GCAL® - plasma and serum calprotectin

Measurement of calprotectin in plasma and serum in the assessment of inflammation and severe infection

GCAL® - Plasma and Serum Calprotectin Immunoassay

The Gentian Calprotectin Immunoassay (GCAL®) is the first turbidimetric assay for the quantitative measurement of calprotectin in plasma and serum intended as an aid in the detection and assessment of inflammation. The open channel assay can be applied on a wide range of automated clinical chemistry analysers.

calprotectin in plasma and serum for inflammation

Plasma and serum calprotectin - Background

Calprotectin is a heterodimer of two calcium-binding proteins and belongs to the S100 protein family (Synonyms: S100A8/A9 or MRP8/14). It is released from activated and consumed immunocytes, such as neutrophils, monocytes and macrophages during inflammation and upon bacterial infection functioning as anti-microbial and pro-inflammatory protein1.

Calprotectin in blood – clinical value

Calprotectin in plasma and serum is a sensitive and early biomarker in detection of inflammation and inflammatory response in infections. During inflammation large amounts of calprotectin are released and concentration of calprotectin in serum and plasma reflects the degree of inflammation. Indications for its use have been reported in both infectious and non-infectious inflammatory conditions2.

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gcal validation kit

Technical details

 

Assay Performance  
Sample type Li-Heparin plasma, Serum
Assay type  PETIA
Format  Liquid reagents, ready to use
Precision (sample >1 mg/L) Total CV 4.0%
LoQ*  0.3 mg/L
Security zone*  Up to 95 mg/L
Measuring range*  0.4 - 20 mg/L
Calibration stability*  4 weeks

 

*Instrument dependent results achieved on Architect c4000 during validation


For more details on GCAL® products and prices please contact us at marketing@gentian.com

The Gentian Calprotectin Immunoassay GCAL® is a Particle-Enhanced Turbidimetric Immunoassay (PETIA) for in vitro diagnostic testing of calprotectin in human plasma and serum samples.

The assay can be applied on a wide range of clinical chemistry analysers and is rapidly performed in only 10 minutes.

For more details on GCAL® products and prices please contact us at marketing@gentian.com

The calibrator for the Gentian Calprotectin Immunoassay GCAL® is available as a 6-point pre-diluted calibrator kit. The calibrator is established according to section 5.6 in ISO 17511:2003.

The calibrator is traceable via a published value transfer protocol* to a highly pure recombinant calprotectin solution with assigned value by total protein determination by UV280 and known extinction coefficient.

For more details on GCAL® products and prices please contact us at marketing@gentian.com 

 

*Blirup-Jensen S et al. IFCC Committee on Plasma Proteins. Protein standardization V: value transfer. A practical protocol for the assignment of serum protein values from a Reference Material to a Target Material. Clin Chem Lab Med. 2008.


Product no. Product Content

1201

Gentian Calprotectin Reagent Kit

R1 54 ml + R2 9 ml

1219

Gentian Calprotectin Control Kit

2 x 1 ml

1251

Gentian Calprotectin Calibrator Kit

6 x 1 ml

 

For more details on GCAL® products and prices please contact us at marketing@gentian.com

Calprotectin in severe infection and sepsis

Calprotectin is released in the first-line defence during infection and the calprotectin levels rise within only a few hours after infection3. This direct and fast response makes calprotectin an ideal biomarker for the inflammatory response to infections.

Calprotectin has been reported as diagnostic marker in the discrimination between bacterial and viral infection4, in assessment of severe infections and sepsis5-7 and in the prediction for development of severe infections8. Interestingly, calprotectin has also been reported a risk marker in severe COVID-199,10, which in contrast to other viral infection induces a hyperinflammation response and pathways mimic bacterial sepsis11.

 

Calprotectin in inflammatory conditions

Calprotectin is also a highly valuable biomarker for non-infectious inflammatory diseases, like rheumatic diseases12. In rheumatoid arthritis (RA) blood calprotectin has been reported to correlated with the inflammation in the arthritic joints and disease severity13.

