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 blood samples
6parallel channels allows either 6 samples or
6 tests for one sample to be run simultaneously
99thpercentile, guideline acceptable Troponin I
results available at point-of-care
 Point-of-Care Immunoassay 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 fea-
tures six parallel channels, allowing for six quantitative
analyses simultaneously, with results in 17 minutes.
The flexibility of the system enables the laboratory to
run either six samples at one time, or six parameters
for one patient simultaneously.
Point-of-Care
The PATHFASTs compact design and quick turn-
around time make it the ideal system in emergency
departments, hospital laboratories and core laborato-
ries. It can be used wherever fast, quantitative results
for the critical care of patients are required.
Equipment and Networking
The PATHFAST features an integrated computer and
printer, operated by a touchscreen monitor. Barcoded
samples are read by handheld scanner. An RS-232C
interface allows it to be easily connected to an LIS
(Laboratory Information System). Networking enables
direct data transfer to the central lab with access to
results from any PC.
Principle and Precision
PATHFAST is a fully automated immunoassay analyz-
er, which combines progressive chemiluminescence
technology with patented Magtration technology.
Small sample volumes can be detected with high
accuracy and precision, while the device and the re-
agent cartridges provide optimum sensitivity. Results
are reproducible and correlate well with lab analyses.
Operation and Safety
The effortless operation of the PATHFAST consists
of a three step method. To use, add the sample to the
reagent cartridge, insert the cartridge into the analyzer
and press the Start button. PATHFAST takes care of
everything else automatically. There are no additional
reagents, buffer solution or sample pipettes (e.g. capil-
laries) required and a water connection or drain is not
necessary. Lab personnel are not required to have any
special skills or certifications. The PATHFAST is opera-
tionally safe and is virtually maintenance free. Best of
all, lab quality results are available in only
17 minutes from whole blood samples.
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 D-Dimer
Measurements of cardiac Troponin I are used as an aid The D-Dimer concentration is an indicator for the fibrino-
in the diagnosis of acute myocardial infarction (AMI). lytic activity of plasmin in the vascular system. Elevated
Troponin I is released rapidly to blood circulation several concentrations of D-Dimer indicate increased coagulatory
hours after the onset of AMI. and fibrinolytic activity. In general, a validated D-Dimer
assay may be useful in assisting with the diagnosis of
deep vein thrombosis and pulmonary embolism.
Assay range 0.019 50 ng/mL Assay range 0.005 5 g/mL FEU

Sample #1 #2 #3 #4 QC-LL QC-L QC-M QC-H

Total % CV in plasma 7.1% 6.1% 5.4% 3.9% Total % CV in plasma 6.1% 6.0% 4.5% 7.1%

Troponin means in ng/mL 0.022 0.029 0.086 0.251 D-Dimer means in g/mL FEU 0.024 0.249 0.654 2.45

Correlation vs. Stratus CS

y = 0.947x 0.005; r = 0.994; n = 57 Correlation vs. Stratus CS

y = 1.01x + 0.069; r = 0.982 ; n = 235

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.
NTproBNP
The result obtained with the 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 5 1,000 ng/mL Assay range 15 30,000 pg/mL

QC-L QC-M QC-H QC-LL QC-L QC-M QC-H
Total % CV in plasma 4.3% 3.8% 2.4% Total % CV in plasma 4.7% 3.4% 4.6% 5.4%
MYO means in ng/mL 33.8 102 688 NTproBNP means in pg/mL 101 425 2388 12058
Correlation vs. Stratus CS y = 1.046x + 5.54; r = 0.996; n = 60 Correlation vs. Elecsys
y = 1.046x + 3.61; r = 0.985; n = 346

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.
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.

Assay range 1 250 ng/mL Assay range 0.05 30 mg/L

QC-L QC-M QC-H QC-LL QC-L QC-M QC-H

Total % CV in plasma 8.4% 6.4% 6.9% Total % CV in serum 7.4% 8.1% 8.5% 5.3%

CK-MB means in ng/mL 2.69 36.0 211 hsCRP means in mg/L 0.916 4.63 15.1 25.6

Correlation vs. Stratus CS

y = 1.007x 0.274; r = 0.988; n = 60 Correlation vs. IMMULITE
y = 1.01x 0.056; r = 0.990; n = 60
PATHFAST Test Principle

Troponin I, Myoglobin, CK-MB, D-Dimer, NTproBNP, hsCRP

Diagnostic safety through parallel

scanning of all significant markers
Reagent Cartridge
Magnetic particles
ALP-conjugated antibody

Chemiluminescent substrate

Sample Diluent

Washing Buffer
Sample Well

Counting Well

Technical Specifications Future Markers

Instrument type: Bench-top Immunoassay Analyzer The PATHFAST features an expanding menu.
Throughput: Up to 6 samples or Coming soon new assays for fertility and
parameters per run sepsis indication.
Measuring time: Less than 17 min for 6 samples
using emergency markers
Sampling material: Whole blood, plasma, serum
Measuring principle: Chemiluminescence enzyme
immunoassay technology (CLEIA)
and Magtration technology
Reaction temperature: 37.5 C
Sample volume: 100 l
Wavelength: 300 650 nm
Data storage: Patient data: 1000
QC data: 1800
CAL data: 300
Data transfer: ASTM standard
Dimensions: 375 (w) x 570 (d) x 510 (h) mm
Weight: 33 kg
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
 Point-of-Care Immunoassay Analyzer

Product List
PATHFAST for critical care diagnostics Item number Pack size

SYSTEM

PATHFAST Immunoassay Analyzer 300929 1x1

Analyzer for the measurement of cardiac and
other emergency parameters

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

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

Manufactured By:

Mitsubishi Chemical Medience Corporation, Tokyo, Japan

2012. Vital Diagnostics, Inc. All rights reserved. Vital Diagnostics is a registered trademark of Vital Diagnostics. 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. A