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Studies to improve the assay performance in the field were performed, showing that assay activity could be preserved for up to 2 months.
The proposed strategy is sensitive, selective and exhibits a good assay performance in complex biological samples.
It is also important to take into consideration the ADA assay performance in terms of drug tolerability before declaring a lack of ADA.
Despite advances in the sensitivity of silicon photonic biosensors, poor biological specificity at the sensor surface remains a significant factor limiting assay performance in complex media (i.e. whole blood, plasma, serum) due to the non-specific adsorption of proteins and other biomolecules.
The utility of limiting dilution assay for conducting platform-independent absolute quantification is also discussed, along with the utility of defining assay performance in terms of absolute accuracy.
This excellent overnight stability coupled with robust assay performance in 1,536-well 1,536-wellat indicates that the assay can be screened in an automated and unattended fashion.
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Comparison of the assays' performance in terms of sensitivity and specificity raises serious questions as to their reliability for identification of infected individuals in the field.
The assay performance characteristics in the laboratory for sFas were a sensitivity of 22.4 pg/ml, an intra-assay coefficient of variance of 2.48% and an inter-assay coefficient of variance of 6.06% and for sFasL were a sensitivity of 7.2 pg/ml, an intra-assay coefficient of variance of 3.64% and an inter-assay coefficient of variance of 6.87%.
Substantial differences in assay performance were observed in the nicarbazin (DNC) assay.
Whether different positivity rates reported for various SARS-CoV assays (12 – 17, 17 ) reflect true differences in assay performance, or merely differences in specimen type or differences in sample preparation (13 ), will only become apparent after comparative quality control tests using identical samples in the various assays and laboratories.
The main handicaps in assay performance were suboptimal sensitivity of in-house IgM detection protocols by comparison with better-performing commercial ELISA tests, and the presence of IgG cross-reactivity with heterologous flaviviruses.
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