Serial PCT testing in the fight against sepsis

The sixth most common principal diagnosis, sepsis, also takes the title as the most expensive inpatient diagnosis, racking up about $20 billion in hospitals' aggregated annual costs. Sepsis isn't backing down, wreaking havoc on patients' health and dwindling hospital funds.

Long immersed in the infectious disease space, Waltham, Mass.-based Thermo Fisher Scientific is committed to combating the poor outcomes associated with sepsis. It is imperative providers treat septic patients early and with the proper management, but the early signs of sepsis are not exclusive to the infection, presenting challenging tasks for providers. Additionally, patients with sepsis likely possess confounding comorbidities.

That's why Thermo Fisher was the first to offer the B•R•A•H•M•S procalcitonin assay for providers in the intensive care unit, emergency department and hospital wards. Procalcitonin is a biomarker associated with the inflammatory response to bacterial infection that rises rapidly (within six to12 hours) after an infectious bacterial insult with systemic consequences such as sepsis. The test takes only 20 minutes to perform, providing physicians with quick information to act.

"When we talk about risk assessment, it's really enabling physicians to understand the bacterial load and severity of infection," explains Sherrie Smartt, MSN, MHA, RN, medical director for the biomarker business of North America and manager of clinical studies and regulatory affairs, Thermo Fisher.

Procalcitonin serves as part of the body's intrinsic response to a bacterial infection, so its accurate measurement offers a physician critical feedback on the cause of the inflammatory reaction and the effectiveness of the source control of the infection. The B•R•A•H•M•S PCT helps physicians understand how a patient is responding to the infection allowing physicians to choose the most successful treatment regimen.

Utilizing the B•R•A•H•M•S PCT, providers can assess an initial procalcitonin measurement. Patients with procalcitonin levels above 0.5 ng/L should be considered at risk of developing severe sepsis or septic shock, while levels above 2 ng/mL are at the greatest risk. .

"It's important for physicians to understand the implications when they see procalcitonin and see the kinetic responses," says Ms. Smartt. "That gives them confidence that they are managing that patient appropriately." Appropriate management is essential, because with every passing hour, mortality increases by 8 percent for a patient with sepsis.

"It's very, very important to intervene early, because it becomes almost impossible to intervene later," Ms. Smartt emphasizes. "One of the biggest challenges is identifying those patients earlier and delivering the right treatment. Procalcitonin, along with the clinical assessment and other laboratory findings, helps with understanding when we're delivering the right treatment and if we are we managing these patients effectively."

MOSES study
In 2014, Thermo Fisher completed a U.S. multicenter clinical trial called Procalcitonin MOnitoring SEpsis Study, to validate the ability of B•R•A•H•M•S PCT to aid in the mortality risk assessment of septic patients.

The MOSES study found a change in procalcitonin over time helped assess cumulative 28-day risk of mortality for patients with severe sepsis or septic shock. The study revealed a two-fold risk of death for patients with a decrease in procalcitonin less than or equal to 80 percent, when compared to patients with a procalcitonin decrease of more than 80 percent during the first four days after diagnosis of severe sepsis or septic shock. In addition, the combination of the first PCT level (< 2.0 ng/L or > 2.0 ng/L) upon initial diagnosis of severe sepsis or septic shock, along with the patient's clinical course and change in PCT level over time until day four provided important additional information about the mortality risk.

The company allowed its license partners, Roche Diagnostics USA and bioMérieux, to use the MOSES patient samples assessed on the Thermo Fisher platform to test their own licensed B.R.A.H.M.S PCT assays on their respective laboratory platforms. The "universal analysis" showed the equivalence of the license partners' assays to Thermo Fisher's FDA-approved B•R•A•H•M•S PCT sensitive KRYPTOR.

"What's unique about this trial, was to share the clinical samples with licensed partners so they could run the same patient samples on their own unique platforms, and significantly decrease their time in the FDA review process," says Ms. Smartt. While Thermo Fisher first paved the way through a year-long review process allowing Roche Diagnostics USA and bioMérieux to both receive FDA approval for their assays within 90 days.

"It allowed clinical performance evaluation across platforms with the same samples on a shared clinical database. This allowed clinicians to have clinically relevant cutoffs that are standardized across platforms," says Ms. Smartt.

Fighting sepsis on all fronts
CMS is establishing incentives for hospitals to manage sepsis patients through core measures formed from the Surviving Sepsis Campaign and CDC sepsis protocols.

The CMS core measures emphasize managing fluid resuscitation and initiating empiric antibiotic therapy, but Ms. Smartt says placing equal weight on host response biomarkers is warranted to create a complete sepsis management initiative. Thermo Fisher wants to emphasize the importance of assessing procalcitonin levels alongside other assessments when testing for sepsis, noting the importance of a patient's response to a bacterial infection as well as the response to antimicrobial treatment.

"It's important to identify and initiate therapy, but it's also important to identify how patients are responding to the management," explains Ms. Smartt. Providers may consider adding B•R•A•H•M•S PCT when treating septic patients, as it will help create confidence in their management of the patients.

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