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Nova StatStrip Glu

Device Name:StatStrip Glu (Hospital Connectivity Glucose Measuring System)
Manufacturer:Sole: Nova Biomedical Corporation, 200 Prospect St, Waltham, MA 02454-9141, UNITED STATES.
Measuring functions:Blood glucose
Primary Client Use:Intended for professional use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Nova StatStrip Glu, to measure blood glucose, has passed in clinical validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; older protocol; multiple clinical validations
MDR CriteriaAdultsValidation with amended protocol - may require further study

Validation Publications

Kost GJ, Tran NK, Louie RF, Gentile NL, Abad VJ. Assessing the performance of handheld glucose testing for critical care. Diabetes Technol Ther. 2008 Dec;10(6):445-51. doi: 10.1089/dia.2008.0049. PMID: 19049373. Available from: PMC2693242.

15197:2003 - Pass General population

de Mol P, Krabbe HG, de Vries ST, Fokkert MJ, Dikkeschei BD, Rienks R, Bilo KM, Bilo HJ. Accuracy of handheld blood glucose meters at high altitude. PLoS One. 2010 Nov 12;5(11):e15485. doi: 10.1371/journal.pone.0015485. PMID: 21103399.

Ad Hoc protocol - Pass High Altitude (Note: Simulated altitude in hypobarbic chamber)

Only "Nova StatStrip" is stated in the paper. The "Nova StatStrip Glu" is inferred.

Makaya T, Memmott A, Bustani P. Point-of-care glucose monitoring on the neonatal unit. J Paediatr Child Health. 2012 Apr;48(4):342-6. Epub: 2011 Nov 23. doi: 10.1111/j.1440-1754.2011.02253.x. PMID: 22112143.

15197:2003 - Pass General population

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 - Fail General population

Tendl KA, Christoph J, Bohn A, Herkner KR, Pollak A, Prusa AR. Two site evaluation of the performance of a new generation point-of-care glucose meter for use in a neonatal intensive care unit. Clin Chem Lab Med. 2013 Sep;51(9):1747-54. doi: 10.1515/cclm-2012-0864. PMID: 23612555.

Ad Hoc protocol Neonates (Note: Protocol not stated in abstrtact)

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.

Wada Y, Nakamura T, Kaneshige M, Takahashi S, Fujinaga H, Tsukamoto K, Ito Y, Sago H. Evaluation of two glucose meters and interference corrections for screening neonatal hypoglycemia. Pediatr Int. 2015 Aug;57(4):603-7. Epub: 2015 Feb 11. doi: 10.1111/ped.12543. PMID: 25441549.

Ad Hoc protocol Neonates

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.

Cho J, Ahn S, Yim J, Cheon Y, Jeong SH, Lee SG, Kim JH. Influence of Vitamin C and Maltose on the Accuracy of Three Models of Glucose Meters. Ann Lab Med. 2016 May;36(3):271-4. doi: 10.3343/alm.2016.36.3.271. PMID: 26915620. Available from: PMC4773272. Letter.

15197:2013 Validation with maltose interference (Note: No significant intereference at any maltose concentration was noted.)

15197:2013 Validation with high Vit C (30 mg/dl) concentrations (Note: Device malfuctioned occasionally at high Vt C concentrations.)

This paper refers to a "Nova StarStrip". The "Nova StatStrip Glu" is inferred.

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 - Pass Neonates

CMA:2016 - Pass Neonates

Relevant Publications

Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.

Reliable correction for potential haematocrit influence.

Lv H, Zhang GJ, Kang XX, Yuan H, Lv YW, Wang WW, Randall R. Factors interfering with the accuracy of five blood glucose meters used in Chinese hospitals. J Clin Lab Anal. 2013 Sep;27(5):354-66. doi: 10.1002/jcla.21611. PMID: 24038220.

The publication evaluates the performance of the Nova Statstrip (Glu), though not in a formal validation.

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.

Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients. Diabetes Technol Ther. 2014 Dec;16(12):828-32. Epub: 2014 Aug 5. doi: 10.1089/dia.2014.0074. PMID: 25093919.

The publication evaluates the performance of the Nova Statstrip (Glu), though not in a formal validation.

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.