Volume 21, Issue 4 (Winter 2024)
Sci J Iran Blood Transfus Organ 2024, 21(4): 281-294 |
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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
URL: http://bloodjournal.ir/article-1-1555-en.html
Sanaz Asiyabi 
, Sedigheh Amini-Kafiabad 
, Hamid Reza Gholizadeh , Ebadollah Salek Moghaddam , Ali Abbasian , Mohammad Hesam Rafiee *
, Sedigheh Amini-Kafiabad , Hamid Reza Gholizadeh , Ebadollah Salek Moghaddam , Ali Abbasian , Mohammad Hesam Rafiee *
Abstract: (496 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.
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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