Seventy routine samples of which five had positive Sickle Solubility tests, and thirty-nine samples with previously identified Hb variants (AC = 8, [β6Glu→Lys]; AD = 1, [β121Glu→Val]; AE = 3, [β26Glu→Lys]; AS = 14, [β6Glu→Val]; CC = 3; SS = 5; SC = 3; Hereditary Persistence of Foetal Hb = 2) were analyzed with the following systems and applications: MODP HbA1c II, I700 HBA1C WB, I700 HBA1C HEM, I800 WB A1C-2, and the Bio-Rad VARIANT? HPLC system (Hb variants only). Concerns regarding accurate recovery with the current Integra HbA1c assay center around the Hb variants S and C. Therefore, box plots with median differences between the MODP HbA1c II assay (considered the predicate device [10] and [11]), versus the other systems and applications (Fig. 2) are shown as described previously [10] and [15] W.L. Roberts, B.K. De and D. Brown et al., Effects of haemoglobin C and S traits on eight glycohaemoglobin methods [Technical Brief], Clin. Chem. 48 (2002), pp. 383–385. View Record in Scopus | Cited By in Scopus (26)[15] for these sample types. Additionally, a test of coincidence of two least-squares linear regression lines was performed to determine whether S or C variant recovery was statistically significantly different for each Integra test method from Hb A/A and gave the following results at a P value of10% different from the MODP HbA1c II values supporting results from previous work [15]. In contrast, the I800 WB A1C-2 assay gave a 0.04% and 0.21% HbA1c mean difference at 6% and 9% HbA1c, respectively, with Hb AS variants; and a ? 0.01% and 0.26% HbA1c mean difference at 6% and 9% HbA1c, respectively, with Hb AC variants, confirming the expectation of equivalent recovery to the Hitachi Tina-quant A1c II assay.
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