Nova Biomedical : World Leader in Biosensor Technology

StatStrip^® Connectivity and StatStrip Xpress Point-of-Care Lactate Analyzers

StatStrip Lactate is a handheld point-of-care testing system that brings lactate testing directly to the patient’s bedside. Lactate is currently measured on blood gas analyzers, which creates numerous problems for bedside testing. Blood gas analyzers require anaerobic, arterial samples; large sample volumes (100-200 microliters); and require long analysis times (up to 2.5 minutes). In addition, blood gas analyzers are complex to operate, fixed in location, and expensive to purchase and use. StatStrip Lactate provides the fastest turnaround time possible (13 seconds), on the smallest whole blood sample (0.6 microliters), and can be easily operated by medical and nursing staff. StatStrip Lactate is a very low cost device that makes lactate testing practical and affordable in any size ED, ICU, or medical unit.

Global sepsis and sepsis mortality rates are alarming
Worldwide, severe sepsis and septic shock affect 18 million people annually, accounting for 1,400 deaths each day.² In the U.S., severe sepsis occurs in over 750,000 patients each year² and accounts for nearly 10% of all ICU admissions.³ An estimated 28% to 50% of all U.S. patients with sepsis die—much higher than the number of deaths from prostate cancer, breast cancer, and AIDS combined.⁴ In the United Kingdom, the annual sepsis mortality rate is 35%,² with an estimated 36,800 deaths occurring in intensive care units (ICU).⁵

Early detection and aggressive treatment of sepsis increases survival chances⁶
Sepsis is a time-critical condition that requires early recognition and initiation of care. Diagnosis is often delayed because the clinical signs and symptoms of sepsis may present subtly; however, a patients’ condition can deteriorate rapidly—especially patients with septic shock, for whom the rate of survival decreases 7.6% for each hour antimicrobial therapy is delayed.⁷

“[We] strongly recommend that more rapid TTAT [therapeutic turnaround time] of lactate results be considered as a way to improve outcomes in ED, OR, and ICU patients.” – National Academy of Clinical Biochemistry¹

New Surviving Sepsis Campaign (SCC) guidelines call for rapid lactate results
SSC now recommends early screening and protocolized goal-directed therapy for sepsis patients with lactate levels great than 4 mmol/L, targeting treatment to normalize lactate.⁸

This recommendation is endorsed by the Society for Critical Care Medicine, European Society of Intensive Care Medicine, Intensive Care Society, College of Emergency Medicine, and National Academy of Clinical Biochemistry, among others.⁵

No Interferences From:

Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin

Operating Ranges:

Temperature: 59°F-104°F (15°C- 40°C)
Altitude: Up to 15,000 feet
Humidity: 10% to 90% relative humidity
Hematocrit: 20% – 65%

Reagents and Strips:

Strips: 25 strips per vial; 2 vials per package
QC: Three levels (Low, Normal, High); sold separately
Linearity: Five levels available

Test Strip & QC Stability:

24 months from date of manufacturing
3 months open-vial stability

Certifications & Compliance: ISO 13485:2003 Quality System Registration, CE Self-Declared complies to IVDD, Meets IEC 61010, UL, CSA Standards
Patented Technology. Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078
Specifications subject to change without notice.

References

1. National Academy of Clinical Biochemistry. (2007). Laboratory medicine practice guidelines: Evidence- based practice for point-of-care testing. Washington, D.C.

2. Perman, S. et al. (2012). Initial emergency department diagnosis and management of adult patients with severe sepsis and septic shock. Scand J Trauma Resusc Emerg Med, 20, 41. doi:10.1186/1757-7241-20-41

3. Nachimuthu, S. et al. (2012). Early detection of sepsis in the emergency department using Dynamic Bayesian Networks. AMIA Ann Symp Proc, 2012, 653-62. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540576/

4. National Institutes of Health. (2012). Sepsis fact sheet. Retrieved from http://www.nigms.nih.gov/Education/factsheet_sepsis.htm

5. Daniels, R. (2011). Surviving the first hours in sepsis: Getting the basics right (an intensivist’s perspective). J Antimicrob Chemother, 66, ii11-23. doi:10.1093/jac/dkq515

6. Hall, M. et al. (2011). Inpatient care for septicemia or sepsis: A challenge for patients and hospitals. N CHS Data Brief, 62, 1-8. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db62.pdf

7. Kumar, A. et al. (2006). Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med, 34(6), 1589-1596. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/16625125

8. Shirey, T. (2007). POC lactate: A marker for diagnosis, prognosis, and guiding therapy in the critically ill. Point of Care, 6, 192-200. doi:10.1097/poc.0b013e3181271545 9. Dellinger, R. et al. (2013). Surviving sepsis campaign: International guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med, 41, 580-637. doi:10.1097/CCM.0b013e31827e83af.

StatStrip^® Connectivity and StatStrip Xpress Point-of-Care Lactate Analyzers

Rapid sepsis detection and monitoring

Fastest turnaround – 13 seconds

0.6 μL whole blood sample

Excellent correlation to central laboratory reference methods

Early sepsis detection

Rapid initiation of lactate goal-directed protocols for sepsis care

Monitoring of resuscitation therapies

Prognosis indication for patient outcomes

Data Storage:

Connectivity:

Battery Information:

Docking Station:

Additional Features: