External quality control method, external quality control computer, preprocessing device, and nucleic acid detecting device

An external quality control method, using an external quality control computer and a plurality of nucleic acid detecting devices connected to the external quality control computer via a network, comprising:

• at the nucleic acid detecting device, measuring a calibrator which contains a predetermined amount of a target nucleic acid to obtain measurement data, wherein the nucleic acid detecting device measures a calibrator by (i) amplifying the target nucleic acid in the calibrator and (ii) measuring a time taken until the target nucleic acid are amplified up to predetermined amount, and the measurement data comprises the measured time;
• from the nucleic acid detecting device, providing the measurement data to the external control computer over the network;
• at the external quality control computer, calculating an average value and a standard deviation of measurement data which were provided from the nucleic acid detecting devices;
• at the external quality control computer, determining whether the nucleic acid detecting device measures the calibrator properly by evaluating received measurement data on the basis of the average value and the standard deviation;
• and
• from the external quality control computer, providing the determination result to the nucleic acid detecting device.

An external quality control method, using an external quality control computer and a plurality of nucleic acid detecting devices connected to the external quality control computer via a network, comprising:

• at the nucleic acid detecting device, measuring a calibrator which contains a predetermined amount of a target nucleic acid to obtain measurement data, wherein the nucleic acid detecting device measures a calibrator by (i) amplifying the target nucleic acid in the calibrator, (ii) measuring a time taken until the target nucleic acid are amplified up to predetermined amount, (iii) generating a calibration curve on the basis of the predetermined amount of the target nucleic acid in the calibrator and the measured time, and (iv) converting the measured time into an amount of the target nucleic acid in the calibrator by using the generated calibration curve, and the measurement data comprises the converted amount of the target nucleic acid in the calibrator;
• from the nucleic acid detecting device, 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 devices;
• at the quality control computer, determining whether the generated calibration curve is proper or not 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 device.

A preprocessing device for preparing an assay sample for detection by a nucleic acid detecting device, comprising:

• a preprocessing section for performing a preprocessing operation, the preprocessing section comprising a reagent dispenser for dispensing a homogenization reagent;
• a homogenizer for homogenizing a sample in the homogenization reagent;
• and a pipette for aspirating an assay sample from the homogenate;
• a measurement section for measuring the assay sample to obtain measurement data;
• a communicating section for communicating with an external quality control computer via a network;
• and
• a display section,
• wherein a patient sample is preprocessed by the preprocessing section to prepare an assay sample for detection, and the nucleic acid detecting device amplifies a target nucleic acid in the assay sample for detection in a mixture of the assay sample for detection and a primer reagent and detects the target nucleic acid in the mixture,
• wherein a quality control sample which contains a predetermined amount of nucleic acid and/or a predetermined amount of cells is preprocessed by the preprocessing section to prepare an assay sample for quality control sample, the measurement section measures the assay sample for quality control to obtain a measurement data, and the communicating section transmits the measurement data to the external quality control computer,
• wherein the external quality control computer executes operations comprising:
• receiving the transmitted measurement data;
• by statistical evaluation, calculating an average value and a standard deviation of stored measurement data;
• determining whether a 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
• providing the determination result to the preprocessing device,
• and wherein the display section is enabled to display the provided determination result.