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Clinical Performance and Utility of Point-of-Care Lactate Technology in Patient Care Pathways

Malic, Andrei PhD; Ntrivalas, Evangelos MD, PhD, HCLD/CC (ABB), D(ABMLI); DuBois, Jeffrey PhD, BCLD/CC (ABB), FAACC

doi: 10.1097/POC.0000000000000185
Review Articles
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Lactate is a commonly evaluated analyte in acutely ill patients. It is used as a prognostic, diagnostic, and monitoring tool in a variety of clinical conditions including sepsis, trauma, infectious diseases, and perinatal conditions. Elevated lactate levels, above specific thresholds for each condition, are considered critical values necessitating intervention. In certain of these cases, a fast lactate result by point-of-care (POC) devices is crucial in assisting with the medical management of the underlying condition. It is becoming increasingly evident that POC technologies are part of the transformation that is being observed in health care. Rapid results of certain analytes at the point of care enable clinicians to make immediate treatment decisions without having to wait for results from centralized laboratories. Lactate, as a critical marker, is a perfect candidate for POC testing and has been utilized as such in a variety of clinical settings, including prehospital and emergency medical services, emergency departments, and intensive care units. The StatStrip Lactate Hospital Meter System (Nova Biomedical, Waltham, Mass) is a POC device that combines a precalibrated, single-test biosensor with a handheld meter. It has been used extensively in various clinical settings to aid in the early identification of elevated lactate levels. StatStrip Lactate utilizes whole-blood measurement technology to provide a lactate result that is equivalent to central laboratory plasma lactate testing. Its rapid results have been demonstrated as useful in a number of studies. This mini review will present the clinical pathways in which lactate is used and describe the clinical utility of StatStrip Lactate in these pathways.

From the Department of Medical and Scientific Affairs, Nova Biomedical, Waltham, MA.

Reprints: Jeffrey DuBois, PhD, BCLD/CC (ABB), FAACC, Department of Medical and Scientific Affairs, Nova Biomedical, 200 Prospect St, Waltham, MA 02453. E-mail: jadubois@novabio.com.

All authors are full-time employees of Nova Biomedical.

Hyperlactatemia in critically ill and hospitalized patients is an indicator of poor clinical outcome, requiring immediate identification and management. In adult trauma and burn patients, raised lactate levels are associated with increased mortality and injury severity.1–5 Hyperlactatemia is frequently encountered in sepsis and postsurgical patients and has been associated with worsening outcomes, including increased mortality and length of hospital stay.6,7 The presence of elevated lactate levels after cardiac surgery has been associated with an increased incidence of postoperative infection, cardiopulmonary dysfunction, renal impairment, prolonged hospital stay, and increased mortality.8–12 Targeting treatment to achieve normal lactate values in the postoperative setting has been shown to decrease hospital length of stay after cardiac surgery.13 The use of lactate as a risk indicator and a triage marker for injury severity and outcomes in sepsis and trauma patients has been substantiated in both in-hospital and prehospital settings.14–17

Point-of-care (POC) lactate testing has a key role to play in monitoring and managing patients both in the hospital setting and, increasingly more, in the prehospital setting. Point-of-care blood lactate meter can provide an immediate indication of a patient's risk and triage requirements and can be used to monitor the effectiveness of treatment and recovery. Implementing a POC lactate program in an emergency department for screening patients with suspected sepsis has been shown to be a cost-effective intervention to identifying and managing patients responsive to early resuscitation.18 In intensive care units, blood gas analyzers are mainly used for lactate measurement in conjunction with other on-board pathophysiological parameters. However, handheld lactate meters can provide a more immediate and easier-to-use approach for serial lactate monitoring and for risk assessment and triage in a prehospital or emergency medical services setting. In addition, handheld lactate meters require a small sample volume and, as such, are more appropriate than blood gas analyzers for monitoring lactate in scalp blood to assess fetal well-being during labor.19 Fetal lactate monitoring with blood gas analyzers is associated with a high failure testing rate due to insufficient sample volume.20 Fetal scalp lactate monitoring is now accepted as an alternative to scalp pH in intrapartum care practice guidelines.21,22

The handheld StatStrip Lactate meter is easy to use, and its application in different patient care pathways has been independently assessed and validated.

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Blood Lactate Monitoring With StatStrip Lactate Hospital Meter System

StatStrip Lactate is a handheld POC lactate meter for the quantitative determination of lactate in fresh whole blood (Fig. 1). The lactate measurement is based on the following methodology:

FIGURE 1

FIGURE 1

LOD is lactate oxidase.

The current generated at the electrode is proportional to the lactate concentration of the sample.

StatStrip Lactate's single-use biosensor utilizes patented multiwell and multilayer technology that incorporates control wells to measure and correct for common interfering substances including hematocrit (Fig. 2). The electrochemistry technology is layered onto a gold platform, providing a stable and robust surface for the electrochemical reaction kinetics. The gold layer also provides a platform for batch-to-batch manufacturing consistency and reproducibility, which eliminates the need for batch-to-batch calibration.

FIGURE 2

FIGURE 2

The testing procedure for StatStrip Lactate is quick and simple, comprising inserting a biosensor into the meter, lancing the patient's finger to obtain 0.6 μL of capillary whole-blood specimen, applying the specimen to the lactate biosensor, and reading the results, which are available in 13 seconds.

