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  • NC 59 of 64 - HbA1c

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    chempathppukm jpmd
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    This document compares HbA1c measurements from two Sebia Capillarys 3 Octa analyzers, models 994 and 1016. A correlation graph shows a slope of 1.000 and R^2 of 0.9991, indicating excellent correlation between the two analyzers. Bland-Altman analysis reveals no pattern bias, with all data evenly scattered and a mean bias of 0 with a 95% confidence interval of -0.15 to 0.15. Both analyzers show acceptable performance at HbA1c medical decision levels of 6.5% and 7.5%.

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    NC 59 of 64 - HbA1c (1)

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    This document compares HbA1c measurements from two Sebia Capillarys 3 Octa analyzers, models 994 and 1016. A correlation graph shows a slope of 1.000 and R^2 of 0.9991, indicating excellent correlation between the two analyzers. Bland-Altman analysis reveals no pattern bias, with all data evenly scattered and a mean bias of 0 with a 95% confidence interval of -0.15 to 0.15. Both analyzers show acceptable performance at HbA1c medical decision levels of 6.5% and 7.5%.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    10 views2 pages

    NC 59 of 64 - HbA1c

    Uploaded by

    chempathppukm jpmd
    This document compares HbA1c measurements from two Sebia Capillarys 3 Octa analyzers, models 994 and 1016. A correlation graph shows a slope of 1.000 and R^2 of 0.9991, indicating excellent correlation between the two analyzers. Bland-Altman analysis reveals no pattern bias, with all data evenly scattered and a mean bias of 0 with a 95% confidence interval of -0.15 to 0.15. Both analyzers show acceptable performance at HbA1c medical decision levels of 6.5% and 7.5%.

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    © All Rights Reserved
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    of 2

    4.3.

    3 HbA1c Correlation (Sebia Capillarys 3 Octa (994) VS Sebia Capillarys 3 Octa (1016) )

    Capillarys 3 Octa 994

    Capillarys 3 Octa 1016

    GRAPH 2: HbA1c Correlation between Sebia Capillarys 3 Octa (994) VS Sebia Capillarys 3 Octa
    (1016)
    y = -0.0319 + 1.0043 x, slope = 1.000, R2= 0.9991, n =44
    Bias of clinical decision limit of 6.5%.
    [(y-x)/x) *100], ‘x’: clinical decision limit
    =0.15%

    Bias clinical decision limit of 7.5%.


    [(y-x)/x) *100], ‘x’: clinical decision limit
    =0%

    Medical Y -0.0319 + Allowable


    Decision Level 1.0043 x Bias %Bias Performance Conclusion
    (X) NGSP Level 1
    6.5 6.49 0.01 0.15 1.5 Acceptable
    7.5 7.5 0 0 Acceptable
    Capillarys 3 Octa 994 & 1016

    Mean of Capillarys 3 Octa 994 & 1016

    FIGURE 1: Bland-Altman Plot for Sebia Capillarys 3 Octa (994) VS Sebia Capillarys 3 Octa (1016)
    There is no pattern bias observed, all data scattered evenly across the concentration. The mean bias for
    Sebia C3O 994 and and Sebia C3O 1016 analyzer for Hemoglobin A1c measurement is 0 with 95%
    confidence interval (-0.15 to 0.15).

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