Quantitative Measurement of Cardiac Biomarkers

1 Cardiac Biomarker AnalyzerQuantitative Measurement of Cardiac BiomarkersTroponin I, Myoglobin, CK-MB, D-Dimer, NTproBNP, hsCRP Results in 17 minutes Direct Measurement from whole blood samples 6 parallel channels allows for any combination of up to 6 patients and tests at one time FDA cleared Troponin I at the 99th percentile with guideline acceptable CV of Biomarker AnalyzerParallel Processing for Fast Action and FlexibilityThe PATHFAST system is efficient and flexible. It features six parallel channels, allowing for six Quantitative analyses simultaneously with results in 17 minutes. The flexibility of the system enables the laboratory to run any combination of up to six patients and tests at one Location VersatilityThe PATHFAST s compact design and quick turnaround time make it the ideal system in emergency departments, satillite laboratories and core laboratories.

2 It can be used wherever fast, Quantitative results for the critical care of patients are required. Equipment and Interface The PATHFAST features an integrated computer and printer, operated by a touchscreen monitor. Barcoded samples are read by a handheld scanner. The PATHFAST can be easily connected to an LIS (Laboratory Information System) or middleware system. Principle and Precision PATHFAST is a fully automated immunoassay analyzer, which combines progressive chemilumi-nescence technology with patented Magtration technology. Small sample volumes can be analyzed with high accuracy and precision, while the analyzer and the reagent cartridges provide optimum sensitivity. Results are reproducible and correlate well with core lab and Safety The effortless operation of the PATHFAST consists of a four step method.

3 To use, add the sample to the reagent cartridge, insert the cartridge into the analyzer, scan or manually input the patient ID and press the Start button. PATHFAST takes care of everything else automatically. There are no addi-tional reagents, buffer solutions or sample pipettes ( capillaries) required and a water connection or drain is not necessary. Testing personnel require only minimal training. The PATHFAST is operation-ally safe and is virtually maintenance free. Best of all, core lab quality results are available in only 17 minutes from whole blood PATHFAST is an easy to use, bench-top, chemiluminescent immunoassay analyzer that rapidly measures concentrations of emergency Biomarkers from a single whole blood sample. With a 17 minute turnaround time, critical results are available to the caregiver quickly, enhancing patient care.

4 Critical Results FasterAvailable MarkersTroponin IMeasurements of Cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI). Troponin I is released rapidly to blood circulation several hours after the onset of AMI. Assay 50 ng/mLSample#1#2#3#4 Total % CV in means in vs. Stratus CSy = ; r = ; n = 57 MyoglobinMyoglobin is one of the first markers associated with myocardial necrosis to rise above normal levels. The Measurement of Myoglobin can be used as a rapid and sensitive test in the early phase of range5 1,000 ng/mLQC-L QC-MQC-HTotal % CV in means in vs. Stratus CSy = + ; r = ; n = 60CK-MBCK-MB is found predominantly in Cardiac muscle cellsaccounting for approximately 10-40% of myocardial CK. Low concentration of CK-MB in healthy subjects is an aid for the diagnosis and monitoring of myocardial injury.

5 Assay range1 250 ng/mLQC-L QC-MQC-HTotal % CV in means in vs. Stratus CSy = ; r = ; n = 60D-DimerThe D-Dimer concentration is an indicator for the fibrinolytic activity of plasmin in the vascular system. Elevated concentrations of D-Dimer indicate increased coagulation and fibrinolytic activity. In general, a D-Dimer assay may be useful in assisting with the diagnosis of deep vein thrombosis and pulmonary 5 g/mL FEUQC-LLQC-LQC-M QC-HTotal % CV in means in g/mL vs. Stratus CSy = + ; r = ; n = 235 NTproBNPThe result obtained from a NTproBNP assay is an aid to assist in the diagnosis and assessment of severity of congestive heart failure (CHF) and risk stratification in patients with acute coronary syndrome (ACS). Assay range15 30,000 pg/mLQC-LLQC-LQC-M QC-HTotal % CV in means in pg/mL101425238812058 Correlation vs.

6 Elecsys y = + ; r = ; n = 346hsCRPM easurement of CRP by a high sensitivity CRP assay may add to the predictive value of other markers used to assess the risk of cardiovascular and peripheral vascular 30 mg/LQC-LLQC-LQC-M QC-HTotal % CV in means in vs. IMMULITE y = ; r = ; n = 60 PATHFAST determines the quantity of Troponin I, Myoglobin, CK-MB, D-Dimer, NTproBNP and hsCRP from one single whole blood sample. The Quantitative data of the parallel analyses provide results within minutes, which facilitates the critical care decision for patients with acute coronary syndrome, venous thromboembolism and suspected coronary Test Principle Troponin I, Myoglobin, CK-MB, D-Dimer, NTproBNP, hsCRP Diagnostic safety through parallel reagent barcode scanning of all significant markers Instrument type: Bench-top Cardiac Biomarker Analyzer Throughput: Up to 6 samples or parameters per run Measuring time: 17 minutes for one to six samples Sampling material: Whole blood, plasma, serum Measuring principle: Chemiluminescence enzyme immunoassay technology (CLEIA) and Magtration technology Reaction temperature: C Sample volume: 100 l Wavelength.

7 300 650 nm Data storage: Patient data: 1000 QC data: 1800 CAL data: 300 Data transfer: ASTM standard Dimensions: (w) x (d) x 20 (h) in Weight: 72 lbs Electrical requirements: 100 240 Vac Power consumption: 360 Vac Monitor/keyboard: LCD touch-screen Printer: Integrated PC: Integrated Interface: RS-232C Calibration: Factory calibration, 2-point calibration every 4 weeks 24-h operation (stand-by): RecommendedCounting WellReagent Cartridge Magnetic particles ALP-conjugated antibody Chemiluminescent substrate Sample Diluent Washing BufferTechnical SpecificationsFuture Markers The PATHFAST features an expanding menu. Coming soon new assays for fertility and sepsis indication. Sample WellCardiac Biomarker AnalyzerProduct ListPATHFAST for critical care diagnosticsItem numberPack sizeSYSTEMPATHFAST Immunoassay AnalyzerAnalyzer for the Measurement of Cardiac and other emergency parameters3009291 x 1 REAGENT KITSPATHFAST cTnl-IIPF1101-K60 testsPATHFAST Myo-IIPF1111-K60 testsPATHFAST CK-MB-IIPF1121-K60 testsPATHFAST D-DimerPF1051-KUS60 testsPATHFAST NTproBNPPF1061-KUS60 testsPATHFAST hsCRPPF1071-KUS60 testsCONSUMABLES AND ACCESSORIESPATHFAST Tips3009365 x 42 unitsPATHFAST Waste Box30095010 unitsPATHFAST Roll Paper30094310 rollsPATHFAST Diluent 1PF01D2 x 20 mLPATHFAST Diluent 2PF02D2 x 20 mL:Mitsubishi Chemical Medience Corporation, Tokyo, Japan27 Wellington Road, Lincoln, RI 02865 Tel: 800-345-2822 Fax: By:Distributed By:: 2013.

8 Vital Diagnostics, Inc. All rights reserved. Vital Diagnostics is a registered trademark of ELITechGroup SAS. PATHFAST is a registered trademark of Mitsubishi Chemical Medience Corporation. Magtration is a registered trademark of Precision System Science Co., Ltd. Stratus and IMMULITE are registered trademarks of Siemens Healthcare Diagnostics Inc. Elecsys is a registered trademark of Roche Diagnostics subject to change without notice. L7323, Rev. C