6) You are in charge of the developmental validation of a new DNA typing method. Explain in detail what tests you would use to complete the validation of this technique, and what you would need to do before the technique would be available to forensic labs.
Characterization of genetic markers: The basic characteristics of a genetic marker should be determined and documented as in Inheritance, Mapping, Detection, and Polymorphism. Species specificity: The ability to detect genetic information from non-targeted species (e.g., detection of microbial DNA in a human assay) should be determined. Sensitivity studies The ability to obtain reliable results from a range of DNA quantities, to include the upper and lower limits of the assay, should be evaluated. & Stability studies The ability to obtain results from DNA recovered from biological samples deposited on various substrates and subjected to various environmental and chemical insults should be evaluated. Precision characterizes the degree of mutual agreement among a series of individual measurements, values and/or results & Accuracy is the degree of conformity of a measured quantity to its actual (true) value. Repeatability the precision and accuracy of results with same operators and/or detection instruments should be evaluated. Reproducibility: Precision and accuracy of results among different operators and/or detection instruments should be evaluated. Case-type samples: The ability to obtain reliable results should be evaluated using samples that are representative of those typically encountered by the testing laboratory. Population studies The distribution of genetic markers in populations should be determined in relevant population groups and mixture studies The ability to obtain reliable results from mixed-source samples should be determined, PCR-based studies The reaction conditions needed to provide the required degree of specificity and robustness should be determined. The potential for differential...