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The copy number of the NANOG targeting vector in NANeG cells was determined by quantitative PCR following the guidelines for assay design, controls and evaluation given in [31].
Past proficiency panels have focused on various aspects of the ELISPOT technology including first harmonization guidelines for assay conduct [ 10, 11], recommendations for response determination [ 12], a framework for structured reporting of T-cell assay results [ 13], as well as systematic studies of the impact of different test media on assay results [ 14, 15].
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The method was validated according to ICH guidelines for drug assay and determination of impurities and was applied to oxybutynin tablet analysis.
The chromosome aberration test was conducted according to the international guidelines for this assay [ 17].
They provide first harmonization guidelines for ELISPOT assay and Tetramer staining.
And all but one group expressed their wish for published guidelines for Elispot assay validation and training.
The guidelines for biomarker assay validation set out by Lee et al. (21) were used as guiding principles.
We also used these criteria for serologic diagnosis of murine typhus infection because there are no evidence-based guidelines for IFA assay cut-off values for this disease.
Finally, we propose initial guidelines for harmonizing assay performance which include the introduction of standard operating protocols to allow for adequate training of technical staff and auditing of test analysis procedures.
H2O2 production by BM-derived macrophages and wound-derived myeloid (CD11b+) cells was measured using the Hydrogen Peroxide Assay Kit (Abcam) and by following the manufacturer's guidelines for the fluorometric assay.
We therefore modified our guidelines for the tetramer assay and recommended staining at least 1 × 10 PBMC and analyzing all cells in the tube.
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