The final CCPP cELISA kit protocol differed slightly from the original published protocol, as it was a strict competitive assay rather than a blocking assay.
However, a strict potency assay, ideally a product's in vivo mechanism of action, may not be possible since the product may encompass complex multiple functions, some of which are not well defined.
These include employing strict computational assay design algorithms [22], [23], interrogating amplified targets with specific extenders or probes [24] [27], and/or validating amplified target sizes [28], [29].
Since the flow cytometer directly measure the nuclear damage of each tumour cell at the final stage of the assay, strict single-cell suspension is theoretically unnecessary at the initial stage.
The dynamic range of real-time RT-PCR affords high sensitivity for the measurement of gene expression, but this mandates the need for strict controls to ensure assay validity.
Samples from 41 men (30 exposed, 11 unexposed) were analyzed by a single expert scorer who was blind to exposure status, using the sperm ACM-FISH assay and strict scoring criteria (Sloter et al. 2000).
All cell types were characterized for epithelial origin and growth patterns and following optimization of dosing strategies and assay procedures, a strict study design was implemented to avoid systemic variations.
Since all three Ficolins have been shown to bind to acetylated compounds the importance of keeping the assay conditions under strict surveillance should be stressed.
The alternative strategy is instead to use an assay with a strict cut-off allowing only 2% false positives as assessed in the local blood donor population for IgM and IgG antibody, respectively.
