar PC, dos Santos Ferreira J, et al. Comparison between two portable hemoglobinometers and a reference method to verify the reliability of screening in blood donors. Transfus Apher Sci 2013; 49(3): 578-82. [DOI:10.1016/j.transci.2013.09.004] [PMID]
19. Daae L, Halvorsen S, Mathisen P, Mironska K. A comparison between haematological parameters in 'capillary'and venous blood from healthy adults. Scand J Clin Lab Invest 1988; 48(7): 723-6. https://doi.org/10.3109/00365518809085796 [DOI:10.1080/00365518809085796]
20. Bland JM, Altman D. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 327(8476): 307-10. [DOI:10.1016/S0140-6736(86)90837-8]
21. Shahshahani HJ, Meraat N, Mansouri F. Evaluation of the validity of a rapid method for measuring high and low haemoglobin levels in whole blood donors. Blood Transfus 2013; 11(3): 385.
22. da Silva Pereira A, de Castro IRR, Bezerra FF, Neto JFN, da Silva ACF. Reproducibility and validity of portable haemoglobinometer for the diagnosis of anaemia in children under the age of 5 years. J Nutr Sci 2020; 9: e3. [DOI:10.1017/jns.2019.43] [PMID] []
23. De Clippel D, Van Heddegem L, Vandewalle G, Vandekerckhove P, Compernolle V. Hemoglobin screening in blood donors: a prospective study assessing the value of an invasive and a noninvasive point of care device for donor safety. Transfusion 2017; 57(4): 938-45. [DOI:10.1111/trf.13987] [PMID]

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