Siemens Healthineers Point of Care Diagnostic Solution for Near-Patient Settings

Near-patient settings with lab-quality results

Timeliness, effectiveness and safety are critical for acute care.^1,2 Keeping this fact in mind, Siemens Healthineers Point of Care Diagnostics has designed the Stratus CS Acute Care Diagnostic System to best meet the requirements of the near-patient settings.

This solution is the ideal fit for near-patient testing. Intelligent design ensures ease of use and gold-standard quality results. It delivers the needed biomarkers to cover the spectrum of acute cardiac care.

The benefits of near-patient testing^2,3

A study conducted using the Stratus CS Acute Care Diagnostic System to evaluate the impact of point-of-care testing with cTnI against routine testing documented several benefits of the system:

• For near-patient testing, turnaround time was shortened from 76 to 20 minutes
• 25% reduction in total costs for point-of-care cTnl testing

Caring for patients comes before handling specimens

Confidence in near-patient cardiac marker results

• Reduces time to 14 minutes compared to 60–120 minutes from the central lab
• Select from a robust diagnostic and risk stratification menu
• Less hands-on manipulation compared to hand-held devices decreases the opportunity for error

Easy to use by personnel of all skill levels^4,5,6,7

• Daily maintenance is not needed
• Can be integrated into the information system of an institution
• Reduced risk of biohazard
• Closed whole blood sample processing using on-board centrifugation

Laboratory practices must be perfectly fulfilled

The Stratus CS Acute Care Diagnostic System is developed in compliance with laboratory accrediting agencies (CLSI, JCAHO, CAP). Daily system check with a programmable time lock-out includes:

• Fluid handling system
• Mechanical alignments
• Optical detection system
• Temperature
• Liquid control check and programmable time/range lock-outs are also available, if required by an institution or local regulations

Harmonizing the central lab and near-patient testing

“As more assay systems are devised for point-of-care (POC) testing, identical criteria must apply to both central laboratory methodologies and POC testing systems.”⁸

Siemens has been proactive in taking steps to ensure the alignment of cardiac Troponin I assays in the near-patient setting and central laboratory. cTnI and NT-proBNP need to be harmonized for laboratory medicine.^8,9,10

The Stratus CS Acute Care cTnI assay has been shown to agree well with the Siemens central laboratory platforms (the Dimension Vista^® Intelligent Lab System, Xpand^® Plus integrated chemistry systems, and Dimension^® RxL Max^®) across the measurement range.

Siemens supplies the only point-of-care/central-lab pair of instruments that show real cTnI harmony,^6,11,12 making the Stratus CS Acute Care Diagnostic System a perfect backup solution in satellite sites and central laboratories.

Guideline acceptable Troponin I

The preferred biomarker for myocardial necrosis^8,9

• Meets internationally accepted guidelines (ESC/ACC/AHA/NACB/IFCC)^8,9,11
• 10% CV at 0.06 ng/mL
• Excellent cardiac specificity and sensitivity^13,14
• 99th percentile of normal: 0.07 ng/mL^11,13

NT-proBNP^15,16

Helps evaluate and manage acute coronary syndromes (ACS) and heart failure (HF)

• Additional risk factor for poor outcomes in ACS patients
• Early and accurate diagnosis

Myoglobin^8,9

For patients who need early diagnosis

• Usable for reperfusion monitoring and re-infarction
• Outstanding negative predictive value can be rapidly observed in blood after injury

CardioPhase^® CRP

Increases the prediction value of other markers employed for evaluating the risk of peripheral vascular and cardiovascular disease

• Inflammation contributing to plaque instability/rupture

CKMB mass^8,9

An alternative solution to Troponin I

• Estimation of infarct-size¹⁴
• Usable for re-infarction detection¹⁷

Additional assays available on the Stratus CS Analyzer.

D-dimer^18,19

An important test carried out on patients who are suspected of thrombotic disorders

• High precision at the cut-off level
• Outstanding sensitivity
• High negative predictive value for venous thromboembolism (VTE)
• Excludes pulmonary embolism (PE)*

βhCG²⁰

For answering the question of pregnancy quickly and quantitatively to ensure the safest treatment possible

We found that a cTnl value of 0.07 ng/mL corresponded to the 99th percentile of a reference control population. A cTnI concentration of 0.06 ng/mL corresponded to a total imprecision of 10% CV for two

independent Stratus CS analyzers in routine use. Thus, the 10% CV for the Stratus CS cTnI assay is below the 99th percentile of a reference control population, and in compliance with specifications of the ESC/ACC** redefinition of MI.”¹¹

R. Christenson et al., Clin Biochem 2004

First guideline acceptable Troponin I method

A guideline acceptable Troponin I method is defined by the joint ESC/ASCC committee as having an imprecision level of ≤10% at the 99^th percentile of a normal population.^8,9,11,21 The assay can be used for the measurement of cardiac Troponin I to aid in the diagnosis of acute myocardial infraction (AMI) and in the risk stratification of patients with acute coronary syndrome (ACS).¹³

Siemens Acute Care Markers

The Stratus CS Acute Care Diagnostic System’s panel of robust and comprehensive cardiac markers delivers reliable answers to important questions.

