EKF Diagnostics DiaSpect Tm, Руководство пользователя

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DiaSpect Tm User Manual
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Capillary All Donors Hb 301 ≥Cutoff Hb 301 <Cutoff
DiaSpect Tm ≥Cutoff 127 2
DiaSpect Tm <Cutoff 7 14
Agreement (Score 95% CI)
Accept = 127/134 = 94.8% (89.6~97.4%)
Reject = 14/16 = 87.5% (64.0~96.5%)
Overall = 141/150 = 94.0% (89.0~96.8%)
Venous All Donors Hb 301 ≥Cutoff Hb 301 <Cutoff
DiaSpect Tm ≥Cutoff 120 1
DiaSpect Tm <Cutoff 13 13
Agreement (Score 95% CI)
Accept = 120/133 = 90.2% (84.0~94.2%)
Reject = 13/14 = 92.9% (68.5~98.7%)
Overall = 133/147 = 90.5% (84.6~94.2%)
The discordance observed was investigated by comparison to a laboratory
reference method. In a separate study, 100 capillary and 100 venous samples
were tested with the DiaSpect Tm, the HemoCue Hb 301 and the Sysmex XP-300.
The DiaSpect Tm was found to be substantially equivalent to the Sysmex XP-300
(calibrated to the hemiglobincyanide method, HiCN), while the HemoCue Hb 301
consistently provided results that were higher by approximately 0.6 g/dL. These
results are summarized below.
The bias of the DiaSpect Tm at donor eligibility cutoffs was calculated from the
regression curves using the Sysmex XP-300 as the reference method.
Donor Cutoff, XP-300
DiaSpect Tm Capillary DiaSpect Tm Venous
Hb Level % Bias Hb Level % Bias
Adult Female, 12.5 g/dL 12.56 0.5% 12.53 0.2%
Adult Male, 13 g/dL 13.05 0.4% 13.07 0.7%
The positive bias of the Hb 301 at donor eligibility cutoffs was calculated using
the Sysmex XP-300 as the reference method. The positive bias of the Hb 301 is
consistent with its higher acceptance rate of donors near the eligibility cutoff, and
is supported by the literature.
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Donor Cutoff, XP-300
Hb 301 Capillary Hb 301 Venous
Hb Level % Bias Hb Level % Bias
Adult Female, 12.5 g/dL 13.12 5.0% 13.03 4.2%
Adult Male, 13 g/dL 13.62 4.8% 13.55 4.2%