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 now certified by TüV SÜD as complying with the European In-Vitro Diagnostic Regulation (IVDR), EU 2017/746
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 immunocytes, such as neutrophils, monocytes and macrophages during inflammation and upon bacterial infection functioning as anti-microbial and pro-inflammatory protein1.
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.
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 |
1202 | Gentian Calprotectin Reagent Kit S | R1 30mL + R2 5 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 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 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.
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 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
GCAL® can be applied on a wide range of clinical chemistry analysers, including but not limited to: