GCAL® - plasma and serum calprotectin

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

Calprotectin - S100A8/A9 Heterodimer

Calprotectin is a heterodimer of two calcium-binding proteins (S100A8/A9 or MRP8/14) and belongs to the S100 protein family, highly expressed by immunocytes. It is released from activated immunocytes, such as neutrophils, monocytes and macrophages during inflammation and upon bacterial infection functioning as anti-microbial and pro-inflammatory protein.1

calprotectin in plasma and serum for inflammation

Calprotectin in blood 

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 in the blood stream and the concentration of circulating calprotectin reflects the degree of inflammation. Indications for its use have been reported in both infectious and non-infectious inflammatory conditions.2

 

 

 

Calprotectin on clinical chemistry systems 

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.

GCAL® is CE-marked and IVDR certified.

1251_Gentian Calprotectin Calibrator Kit
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.

 

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:

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 GCAL® Calprotectin Reagent Kit R1 54 mL + R2 9 mL
1202 Gentian GCAL® Calprotectin Reagent Kit S R1 30mL + R2 5 mL
1219 Gentian GCAL® Calprotectin Control Kit 2 x 1 mL
1251 Gentian GCAL® 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 infections

Calprotectin is released in the first-line defence during infection and levels rise within only a few hours after infection.3 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 infections.8 Interestingly, calprotectin has also been reported a risk marker in severe COVID-199-11, which in contrast to other viral infection induces a hyperinflammation response and pathways mimic bacterial sepsis.12

 

 

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Circulating calprotectin in inflammatory conditions

Calprotectin is also a highly valuable biomarker for non-infectious inflammatory diseases; most established in rheumatic diseases, where serum and plasma calprotectin has been reported to correlated with the inflammation in the arthritic joints and disease severity13, 14;

  • Rheumatoid Arthritis (RA)
  • Juvenile Idiopathic Arthritis (JIA)
  • Systemic JIA (sJIA)
  • Adult-Onset Still’s Disease (AOSD)

Diagnostic value for circulating calprotectin has been appraised in the assessment of disease activity, including remission and relapse, and monitoring of treatment response.13,15,16 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 levels.13

 

 

Circulating calprotectin  in rheumatic diseases

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 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 and IVDR certified
  • 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.

calprotectin in plasma and serum

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.

What is S100A8/A9 heterodimer?

The S100A8/A9 heterodimer is a protein complex composed of two subunits, S100A8 and S100A9 (also called MRP8 and MRP14 or Calgranulin A and Calgranulin B, respectively). The heterodimer is also called calprotectin. These subunits belong to the S100 family of calcium-binding proteins and are expressed by various cells of the immune system, including neutrophils, monocytes, and macrophages. Each monomer S100A8 and S100A9 exhibits two calcium-binding EF hand motifs and the heterodimer has two transition metal binding sites, which can bind zinc and manganese.

Can calprotectin be measured in serum and plasma?

Calprotectin levels are matrix dependent. Slightly higher levels are reported in serum samples, especially in low concentrated samples, likely due to release of calprotectin during clotting phase. Therefore, Gentian provides dedicated refence limits per sample type and recommends to process the samples as fast as possible, min. within 2 h.

 

Both serum and lithium heparin plasma samples are validated and suitable. Please note specific handling for serum and do not use sample matrixes interchangeably, see IFU.

Can calprotectin be measured in gel-tubes?

It seems that the gel and/or passage of cells through the gel can activate neutrophils and cause a leakage of calprotectin. Therefore, gel tubes might cause higher pre-analytical variation. Therefore, Gentian provides dedicated refence ranges split into non-gel versus gel tubes.

 

Both gel and non-gel tubes of serum and lithium-heparin plasma are validated and suitable. Please note specific handling for serum and do not use sample matrixes interchangeably, see IFU.

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

 

calprotectin literature and study list



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. 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. Scientific reports, 2020
  5. Larsson A et al. Calprotectin is superior to procalcitonin as a sepsis marker and predictor of 30-day mortality in intensive care patients. Scand J Clin Lab Invest, 2019
  6. Jonsson N 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 as an indicator of need of transfer to intensive care in patients with suspected sepsis at the emergency department. BMC Emerg Med, 2023
  9. Bauer W et al. Outcome prediction by serum calprotectin in patients with COVID-19 in the emergency departmentJ Infect. 2021
  10. de Guadiana Romualdo LG et al. Circulating levels of GDF-15 and calprotectin for prediction of in-hospital mortality in COVID-19 patients: A case series. J Infect, 2020
  11. de Guadiana-Romualdo L et al. Circulating levels of calprotectin, a signature of neutrophil activation in prediction of severe respiratory failure in COVID-19 patients: a multicenter, prospective study (CalCov study). Inflamm Res, 2021
  12. Vincent JL. COVID-19: it's all about sepsisFuture Microbiol. 2021
  13. Wang Q et al. The Role of Calprotectin in Rheumatoid Arthritis. J Transl Int Med. 2019
  14. Ometto F et al. Calprotectin in rheumatic diseasesExp Biol Med (Maywood). 2017
  15. Abildtrup M et al. Calprotectin as a biomarker for rheumatoid arthritis: a systematic review. J Rheumatol. 2015
  16. Jung JY et al. Roles of Interactions Between Toll-Like Receptors and Their Endogenous Ligands in the Pathogenesis of Systemic Juvenile Idiopathic Arthritis and Adult-Onset Still's Disease. Front Immunol, 2020

 

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