Cardiac Biomarker Analyzer

Quantitative 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 5.1%

Cardiac Biomarker Analyzer

Parallel 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 time.

Test Location VersatilityThe 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 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 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 addi-tional 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 operation-ally safe and is virtually maintenance free. Best of all, core lab quality results are available in only 17 minutes from whole blood samples.

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.

Critical Results Faster

Available 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 range 0.019 – 50 ng/mL

Sample #1 #2 #3 #4

Total % CV in plasma 7.1% 6.1% 5.4% 3.9%

Troponin means in ng/mL 0.022 0.029 0.086 0.251

Correlation vs. Stratus® CS y = 0.947x – 0.005; r = 0.994; 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 AMI.

Assay range 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 33.8 102 688

Correlation vs. Stratus® CS y = 1.046x + 5.54; r = 0.996; n = 60

CK-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.

Assay range 1 – 250 ng/mL

QC-L QC-M QC-H

Total % CV in plasma 8.4% 6.4% 6.9%

CK-MB means in ng/mL 2.69 36.0 211

Correlation vs. Stratus® CS y = 1.007x – 0.274; r = 0.988; n = 60

D-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 embolism.

Assay range 0.005 – 5 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 0.024 0.249 0.654 2.45

Correlation vs. Stratus® CS y = 1.01x + 0.069; r = 0.982 ; 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 range 15 – 30,000 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 101 425 2388 12058

Correlation vs. Elecsys® y = 1.046x + 3.61; r = 0.985; n = 346

hsCRPMeasurement 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.

Assay range 0.05 – 30 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 0.916 4.63 15.1 25.6

Correlation vs. IMMULITE® y = 1.01x – 0.056; r = 0.990; 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 insufficiency.

PATHFAST® 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: 37.5 °C Sample volume: 100 μl Wavelength: 300 – 650 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: 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): Recommended

Counting Well

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

Technical Specifications Future Markers

The PATHFAST features an expanding menu. Coming soon – new assays for fertility and sepsis indication.

Sample Well

Cardiac Biomarker Analyzer

Product ListPATHFAST for critical care diagnostics Item number Pack size

SYSTEM

PATHFAST Immunoassay AnalyzerAnalyzer for the measurement of cardiac and other emergency parameters

300929 1 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 300936 5 x 42 units

PATHFAST Waste Box 300950 10 units

PATHFAST Roll Paper 300943 10 rolls

PATHFAST Diluent 1 PF01D 2 x 20 mL

PATHFAST Diluent 2 PF02D 2 x 20 mL

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Mitsubishi Chemical Medience Corporation, Tokyo, Japan

27 Wellington Road, Lincoln, RI 02865Tel: 800-345-2822 • Fax: 401-642-9001www.vitaldiagnostics.com

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©2013. 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