Antibody validation roundtable specificity + sensitivity + reproducibility = validation

TDM Roundtable Recommendations: Lamotrigine Assay Validation Guidance

TDM Roundtable Recommendations: (Generic) Assay Validation Guidance

Antibody validation.

Antibodies are among the most frequently used tools in basic science research and in clinical assays, but there are no universally accepted guidelines or standardized methods for determining the validity of these reagents. Furthermore, for commercially available antibodies, it is clear that what is on the label does not necessarily correspond to what is in the tube. To validate an antibody, it ...

A two-stage validation study for determining sensitivity and specificity.

A two-stage procedure for estimating sensitivity and specificity is described. The procedure is developed in the context of a validation study for self-reported atypical nevi, a potentially useful measure in the study of risk factors for malignant melanoma. The first stage consists of a sample of N individuals classified only by the test measure. The second stage is a subsample of size m, strat...

Sensitivity, specificity, and reproducibility of the Capilia TB-Neo assay.

The performance of the Capilia TB-Neo assay, a new-generation assay, was assessed by determining its sensitivity, specificity, reproducibility, and cross-reaction with contaminating organisms. The sensitivity and specificity were 99.2 and 96.4% and 89.3 and 100% in pure and mixed-culture isolates, respectively. The kappa statistic was 95.0 and 77.9% in pure and mixed culture isolates, respectiv...