Quantitative Measurement of Cardiac Biomarkers

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Cardiac Biomarker Analyzer Quantitative Measurement of Cardiac Biomarkers Troponin I, Myoglobin, CK-MB, D-Dimer, NTproBNP, hscrp Results in 17 minutes Direct measurement from whole

1 Cardiac Biomarker Analyzer Quantitative Measurement of Cardiac Biomarkers Troponin 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 5.1%

Cardiac Biomarker Analyzer Critical Results Faster The PATHFAST is an easy to use, bench-top, chemiluminescent immunoassay analyzer that rapidly measures concentrations of emergency biomarkers from a

2 Cardiac Biomarker Analyzer Critical Results Faster The 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. Parallel Processing for Fast Action and Flexibility The 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 time. Test Location Versatility The PATHFAST s compact design and quick turnaround time make it the ideal system in emergency departments, satillite laboratories and core laboratories. 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 chemiluminescence 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 analyzers. Operation and Safety The effortless operation of the PATHFAST consists of a four step method. 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 additional reagents, buffer solutions or sample pipettes (e.g. capillaries) required and a water connection or drain is not necessary. Testing personnel require only minimal training. The PATHFAST is operationally safe and is virtually maintenance free. Best of all, core lab quality results are available in only 17 minutes from whole blood samples.

3 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 insufficiency. Available Markers Troponin I Measurements 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 ng/ml Sample #1 #2 #3 #4 Total % CV in plasma 7.1% 6.1% 5.4% 3.9% Troponin means in ng/ml Correlation vs. Stratus CS y = 0.947x 0.005; r = 0.994; n = 57 Myoglobin Myoglobin 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 AMI. 5 1,000 ng/ml QC-L QC-M QC-H Total % CV in plasma 4.3% 3.8% 2.4% MYO means in ng/ml Correlation vs. Stratus CS y = 1.046x ; r = 0.996; n = 60 CK-MB CK-MB is found predominantly in cardiac muscle cells accounting 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 ng/ml QC-L QC-M QC-H Total % CV in plasma 8.4% 6.4% 6.9% CK-MB means in ng/ml Correlation vs. Stratus CS y = 1.007x 0.274; r = 0.988; n = 60 D-Dimer The 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 embolism μg/ml FEU QC-LL QC-L QC-M QC-H Total % CV in plasma 6.1% 6.0% 4.5% 7.1% D-Dimer means in μg/ml FEU Correlation vs. Stratus CS y = 1.01x ; r = ; n = 235 NTproBNP The 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) ,000 pg/ml QC-LL QC-L QC-M QC-H Total % CV in plasma 4.7% 3.4% 4.6% 5.4% NTproBNP means in pg/ml Correlation vs. Elecsys y = 1.046x ; r = 0.985; n = 346 hscrp Measurement 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 diseases mg/l QC-LL QC-L QC-M QC-H Total % CV in serum 7.4% 8.1% 8.5% 5.3% hscrp means in mg/l Correlation vs. IMMULITE y = 1.01x 0.056; r = 0.990; n = 60

4 PATHFAST Test Principle Troponin I, Myoglobin, CK-MB, D-Dimer, NTproBNP, hscrp Diagnostic safety through parallel reagent barcode scanning of all significant markers

Reagent Cartridge Magnetic particles ALP-conjugated antibody Chemiluminescent substrate Sample Diluent Sample Well Washing Buffer

parameters per run Measuring time: 17 minutes for one to six samples Sampling material: Whole blood, plasma, serum Measuring

5 C Sample volume: 100 μl Wavelength: 300 650 nm Data storage: Patient data: 1000 QC data: 1800 CAL data: 300 Data transfer: ASTM

4 (d) x 20 (h) in Weight: 72 lbs Electrical requirements: 100 240 Vac Power consumption: 360 Vac Monitor/keyboard: LCD touch-screen

5 Reagent Cartridge Magnetic particles ALP-conjugated antibody Chemiluminescent substrate Sample Diluent Sample Well Washing Buffer Counting Well Technical Specifications 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: 37.5 C Sample volume: 100 μl Wavelength: nm Data storage: Patient data: 1000 QC data: 1800 CAL data: 300 Data transfer: ASTM standard Dimensions: 14.7 (w) x 22.4 (d) x 20 (h) in Weight: 72 lbs Electrical requirements: 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): Recommended Future Markers The PATHFAST features an expanding menu. Coming soon new assays for fertility and sepsis indication.

6 Cardiac Biomarker Analyzer Product List PATHFAST for critical care diagnostics Item number Pack size SYSTEM PATHFAST Immunoassay Analyzer Analyzer for the measurement of cardiac and other emergency parameters x 1 REAGENT KITS PATHFAST ctnl-ii PF1101-K 60 tests PATHFAST Myo-II PF1111-K 60 tests PATHFAST CK-MB-II PF1121-K 60 tests PATHFAST D-Dimer PF1051-KUS 60 tests PATHFAST NTproBNP PF1061-KUS 60 tests PATHFAST hscrp PF1071-KUS 60 tests CONSUMABLES AND ACCESSORIES PATHFAST Tips x 42 units PATHFAST Waste Box units PATHFAST Roll Paper rolls PATHFAST Diluent 1 PF01D 2 x 20 ml PATHFAST Diluent 2 PF02D 2 x 20 ml : : Distributed By: 27 Wellington Road, Lincoln, RI Tel: Fax: Manufactured By: Mitsubishi Chemical Medience Corporation, Tokyo, Japan 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 GmbH. Specifications subject to change without notice. L7323, Rev. C

Quantitative Measurement of Emergency Biomarkers in Parallel

Point-of-Care Immunoassay Analyzer Quantitative Measurement of Emergency Biomarkers in Parallel Troponin I, Myoglobin, CK-MB, D-Dimer, NTproBNP, hscrp Results in 17 minutes Direct measurement from whole