BÜHLMANN fCAL® turbo

BÜHLMANN fCAL® turbo
BÜHLMANN fCAL® turbo (K190784): FDA 510(k) cleared. For in vitro Diagnostic Use.
BÜHLMANN fCAL® turbo + CALEX® Cap (191718): FDA 510(k) cleared. For in vitro Diagnostic Use.
Health Canada Licenses: BÜHLMANN fCAL® turbo (96808), CALEX® Cap (K191718)
CPT Code: Calprotectin – 83993

An FDA-Cleared Gastrointestinal Test to Distinguish IBD from IBS

Calprotectin is a highly-sensitive clinical biomarker that has been shown to be extremely useful as an aid in diagnosis of inflammatory diseases in the gastrointestinal tract.

The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.

This FDA 510k cleared, non-invasive, sensitive and specific assay is unique in speed, quality, and flexibility.  This offers accurate results and reliable information to aid clinicians in selecting patients for further diagnostic procedures.

 

  • Speed: fastest calprotectin test in the market, time-to-first-result within 10 minutes

  • Quality: standardized against BÜHLMANN fCAL® ELISA, uses highly precise and reproducible PETIA technology

  • Flexibility: can be applied on most open chemistry platforms streamlining your workflow using random access automation

Product Information

Name BÜHLMANN fCAL® turbo
Method Immunoturbidimetric
Time-to-first-result 10 min (approx.)
Sample type less than 1 g
Standard range 30-10,000 µg/g **with retesting
Sensitivity (LoQ) 30 µg/g
Instructions for Use & Other Downloads  see below

Because Accuracy is What Matters

  • Robust: accurate, precise & efficient assay to instill confidence
  • Validated:  in use worldwide providing over 1 million reliable patient results a year
  • Published: highly referenced, >75 peer reviewed scientific articles

CLINICIANS
Learn about the benefits of the BÜHLMANN fCAL® turbo for your patients.

buhlmann-fcal-turbo-2

LABORATORY
Learn about the performance of the BÜHLMANN fCAL® turbo

Learn More

The BÜHLMANN fCAL® turbo sets a new standard in the industry:

A clinical study with a total of 248 adult and pediatric patients was performed to assess the ability of the BÜHLMANN fCAL® turbo to discriminate between patients with IBD and other non-inflammatory GI disorders, including IBS. A subset of this population (94 IBD vs 108 IBS) that included only samples that were run with another manufacturer’s assay were used to create the ROC curve below to provide a competitive comparison.

 

  • Excellent sensitivity at cut-off of 80 ug/g of 91.1%: avoid false negatives in IBD/IBS screening!
  • Clinically proven, stable and consistent standardization (same as BÜHLMANN fCAL® ELISA) established in 2006
  • Outstanding method comparison to the BÜHLMANN fCAL® 
  • Narrow clinical grey zone between 80 ug/g and 160 ug/g
  • The BÜHLMANN fCAL® turbo and BÜHLMANN fCAL® ELISA are the only global assays with IVD registrations in the US (FDA), Canada (HC), Europe (CE-IVD), Japan (PMDA), China (SFDA), Australia (TGA), Brazil (ANVISA) etc.

Workflow: Streamlined Workflow with Total Laboratory Automation (TLA)

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BÜHLMANN fCAL® turbo currently has validated application notes for the Roche c501/502 for use in the U.S. Other major chemistry system validation packages are in process. Please contact BUHLMANN Diagnostics Corp for a complete list of validated applications.

Precision and Reproducibility

Table 1: Reproducibility Study Results- within-run, between-run and between-day variance component estimates

Table 2: Lot to Lot Precision and Reproducibility Results

Linearity

Figure 1: Linearity Data- observed vs. expected results, dilution series #1

y = 2.0 + 1.063 x
r = 0.999

Figure 2: Linearity Data- observed vs. expected results, dilution series #2:

y = 2.3 + 1.033 x
 r = 0.999

Instrument Dilution

Table 3: Dilution Study Results – Manual dilution vs automated dilution performed by the instrument for an automated rerun

Figure 3: Difference Plot  – automated vs. manual dilution
(a mean bias of 2.79% )

Safe stool extract application on clinical chemistry platforms with BÜHLMANN fCAL® turbo and CALEX® Cap.

Download IFU and Catalog Numbers

View the appropriate tab below for your location (US or Canada) and click on the blue underlined catalog number to view the Instructions for Use.

Extraction Device:

CALEX® Cap Device – B-CALEX-C50/ B-CALEX-C200/ B-CALEX-C500

Automation: 

BÜHLMANN fCAL® turbo – KK-CAL

This kit contains all the components: extraction kit, reagent kit, calibrator kit, and control kit.

Components:
All components below are available for sale separately.

Extraction Kit for BÜHLMANN fCAL® turbo  B-CAL-EX12 

Reagent kit        B-KCAL-RSET

Calibrator kit     B-KCAL-CASET 

Control kit       B-KCAL-CONSET

BÜHLMANN fCAL® turbo – KK-CAL
This kit contains all the components: extraction kit, reagent kit, calibrator kit, and control kit.

Components:
All components below are available for sale separately.

Extraction Kit for BÜHLMANN fCAL® turbo B-CAL-EX12
Reagent kit B-KCAL-RSET [EN] B-KCAL-RSET [FR]
Calibrator kit B-KCAL-CASET [EN] B-KCAL-CASET [FR]
Control kit B-KCAL-CONSET [EN] B-KCAL-CONSET [FR]