Procalcitonin (PCT) – the biomarker of choice to aid in the diagnosis of sepsis

Procalcitonin is regarded as a biomarker with both diagnostic and prognostic impact, offering emergency department and intensive care clinicians a key tool to aid in the diagnosis of sepsis, and thereby improve antibiotic decision-making and potentially improve clinical outcomes [1].

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Procalcitonin (PCT), a 116–amino acid polypeptide prohormone of calcitonin, has emerged as a biomarker to aid in the diagnosis of sepsis and with a high potential to improve the clinical assessment of patients [1].

PCT is synthesized primarily by the C-cells of the thyroid gland, and to a lesser extent in the neuroendocrine tissue of other organs such as the lungs and intestines. Normal procalcitonin levels in the blood are very low.

However, production can be stimulated in almost every organ by inflammatory cytokines and especially bacterial endotoxins present e.g. during sepsis, causing high amounts of procalcitonin to be released in the blood.

This allows procalcitonin levels to be used as a biomarker of e.g. sepsis. The higher the level of PCT, the greater the likelihood of systemic infection and sepsis [2].

The favorable kinetics of PCT potentially enable earlier diagnosis of sepsis and better monitoring of its progression. The primary utility of PCT is therefore to help uncover the presence of systemic bacterial infections such as sepsis, and numerous studies have investigated the potential roles of PCT in diagnosis and management of e.g. sepsis [2-4].

A recent consensus paper by Schuetz et al. offers recommendations on antibiotic management of patients in ED and ICU based on clinical severity, probability of bacterial infection and PCT levels. See figures 1 - 3 [1].

Patient with mild illness outside ICU

(Defined by setting specific scores, e.g. qSOFA, MEDS, NEWS)

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Figure 1. PCT use in patients with mild illness, i.e. indicative of mild symptoms of sepsis, outside the ICU. Permission obtained through Copyright Clearance Center.

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Patient with moderate illness outside ICU

(Defined by setting specific scores, e.g. qSOFA, MEDS, NEWS)

Figure 2. PCT use in patients with moderate illness, i.e. indicative of moderate symptoms of sepsis, outside the ICU. Permission obtained through Copyright Clearance Center

Growing evidence for using PCT as a diagnostic biomarker for early detection of sepsis


Currently there is no recognized diagnostic test available for sepsis diagnosis as stated by the Sepsis-3 task force [5].


The recognition of sepsis requires careful patient monitoring and observation. This philosophy is also found in the Sepsis Six initiative [6], NICE Guideline NG51 [7], and 2018 sepsis bundle [8], which is a combination of both monitoring and proactive measures that should be performed within an hour, one of them being administering empiric intravenous antibiotics.


During the past decade, the role of biomarkers to assist in the diagnosis and management of infections and sepsis has been extensively explored. The measurement of procalcitonin is now commonly used in many parts of the world to assist in the diagnosis of e.g. sepsis and to help define the duration of antimicrobial therapy [9].


Compared to C-reactive protein (CRP)—another biomarker frequently used to aid in the diagnosis of systemic inflammation and infection—procalcitonin has superior biokinetics, characterized by concentrations increasing earlier in the event of bacterial infection and sepsis, and decreasing faster in case the infection is controlled [10].

PCT-guided use of antibiotic therapy

The use of PCT is described in the Surviving Sepsis Campaign guidelines [9], with the suggestion that PCT could be used for antimicrobial stewardship. It would be advisable to measure PCT in the diagnostic phase of sepsis, to have an initial baseline PCT value, before antibiotics are administered [11].

Empiric antibiotic therapy should be initiated immediately, and the patient referred to ICU in the suspicion of sepsis. It is recommended to repeat the PCT testing regularly to ensure that the patient is responding to the treatment (fig. 1-3).

De-escalation of antimicrobial therapy is a mainstay of antibiotic stewardship programs and is associated with less resistant microorganisms, fewer side effects, and lower costs (SSC guidelines 2016) [9].

