Evaluation and Interference Study of Hemoglobin A_1cMeasured by Turbidimetric Inhibition Immunoassay

Abstract

The technical performance of the turbidimetric immunoinhibition (TI) assay for hemoglobin (Hb) A l c (Tina-quant Hb A l c , Boehringer Mannheim, Indianapolis, Ind) was evaluated by using the BM/Hitachi 911 analyzer. Intra-assay imprecision was less than 2.7%, and interassay imprecision was less than 2.8% as measured by coefficient of variation. In 93 subjects with diabetes who did not have hemoglobin variants, results of the TI assay for Hb A l c correlated strongly with those obtained by using a highperformance liquid chromatography analyzer (Diamat, BioRad Laboratories, Hercules, Calif). Among 241 subjects who had or did not have hemoglobin variants, the TI assay for Hb A l c correlated strongly with results of affinity chromatography for total glycated hemoglobin (Glyc-Affin GHb, IsoLab, Akron, Ohio). We also studied the effect of various percentages of hemoglobin S, C, Since the early 1980s, glycated hemoglobin has become widely available to clinical laboratories for use in routine testing.1 Two major categories of assay methods exist: those based on charge differences between glycated hemoglobin and nonglycated hemoglobin (cationexchange high-performance liquid chromatography [HPLC] P r e s e n t e d at the 48th A n n u a l M e e t i n g , A m e r i c a n Association of Clinical Chemistry, Chicago, Illinois, July 30, 1996, and published in abstract form in Clin Chem. 1996;42(6 Pt 2):S147-S148.Manuscript received January 28, 1997; revision accepted April 14,1997.A d d r e s s reprint requests to Ms C h a n g : D e p a r t m e n t of Chemistry, Kaiser Permanente Regional Laboratory, 1725 Eastshore Hwy, Berkeley, CA 94710-1798. E, and F on the accuracy of the TI Hb A lc assay. Only high hemoglobin F percentages caused interference. More than 14 times as many samples can be analyzed per hour by using the TI Hb A l c assay than can be analyzed by using the HPLC assay. For highvolume reference laboratories, using the fully automated TI Hb A l c assay to monitor glycemic control in patients with diabetes may be preferable to using the conventional ion-exchange highperformance liquid chromatography Hb A l c assay because the TI assay measures Hb A l c more accurately in patients with diabetes who have hemoglobin variants, and it requires less time.

Hormone Replacement Therapy Is Associated With Better Glycemic Control in Women With Type 2 Diabetes

“…All HbA 1c measurements were analyzed at the regional laboratory by a highperformance liquid chromatography analyzer from 1 January 1995 to 4 November 1995 and turbidimetric immunoinhibition assay from 5 November 1995 to 31 December 1996. The two methods were highly correlated (r ϭ 0.986) (13). The majority (88%) of HbA 1c levels reported in this study were measured by the turbidimetric immunoinhibition assay.…”

A prospective study of lipoprotein(a) and risk of coronary heart disease among women with type 2 diabetes

“…Plasma levels of sE-selectin were assayed with the human sEselectin ELISA kit (R&D Systems), with a CV of <8.8%. Concentrations of glycosylated HbA 1 c [18] were based on turbidimetric immunoinhibition with haemolysed whole blood or packed red cells, with a CV of <3.0%.…”

Effects of hemoglobin S variants on the measurement of glycosylated hemoglobin A1c by four analytical methods

“…The epitopes recognized by the antibodies used in the DCA-2000 and Tina-quant methods fall within the first four to six amino acids and are not affected by the HbS mutation [19,20]. However, a significant, spurious increase has been noted with the Roche Unimate immunoassay, which uses the same antibody as the Bayer DCA-2000+ [21].…”