Serum calprotectin Immuno turbidimetric reagent set sCAL® turbo BÜHLMANN approx 100 tests to determine the inflammatory status of patients

The BÜHLMANN sCAL® turbo is an in vitro diagnostic test designed for the quantitative determination of calprotectin (MRP8/14) in human serum samples. Calprotectin serum levels can be used to determine the inflammatory status of patients. The test is used in combination with clinical chemistry analysers.
The BÜHLMANN sCAL® turbo test is a particle enhanced turbidimetric immunoassay (PETIA) and allows quantification of calprotectin in human serum samples on clinical chemistry analysers. Samples can be measured without any additional dilution steps. Samples are incubated with reaction buffer and mixed with polystyrene nanoparticles coated with calprotectin-specific antibodies (immunoparticles). Calprotectin available in the sample mediates immunoparticle agglutination. Sample turbidity, measured by light absorbance, increases with calprotectin-immunoparticle complex formation and is proportional to serum calprotectin concentration. The detected light absorbance allows quantification of calprotectin concentration via interpolation on an established calibration curve.
Code: B-SCAL-RSET: 1 of each of R1 & R2 reagents
Storage conditions: 2-8C. Do NOT freeze
Sample Type: Serum
Sample preparation: Collect blood into tubes without any additives or into gel separator tubes according to manufacturer’s instructions and avoid haemolysis. Centrifuge the venipuncture tube at 1800 x g for 15 minutes at room temperature (18-28°C) and transfer the serum into plain tubes within 6 hours after blood collection. Avoid co-transferring any blood cells. Do not heat-inactivate samples.
Sample volume: ~2-3µl
Time to first result: 10 minutes
Assay Range: 0.23 - 15µg/ml but can dilute 1:15 to cover 15 - 225µg/ml
Number of tests: Approximately 100 (dependent on the platform used)
Assay protocols available: Mindray BS-480, protocols under validation (Roche Cobas c501 & Pure c303, Abbott Alinity, Beckman AU480 and the Biosystems BA200)
Standardisation: The BÜHLMANN sCAL® turbo is standardized against internal reference material (purified native calprotectin). Calibrator and control values are assigned according to a value transfer protocol (ref. 1, 2), to guarantee metrological traceability. The analytical measuring interval of the BÜHLMANN sCAL® turbo, established on the Mindray BS-480 instrument, is 0.23-15.0 μg/mL.
All reagents are ready to use and have an on-board stability of 55 days
Calibration is stable for at least 30 days, but is analyser dependant
Reproducibility: 2.9 - 11.1% CV. Established according to CLSI guideline EP05-A3 using a 3 instrument/lot/operator x 5 days x 5 replicates study design and an acceptance criterion of 15% CV. Performed on Roche cobas c501, Beckman Coulter AU480, & Mindray BS-480 instruments
Repeatability: 0.5 - 3.9% CV. Established according to CLSI guideline EP05-A3 using the standardized 20 days x 2 runs x 2 replicates study design.
Accuracy/Recovery: 92 - 112.8%
Limit of Detection: 0.11µg/ml
Limit of Quantification: 0.23µg/ml. Established according to CLSI guideline EP17-A2, based on 60 determinations and a precision goal of 20% CV.