SSC guidelines 2016 suggest that measurement of procalcitonin levels: 


  • can be used to support shortening the duration of antimicrobial therapy in sepsis patients

  • can be used to support the discontinuation of empiric antibiotics in patients who initially appeared to have sepsis, but subsequently have limited clinical evidence of infection

A number of clinical studies have proven the effectiveness and safety of PCT-guided therapy [3, 12, 13-16]. Guided by PCT measurements, the duration of ABx in patients in both ED and ICU settings was shortened consistently by several days, without compromising clinical safety [11, 13, 15, 16].

Patient with severe illness in ICU

(Defined by setting specific scores, e.g. qSOFA, SOFA, APACHE)

Figure 3. PCT use in patients with severe illness, i.e. indicative of severe symptoms of sepsis, in the ICU. Permission obtained through Copyright Clearance Center.

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References

1.Schuetz P. et al. Procalcitonin (PCT)-guided antibiotic stewardship: an international experts consensus on optimized clinical use. Clin Chem Lab Med 2019; 57, 9.
2. Becker KL, Snider R, Nylen ES. Procalcitonin assay in systemic inflammation, infection, and sepsis: Clinical utility and limitations. Crit Care Med 2008; 36,
3. Tang H, Huang T, Jing J, Shen H, Cui W. Effect of procalcitoninguided treatment in patients with infections: a systematic review and meta-analysis. Infection 2009; 37.
4. Jones AE, Fiechtl JF, Brown MD, Ballew JJ, Kline JA. Procalcitonin test in the diagnosis of bacteremia: a meta-analysis. Ann Emerg Med 2007; 50.
5. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315, 8.
6. Daniels, R.; Nutbeam, T.; McNamara, G.; Galvin, C. The sepsis six and the severe sepsis resuscitation bundle: A prospective observational cohort study. Emerg. Med. J. 2011, 28.
7. National Institute for Health and Care Excellence. Sepsis: Recognition, Diagnosis and Early Management (NICE Guideline NG51). 2016. Available online: https://www.nice.org.uk/guidance/ng51 (last accessed June 2020)
8. Levy, MM. Evans, LE. Rhodes, A. The surviving sepsis campaign bundle: 2018 update. Crit. Care Med. 2018; 46.
9. Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med 2017; 43, 3.
10. Meisner M, Tschaikowsky K, Palmaers T, Schmidt J. Comparison of procalcitonin (PCT) and C-reactive protein (CRP) plasma concentrations at different SOFA scores during the course of sepsis and MODS. Crit Care 1999; 3.
11. Broyles M. Impact of Procalcitonin-Guided Antibiotic Management on Antibiotic Exposure and Outcomes: Real-world Evidence. Open Forum Infectious Diseases 2017.
12. Balk RA et al. Effect of procalcitonin testing on health-care utilization and costs in critically ill patients in the United States. CHEST 2017; 151.
13. Christ-Crain M, Stolz D, Bingisser R et al. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med 2006; 174.
14. Schuetz P, Briel M, Christ-Crain M et al. Procalcitonin to guide initiation and duration of antibiotic treatment in acute respiratory infections: an individual patient data meta-analysis. Clin Infect Dis 2012; 55.
15. Christ-Crain M, Jaccard-Stolz D, Bingisser R et al. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, singleblinded intervention trial. Lancet 2004; 363.
16. Bouadma L, Luyt C-E, Tubach F et al. Use of procalcitonin to reduce patients’ exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet 2010; 375.

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Effective April 18, 2018

This Online Privacy Notice (“Privacy Policy”) explains how we handle the Personal Data provided to us on websites, mobile sites, mobile applications, and other digital services and products controlled by Radiometer Medical ApS, Åkandevej 21, 2700 Brønshøj, Denmark, that link to this Privacy Policy (collectively, “Radiometer Sites”).  Radiometer is the data controller for the processing of Personal Data under applicable law.

This Privacy Notice does not apply to third-party websites to which Radiometer Sites may link.

Types of Information We Collect Online

The types of Personal Data that we may collect while you use the Radiometer Sites are described in this section and include both information that you provide to us and information that we collect automatically when you use the Radiometer Sites.
For purposes of this Privacy Policy, “Personal Data” means information that identifies you or that could reasonably be used to identify you. Examples of Personal Data include name, address, telephone number, and email address.

Information You Provide

You do not have to register for a service or program to receive much of the information available through Radiometer Sites. However, some of our content is available only to registered or identified users and will require you to set up a profile or provide specific information about yourself in order to provide you the service.

Personal Data You Provide When Visiting Radiometer Sites

Radiometer collects Personal Data that you provide on Radiometer Sites, for example, when purchasing a product, to receive marketing products and information, contact Radiometer customer service, or respond to Radiometer questionnaires or surveys. This could include:

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Personal Data You Share During Other Interactions with Radiometer

You may contact Radiometer to ask questions, discuss your concerns, or report issues regarding our products. If you communicate with or request information from Radiometer, you may be prompted to provide your contact information as well as any Personal Data that is relevant to your request.

Information That May Be Collected Automatically

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IP Address

We may record the Internet Protocol (“IP”) address of your computer or other electronic device when you visit the Radiometer Sites. An IP address identifies the electronic device you use to access the Sites, which allows us to maintain communication with your computer as you move about Radiometer Sites and to customize content.

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We utilize Google Display Advertising (such as Retargeting with Google Analytics, Google Display Network Impression Reporting, DoubleClick Campaign Manager integration, and Google Analytics Demographics and Interest Reporting) to (1) show you our ads on other websites based on your prior visits to Radiometer Sites, and (2) better understand our ad impressions and use of ad services. In connection with the Google Analytics Demographics and Interest Reporting service, we may use data from Google's interest-based advertising or third-party audience data (such as age, gender and interests) with Google Analytics to understand and improve our marketing campaigns and Site content. 

Some of our online advertising takes place through Google Display Advertising. As part of this program, we use Google Analytics features such as Retargeting. In connection with that feature and others offered by ad networks, we and the operators of ad networks, including Google, may use third-party cookies (such as the DoubleClick cookie) – and in some cases first-party cookies (such as the Google Analytics cookie) – to inform, optimize and serve ads across the Internet, based on a user's past visits to Radiometer Sites. We also may show you ads from some of our affiliated companies when you visit Radiometer Sites. 

You can opt out of Google Ads by visiting http://www.google.com/ads/preferences. If you do not want your data used by Google Analytics, you can install the Google Analytics opt-out browser add-on at the Google Analytics opt-out page.

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Information Collected from Other Sources

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We use your Personal Data to provide you the product and services you request, communicate with you, improve your experience on the Radiometer Sites, generally improve our products and services and for other internal business purposes. These uses may also include the recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction of Personal Data. The Personal Data we collect about you may be stored for five years following the most recent interaction we have had with you, after which point it will be archived only for so long as reasonably necessary for the purposes set out above, in accordance with applicable laws.

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The Personal Data that you provide may be used to create customized offers, information, or services tailored to your interests and preferences. Also, we may use your IP address and the data that we obtain automatically through the use of cookies or similar tracking technologies to make our Radiometer Sites easier to use and navigate as well as to personalize the content provided on Radiometer Sites by anticipating the information and services that may be of interest to you.

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Under European data protection laws, Radiometer must have a legal basis to process your Personal Data. The legal basis that applies in a particular instance will depend on for which of the specific purposes described above Radiometer is processing your Personal Data:

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Information We Share

We only share your Personal Data with third parties as described below. We do not sell or rent Personal Data to third parties for their own marketing purposes.

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You may be provided with online advertisements of Radiometer products and services on third-party websites and mobile services that are tailored to you, for example, on the basis of information that you provide to Radiometer or a third-party website you are visiting, or of your browsing activity, purchases, or interests. These types of tailored online advertisements may come through several sources, such as the following:

