Device for detection determination
A technology for judging devices and test results, applied in measurement devices, biochemical cleaning devices, enzymology/microbiology devices, etc., can solve problems such as false negatives in test results, avoid false negatives, and achieve negative judgment accuracy Effect
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no. 1 approach
[0121] The detection and judgment device of the present invention is used in a detection and judgment method, and the detection and judgment method includes a detection step: when the test target in the sample is detected by amplifying the test target and the amplifiable reagent, when the amplifiable reagent is amplified and When the test target is amplified, it is determined that the test target is present and the test result is positive, and when the amplifiable reagent is amplified but the test target is not amplified, it is determined that the test target does not exist or is at least less than the specific copy number of the amplifiable reagent And the test result was negative. The detection and judgment device includes at least one hole and an amplifiable reagent contained in the at least one hole with a specific copy number, and preferably further includes an identification unit and a substrate, and further includes other components as required.
[0122] In this specificat...
no. 2 approach
[0377] In another mode of the first embodiment, the device of the present invention may include wells where the specific copy number of the amplifiable reagent is less than 100; and wells where the specific copy number of the amplifiable reagent is 100 or more.
no. 2 example
[0378] The second embodiment is based on the finding that the quantification of samples of unknown concentration based on the serial dilution of nucleic acid samples using the calibration curve results in very poor accuracy of quantification of very trace amounts of nucleic acids.
[0379] Regarding the coefficient of variation CV of wells where the specific copy number of the amplifiable reagent is less than 100, a formula is established between the coefficient of variation CV of the specific copy number of the amplifiable reagent and the average specific copy number x: CV <1 / √x, or preferably CV <1 / 2√x. In addition, regardless of the average specific copy number, it is preferable that the coefficient of variation CV of wells in which the specific copy number of the amplifiable reagent is less than 100 is 20% or less, or more preferably 10% or less. Within this range, the amplifiable reagent can be filled with high accuracy when the specific copy number is less than 100.
[0380] ...
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Abstract
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