The clinical performance of the novel POC Minicare ctni-assay. Per Venge, MD PhD Professor in Clinical Chemistry Uppsala University Uppsala, Sweden

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1 The clinical performance of the novel POC Minicare ctni-assay Per Venge, MD PhD Professor in Clinical Chemistry Uppsala University Uppsala, Sweden Disclosure: Per Venge has received consultancy honoraria from Philips Handheld Diagnostics

2 Minicare ctni A magnetically controlled sandwich immunoassay Particle antibody: ctni AA Surface bound antibodies: Two ctni antibodies AA and one ctnc antibody

3 Minicare ctni-assay Analytical performance Analytical performance data Limit of blank (LoB): 8.5 ng/l Limit of detection (LoD): 18 ng/l Limit of quantitation (LoQ): 38 ng/l 99 th percentile URL (whole blood): 39 ng/l Reference population: 750 healthy volunteers (373 males and 377 females; age range from 18 to 86 years)

4 A Passing-Bablok regression analysis of Minicare ctni Whole blood vs Plasma R s =0.85 y = x

5 A Passing-Bablok regression analysis of Minicare ctni Whole blood vs Architect hs-ctni Plasma R s =0.68 y = x

6 A Passing-Bablok regression analysis of Minicare ctni Whole blood vs I-Stat ctni Plasma R s =0.60 y = x

7 Patients Adjudication on the final diagnosis of AMI was done according to the Third Universal Definition of Myocardial Infarction by an external board of cardiologist. CE study Minicare ctni Efficacy pop. at t=0 whole blood Efficacy pop. at t=2-4h whole blood Efficacy population Only patients with a positive ctn test (value above the 99 th percentile URL) performed with the N= 465 patients hospital standard ctn assay (ROCHE hs TNT) were submitted to the adjudication board. The N=74 MI positive other samples were considered as non-ami. Efficacy pop. at t=0 Plasma Efficacy pop. at t=2-4h plasma STEMI: 26% NSTEMI: 74% N= 453 patients N= 71 MI positive N= 382 patients N=65 MI positive N= 456 patients N= 73 MI positive N= 378 patients N= 64 MI positive Post Market Study Architect hs-ctni and I-STAT ctni Uppsala Study population N= 463 patients N=74 MI positive Study population T=0 N= 457 patients N=72 MI positive Study population T=2-4h N= 379 patients N=62 MI positive Test population Architect at t=0 Architect hs-ctni Test population Architect at t=2-4h Test population I-STAT at t=0 I-STAT ctni Test population I-STAT at t=2-4 N= 438 patients N= 67 MI positive N= 362 patients N= 59 MI positive N= 448 patients N= 72 MI positive N= 377 patients N= 62 MI positive

8 The comparison between Minicare and Architect ctni results in patients with suspicion of AMI

9 The clinical performance of Minicare ctni AUROC AUROC Minicare ctni AUROC Sensitivity Specificity PPV NPV Lr+ Lr- Admission ( ) 71% (59-81%) 91% (88-94%) 61% (49-71%) 95% (92-97%) 8 (6-12) 0.32 ( ) 2-4 hours ( ) 95% (86-99%) 89% (85-93%) 64% (53-76%) 99% (97-100%) 9 (7-12) 0.06 ( )

10 The clinical performance of Architect hs-ctni AUROC AUROC Architect hs-ctni AUROC Sensitivity Specificity PPV NPV Lr+ Lr- Admission ( ) 72% (59-82%) 92% (89-95%) 62% (51-73%) 95% (92-97%) 9 (6-13) 0.31 ( ) 2-4 hours ( ) 97% (89-100%) 84% (80-88%) 55% (45-64%) 99% (97-100%) 6 (5-8) 0.04 ( )

