BÜHLMANN fPELA® turbo | Buhlmann Diagnostics Corp

BÜHLMANN fPELA® turbo

previous arrow
next arrow
Slider
BÜHLMANN fPELA® turbo
BÜHLMANN fPELA®: FDA Exempt. For in vitro Diagnostic Use.

A Gastrointestinal Test to Detect Endocrine Pancreatic Insufficiency

The BÜHLMANN fPELA® turbo is a test for the quantitative determination of pancreatic elastase in human fecal extracts and is intended to be run on clinical chemistry analyzers.

This test is a particle enhanced turbidimetric immunoassay (PETIA) assay developed to be run directly with stool extracts derived from the CALEX® Cap extraction device. This device is pre-filled with unique extraction buffer designed for fecal extraction of pancreatic elastase and calprotectin, allowing for quantification of both analytes at the same time.

Fecal pancreatic elastase is a well-established biomarker to detect exocrine pancreatic insufficiency in patients suffering from conditions such as chronic pancreatitis and cystic fibrosis. The concentration of pancreatic elastase levels in feces reflects the level of pancreatic output and correlates with the output of other pancreatic enzymes such as lipase, amylase, and trypsin.

Speed, Quality, Flexibility

This assay is a non-invasive, sensitive and specific assay that 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:
fast pancreatic test, time-to-first-result within 10 minutes

Quality:
high correlation to the manual gold standard reference method, specific to human enzymatic isoforms, and uses highly precise and reproducible PETIA technology

Flexibility
can be applied on most open chemistry platforms (in the same fecal extract used for calprotectin testing) streamlining your workflow using random access automation

Product Information

Name BÜHLMANN fPELA® turbo 
Method particle-enhanced turbidimetric immunoassay (PETIA)
Sample Type Fecal extracts
Kit Format 2 reagents (R1/ R2)
Calibrators and controls provided separately
Sample Preparation CALEX® Cap extracts ready to use without dilution
Measuring Range 10-5000 µg/g
Sensitivity (LoQ) 5.7 µg/g
Sample Volume ~10 ul centrifuged fecal Extract (1:500)
Time to Result ~10 min
CALEX® Extraction ~20 min
Applicable on most chemistry platforms  (contact us for information on application notes)
Instructions for Use & Other Downloads  see below

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

buhlmann-fcal-turbo-2

LABORATORY
Learn about the performance of the BÜHLMANN fPELA® turbo

Learn More

The BÜHLMANN fPELA® turbo specificity and correlation to the manual reference method

  • The BÜHLMANN fPELA® turbo is based on polyclonal antibodies specific for the relevant human isoforms of the enzyme.
  • The assay is not affected by PERT (pancreatic enzyme replacement therapy).
  • Method comparison: A total of 130 stool samples from normal donors and PEI patients spanning the assay range were tested by the BÜHLMANN fPELA® turbo assay and a commercial Elastase-1 monoclonal assay. Results are summarized in the table below. Applying a cut-off at 200 μg/g, an overall agreement of 93.1% was found.

Workflow: Streamlined Workflow with Total Laboratory Automation (TLA)

//set your background image

Please contact BUHLMANN Diagnostics Corp for a complete list of validated applications.

Precision and Reproducibility

Testing was performed on Roche c501, Beckman Coulter AU480, and Mindray BS380 instruments. Six (6) stool specimen extracts were assayed.

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

Table 2: Within-Laboratory Precision and Reproducibility Results

Linearity

Linearity range: 3.4 to 5024.2 µg/g

The linear range of the BÜHLMANN fPELA® turbo was determined according to the CLSI guideline EP06-A. Samples with a concentration of over 500 μg/g were diluted automatically 1:10 by the analyzer. A maximum deviation from linearity of 10% or 10 µg/g, for samples below 100 µg/g, was allowed.

Method Comparison

Table 3: Method Comparison Study Results – BÜHLMANN fPELA® turbo vs ScheBo® Pancreatic Elastase 1TM

The method comparison study was performed according to the CLSI guideline EP09-A3. One hundred and eight (108) samples were measured using three lots of BÜHLMANN fPELA® turbo over four days. Mean reference values, with elastase concentrations falling within the measuring range of 15– 500 µg/g µg/g, were established with two lots of the ScheBo® Pancreatic Elastase 1TM test. Bias was determined using Passing-Bablok linear regression and Bland-Altman analysis.

BÜHLMANN fPELA® turbo
Elastase 1 ELISA
> 200 μg/g 100-200 μg/g < 100 μg/g TOTAL
> 200 μg/g 37 9 2 48
100-200 μg/g 5 22 9 36
< 100 μg/g 1 8 37 46
Total 43 39 48 130

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

BÜHLMANN fCAL® turbo – KK-PELA

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 fPELA® turbo B-KPELA-EX12

Reagent kit B‐KPELA‐RSET

Calibrator kit B‐KPELA‐CASET

Control kit B‐KPELA‐CONSET

Extraction Device:

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

BÜHLMANN fCAL® turbo – KK-PELA-U
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-KPELA-EX12
Reagent kit B-KPELA-RSET [EN] B-KPELA-RSET [FR]
Calibrator kit B-KPELA-CASET [EN] B-KPELA-CASET [FR]
Control kit B-KPELA-CONSET [EN] B-KPELA-CONSET [FR]

BÜHLMANN fPELA turbo® Clinical Flyer for US

BÜHLMANN CALEX® Cap (Fecal Extraction Device) Flyer for US 

BÜHLMANN CALEX ® Cap (Fecal Extraction Device) Flyer for Canada

BÜHLMANN fCAL turbo Customer Testimonials

BÜHLMANN Fecal Calprotectin Key Literature List