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

Background and ObjectivesHemoglobin 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 MethodsIn 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. ResultsThe 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% (0.8ICC0.89).The sensitivity, specificity, PPV, NPV and accuracy of the study device compared. ConclusionsAccording 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.