Lactate, Hemoglobin, and Hematocrit

Lactate Testing Bedside
StatStrip LAC/Hb/Hct is a point-of-care (POC) system that enables rapid and timely trending of lactate in hypoperfusion during sepsis (or other conditions of hypoperfusion) for assessment of resuscitation or treatment efforts. Compared to testing with blood gas analyzers which require arterial samples, large samples volumes (up to 95 microliters), and long analysis times (up to 2.5 minutes); StatStrip’s single-use biosensor provides the fastest turnaround time (13 seconds) on the smallest whole blood sample (0.6 μL) with excellent correlation to central laboratory reference methods.

Solves Lactate Pre-Analytical issues
Lactate is not stable in whole blood samples. Blood lactate levels rise steeply in less than 5
minutes if samples are transported or kept at room temperature.¹ StatStrip point-of- care
testing ensures rapid, accurate results by eliminating sample transport preanalytical effects.

Hemoglobin and Hematocrit Testing Bedside
StatStrip LAC/Hb/Hct is the only POC system to provide anemia screening and monitoring with measured, not calculated, Hb and Hct tests. This important breakthrough is possible because of new, patented biosensor technologies developed by Nova Biomedical.

Accurate Assessment of Anemia
Accurate anemia evaluation requires both measured Hct and measured Hb. However, current POC Hb meters only provide a calculated estimate of Hct. Calculated estimates of Hct are inaccurate in many conditions including red cell structural abnormalities, hemolysis, hemoglobinopathies, and other conditions. These conditions necessitate measured Hct because calculated results can negatively impact treatment.

 

Simple and safe testing

Similar to glucose self-testing, StatStrip single-use biosensors do not require calibration or coding. A biosensor ejector allows for touch-free disposal and eliminates a potential biohazard. Testing takes three simple steps:

 

 

 

Choice of Two Meters

StatStrip^® LAC/Hb/Hct Full Connectivity Meter

• Color touchscreen operation and results display
• Onboard storage of 1000 patient results with positive patient ID
• Wired or wireless connectivity to NovaNet middleware, third party middleware, and electronic medical records

 

StatStrip Xpress^®2 LAC/Hb/Hct Meter

• Bright color results screen and touch sensitive buttons for operation
• First in/first out storage of up to 400 test results
• Date, time, and sequential numbering for sample identification, no data transmission

 

Smallest Blood Sample

StatStrip biosensors use a fraction of the blood required by other point-of-care devices that measure only lactate or hemoglobin, allowing patient screening or monitoring with minimal blood loss.

 

Fastest Turnaround Time

StatStrip provides the fastest turnaround time for lactate, hemoglobin and hematocrit, enabling rapid decision-making concerning tissue hypoxia, sepsis, and anemia.

Smallest and Lightest Meters

StatStrip LAC/Hb/Hct meters are smaller and lighter than other POC devices that measure lactate or hemoglobin only. StatStrip lightweight, small meters enable testing at the bedside or patient-side.

 

 

Complete Data Connectivity with NovaNet

NovaNet is a single, economical bidirectional interface solution for StatStrip LAC/Hb/Hct connectivity meters to the LIS/HIS/EMR. Over 60% of U.S. hospitals currently use NovaNet for connectivity and management of either Nova’s StatStrip Glucose meters or Stat Profile Prime Plus blood gas analyzers. Features include:

• Industry standard POCT1a-2, ASTM or HL7 interface formats
• Positive patient ID with 3 or more patient identifiers
• Complete data security and encryption

Clinical Applications

Lactate Monitoring for Sepsis Management

Surviving Sepsis Campaign (SSC) Recommends Early Lactate Testing
The SSC Hour-1 Bundle includes the following recommendations for early sepsis recognition and management:

• Measure lactate within the first hour of sepsis recognition
• Re-measure lactate if the initial result is > 2 mmol/L
• Guide resuscitation to normalize lactate in patients with elevated levels, which is a marker of tissue hypoperfusion²

Pre-Hospital and Emergency Triage

StatStrip LAC/Hb/Hct provides real-time, accurate results when every second counts:

• Rapid evaulation of anemia (due to chronic illness, injury or other blood loss); dehydration
• Rapid evaluation of signs of infection and sepsis; abdominal pain; internal injury; trauma

Prenatal and OB/GYN

In prenatal care, nearly 42% of pregnant women experience anemia. If left untreated, anemia can become severe, which increases risk of premature birth and low birthweight for the baby.^3,4 StatStrip helps clinicians:

• Prevent and monitor anemia in pregnant women
• Adjust treatment including nutrition and supplements
• Measure cord or scalp lactate for detecting or ruling-out fetal distress during labor and delivery

Blood Bank

StatStrip provides the accuracy needed to safely and effectively screen blood donors and avoid false deferrals:

• Accurate over the entire measurement range of 6.5-22 g/dL Hb and 20%-65% Hct
• Portable for use in mobile or temporary blood collection locations

Dialysis

Anemia is a common co-morbidity in patients undergoing dialysis, Maintaining individual and facility level Hb/Hct guidelines is associated with increased survival rates and reduced hospitalization in this population.^5,6 StatStrip point of care testing:

• Helps maintain patients in clinically appropriate ranges
• Provides quantitative data for anemia, EPO and iron therapy decisions

Oncology

Chemotherapy-induced anemia (CIA) affects approximately 83% of cancer patients.⁷ StatStrip provides real time Hb/Hct status needed to proactively identify high risk patients for CIA and provide timely treatment.

References:

1. Rollins G. The state of sepsis care. Clinical Laboratory News 2011;37(3):4.
2. https://www.sccm.org/getattachment/SurvivingSepsisCampaign/Guidelines/Adult-Patients/Surviving-Sepsis-Campaign-Hour-1-Bundle. pdf?lang=en-US. Accessed 15 June 2020.
3. Mayo Clinic. Iron deficiency anemia during pregnancy: Prevention tips. 15 Feb 2017.
4. Townsley DM. Hematologic complications of pregnancy. Semin Hematol 2013;50(3):222-231.
5. Hung S-C et al. Erythropoiesis-stimulating agents in chronic kidney disease: What have we learned in 25 years? J Formos Med Assoc 2014;113:3-10.
6. Jing Z et al. Hemoglobin targets for chronic kidney disease patients with Anemia: A systematic review and meta-analysis. PLoS ONE 2012;7:e43655.
7. Hwasoon R. Chemotherapy-induced anemia in cancer patients. OncoLink: 17 Jan 2012. Certifications and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and ISO 13485:2016. Complies to IVDD Tested According to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2007 *Nova Biomedical Patent Numbers: CA2846887A1 EP2568281A1 US8603309 JP5812957 US9535053B1 US8603309B2 US9638686B1 Nova Biomedical® is a registered trademark of Nova Biomedical Corporation.