James K Fleming1. 1. Laboratory Corporation of America, Elon, NC 27244, USA. fleminj@labcorp.com
Abstract
OBJECTIVES: Evaluate a new whole blood (WB) HbA1c immunoassay and system with closed tube sampling (CTS) capability. DESIGN AND METHODS: Compare the Tina-quant Haemoglobin A1c Gen.2 (A1C-2) application on the COBAS INTEGRA 800 (I800) and new I800 dedicated system with CTS capability to current Integra applications and a HbA1c method accurate with common haemoglobin (Hb) variants. RESULTS: CVs were < or =1.7%. Mean bias against National Glycohaemoglobin Standardization Program (NGSP) samples was 0.3 HbA1c %. Compared to the Hitachi Tina-quant(R) [a] HbA1c II (HbA1c II) assay (accurate with common Hb variants), mean bias was 0.04% and 0.21% HbA1c at 6% and 9%, respectively, with Hb AS variants; and -0.01% and 0.26% HbA1c at 6% and 9%, respectively, with Hb AC variants. CONCLUSIONS: The Integra A1C-2 application is precise, accurate against NGSP-assigned samples and the Hb variants tested; and, the I800 dedicated system with CTS capability offers increased throughput and reduced sample handling.
OBJECTIVES: Evaluate a new whole blood (WB) HbA1c immunoassay and system with closed tube sampling (CTS) capability. DESIGN AND METHODS: Compare the Tina-quant Haemoglobin A1c Gen.2 (A1C-2) application on the COBAS INTEGRA 800 (I800) and new I800 dedicated system with CTS capability to current Integra applications and a HbA1c method accurate with common haemoglobin (Hb) variants. RESULTS: CVs were < or =1.7%. Mean bias against National Glycohaemoglobin Standardization Program (NGSP) samples was 0.3 HbA1c %. Compared to the Hitachi Tina-quant(R) [a] HbA1c II (HbA1c II) assay (accurate with common Hb variants), mean bias was 0.04% and 0.21% HbA1c at 6% and 9%, respectively, with Hb AS variants; and -0.01% and 0.26% HbA1c at 6% and 9%, respectively, with Hb AC variants. CONCLUSIONS: The Integra A1C-2 application is precise, accurate against NGSP-assigned samples and the Hb variants tested; and, the I800 dedicated system with CTS capability offers increased throughput and reduced sample handling.
Authors: Deepti Gurdasani; Tommy Carstensen; Segun Fatumo; Guanjie Chen; Chris S Franklin; Javier Prado-Martinez; Heleen Bouman; Federico Abascal; Marc Haber; Ioanna Tachmazidou; Iain Mathieson; Kenneth Ekoru; Marianne K DeGorter; Rebecca N Nsubuga; Chris Finan; Eleanor Wheeler; Li Chen; David N Cooper; Stephan Schiffels; Yuan Chen; Graham R S Ritchie; Martin O Pollard; Mary D Fortune; Alex J Mentzer; Erik Garrison; Anders Bergström; Konstantinos Hatzikotoulas; Adebowale Adeyemo; Ayo Doumatey; Heather Elding; Louise V Wain; Georg Ehret; Paul L Auer; Charles L Kooperberg; Alexander P Reiner; Nora Franceschini; Dermot Maher; Stephen B Montgomery; Carl Kadie; Chris Widmer; Yali Xue; Janet Seeley; Gershim Asiki; Anatoli Kamali; Elizabeth H Young; Cristina Pomilla; Nicole Soranzo; Eleftheria Zeggini; Fraser Pirie; Andrew P Morris; David Heckerman; Chris Tyler-Smith; Ayesha A Motala; Charles Rotimi; Pontiano Kaleebu; Inês Barroso; Manj S Sandhu Journal: Cell Date: 2019-10-31 Impact factor: 41.582