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We did this in attempt to select a "gold standard" sample of research in each area.
In general, DBS perform with sensitivities and specificities similar or only slightly inferior to gold standard sample types.
Discrepancy analysis indicated that the distribution of HPV types in urine was similar to that observed in the gold standard sample for both males and females.
Percentages of recovery were calculated by comparing the spiked concentration (i.e. difference between the paired spiked and unspiked samples) to the gold standard sample.
Each set had a pooled sample consisting of: a paired sample of spiked serum (50 ppb of mixed standard in pooled serum) and unspiked serum (only pooled serum), besides a gold standard sample (50 ppb into methanol).
This assay was previously validated in urine, in comparison to a gold standard sample (cervical liquid-based cytology sample or penile swab), by measuring the HPV concordance by sample type (Cuschieri et al, 2008).
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Leukocytes (isolated from whole blood) and fibroblasts are considered as the gold standard samples for the measurement of enzyme activity.
Representative sampling of hidden groups, such as men who have sex with men, is difficult and there is no gold standard sampling method to which the results can be compared.
Using this notation, the percent recovery corresponding to exposure p is given by Let m p be the factor used to convert molar units to ppb concentrations, corresponding to exposure p. Therefore, the percent recovery can be expressed as (AI.1) where W p, W p, spiked and W p, gold correspond to the unspiked serum, spiked serum and gold standard samples in log-molar concentrations, respectively.
For each gold standard a sample expression dataset was assembled containing only the subset of genes in the gold standard set resulting in four sample expression datasets, one for each gold standard.
Model systems should be required to: exhibit a fluoride dose response (0, 250, 550, 1100 ppm F); run internal controls for all tests (0, 250, gold standard); have sample size sufficient to achieve statistical power for demonstrating equivalence; and use defined statistical methodology to establish equivalency ("as good as") with an appropriate clinical gold standard.
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