Sepsis Diagnosis and Management in the Lab

Sepsis is a worldwide problem that can cause devastating patient consequences and drive significant healthcare costs. Research has shown that timely administration of antibiotics to patients with sepsis decreases the likelihood of death. However, as this syndrome encompasses a complex pathobiology, treatment may be delayed. Once conclusive evidence—such as organ failure—manifests, the severity of symptoms may have progressed and the risk of patient death may increase.

What if your physicians could act faster and avoid patient health deterioration? Find out how your laboratory can use interdisciplinary insights to support swifter action and better clinical outcomes.

Understanding Sepsis Get the facts on clinical sepsis, a costly and dangerous condition

A life-threatening syndrome

Sepsis is a dysregulated immune response to infection characterized by systemic inflammation. Infection leading to sepsis can start anywhere in the body, including the lungs, urinary tract, skin and abdomen. If not treated quickly and effectively, sepsis can progress to septic shock and lead to organ dysfunction and death.¹

A global healthcare crisis

Sepsis affects more than 49 million people worldwide.¹ Healthcare-related costs to manage sepsis total over $24 billion annually in the U.S.² It is the leading cause of hospital readmissions¹² and accounts for more hospitalization costs than any other disease.⁹

Timely treatment may save lives

Research indicates that the early and appropriate administration of antibiotics decreases sepsis mortality. There is an association between prompt antibiotics administration and improved outcomes in cases of both sepsis and septic shock.³

Early broad-spectrum antimicrobial administration is vital to improving outcomes for severely septic patients admitted through the emergency department (ED).⁴ For every hour that antibiotics are delayed after ED triage, at the beginning of organ dysfunction or at the onset of shock, there may be a 3% to 7% increase in the risk of unfavorable outcomes.³

Sepsis diagnosis remains difficult, due to insufficient sensitivity and specificity of tests and risk scores.^5,6

Identifying and treating sepsis earlier can also reduce the cost of sepsis-related care.^7,8

Supporting Better Outcomes IVD testing that may be used to support sepsis diagnosis and management

Supporting better clinical outcomes in patients with possible sepsis or confirmed sepsis requires a broad and comprehensive approach. That's why when it comes to sepsis diagnosis, it's important to have access to all in vitro diagnostic testing disciplines and management tools, including:

An interdisciplinary portfolio of IVD testing solutions, comprising both common and unique tests, for all stages of the syndrome
Flexibility and breadth to support your institution’s specific sepsis management protocols
Laboratory connectivity and data management tools that automate and expedite delivery of time-critical results to clinicians

Turning Knowledge Into Action Use interdisciplinary laboratory insights to support swift action

Testing for sepsis is done using many different biomarkers and systems belonging to different laboratory disciplines and there is no single, global standard of care.

For septic patients, IVD testing can be crucial to support effective treatment. Our solutions aid in delivering laboratory insights that can speed-up decision making at every stage of the sepsis identification and treatment path. (See Figure 1. Note: While there are variations in the standard of care, this figure generally describes what an IVD testing path may look like.)

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Figure 1. At every stage of the sepsis detection and treatment path, we offer clinical laboratory solutions that provide valuable diagnostic insights.

Suspect

Epidemiology studies show that 2/3 of septic patients enter the healthcare system via the ED.⁹ However, early sepsis detection in the ED is challenging, since patients show myriad symptoms that can be ambiguous and may point toward a variety of causes. This makes a concrete diagnosis difficult and may delay treatment.

Depending on an institution's protocols and a patient's symptoms, the following tests may be ordered. (Note: The list below may not be complete and does not describe any specific sequence in testing.)

CBC with differential and Monocyte Distribution Width (MDW): This sepsis parameter is reported automatically as part of the initial CBC-diff test on the DxH 900 and DxH 690T hematology analyzers,* enabling automatic reporting without added workload burden. MDW is a measure of increased morphological variability of monocytes in response to bacterial, viral or fungal infections. The quantitative analysis of MDW by hematology analyzers using Early Sepsis Indicator (ESId) application received regulatory clearances as a hematology biomarker for sepsis. Together with other laboratory findings and clinical information, MDW provides clinicians with an alert as to the possibility of sepsis or risk of developing sepsis in adult patients entering the ED
Basic or comprehensive metabolic panel: This frequently ordered panel comprising 14 tests gives clinicians insight into organ functions as well as the status of the patient’s metabolism
Urinalysis: According to the CDC, urinary tract infections account for 25% of sepsis cases.⁶ Testing urine samples can help identify whether infection is present in the urinary tract⁹

DxH 900 output buffer with cassettes purple tubes

Monocyte Distribution Width

Learn about the Monocyte Distribution Width, the first early sepsis warning solution to be offered as part of a routine CBC-diff test.

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Diagnose

Additional confirmatory and resistance testing may be ordered to confirm a diagnosis of sepsis.