Diagnostic value for serum and plasma calprotectin has been appraised in the assessment of disease activity, including remission and relapse, and monitoring of treatment response13,14. Importantly, even though calprotectin correlates with other routinely used inflammatory biomarkers C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), it is a superior biomarker since it also reliably detects inflammation activity, even in patients with normal CRP and ESR levels13.

calprotectin rheumatoid arthritis

1-2

Turbidimetric test

17

Faster throughput

2-3

Open channel

5

10 minutes to result

Design uten navn (5)

Avian antibodies

Cost efficient

Cost efficient

Contact us for further information

GCAL® is an immunoassay applied to turbidimetry-based clinical chemistry platforms. It is an open channel assay, meaning it can be added to all clinical chemistry analysers.

  • CE-marked since 2017
  • IVDR registration in progress
  • Developed and manufactured by Gentian
  • Manufactured according to ISO 13485:2016

Explore GCAL® in your laboratory - fill out the form or send an email to marketing@gentian.com for more information about the product and prices.

Frequently asked questions

What is the assay principle for GCAL®?

GCAL® is the first and only Particle-Enhanced Turbidimetric Immunoassay (PETIA) on multiple platforms for in vitro diagnostic testing of calprotectin in human plasma and serum samples.

Is GCAL® an open channel turbidimetric assay?

GCAL® is an open channel assay, meaning it can be added to all clinical chemistry analysers. Diagnostic laboratories are thereby not limited to the use of one specific instrument offering calprotectin but can apply GCAL® on their available instrumentation and thereby fill the open menu gaps.

How is the calibrator standardised?

The calibrator for the Gentian Calprotectin Immunoassay GCAL® is available as a 6-point pre-diluted calibrator kit. The calibrator is established according to section 5.6 in ISO 17511:2003. To date no international standard for serum and plasma calprotectin is available. The Gentian Calprotectin Calibrator is traceable via a published value transfer protocol* to a highly pure recombinant calprotectin solution with assigned value by total protein determination by UV280 and known extinction coefficient.

* Blirup-Jensen S et al. IFCC Committee on Plasma Proteins. Protein standardization V: value transfer. A practical protocol for the assignment of serum protein values from a Reference Material to a Target Material. Clin Chem Lab Med. 2008

Which clinical chemistry analysers can GCAL® be applied on?

GCAL® can be applied on a wide range of clinical chemistry analysers, including but not limited to:

calprotectin test for plasma and serum

References:

  1. Pruenster M et al. S100A8/A9: From basic science to clinical application. Pharmacol Ther. 2016.
  2. Chan JK et al. Alarmins: awaiting a clinical responseJ Clin Invest. 2012.
  3. Fullerton J et al. Kinetics of calprotectin, procalcitonin and C-reactive protein in healthy volunteers administered intravenous endotoxin. 40th International Symposium on Intensive Care & Emergency Medicine. Critical Care. 2020.
  4. Havelka A et al. Calprotectin, a new biomarker for diagnosis of acute respiratory infections. Sci Rep. 2020.
  5. Larsson A  et al. Calprotectin is superior to procalcitonin as a sepsis marker and predictor of 30-day mortality in intensive care patientsScand J Clin Lab Invest. 2020.
  6. Jonsson  et al. Calprotectin as an early biomarker of bacterial infections in critically ill patients: an exploratory cohort assessment. Crit Care Resusc. 2017.
  7. Simm M et al. Performance of plasma calprotectin as a biomarker of early sepsis: a pilot studyBiomark Med. 2016.
  8. Parke Å et al. Plasma-calprotectin compared with routine biomarkers for prediction of early severe event in sepsis. 40th International Symposium on Intensive Care & Emergency Medicine. Critical Care. 2020.
  9. Bauer W et al. Outcome prediction by serum calprotectin in patients with COVID-19 in the emergency departmentJ Infect. 2021.
  10. Luis García de Guadiana Romualdo et al. Circulating levels of GDF-15 and calprotectin for prediction of in-hospital mortality in COVID-19 patients: A case seriesJ Infect. 2021.
  11. Vincent JL. COVID-19: it's all about sepsisFuture Microbiol. 2021.
  12. Ometto F et al. Calprotectin in rheumatic diseasesExp Biol Med (Maywood). 2017.
  13. Wang Q et al. The Role of Calprotectin in Rheumatoid Arthritis. J Transl Int Med. 2019.
  14. Abildtrup M et al. Calprotectin as a biomarker for rheumatoid arthritis: a systematic review. J Rheumatol. 2015.