Test Catalog

Test Id : PRCAL

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Procalcitonin, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring antibiotic therapy and all-cause mortality for patients diagnosed with severe sepsis or septic shock in the Intensive Care Unit (ICU) or when obtained in the emergency department or other medical wards prior to ICU admission

Method Name
A short description of the method used to perform the test

Electrochemiluminescence

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Procalcitonin, S

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.6 mL

Collection Instructions:

1. Serum gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and the serum aliquoted into a plastic vial within 2 hours of collection.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 90 days
Refrigerated 48 hours
Ambient 24 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring antibiotic therapy and all-cause mortality for patients diagnosed with severe sepsis or septic shock in the Intensive Care Unit (ICU) or when obtained in the emergency department or other medical wards prior to ICU admission

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Procalcitonin (PCT) is a biomarker associated with the inflammatory response to bacterial infection and aids in the risk assessment of critically ill patients on their first day of admission to the intensive care unit (ICU), or when obtained in the emergency department or other medical wards prior to ICU admission, for progression to severe sepsis and septic shock. The percent change in PCT level over time aids in the prediction of cumulative 28-day mortality in patients with severe sepsis and septic shock.

 

A PCT level that declines 80% or less from the day that severe sepsis or septic shock was clinically diagnosed (day 0) to 4 days after clinical diagnosis (day 4) is associated with higher cumulative 28-day risk of all-cause mortality than a decline above 80%.

 

The PCT level on day 1 (the day after severe sepsis or septic shock is first clinically diagnosed) can be used to calculate the percent change in PCT level at day 4 if the day 0 measurement is unavailable.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

0.00-0.24 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Systemic inflammatory response syndrome, sepsis, severe sepsis, and septic shock were categorized according to the criteria of the consensus conference of the American College of Chest Physicians/Society of Critical Care Medicine.(1)

 

The change of procalcitonin (PCT) concentration over time provides prognostic information about the risk of mortality(2) within 28 days for patients diagnosed with severe sepsis or septic shock coming from the emergency department, intensive care unit, other medical wards, or directly from outside the hospital. Data support the use of procalcitonin determinations from the day severe sepsis or septic shock is first diagnosed (day 0) or the day thereafter (day 1) and the fourth day after diagnosis (day 4) for the classification of patients into higher and lower risk for mortality within 28 days.

 

Change in procalcitonin of 80% or less:

A decrease of PCT levels below or equal to 80% defines a positive change in PCT test result representing a higher risk for 28-day all-cause mortality of patients diagnosed with severe sepsis or septic shock.

 

Change in procalcitonin above 80%:

A decrease of PCT levels of more than 80% defines a negative change in PCT result representing a lower risk for 28-day all-cause mortality of patients diagnosed with severe sepsis or septic shock.

 

Positive results:

Procalcitonin greater than or equal to 0.25 ng/mL may indicate bacteremia or bacterial pneumonia; however, it is a non-specific biomarker. False positives can be seen in patients with a variety of illnesses, including but not limited to severe trauma, shock, recent surgery, burns, renal insufficiency, severe liver disease, COVID-19, and certain malignancies.

 

Negative results:

Procalcitonin less than 0.25 ng/mL may indicate lower probability of bacteremia or bacterial pneumonia. Intracellular bacteria, viruses, and fungi do not cause elevation of procalcitonin, so low values (<0.25 ng/mL) do not rule out other infections.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This assay is not indicated to be used as a stand-alone diagnostic assay to determine the risk of 28-day all-cause mortality. Changes in procalcitonin should always be interpreted in the context of the clinical status of the patient and other laboratory results. There is no uniformly recognized interpretation of the change in procalcitonin concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-existing patient risk factors and clinical course.

 

The need to continue intensive care unit care at day 4 and other covariates (eg, age, SOFA score) are also significant predictors of 28-day cumulative mortality risk.

 

Validation of this test as an aid in predicting mortality was performed in a study population with an overall 28-day mortality of 22%.

 

Serum biotin concentrations up to 1200 ng/mL do not interfere with this assay. Concentrations up to 1200 ng/mL may be present in specimens collected from patients taking extremely high doses of biotin up to 300 mg per day.(3) In a study among 54 healthy volunteers, supplementation with 20 mg/day biotin resulted in a maximum serum biotin concentration of 355 ng/mL 1 hour post-dose.(4)

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992;20(6):864-874

2. Schuetz P, Maurer P, Punjabi V, Desai A, Amin DN, Gluck E. Procalcitonin decrease over 72 hours in US critical care units predicts fatal outcome in sepsis patients. Crit Care. 2013;17(3):R115. doi:10.1186/cc12787

3. Peyro Saint Paul L, Debruyne D, Bernard D, Mock DM, Defer GL. Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis. Expert Opin Drug Metab Toxicol. 2016;12(3):327-344. doi:10.1517/17425255.2016.1136288

4. Grimsey P, Frey N, Bendig G, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. J Pharmacokinet Pharmacodyn. 2017;2(4):247-256. doi:10.4155/ipk-2017-0013

5. Chambliss AB, Patel K, Colon-Franco JM, et al. AACC guidance document on the clinical use of procalcitonin. J Appl Lab Med. 2023;8(3):598-634. doi:10.1093/jalm/jfad007

Method Description
Describes how the test is performed and provides a method-specific reference

The procalcitonin method employs monoclonal antibodies specifically directed against procalcitonin. A biotinylated monoclonal antibody and a second monoclonal antibody labeled with a ruthenium complex react to form a sandwich complex. After the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Application of a voltage to the electrode then induces chemiluminescent emission, that is measured by a photomultiplier.(Package insert: PCT. Roche Diagnostics; 04/2023)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

84145

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
PRCAL Procalcitonin, S 33959-8
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
PRCAL Procalcitonin, S 33959-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

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Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports