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While the main focus of this document is assay design considerations, we provide scientific focus and background to the various assay performance parameters necessary for developing a valid assay.
Because this assay measures phospholipid externalization directly, versus indirectly by annexin V binding, it might be considered a more valid assay for detecting active PS-specific externalization.
Although many HNSCC lines do not grow well in agar, some do and most grow better than normal keratinocytes [12], suggesting that anchorage independence is a valid assay of malignant transformation.
To ensure that the RT-PCR assay is a valid assay for measuring mRNA distribution along the sucrose density gradient, L34 and β-actin mRNA distribution was also determined by Northern blotting.
Open-field behavior has been studied in mammals for some time [17] [20] and in flies under other contexts (such as Buridan's paradigm [12], [21]), but has only recently been utilized as a valid assay for determining fly locomotor behavior [6], [7], [13], [16].
A final requirement for a valid assay is relevance to the property that is of interest.
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Requirements are needed for the development of valid assays so that enforcement and post market surveillance activities can be conducted.
A recent study has demonstrated that error in the liver biopsy result itself makes it impossible to distinguish a perfect non-invasive marker from less valid assays [ 27].
Among the total 204 valid assays of QTF and TST, 59 (29%) were discordant, when TST positivity was defined as an induration of ≥ 10 mm (kappa = 0.41).
Of study participants, 444 (82%) provided self-reported tobacco use status within 7 days of a valid cotinine assay and constitute the sample for validity analyses.
The plasma aldosterone-renin ratio (ARR) is a valid screening assay for primary aldosteronism, but antihypertensives are usually discontinued before obtaining this ratio, limiting its utility.
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