Gyrolab™ Assay Kits
High Sensitivity Human IgG Kit in Rat Serum for the Gyrolab™ XP Workstations
Obtain analytical measurements for pharmacokinetics evaluation of antibody-based biotherapeutics in a preclinical animal setting. This kit meets the demands of GyroLab customers requiring higher sensitivity assays due to lower dosing regimen PK studies.
Features:
- Ready-to-use assay components
- Improved consistency of results across users
- Standardized format for lab automation
- Higher assay sensitivity than standard IgG kit (<30 ng/mL vs >100 ng/mL)
Vital to the drug development workflow is an understanding of pharmacokinetic (PK) properties of a biotherapeutic. A better understanding of PK properties will allow optimized design of treatment regimens to maximize clinical benefit of a therapeutic. In addition, the risk of side effects of treatments can be reduced and the efficiency of treatment improved by finding the ideal dosage and schedule of treatments to maintain the desired concentration of the therapeutic in the blood. Using Gyrolab technology, analytes can be measured in samples on the nanoliter scale, making it possible to obtain vastly more data from a single animal than with other, high sample volume requiring platforms.
The goal of this assay kit is to provide analytical measurements for clients that need to evaluate the pharmacokinetics of their antibody-based biotherapeutics in a low-volume sample on the Gyrolab instrument. This kit has been developed under Fit-for-Purpose standards and the core principles of the 21st Century Bioanalytical Lab Initiative. Kit performance criteria include precision, accuracy, dilutional linearity, and specificity determinations. To facilitate lab to lab harmonization, the standards and controls are prediluted in matrix in automation compliant single use vials. The QC’s consist of a Low, a Medium, a High, and a Dilutional QC. The kit also provides an optimized method stored on a USB hard drive which can be imported directly into the Gyrolab software.
Contains:
- Automation-compliant reagents (packaged in SBS standardized vials)
- Standards & QCs — human IgG in pooled rat serum
- Blank & QC Diluent — pooled rat serum
- Capture Antibody — biotin-conjugated anti-human IgG in a buffered solution with detergent and preservatives
- Detection Antibody — fluorescent-labeled anti-human IgG in a buffered solution containing preservatives
- Assay Buffer — buffered protein base containing preservatives
- Four QC’s — Ready to use LQC, MQC, HQC, and a dilutional QC
Sensitivity and Specificity
Sensitivity Comparison between Standard and High Sensitivity hIgG Gyrolab Kit.
Assay Specificity for Standard hIgG Gyrolab Kit. Concentration response curves demonstrate greater than 4-log differential between intact human IgG, human IgG Fab fragments, human IgG (Fab)'2 fragments, or human IgM.
Performance Characteristics
| High Sensitivity Assay Performance Characteristics | Standard Assay Performance Characteristics | |||||||||
HQC |
MQC |
LQC |
Dil. QC (100x) |
HQC |
MQC |
LQC |
Dil. QC (100x) |
|||
|---|---|---|---|---|---|---|---|---|---|---|
| Nominal (ng/mL) | 1,766 |
176 |
74.6 |
616 (final) |
Nominal (ng/mL) | 17,731 |
1,766 |
176 |
5,600 (final) |
|
| Accuracy, Mean Bias (%RE) | 7.9 |
-10.0 |
7.9 |
1.5 |
Accuracy, Mean Bias (%RE) | -5.1 |
1.9 |
0.5 |
-3.1 |
|
| Precision, Intrabatch (% CV) | Precision, Intrabatch (% CV) | |||||||||
| Batch 1 | 1.1 |
1.7 |
9.2 |
1.5 |
Batch 1 | 3.5 |
7.0 |
5.5 |
N/A |
|
| Batch 2 | 3.6 |
3.3 |
4.2 |
4.1 |
Batch 2 | 0.4 |
2.5 |
1.3 |
0.8 |
|
| Batch 3 | 3.3 |
0.7 |
0.9 |
4.3 |
Batch 3 | 4.9 |
4.3 |
6.7 |
4.4 |
|
| Precision, Interbatch (%CV) | 4.2 |
4.8 |
6.5 |
4.7 |
Precision, Interbatch (%CV) | 7.3 |
5.8 |
7.9 |
3.5 |
|
| Total Error, l %RE l + Interbatch |
12.2 |
14.8 |
14.4 |
6.1 |
Total Error, l %RE l + Interbatch |
12.4 |
7.8 |
8.4 |
6.7 |
|