Stratus CS Acute Care System designed for acute care diagnostics

System, sample, and reagent specifications

Please refer to the assay insert sheets or operator’s guide for more detailed information.

Automatic alignment

Level-sensing capabilities automatically align to each TestPak and module

Computer interface specifications

Uni-directional

Environmental specifications

Humidity: 20–80%

Room temperature: 17–30°C

Waste disposal

All hazardous materials are held in a disposable waste liner

Centrifuge speed

Microprocessor-verified between 18,000 and 22,000 rpm

Sample and TestPak identification

Universal barcode reader

Automatic dilutions

Single-use DilPaks per method

Real-time fluid management

Liquid level sensing capability in combination with fluidic dispense monitoring system

Turnaround time

System delivers first result in as little as 14 minutes and a panel of 4 tests in 26 minutes from a whole blood sample

Specimen type

Sodium heparin or lithium heparin for all methods except D-dimer. D-dimer needs lithium heparin or sodium citrate whole blood or plasma.

Quality control

• Daily system check (electronic QC) with programmable time lockout

• Liquid controls are processed following calibration, once a previously calibrated lot of reagents is received or whenever the site wants to verify performance, and in accordance with local, state, and/or federal regulations
• On-board “QC Required” alert for a time element and/or range check

Software features

• POC interface mode for connectivity
• Can store the last 20 results and can be reprinted and/or transmitted to LIS
• Unauthorized operator lockout capability
• Patient ID and/or sample ID entry sample collection time entry
• TestPak lot expiration notification password protection of advanced setup functions

Storage requirements

DilPaks, CalPaks and TestPaks: 2 to 8°C (Troponin-I CalPak and NT-proBNP CalPak: -10 to -20°C)

Calibration stability

• 30 days for NT-proBNP
• 60 days for cTnI, CKMB, Myoglobin, D-dimer and hsCRP
• 90 days for βhCG

Calibration

Can store up to 3 separate TestPak lots per assay

Reagent capacity

Single-use assay cartridges

Assay technology

Dendrimer enhanced radial partition immunoassay

Ordering information

References

1. Hamm C, et al. N Engl J Med. 1997;337(23):1648-53
2. Sabatine MS, et al. Circulation 2002;105:1760-63
3. Casagranda I, et al. Clinica Chimica Acta 2001;311:63-66
4. Altinier S, et al. Clinica Chimica Acta 2001;311:67-72
5. Walker T, et al. Am Clin Lab 2001;37-39
6. Gantzer, ML, et al. Poster Presentation AACC 2002. Clin Chem 2002;48(6)
7. Bauer R, et al. Point of Care 2002;1(1):54-57
8. NACB and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice. Guidelines: Analytical Issues for Biochemical Markers of Acute Coronary Syndromes. Clin Chem 2007;53:547-551 and Circulation 2007;115:352-355
9. ESC/ACC Joint Committee – J Am Coll Cardiol 2000;36:959-69 Eur Heart J 2000;21:1502–13,

1. Clin Chem 2001;47:382–92

10. Collinson P. Global Perspective: Managing Cardiovascular Disease (Educational Video/CD-ROM)
11. Christenson R, et al. Clin Biochem 2004;37:679-683
12. Kim WJ, et al. Clin Chem 2002;48(7):1028-34
13. Stratus CS cTnI TestPak (product insert).
14. NACB Laboratory Medicine Practice Guidelines: Clinical Characteristics and Utilization of Biochemical Markers in Acute Coronary Syndromes. Clin Chem 2007;53:552-574
15. Mueller T, et al. N Engl J Med. 2004;350(7):647-654
16. Januzzi JL, van Kimmenade R, et al. Eur Heart J Advance Access, November 17, 2005
17. Braunwald E, et. al. Circulation 2000;102:1193-1209
18. Engelhardt W, et al. Thromb Res. 2004,112,25-32
19. Reber G, et al. Blood Coagul and Fibrinolysis, 15(5),2004.
20. Di Serio F, et al. Poster Presentation, 20th Intl Symposium on Critical Care and POCT. Wuerzburg, 2004
21. Panteghini M, et al. Clin Chem 2004;50(2): 327-32

About Siemens Healthineers Point of Care Diagnostics

Point-of-care solutions are designed to provide immediate, convenient, and easy-to-use diagnostic testing. From the ED to the physician’s office, clinical management decisions can be made immediately and result in improved patient safety, clinical outcomes, and overall patient satisfaction.

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