11 The clinical performance of I-Stat ctni AUROC AUROC I-Stat ctni AUROC Sensitivity Specificity PPV NPV Lr+ Lr- Admission ( ) 56% (43-67%) 99% (97-100%) 89% (76-96%) 92% (89-95%) 42 (17-102) 0.45 ( ) 2-4 hours ( ) 74% (62-85%) 98% (96-100%) 90% (79-97%) 95% (92-97%) 47 (19-113) 0.26 ( )

12 Cardiac troponin levels at admission relative to length of symptoms in the AMI group

13 Cardiac troponin levels at admission relative to length of symptoms in the non-ami group 7% above 99 th perc 7% above 99 th perc 1% above 99 th perc 24% above 99 th perc

14 History of Coronary artery disease in non-ami group Minicare ctni, Median (95% CI) Architect hs-ctni Median (95% CI) Roche hs-ctnt Median (95% CI) 8 ng/l ( ) N= ng/l ( ) N=135 Yes No P 13.0 ng/l ( ) N= ng/l (1-4) N= ng/l ( ) N= ng/l (6-10) N=247 <0.001 <0.001 < of 28 (46%) patients with Minicare ctni >39 ng/l had history of CAD 14 of 28 (50%) patients with Architect hs-ctni >26.2 ng/l had history of CAD 53 of 96 (55%) patients with Roche hs-ctnt >14 ng/l had history of CAD 21% of CAD patients had ctni >99 th percentile 69% of CAD patients had ctnt >99 th percentile P<0.0001

15 The clinical performances of the three ctni assays Admission Assay Cut-off, ng/l Minicare WB 39 ng/l Minicare WB >39 ng/l Concordance Architect 26.2 AMI n=16 AMI n=2 >26.2 AMI n=2 AMI n=44 94% i-stat 80 AMI n=19 AMI n=12 >80 AMI n=1 AMI n=37 81% 2-4 hours after admission Assay Cut-off, ng/l Minicare WB 39 ng/l Minicare WB >39 ng/l Concordance Architect 26.2 AMI n=3 AMI n=3 >26.2 AMI n=0 AMI n=52 95% i-stat 80 AMI n=3 AMI n=11 >80 AMI n=0 AMI n=47 82%

16 Conclusions The clinical performance, in terms of diagnosing AMI, of the Minicare ctni POC assay equals the performance of the hs-ctni Architect laboratory assay The clinical performance is superior to the contemporary I-Stat ctni POC assay The sensitivity of the Minicare ctni assay should allow safe rule-out of AMI after 3 hours The clinical sensitivity of the Minicare ctni assay relates to the positive identification of both cardiac troponin I and C

17 Contributors Lian van Lippen 1, Veronique Semjonow 1, Femke de Theije 1, Diederick Keizer 1, Danielle WM Kemper 1, Johannes Mair 2, Bernadette Wille 2, Michael Christ 3, Felicitas Geier 3, Pierre Hausfater 4, David Pariente 4, Volkher Scharnhorst 5, Joyce Curvers 5, Jeroen Nieuwenhuis 1, Emil Hagström 6 1: Philips Handheld Diagnostics, Eindhoven, the Netherlands 2: Department of Internal Medicine III Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria 3: Department of Emergency and Critical Care Medicine, Paracelsus Medical University, Nuernberg General Hospital, Nuernberg, Germany 4: Emergency Department, Hôpital Pitié-Salpêtrière, AP-HP et Sorbonne Universités UPMC Univ-Paris 06, France 5: Clinical laboratory, Catharina Ziekenhuis Eindhoven and Technical University Eindhoven, Eindhoven, the Netherlands 6: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

18 The change in ctni concentrations from admission to 2-4 hours after Minicare ctni whole blood STEMI P= NSTEMI P< Admission 2-4 hours Admission 2-4 hours

BioRemarkable Symposium

BACC BioRemarkable Symposium Acute Myocardial infarction Stefan Blankenberg University Heart Center Hamburg London, September 7th, 2017 Universitätsklinikum Hamburg-Eppendorf Third Universal-Definition