title: Performance analysis of newly developed point-of-care hemoglobinometer (TrueHb) against an automated hematology analyzer (Sysmex XT 1800i) in terms of precision in hemoglobin measurement.
abstract: BACKGROUND
  The aim of this study was to evaluate the performance of the newly developed handheld hemoglobinmeter (TrueHb) by comparing its performance against and an automated five-part hematology analyzer, Sysmex counter XT 1800i (Sysmex).
  
  
  METHODS
  Two hundred venous blood samples were subjected through their total hemoglobin evaluation on each device three times. The average of the three readings on each device was considered as their respective device values, that is, TrueHb values and Sysmex values. The two set of values were comparatively analyzed. The repeatability of the performance of TrueHb was also evaluated against Sysmex values.
  
  
  RESULTS
  The scatter plot of TrueHb values and Sysmex values showed linear distribution with positive correlations (r = 0.99). The intraclass correlation (ICC) values between the two set of values was found to be 0.995. Regression coefficients through origin, β, was found to be 0.995, with 95% confidence intervals (CI) ranging between 0.9900 and 1.0000. The mean difference in Bland-Altman plots of TrueHb values against the Sysmex values was found to be -0.02, with limits of agreement between -0.777 and 0.732 g/dL. Statistical analysis suggested good repeatability in results of TrueHb, having a low mean CV of 2.22, against 4.44, that of Sysmex values, and 95% confidence interval of 1.99-2.44, against 3.85-5.03, that of Sysmex values.
  
  
  CONCLUSIONS
  These results suggested a strong positive correlation between the two measurements devices. It is thus concluded that TrueHb is a good point-of-care testing tool for estimating hemoglobin.
authors.affiliation: Technology Business Incubation Unit, Indian Institute of Technology - Delhi, New Delhi, India.
authors.forename: A
authors.initials: A
authors.lastname: Srivastava
authors.affiliation: Centre for Biomedical Engineering, Indian Institute of Technology - Delhi, New Delhi, India.
authors.forename: V
authors.initials: V
authors.lastname: Koul
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: S N
authors.initials: SN
authors.lastname: Dwivedi
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: A D
authors.initials: AD
authors.lastname: Upadhyaya
authors.affiliation: Department of Hematology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: A
authors.initials: A
authors.lastname: Ahuja
authors.affiliation: Department of Hematology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: R
authors.initials: R
authors.lastname: Saxena
mesh_terms: D057205:Automation, Laboratory / Q000295:instrumentation / Q000592:standards*; D001772:Blood Cell Count / Q000379:methods; D006405:Hematology / Q000295:instrumentation*; D006452:Hemoglobinometry / Q000295:instrumentation / Q000592:standards*; D006454:Hemoglobins / Q000032:analysis* / Q000378:metabolism; D006801:Humans; D016014:Linear Models; D019095:Point-of-Care Systems; D015203:Reproducibility of Results
chemical_list: D006454:Hemoglobins
keywords: Sysmex; TrueHb; hemoglobin; hemometer; performance validation