Patent ID: 8078409

Claim:
An external quality control method, using an external quality control computer and a plurality of nucleic acid detecting systems connected to the external quality control computer via a network, each of the nucleic acid detecting systems comprising a preprocessing device for preparing an assay sample by preprocessing a patient sample and a nucleic acid detecting device for detecting a target nucleic acid in the assay sample prepared by the preprocessing device, the method comprising: at the preprocessing device of the nucleic acid detecting system, performing a preprocessing operation on a quality control sample to prepare an assay sample for quality control by homogenizing a quality control sample in a homogenization reagent, wherein the quality control sample contains a predetermined amount of nucleic acid and/or a predetermined amount of cells; at the nucleic acid detecting system, measuring the assay sample for quality control to obtain measurement data; from the nucleic acid detecting system, providing the measurement data to the external control computer over the network; at the quality control computer, calculating an average value and a standard deviation of measurement data which were provided from the nucleic acid detecting systems; at the quality control computer, determining whether the preprocessing operation of the preprocessing device is properly performed by evaluating the received measurement data on the basis of the average value and the standard deviation; and from the quality control computer, providing the determination result to the nucleic acid detecting system, wherein in the nucleic acid detecting system, the preprocessing device prepares an assay sample for detection by performing the preprocessing operation on a patient sample, and wherein the nucleic acid detecting device amplifies a target nucleic acid in a mixture of the assay sample for detection and a primer reagent and detects the target nucleic acid in the mixture.