Key result
The Afinion2 and Quo-Lab HbA1c point-of-care devices demonstrated excellent analytical performance (CVs ≤2.4%, bias ≤2 mmol/mol), while the HbA1c 501 was acceptable and the A1Care was unacceptable.
Why the study?
Do four HbA1c point-of-care devices meet international quality targets for imprecision, accuracy, and bias compared to reference procedures?
Do four HbA1c point-of-care devices meet international quality targets for imprecision, accuracy, and bias compared to reference procedures?
The Afinion2 and Quo-Lab HbA1c point-of-care devices meet international quality targets, whereas the A1Care device fails to meet acceptable analytical performance criteria.
Answers are grounded in this paper and cite their sources.
Supports standardized CLSI evaluation of HbA1c POC devices; leaves open real-world clinical impact.
BACKGROUND: Point-of-care (POC) testing is becoming increasingly valuable in health care delivery, and it is important that the devices used meet the same quality criteria as main laboratory analyzers. While external quality assessment (EQA) provides a great tool for assessing quality, many POC devices are not enrolled in these schemes and standard laboratory evaluations are needed to assess performance. METHODS: The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5 and EP-9 were applied to investigate imprecision, accuracy and bias. We assessed bias using the mean of 4 certified secondary reference measurement procedures (SRMPs). RESULTS: The Afinion2™ and the Quo-Lab had CVs of ≤1.7 and ≤2.4% respectively in IFCC SI units (≤1.2 and ≤1.7% NGSP) and a bias ≤2 mmol/mol (≤0.2% NGSP) at 48 and 75 mmol/mol (6.5 and 9.0% NGSP). Sigma for the Afinion2 was 5.8 and for the Quo-Lab 4.0. Both methods passed the NGSP criteria with 2 instruments when compared with 4 individual SRMPs. The HbA1c 501 had a CV of 3.4% and 2.7% in IFCC SI units (2.1% and 1.7% NGSP) and a bias ≤2.4 mmol/mol (≤0.2% NGSP) and passed the NGSP criteria with 2 instruments compared with 4 individual SRMPs except for instrument 2 compared with the Tosoh G8. Sigma was 2.1. The A1Care had a sigma of 1.4 and failed all criteria mainly due to a high CV (6.2% and 4.1% in IFCC SI units [4.1% and 2.9% NGSP] at 48 and 75 mmol/mol [6.5 and 9.0% NGSP]). CONCLUSIONS: The analytical performance was excellent for the Afinion2 and the Quo-Lab, acceptable for the HbA1c 501 and unacceptable for the A1Care according to different used criteria, demonstrating that whilst performance is improving there are still areas for considerable improvement.
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Lenters‐Westra et al. (2018) studied this question. Four HbA1c point-of-care devices (Afinion2, Quo-Lab, HbA1c 501, A1Care) vs. 4 certified secondary reference measurement procedures (SRMPs) was evaluated on Imprecision, accuracy and bias. The Afinion2 and Quo-Lab HbA1c point-of-care devices demonstrated excellent analytical performance (CVs ≤2.4%, bias ≤2 mmol/mol), while the HbA1c 501 was acceptable and the A1Care was unacceptable.
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