Procalcitonin* (PCT): Procalcitonin is a biomarker for sepsis, and can be a powerful tool for insights when combined with other findings from the patient’s medical history, physical examination and other assessments. Our PCT assays enable laboratories to run PCT tests more efficiently
Lactate: Lactate results can complement the results of other tests, giving insight into the progression of illness, its severity and effectiveness of treatment
C-reactive protein (CRP) and interleukin-6 (IL-6*): These related biomarkers of inflammation can be useful in supporting early diagnosis of infection. CRP is widely used for adults, while IL-6 is used for neonates and infants

Access PCT*

Empower fast, accurate clinical decision making for patients with sepsis or suspected sepsis while simplifying your sample-processing flow and reducing the operational expenses associated with maintaining a separate, dedicated immunoassay workstation for PCT analysis.

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Confirm

Once a diagnosis of sepsis is reached, clinicians typically start treatment with broad-spectrum antibiotics while investigating the type of infection, identifying the exact pathogen responsible for the infection and determining a targeted course of antibiotics.

Fast bacterial identification (ID): The industry-leading Bruker MALDI Biotyper^® system provides rapid microbial identification. Together with the DxM WalkAway microbiology system and software, it can deliver accurate ID results within minutes to support proactive patient management
Antibiotic susceptibility testing (AST): MicroScan panels have the fewest clinically significant drug-pathogen limitations¹⁰ of all the major automated ID/AST methods, enabling more first-time reporting treatment options for septic patient therapy¹¹

Manage

Receiving actionable insights quickly from ongoing testing helps clinicians monitor treatment effectiveness to stop the progression of sepsis, resolve the infection and, ultimately, discharge the patient.

Clinical informatics solution REMISOL Advance reports results to your laboratory, empowering you to deliver robust, standardized insights into sepsis for informed decision making. Automated reporting ranges and rules for Beckman Coulter IVD sepsis diagnosis and management tools are synchronized and preloaded within REMISOL Advance, saving you and your staff from time-consuming rule definition and writing. In addition, values and rules are customizable with just a few clicks, so you can tailor reporting to the specific sepsis treatment guidelines of your institution.

Define Your Solution

How can your clinical laboratory help physicians know sooner and act faster? Our sepsis IVD portfolio can help. We can provide recommendations tailored to the needs of your patient population and institutional requirements.

¹.Rudd, et al., Lancet. 2020 Jan 18; 395 (10219): 200-211.
²Torio C, Moore B. “National Inpatient Hospital Costs: The Most Expensive Conditions by Payer.” www.hcup-us.ahrq.gov/reports/statbriefs/sb204-Most-Expensive-Hospital-Conditions.pdf, May 2016. Accessed 15 Jan. 2018.
³Seymour CW et al. “Delays from First Medical Contact to Antibiotic Administration for Sepsis.” Crit Care Med 2017; 4595:759–765.
⁴Whiles BB, Deis AS and Simpson SQ. “Increased Time to Initial Antimicrobial Administration is Associated with Progression to Septic Shock in Severe Sepsis Patients.” Crit Care Med 2017; 45(4):623–629.
⁵Ljungström L et al. “Diagnostic Accuracy of Procalcitonin, Neutrophil-lymphocyte Count Ratio, C-reactive Protein, and Lactate in Patients with Suspected Bacterial Sepsis.” PLoSONE 2017;12(7): e0181704.
⁶CDC Vital Signs, August 2016. www.cdc.gov/vitalsigns/pdf/2016-08-vitalsigns.pdf. Accessed 14 Mar. 2019.
⁷Judd WR, Stephens DM, Kennedy DA. “Clinical and Economic Impact of a Quality Improvement Initiative to Enhance Early Recognition and Treatment of Sepsis.” Ann Pharmacol 2014; 48(10):1269–75.
⁸Filbin MR et al. “Presenting Symptoms Independently Predict Mortality in Septic Shock: Importance of a Previously Unmeasured Confounder.” Crit Care Med 2018; 46:1592–9.
⁹ Perman S M, Goyal M and Gaieski, DF. “Initial Emergency Department Diagnosis and Management of Adult Patients with Severe Sepsis and Septic Shock.” Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine 2012; 20:41. http://doi.org/10.1186/1757-7241-20-41.
¹⁰"Drugs of First and Second Choice.” The Medical Letter, 20th ed., 2015; CLSI, M100-ED29:2019 Performance Standards for Antimicrobial Susceptibility Testing, 29th ed.; product Instructions for Use; FDA 510(k) clearances; product recall notices.
¹¹ServiceTrak Clinical Executive Summary Report for ID/AST Systems, 2016.
¹²Sepsis Alliance. “Fact Sheet. 2018.” Sepsis.org. Accessed 6 Mar. 2019.

*Not available in all countries. Please contact your local Beckman Coulter representative for more information.

MALDI Biotyper is the property of Bruker Daltonik GmbH.
REMISOL Advance is a trademark or registered trademark of Normand-Info SAS in the United States and other countries. Used under license.

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