救救我吧。。。。翻译啊。。
Traceability to, and recovery of NGSP values has become a necessity in monitoring diabetic compliance in order to reduce inter-instrument and inter-laboratory variation. Therefore, 20 samples with values assigned by an NGSP SRL were analyzed on the I800 utilizing the WB A1C-2 assay with both capped and open tubes. The twenty samples included five with haemoglobinopathies, of which three were Hb AS and two were Hb AC phenotypes. The fifteen Hb AA samples had NGSP values derived by Tosoh HPLC at the SRL, and ranged in concentration from 5.7 HbA1c % to 12.1 HbA1c %. The five variants had NGSP values derived by Primus at the same SRL, as recovery using boronate affinity has been shown previously to be uninfluenced by haemoglobin variants [7]. These samples ranged in concentration from 5.8 HbA1c % to 11.9 HbA1c %. The College of American Pathologists (CAP) has in the past utilized a peer group grading system for HbA1c. With the first survey of 2007, participating laboratories will be required to recover the assigned NGSP target value for each sample within a range limit of ± 15%. CAP proficiency testing specimens have target values determined based on the mean recoveries from four NGSP SRLs. The mean % difference (both closed and open tube) from the NGSP target values for samples used in this study was 3% (mean absolute bias 0.3 HbA1c %). No individual sample exceeded a 7% difference from the NGSP target value. Fig. 4a (open tube) and Fig. 4b (closed tube) show Deming regression analyses compared to NGSP values (x): I800 WB A1C-2 (y) = 1.011 (0.967 to 1.055) × − 0.32 (− 0.67 to 0.02) (SEE = 0.18), mean bias to NGSP = 0.3 HbA1c %; I800CTS WB A1C-2 (y) = 1.023 (0.985 to 1.060) − 0.39 (− 0.68 to − 0.10) (SEE 0.15), mean bias to NGSP = 0.3 HbA1c %.
