Volume 21, Issue 4 (Winter 2024)                   Sci J Iran Blood Transfus Organ 2024, 21(4): 281-295 | Back to browse issues page

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Asiyabi S, Amini-Kafiabad S, Gholizadeh H, Salek Moghaddam E, Abbasian A, Rafiee M. 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) :281-295
URL: http://bloodjournal.ir/article-1-1555-en.html
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
S. Asiyabi , S. Amini-Kafiabad , H.R. Gholizadeh , E. Salek Moghaddam , A. Abbasian , M.H. Rafiee *
Keywords: Hemoglobin, Blood Donors, Anemia
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  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. 
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  20. Bland JM, Altman D. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 327(8476): 307-10.
  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.
  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.






 



Sci J Iran Blood Transfus Organ 2024;21 (4): 281-295
Original Article
 
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

Asiyabi S.1, Amini-Kafiabad S.1, Gholizadeh H.R.1, Salek Moghaddam E.1, Abbasian A.1, Rafiee M.H.1


1Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran

Abstract
Background and Objectives
Hemoglobin screening is one of the requirements before donating blood, which is performed on all donors. Hemoglobinometer devices are one of the conventional methods for performing this screening in blood transfusion centers. The purpose of study is to evaluate the quality control of a hemoglobinometer device produced by a knowledge enterprise company before being used in blood transfusion centers.

Materials and Methods
In this cross sectional study, venous and capillary blood samples from donors referred to the Blood Transfusion centers of Tehran, Qazvin, Alborz and Fars were used to measure hemoglobin. A comparative evaluation of the study device with Reference was performed on 135 samples. Then a comparative evaluation of study device with hemoglobinometer devices was done on 194 samples. Bland-Altman analysis, sensitivity, specificity, PPV, NPV, accuracy and ICC were evaluated by R.4.4.1.

Results
The mean and standard deviation of hemoglobin concentration with reference and study device were 12.55 ± 2.32 and 12.42 ± 1.60 g/dL, respectively, Based on the Bland-Altman curve, no significant difference was observed between the readings of the two study device and the reference devices (p= 0.1) and the ICC between the two devices showed an almost complete agreement with a confidence factor of 95% (0.8˂ICC˂0.89). The sensitivity, specificity, PPV, NPV and accuracy of the study device compared.

Conclusions 
According to the results of this study and examination with a Reference, the knowledge enterprise device can be used to screen the hemoglobin of blood donors according to the permissible range of blood donation in blood transfusion centers.

Key words: Hemoglobin, Blood Donors, Anemia




Received: 28 Aug 2024
Accepted:19 Nov 2024



Correspondence: Rafiei MH., PhD in Clinical Biochemistry. Assistant Professor of Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine.
P.O.Box: 14665-1157, Tehran, Iran. Tel: (+9821) 82052230; Fax: (+9821) 88601555
E-mail: mh58rafiee@yahoo.com
 
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.
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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.
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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]
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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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