Gijzen K, Moolenaar DL, Weusten JJ, Pluim HJ, Demir AY. Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit. Clin Chem Lab Med. 2012 Nov;50(11):1985-92. PMID: 22718643.

15197:2003 - Pass General population

Mitsios JV, Ashby LA, Haverstick DM, Bruns DE, Scott MG. Analytic evaluation of a new glucose meter system in 15 different critical care settings. J Diabetes Sci Technol. 2013 Sep 1;7(5):1282-7. doi: 10.1177/193229681300700518. PMID: 24124955. Available from: PMC3876372.

CLSI:2013 - Pass Critically ill patients

Ba Y, Xu J, Yuan L, Zhu H, Yang Y, Lam MM, Zhang S, Xiao M, Xu J, Zhang R, Chen C. Assessment of the performance of blood glucose monitoring systems for monitoring dysglycaemia in neonatal patients. BMJ Paediatr Open. 2018 Oct 23;2(1):e000339. doi: 10.1136/bmjpo-2018-000339. PMID: 30397671. Available from: PMC6203032. eCollection 2018.

CLSI:2013 - Fail Neonates (Note: Meter is susceptible to interference by low concentrations of galactose that could potentially influence the ability to detect hypoglycaemia.)

CMA:2016 Neonates

Kim HN, Moon KC, Yoon SY. Performance evaluation of three i-SENS glucometers using arterial blood samples compared with the YSI 2300 Glucose Analyzer. J Clin Lab Anal. 2020 Aug;34(8):e23356. Epub: 2020 May 19. doi: 10.1002/jcla23356. PMID: 32430994. Available from: PMC7439437.

15197:2013 - Pass General population (Note: Modified protocol: Fewer samples with low and high blood glucose concentrations than recommended. One reagent system lot.)

Nichols JH, Brandler ES, Fantz CR, Fisher K, Goodman MD, Headden G, Hoppensteadt D, Matika R, Peacock WF, Rodrigo J, Schützenmeister A, Swanson JR, Canada-Vilalta C, Miles G, Tran N. A Multicenter Evaluation of a Point-of-Care Blood Glucose Meter System in Critically Ill Patients. J Appl Lab Med. 2021 Jul 7;6(4):820-833. doi: 10.1093/jalm/jfab005. PMID: 33837390.

FDA:2020P - Pass Neonates (0-28 days), arterial samples (n=100)

FDA:2020P - Pass Neonates (0-28 days), heel-stick samples (n=100)

FDA:2020P - Pass Infants to Adults (29 days to over 22 years), arterial samples (n=376)

FDA:2020P - Pass Infants to Adults (29 days to over 22 years), venous samples (n=375)

Lascaris B, Freling HG, Edens MA, Fokkert MJ, Olthof CG, Slingerland RJ. Comparison of Accu Chek Inform II point-of-care test blood glucose meter with Hexokinase Plasma method for a diabetes mellitus population during surgery under general anesthesia. J Clin Monit Comput. 2022 Apr;36(2):355-361. Epub: 2021 Jan 26. doi: 10.1007/s10877-021-00656-6. PMID: 33496941. Available from: PMC9123023.

IA protocol - Pass During anaesthesia (n=75)

Joseph JI. Analysis: New point-of-care blood glucose monitoring system for the hospital demonstrates satisfactory analytical accuracy using blood from critically ill patients--an important step toward improved blood glucose control in the hospital. J Diabetes Sci Technol. 2013 Sep 1;7(5):1288-93. doi: 10.1177/193229681300700519. PMID: 24124956. Available from: PMC3876373.

The publication is a letter or correspondence in which the Roche Accu-Chek Inform II is referenced.

Jeong TD, Cho EJ, Ko DH, Lee W, Chun S, Hong KS, Min WK. Large-scale performance evaluation of Accu-Chek inform II point-of-care glucose meters. Scand J Clin Lab Invest. 2016 Dec;76(8):657-63. Epub: 2016 Oct 14. doi: 10.1080/00365513.2016.1233575. PMID: 27739331.

The publication evaluates the performance of the Roche Accu-Chek Inform II, though not in a formal validation.

Kim HN, Yoon SY. Comparative study of i-SENS glucometers in neonates using capillary blood samples. Clin Chem Lab Med. 2021 Jan 22;59(6):1133-1141. doi: 10.1515/cclm-2020-1367. PMID: 33915605.

15197:2013 - Pass Neonates