  • We may share with our advertising service providers your non-identifying information that we have obtained from cookies and other tracking technologies on our Radiometer Web sites.
  • Some Radiometer Web sites participate in online behavioral advertising (this is also sometimes called re-target advertising or interest-based advertising). You can identify these sites by the “Advertising Choices” link in the footer. Our advertising network partners may place and use cookies on Radiometer Web sites and on other third-party Web sites to collect information about your activities in order to provide you with online advertisements that are based on your interests. When a Radiometer online behavioral advertisement is delivered to you, you will see an “Ad Choices” icon. Clicking on the icon or link will take you to a Web site where you can manage or opt out of the use of data about your browsing history that is used for the delivery of online behavioral advertisements. If you opt out, you may still see advertisements online, including advertisements from Radiometer that are based on other information (e.g., based on the content of the page being viewed rather than your prior clickstream activity). In some cases, data may still be collected about your browsing activity by these third-party advertisers, but they will not use this data to deliver advertisements that are based on your past online browsing behavior. You can also opt out now by clicking here.
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We have relationships with suppliers and affiliated companies, who help us operate our business and for whom it may be necessary to have access to your Personal Data in the course of providing services to Radiometer. We will not authorize these parties to use your Personal Data for any purpose that is not related to Radiometer and its related affiliates business operation, and we do not share Personal Data from countries that require consent, unless appropriate consent has been obtained in advance to sharing with related affiliates. We require them to handle your Personal Data collected in accordance with this Privacy Notice.

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We may partner with other companies to provide you with content or services on a joint or “co-branded” basis. At a cobranded site, you will see both the Radiometer logo and the logo of the co-branding partner displayed on your screen. You should read the individual privacy policies of our co-branding partners, as they may differ in some respects from ours. Reading these policies will help you to make an informed decision about whether to provide your information to a given site.

Product Reports

If you contact Radiometer regarding your experience in using one of our products, we may use the information that you provide in submitting reports to the designated government regulatory authority, as required of us by law.

Legal Rights and Obligations

In certain limited circumstances, Radiometer may need to disclose your Personal Data in order to comply with a legal obligation or demand, such as to comply with reporting obligations to our governing regulatory authorities regarding the safety of our products, or in connection with the sale or transfer of one of our product lines or divisions, which includes the services provided through one or more of the Radiometer Sites. In such instances, we will take measures to protect your Personal Data to the extent possible. We also reserve the right to use Personal Data to investigate and prosecute users who violate our rules or who engage in behavior that is illegal or harmful to others or to others’ property.

Change in Organization

In the event Radiometer decides to reorganize or divest our business through sale, merger, or acquisition, Radiometer may share Personal Data about you with actual or prospective purchasers.  We will require any actual or prospective purchasers to treat this Personal Data in a manner consistent with this notice.

Children Privacy

Radiometer does not knowingly collect or use any Personal Data directly from children on Radiometer Sites (Radiometer defines as “children” as minors younger than 18). We do not knowingly allow children to order our products, to communicate with us, or to use any of our online services. If you are a parent and become aware that your child has provided us with information, please contact us using one of the methods specified below, and we will work with you to address this issue.

Your Privacy Choices

You have the right to see and get a copy of Personal Data about you that we maintain as well as to ask us to make corrections to inaccurate or incomplete Personal Data about you.  

You have the right to receive data you have provided to us in a machine-readable format and to transmit that data to another controller. 
You may also request the erasure of your Personal Data or the restriction of its processing, or object to the processing of Personal Data about you. 
To seek access to Personal Data about you, to file a concern, complaint, or request for correction, or to opt-out of particular programs, please:

  • contact our Legal & Compliance team by clicking on the “Contact Us” link on the Radiometer Site you are using (please add “Privacy” in the headline)
  • contact us by using the Radiometer contact information on the Radiometer mobile application you are using
  • contact us by emailing us at privacy@radiometer.dk.

 

You may also send a letter to the following address:
Radiometer Medical ApS Attn: Legal & Compliance (Privacy)
Åkandevej 21
2700 Brønshøj
Denmark

For more information about your privacy rights, or if you are not able to resolve a problem directly with us and wish to make a compliant, contact your local data protection authority, if applicable.

In all communications to Radiometer, please include your email address, the website address, mobile application, and/or the specific Radiometer product to which you provided Personal Data (e.g., www.radiometer.com), and a detailed explanation of your request. If you would like to delete, amend, or correct your Personal Data and are contacting us by email, please put “Deletion Request” or “Amendment/Correction Request” in the subject line of the email. We will respond to all reasonable requests in a timely manner and may need to further confirm your identity in order to process certain requests.

