Volume 22, Issue 3 (Autumn 2025)
bloodj 2025, 22(3): 183-195 |
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Ethics code: IR.TMI.REC.1403.023
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Asiyabi S, Amini-Kafiabad S, Teimourpour A, Gholizadeh H R, Alizadeh Haghighi S, Rafiee M H. Evaluation of the Sensitivity and Specificity of a Hemoglobinometer Device Produced by a Knowledge-Enterprise Company in Thalassemia Patients. bloodj 2025; 22 (3) :183-195
URL: http://bloodjournal.ir/article-1-1585-en.html
URL: http://bloodjournal.ir/article-1-1585-en.html
Sanaz Asiyabi 
, Sedigheh Amini-Kafiabad , Amir Teimourpour , Hamid Reza Gholizadeh , Samaneh Alizadeh Haghighi , Mohammad Hesam Rafiee *
, Sedigheh Amini-Kafiabad , Amir Teimourpour , Hamid Reza Gholizadeh , Samaneh Alizadeh Haghighi , Mohammad Hesam Rafiee *
Abstract: (157 Views)
A B S T R A C T
Background and Objectives
Accurate Haemoglobin measurement in thalassemia patients is critical for effective management and prevention of complications. Hemoglobinometers, due to their precision, rapid results, and ease of use, serve as practical tools for monitoring Hb level. This study evaluates the performance of a hemoglobinometer developed by a knowledge-based company, comparing its efficacy with a standard reference device in measuring haemoglobin level.
Materials and Methods
This cross-sectional study was conducted on 83 thalassemia patients referred to the adult thalassemia clinic. Hb levels were measured using both the test hemoglobinometer and the reference device (Sysmex XP-300). Statistical analysis included the evaluation of sensitivity, specificity, positive predictive value (PPV/NPV)/negative predictive value, Bland-Altman diagram, Intracalss Correlation Coefficient (ICC) and Receiver-Operating Characteristic (ROC) curve was done.
Results
The median hemoglobinometer readings was 9.65 ± 1.40 g/dL with a median of 9.70 g/dL. A strong correlation was observed between the two devices (ICC= 0.96%, 95% CI = 0.94- 0.98). The Bland-Altman diagram revealed no significant difference and the coefficient of determination (R2) was calculated 92.60%. The device demonstrated sensitivity of 83.90%, specificity of 96.30%. PPV of 97.90%, NPV of 74.30%, accuracy of 87.90% and a Kappa coefficient of 74.50%. The optimal cut-off based on the ROC curve, was determined to be 10.30.
Conclusions
The hemoglobinometer demonstrated high diagnostic accuracy for detecting positive cases (PPV: 97.90%), with only one false positive result among 48 positive readings, indicating its suitability for identifying thalassemia patients requiring blood transfusion. However, among negative cases (NPV: 74.30%), 9 false negative cases were recorded out of 35 readings. It emphasizes the necessity of re-evaluating negative results using a reference device or other diagnostic methods.
Background and Objectives
Accurate Haemoglobin measurement in thalassemia patients is critical for effective management and prevention of complications. Hemoglobinometers, due to their precision, rapid results, and ease of use, serve as practical tools for monitoring Hb level. This study evaluates the performance of a hemoglobinometer developed by a knowledge-based company, comparing its efficacy with a standard reference device in measuring haemoglobin level.
Materials and Methods
This cross-sectional study was conducted on 83 thalassemia patients referred to the adult thalassemia clinic. Hb levels were measured using both the test hemoglobinometer and the reference device (Sysmex XP-300). Statistical analysis included the evaluation of sensitivity, specificity, positive predictive value (PPV/NPV)/negative predictive value, Bland-Altman diagram, Intracalss Correlation Coefficient (ICC) and Receiver-Operating Characteristic (ROC) curve was done.
Results
The median hemoglobinometer readings was 9.65 ± 1.40 g/dL with a median of 9.70 g/dL. A strong correlation was observed between the two devices (ICC= 0.96%, 95% CI = 0.94- 0.98). The Bland-Altman diagram revealed no significant difference and the coefficient of determination (R2) was calculated 92.60%. The device demonstrated sensitivity of 83.90%, specificity of 96.30%. PPV of 97.90%, NPV of 74.30%, accuracy of 87.90% and a Kappa coefficient of 74.50%. The optimal cut-off based on the ROC curve, was determined to be 10.30.
Conclusions
The hemoglobinometer demonstrated high diagnostic accuracy for detecting positive cases (PPV: 97.90%), with only one false positive result among 48 positive readings, indicating its suitability for identifying thalassemia patients requiring blood transfusion. However, among negative cases (NPV: 74.30%), 9 false negative cases were recorded out of 35 readings. It emphasizes the necessity of re-evaluating negative results using a reference device or other diagnostic methods.
Type of Study: Research |
Subject:
Hematology
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