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Although not addressed in this study, this suggests that loss of conformity to the LRE model could be used to identify aberrant amplification kinetics that can impact assay performance (data not shown).
Roche Diagnostics GmbH provided the IMPACT assay kits used in this study.
To determine whether the automated IMPACT platform could recapitulate this finding, we used the IMPACT platform in conjunction with bead-based multiplex assays to characterize serum samples from 120 RA patients, of which 73 had anti-CCP antibodies (as assessed by the IMPACT assay), 78 had RF (as assessed by the IMPACT assay), and 74 had one or two SE alleles.
Another factor that can impact assay timelines dramatically is the lead time for an agreement with a Testing Lab or diagnostic partner, which can easily add several additional months, especially if there are intellectual property issues to address.
In assessing the analytical precision of the IMPACT assay, we used serum samples from the REFLEX study, a phase III trial on the efficacy of rituximab on a background of methotrexate in RA refractory to anti-TNF therapy [ 10].
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Factors impacting assay optics can severely compromise LRE quantification.
Our results indicated that the shorter incubation time could be used without significantly impacting assay performance.
As described in the next section, lambda gDNA has proven to be a reliable quantitative standard that allows monitoring of the many factors impacting assay optics, through the ability to express the fluorescence intensity of an assay in quantitative terms.
Data analysis methods had a pronounced impact on assay sensitivity and specificity calculations.
To better understand the impact of assay selection on study outcome of unstructured medical devices, we evaluated contact lens multi-purpose solutions (MPS) in the agar diffusion, direct contact and two elution cytotoxicity assays.
The sample volumes and the impact on assay sensitivity are summarised in Table 1.
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