FAQ: What type of assay is the Gentian Calprotectin Immunoassay GCAL®?
28. Apr 2021 |
12 min read
What type of assay is GCAL®?
In our Frequently Asked Questions about calprotectin series we will answer questions we often receive about plasma and serum calprotectin and the Gentian Calprotectin Immunoassay GCAL®. If you have any additional questions don't hesitate to contact us on firstname.lastname@example.org.
In this section we will explain what type of assay the Gentian Calprotectin Immunoassay GCAL® is and what the advantages of this assay are.
Quantitative analysis of total calprotectin in blood sample
The Gentian Calprotectin Immunoassay (GCAL®) is an in vitro diagnostic product for the quantitative determination of calprotectin in human lithium heparin plasma and serum samples. The measurement of calprotectin in lithium heparin plasma and serum is used in the assessment of inflammation.
CE-marked since 2017
IVDR registration in progress
Developed and manufactured by Gentian
Manufactured according to ISO 13485:2016
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. The use of avian antibodies provides the advantage of less interference and cross-reaction from human samples, thereby decreasing backgrounds levels and increasing sensitivity. The assay is rapidly performed in only 10 minutes and can be applied on a wide range of clinical chemistry analysers, including but not limited to:
What are the advantages of an open channel turbidimetric immunoassay?
GCAL® is an immunoassay applied to turbidimetry-based clinical chemistry platforms. Gentian has experience in nano-particle technology, converting classical immunoassays to the clinical chemistry platforms while maintaining high sensitivity and accuracy. Switching to clinical chemistry from manual systems, like ELISA, or lower throughput immunoassays, this enables the laboratory to increase work-flow efficiency and productivity, decreases manual work and thereby reduces time and costs. Moreover, the random access and short assay time allows a fast time to result providing rapid answers in critical patient care.
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 protocol1 to a highly pure recombinant calprotectin solution with assigned value by total protein determination by UV280 and known extinction coefficient.
What are the technical specifications?
Gentian Calprotectin Immunoassay Performance
Li-Heparin plasma, Serum
Liquid reagents, ready to use
Precision (sample >1 mg/L)*
Total CV 4.0%
Up to 95 mg/L
0.4 - 20 mg/L
*Instrument dependent results achieved on Architect c4000 during validation.
Gentian Calprotectin Reagent Kit
R1 54 mL + R2 9 mL
Gentian Calprotectin Reagent Kit S
R1 30 mL + R2 5 mL
Gentian Calprotectin Control Kit
2 x 1 mL
Gentian Calprotectin Calibrator Kit
6 x 1 mL
Why choose the Gentian Calprotectin GCAL® Immunoassay?
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