Gyrolab™ huIgG Kits

Two Gyrolab huIgG Kits have been developed to quantify intact human IgG (IgG1, IgG2, IgG4) in cell supernatants. The kits are based on one set of reagents that are used in combination with a specific CD to determine high titers and low titers of IgG in samples. See table below for kit characteristics.

The Gyrolab IgG assay is based on a standard sandwich assay format. A biotinylated reagent is introduced into a microstructure in the CD to saturate a capture column packed with porous beads coupled with streptavidin. Cell supernatant or bioprocess samples containing intact human IgG are then volume-defined and introduced into the microstructures where intact IgG is captured in the capture column. Finally, a detecting reagent labeled with a suitable fluorophore is added. The integrated signal in the capture column represents the total response from the sample.

Kit characteristics

 

 

 

 

 

 

 

Gyrolab huIgG Kits do not include a standard. There are two options for preparing standards and QC controls:

  • Select a representative IgG molecule at a known concentration. Standards and QC samples are diluted in Sample Dilution Buffer (provided in the Gyrolab hulgG Kits)
  • Order a standard from Gyros (P0020379). This standard contains a human monoclonal IgG1 at 4 mg/mL in 50 µL.

Gyrolab huIgG Kits are intended for quantification of intact human monoclonal IgG in cell culture or bioprocess samples. Gyrolab huIgG Kits are compatible with monoclonal IgG1, IgG2 and IgG4.

hulgg standard curve

 

 

 

 

 

 

 

 


Fig 1. Standard curves for both kits generated by the same reagent kit in combination with the Bioaffy 20 HC (High Titer) and Bioaffy 1000 HC (Low titer)

We recommend that you qualify the assay for its intended use to ensure that the assay protocol provides acceptable performance, such as quantifiable range, accuracy, and precision.

All samples must be diluted at least 1+1 by volume. However, depending on expected IgG titers, samples may have to be diluted further to hit the working range of the particular version of IgG titer assay selected.

To run the kits you need to import the Gyrolab method. For Gyrolab huIgG Kit – Low Titer you will also need to download the CD design file for Bioaffy 1000 HC.

This is done with a few simple steps.

Prepare Gyrolab instrument

  1. Open admin tool se section F2 in Gyrolab User Guide Create a folder under the Root and name it to IgG, see section F 2.2.2. on how to create folders
  2. Import the Method: Gyrolab huIgG kit method to the huIgG folder, see section F 2.2.4 in User Guide on how to import a method
  3. Import the CD design: Gyrolab Bioaffy 1000 HC, see section F 2.2.7 in User Guide on how to import a CD design

You can download Gyrolab huIgG Kit Instruction For Use’ here:  Download (PDF, 203.7 KB)

You can download the Method and Run here:

Method Gyrolab huIgG Kit High titer method: Download (ZML, 2.3 KB)
Method Gyrolab huIgG Kit Low titer method: Download (ZML, 2.7 KB)
CD design: Download (ZML, 2.8 KB)