Technical Information

Drug safety has always played a key role in drug development.  Unfortunately, drug toxicity studies often omit careful assessment of kidney function as indicated by recent publications. 

Accurate measurements of kidney function using a measured glomerular filtration rate (GFR) test provides necessary and reliable information, while biomarker-based estimates are often misleading.  On May 2010, the FDA published a draft recommending that the drug development process should include a "measure" GFR.¹

Based on functional immunoassay technology (FIT^™), BioPAL has developed immunoassay kits to measure the renal clearance of ideal filtration markers in order to obtain an accurate GFR measurement.  We offer four different kits - Inulin (the gold standard), Iohexol, Gd-DTPA, and Gd-DOTA.

1) A recommendation from the conference is the in drug development, GFR should be measured directly with an inert tracer (e.g. inulin, iohexol, iothalamate, etc.) to determine pharmacokinetic or pharmacodynamic alterations due to kidney dysfunction.  FDA KDIGO. Released draft.  Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling. Docket Number FDA-2010-D-0133 May 16, 2010.

FOR RESEARCH USE ONLY.
NOT FOR USE IN DIAGNOSTIC PROCEDURES.

The Product

FIT-GFR Test Kits (Patents Pending)
BioPAL offers FIT-GFR kits that support either Inulin, Iohexol, Gd-DTPA or Gd-DOTA as the filtration marker.  E-mail your questions to the customer service mailbox.

1. FIT-GFR Test Kit for Inulin
   BioPAL's FIT-GFR test kit contains inulin concentrate, rabbit inulin antiserum, goat anti-rabbit IgG-HRP, HRP substrate and stop reagents, an inulin 96 well coated plate, two plate sealer, inulin kit manual and documentation.  Ready-to-use inulin injectate is also available.
   Download a PDF price list.
   Download a PDF kit manual.
   Download a PDF kit worksheet and checklist.
   Download a PDF MSDS.
   
   BioPAL's inulin immunoassay kits provide a superior analytical method to measure inulin for GFR and nutritional research studies.  This inulin test uses immunoassay to overcome all the major limitations associated with current analytical technology to measure inulin.  The kit provides a sensitive assay that exceeds other methods to measure inulin and can detect inulin at a concentration of 10 ng/ml.
   
   CLINICAL-GRADE INULIN:  At this time, BioPAL only provides non-clinical grade inulin for preclinical research ONLY.  For investigators that would be interested in clinical-grade inulin to support their clinical research, please download and submit our survey.  After completing the survey please FAX (508-770-1191) or e-mail (cs@BioPAL.com) the form to BioPAL.  Download a Survey Form.
   
   SINISTRIN (Inutest®):  BioPAL's FIT-GFR (Inulin) kit is compatible with Fresenius's sinistrin, which is an inulin-like compound and is highly soluble in water.  Sinistrin is marketed under the brand-name Inutest®.  You should contact your Fresenius representative for availability.  Download a Comparison Curve.
    
2. FIT-GFR Test Kit for Iohexol  New!
   BioPAL's FIT-GFR test kit contains iohexol concentrate, rabbit iohexol antiserum, goat anti-rabbit IgG-HRP, HRP substrate and stop reagents, an iohexol 96 well coated plate, two plate sealer, iohexol kit manual and documentation.
   Download a PDF price list.
   Download a PDF kit manual.
   Download a PDF kit worksheet and checklist.
   Download a PDF MSDS.
   Download a PDF Protocol Guide.
    
3. FIT-GFR Test Kit for Gd-DTPA
   BioPAL's FIT-GFR test kit contains Gd-DTPA concentrate, rabbit Gd-DTPA antiserum, HRP-Gd-DTPA conjugate, HRP substrate and stop reagents, a goat anti-rabbit IgG coated 96 well plate, a plate sealer, Gd-DTPA kit manual and documentation.
   Download a PDF price list.
   Download a PDF kit manual.
   Download a PDF MSDS.
   Download a PDF Protocol Guide.
    
4. FIT-GFR Test Kit for Gd-DOTA
   BioPAL's FIT-GFR test kit contains Gd-DOTA concentrate, rabbit Gd-DOTA antiserum, HRP-Gd-DOTA conjugate, HRP substrate and stop reagents, a goat anti-rabbit IgG coated 96 well plate, a plate sealer, Gd-DOTA kit manual and documentation.
   Download a PDF price list.
   Download a PDF kit manual.
   Download a PDF MSDS.

The Laboratory Service

BioPAL offers laboratory services for veterinarians who need to run a measured GFR test on canine or feline patients, but do not have the capability to perform the immunoassay in-house.

Published Data

Download PDF files of abstracts and posters.
Clinical Research:  Poster [PDF]   -   Paper [PDF]
Veterinary Research:  Abstract [PDF]   -   Paper [PDF]
GFR in Mice:  Abstract [PDF]

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