Data Security

Radiometer maintains reasonable technical, administrative and physical controls to secure any Personal Data collected through the Radiometer Sites. However, there is always some risk that an unauthorized third party could intercept an Internet transmission, or that someone will find a way to thwart our security systems. We urge you to exercise caution when transmitting Personal Data over the Internet, especially your financial-related information. Radiometer cannot guarantee that unauthorized third parties will not gain access to your Personal Data; therefore, when submitting Personal Data to Radiometer Sites, you must weigh both the benefits and the risks.

Third Party Sites and Social Media Plug-ins

This Privacy Notice does not apply to third-party websites to which Radiometer Sites may link. Radiometer Sites may use social media plug-ins (e.g., the Facebook “Like” button, “Share to Twitter” button) to enable you to easily share information with others. When you visit Radiometer Sites, the operator of the social plug-in can place a cookie on your computer or other electronic device that enables that operator to recognize individuals who have previously visited our Site. If you are logged into the social media website (e.g., Facebook, Twitter) while browsing on our Radiometer Site, the social media plug-in allows that social media website to receive information that you have visited our Radiometer Site. The social media plug-in also allows the social media website to share information about your activities on our Radiometer Site with other users of their social media website. These sharing settings are managed by the social media website and governed by its privacy policy.

Accessing Our Sites Globally

This site is owned and operated by Radiometer in Denmark, but the information you provide will be accessible to our affiliates, vendors, and suppliers in other countries in accordance with this policy. Furthermore, if you are visiting this site from a country other than Denmark, your communication with us will necessarily result in the transfer of information across international borders. The level of legal protection for Personal Data is not the same in all countries; however, we will take the security measures described in this Privacy Notice in an effort to keep your information secure. By using this site, you understand that your Personal Data may be stored and processed in the United States and in any country to which we may transfer your information in the course of our business operations.

Notice to California Residents 

Subject to certain limits under California Civil Code § 1798.83, California residents may ask us to provide them with (i) a list of certain categories of Personal Data that we have disclosed to third parties for their direct marketing purposes during the immediately preceding calendar year, and (ii) the identity of those third parties. To make this request, California residents may contact us at privacy@radiometer.dk.

Changes to Our Privacy Policy

We will only use Personal Data in the manner described in this Privacy Policy in effect when the information was collected from you or as authorized by you. However, and subject to any applicable consent requirements, we reserve the right to change the terms of this Privacy Policy at any time. Any changes to this Privacy Policy will be reflected on this page with a new effective date. Radiometer encourages you to review this Privacy Policy regularly for any changes. Any Personal Data collected upon your continued use of Radiometer Sites will be handled in accordance with the currently-posted Privacy Policy.

Privacy and Security

Radiometer Medical ApS (“Radiometer”), along with its affiliates and subsidiaries respect your privacy, value our relationship, and are committed to safeguarding your privacy. We understand the importance of privacy to our customers and visitors to the Radiometer websites. Our use of Personal Data is governed by our Privacy Policy and by accessing and using the Radiometer websites, you agree to be bound by that Privacy Policy.

You recognize and agree that when submitting your personally identifiable information to Radiometer websites, while Radiometer has safeguards in place to prevent unauthorized access or interception, there is no absolute guarantee of security. IN THE UNLIKELY EVENT OF AN INTERCEPTION OR UNAUTHORIZED ACCESS DESPITE OUR EFFORTS, RADIOMETER SHALL NOT BE RESPONSIBLE FOR SUCH INTERCEPTIONS OR UNAUTHORIZED ACCESS, OR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) SUFFERED BY A CUSTOMER OR USER, EVEN IF RADIOMETER HAS PREVIOUSLY BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, RADIOMETER DOES NOT WARRANT, EITHER EXPRESSLY OR IMPLIED, THAT THE INFORMATION PROVIDED BY ANY CUSTOMER SHALL BE FREE FROM INTERCEPTION OR UNAUTHORIZED ACCESS, AND DOES NOT PROVIDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. EACH CUSTOMER IS RESPONSIBLE FOR MAINTAINING THE CONFIDENTIALITY OF HIS OR HER OWN PASSWORD.

 

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