Performance Data for NGSP-Certified A1C POC Devices

Assay MethodLabs (n)NGSP A1C Reference Value (95% CI)
5.30 (5.26–5.34)6.14 (6.10–6.18)8.05 (8.01–8.09)
Mean A1C (%)Mean biasCV (%)Mean A1C (%)Mean biasCV (%)Mean A1C (%)Mean biasCV (%)
Bayer A1CNow*134.95–0.354.65.70–0.445.57.43–0.625.7
Axis-Shield Afinion345.25–––0.412.4
Siemens DCA Vantage2585.21–––0.212.7
  • Adapted from ref. 18.

  • * EDTA in the CAP sample has been shown by the manufacturer of A1CNow to cause artificially low results by this method. Routine samples for this method are from fingerstick and do not include EDTA. The manufacturer recommends the use of heparin anticoagulant instead of EDTA when testing venous samples.