Commercial assay kits

The protein content was determined using a commercial assay kit (Bio-Rad Protein Assay kit) with Bovine Serum Albumin as standard, following the procedure described by Bradford [13]. 

Table 6.4 Comparison of three parathyroid hormone (PTH) commercial assay kits.

The Use of Commercial Assay Kits for PK/PD Analysis in Drug Development... 

THE USE OF COMMERCIAL ASSAY KITS FOR PK/PD ANALYSIS IN DRUG DEVELOPMENT... 

Quality control and acceptance criteria have also been topics of much debate. We will attempt to address the main points to be considered when using commercial assay kits here. 

Quality Control Acceptance Criteria Commercial assay kits that also have QC samples supplied will normally contain data on expected target value for each QC sample and usually also expected or acceptable ranges. The procedures used to produce these figures and reasoning behind them can vary widely between different manufacturers and so great caution is required, particularly with R D type kits. It is common to find that these ranges do not have any connection to the actual performance of the assay from a statistical standpoint, and also that they are usually much wider than one may want to accept (or achieve). 

However, spiked recovery can give insights into possible matrix effects. Moreover, many commercial assay kits quote recovery experiment results from the manufacturer s internal validation procedures and hence reproducing those experiments in the assay validation exercise is often useful in demonstrating that the assay is performing as expected by comparing results with the manufacturer s quoted data. 

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