I think specificity and sensitivity and other validation parameters (such as detection limit, quantification limit etc) is depended on the instruments that will be used. For example LC-Qtof HRMS will be more selective compared to LC-MS only or HPLC DAD,  Therefore we should know the sensitivity, limit detection or quantification limit etc that we want to have in our assay, after we know than we can determine the instruments that we can to apply; I think we can search from net/on line data base the suitable methods for our target compounds.

The LOD is the estimated amount of analyte in a specified matrix that would produce a positive result at least a specified percent of the time. Typically, estimated LOD will be based on spiking of the analyte into the target matrix.  Sensitivity & specificity are two different parameters. Minimum sensitivity of diagnostic assay is depends on analyte, each analyte assay has different sensitivity.

Hi Bhagya,

There are two different concepts to take into account: Analytical or Clinical (sensibility and specificity). Analytical sensibility parameter refers to Limit of Detection (3x negative control or blank) and Limit of Quantitation (10x negative control or blank) and there is several methods to determine its value in accordance with the assay that you are employing. Analytical specificity is related with cross reactions. But if you refer to clinical parameters other terms should be taken into account (true positive and negative referred to a golden standard test)

This is entirely relative. It depends how much it increases the accuracy or efficiency of the diagnostic investigation. Suppose the actual test has accuracy of 90%, thus if the new test is developed to replace the old one, it should be better than 90%. Therefore, It depends if the test is replace to an old one, or it is to combine to old one in series or in parallel, for screening purposes or to confirm diagnosis,  and how accurate the alternatives are.