The reportable range for StatStrip Lactate is 0.3 to 20.0 mmol/L, covering the clinical ranges of lactate seen in patients. It operates over wide temperature (59°F–104°F/15°C–40°C) and humidity (10%–90% relative humidity) ranges favorable for use in prehospital settings.

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Analytical Performance

Although international reference materials are not available for lactate standardization, the traceability and correlation of StatStrip Lactate to laboratory methods and blood gas analyzers have been shown to be excellent in several independent studies.20,23,24 In a recent study, StatStrip Lactate demonstrated strong correlation with minimal bias to a ZnSO4-precipitated, whole-blood-flow injection mass spectrometry reference method.25 The meter's good precision has been reported in several analytical studies.23,24,26 StatStrip Lactate is designed to eliminate interferences commonly associated with other handheld POC blood lactate meters, and this has been substantiated in both patient studies and laboratory interference studies (Table 1).23

TABLE 1

TABLE 1

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Clinical Performance of StatStrip Lactate in Patient Care Pathways

Sepsis

The role of lactate monitoring is now established as part of the Surviving Sepsis Campaign guideline.27 However, this guideline focuses on the hospital sepsis care pathway; for community-acquired sepsis, it is prehospital identification and management that can have a beneficial effect on reducing mortality and severity of disease. The clinical utility and application of StatStrip Lactate have been demonstrated throughout the sepsis care pathway. A study in a paramedical setting has shown the feasibility of prehospital lactate testing with StatStrip Lactate and its usefulness in supporting paramedics in their decision making.28

Studies in emergency department patients with sepsis have demonstrated that StatStrip Lactate can provide rapid and reliable results to aid immediate clinical decision making by providing results comparable to the central laboratory method.29,30 Similarly, in an intensive care setting, StatStrip Lactate's fingerstick capillary lactate measurements have been shown to correlate strongly with arterial lactate levels measured by standard laboratory reference methods in adult patients.31–33 In addition, capillary lactate measurements trended closely over time with arterial lactate in patients undergoing resuscitation for septic and hemorrhagic shock, providing rapid feedback for ongoing resuscitation and early goal-directed therapy. StatStrip Lactate measurements have also been shown to correlate closely to the laboratory method in neonatal and pediatric intensive care patients.31 A key advantage of using StatStrip Lactate in neonatal and pediatric patients is the very small sample volume required for testing, enabling StatStrip Lactate to be used for serial lactate measurement.34

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Intrapartum Care

Intrapartum care practice guidelines now include fetal scalp lactate testing as an alternative to scalp pH.21,22 Several studies have been undertaken in Austria,20,35 France,23 the Netherlands,36 and Australia,37 demonstrating the applicability, reliability, and utility of StatStrip Lactate for fetal lactate testing. In each of these studies, a lactate cutoff value and range were established for StatStrip Lactate for predicting fetal acidosis. The recent Australian study reported that StatStrip Lactate demonstrated better reproducibility of lactate measurements at decision-making levels and more consistency with meeting guideline cutoff levels than an alternative lactate meter.37

The use of umbilical cord blood has also been shown to be a valuable approach for the assessment of fetal metabolic acidosis.38–40 A French study assessing StatStrip Lactate using umbilical cord blood demonstrated a close correlation and concordance to the laboratory reference method.23 There was a minimal bias between StatStrip Lactate and the laboratory method, whereas the 2 other lactate meters assessed significantly underestimated lactate. In this study, the investigators also assessed the influence of patient hemoglobin, pH, and PO2 levels on the accuracy of readings and found that the accuracy of StatStrip Lactate results were unaffected by variable levels of these parameters.

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Other

Early identification and management of hyperlactatemia are also of significance in trauma patients, and it has been shown to improve patient recovery.17 A preliminary study has reported that using StatStrip Lactate in a prehospital setting helped to triage and manage trauma patients. Intervention to reduce lactate levels led to a decrease in mortality at 28 days.41

Blood lactate levels have been used as a prognostic factor in patients with acute poisoning due to various factors such as metformin, carbon monoxide, and cyanide.42–44 A recent study using StatStrip Lactate to monitor lactate levels in patients with acute aluminum phosphide poisoning reported that blood lactate level could be successfully used as a prognostic factor to aid the early identification and management of these patients.45

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CONCLUSIONS

Point-of-care lactate testing has a key role to play in identifying and managing hyperlactatemia in a range of acute and critical care patient pathways. In many situations, managing hyperlactatemia is time critical, and in sepsis and trauma patients, intervention in the prehospital and emergency medical services settings improves outcomes. Handheld lactate meters provide results quickly and simply, enabling immediate triage and resuscitation pathways to be implemented. The application and clinical utility of StatStrip Lactate have been demonstrated in the clinical pathway of critically ill patients from prehospital admission through the intensive care unit. StatStrip Lactate's measurement correlates closely to laboratory methods, and the accuracy of its results is unaffected by pathophysiological and therapeutic substances present in whole blood.

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Keywords:

critically ill patients; lactate; point-of-care testing; sepsis; trauma

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