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 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
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.
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.
GCAL® can be applied on a wide range of clinical chemistry analysers, including but not limited to:
Optilite® - Binding Site
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 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
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;
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
Turbidimetric test
Faster throughput
Open channel
10 minutes to result
Avian antibodies
Cost efficient
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.
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.
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.
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.
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.
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.
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.
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
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