Sentence examples for qualified assay from inspiring English sources
In addition, we qualified assay reagents according to reagent-specific procedures based on their intended use and performed side-by-side comparisons between new and qualified lots to demonstrate equivalency.
Acceptance criteria were pre-determined to accept or reject a new lot of reagent before implementation, and the trending of qualified assay quality controls was applied for a continuous monitoring of assay performance over time.
Therefore, the successful development and validation of a dengue serotype-specific PRNT and inclusion of qualified assay reagents are key factors in the ability to provide accurate and reliable data crucial for vaccine studies, and especially to ensure the reproducibility of neutralization assay performance over extended periods.
The fully humanized Lewis-Y carbohydrate specific monoclonal antibody (mAb) IGN311 is currently tested in a passive immunotherapy approach in a clinical phase I trail and therefore regulatory requirements demand qualified assays for product analysis.
Serum anti-Ad5 neutralizing titers were measured at baseline and designated time points throughout the study (Table 1) using previously described qualified assays [12], [13].
The resulting data were then exported into individual files where each file represented the results of all qualified assays for a single sample.
Once we had further qualified the assay on real SCID patient samples I was seeing in the hospital, Dr Baker's group then validated the assay and determined that it ready to start a full-scale pilot study and incorporate it in the Wisconsin NBS program as a screening assay for SCID.
"It occurred to me that being qualified to assay this role, it is inescapable I'm bringing to it a sensibility that is racially explosive," he said.
We qualified an assay for measuring serum caspase 3/7 levels from clinical samples and found that circulating caspase 3/7 increased in a statistically significant manner in CRC and sarcoma patients treated with dulanermin.
Thus, qualified immunological assays using human immune cells that can predict in vivo induction of CD8 immunity in humans is required.
To qualify the assay method, validation has to be conducted and an assay control strategy has to be determined by demonstrating that the assay performs according to its intended use.
