A quality control chart is a chart that compares the performance data of a certain test with the calculated expected "control limits". This performance data is selected in chronological order when it is carried out normally according to the regulations. Its purpose is to detect the "traceable" cause of the variation in the inspection process. The "reversible" error causes refer to other causes than random errors. The "control limit" is calculated by statistics, and we will introduce it in detail later. The quality control serum is a serum with a target value. Add one or several copies to each routine test of the human ELISA kit, and understand the status of this test by the results obtained. If the result of the quality control serum test can control the error within a certain range, it means that the test has not allowed no error. If there is an abnormal result that exceeds the allowable error range, it indicates that the inspection is unqualified, and the cause should be found. After correction, the specimen to be tested should be re-examined. Therefore, quality control serum plays an important role in quality control. Under the best conditions of the laboratory (including operators, reagents, instruments, etc.), the quality control serum is tested 20-30 times, and the measured results are calculated. The mean and standard deviation (SD) of the set of data are calculated to indicate The best quality of work. In this laboratory, select the technician with the best quality and the most skilled operation to carry out careful and specific determination, and choose the best. Before testing, the constant box, sampler, etc. shall be carefully calibrated, adjusted, adjusted and debugged, and the Sample tip, etc., that is to detect under the best and most ideal conditions. In addition to the quality control serum, the negative control and positive control were measured simultaneously. And make a double determination, get two absorbance values ​​(A value), find X. Do 20 times in a row, find 20 X, namely X1 ... X20. From these 20 data, find X and SD of OCV. Human ELISA kit quality control is a management process that monitors the entire process, eliminates errors, prevents changes, and maintains the status quo of standardization. This process is carried out through a feedback loop. Compare or compare the difference between the actual data and the expected value, and explain the reason for this difference. If the predetermined error range is exceeded, the alarm system sends a signal and the feedback channel is interrupted. Take action to resolve the differences. The means of restoring the original state (original standard state) come into play. Quality control is mainly carried out using quality control charts. In the human ELISA kit test, when the same sample is tested more than 20 times, you will find that this set of data (referred to as the absorbance value of the measurement result) is distributed on both sides of the mean, most of which are concentrated around the mean. If the measured value is plotted on the abscissa and the frequency of occurrence on the ordinate, a bell-shaped curve can be drawn. The mean is at the top of the bell, and the other values ​​are symmetrically distributed with the mean at the center. This is the normal distribution. The area under the normal curve is called probability, which is usually expressed by the mean (X) and standard deviation (SD) of the sample. The calculation method is as follows: The relationship between the mean, standard deviation and probability is as follows: X ± 1SD, probability 0.68X ± 2SD , Probability 0.95X ± 3SD, probability 0.99. In other words, a set of data obtained after testing the same sample for a certain number of times, the data within ± 1SD range near the mean (X) accounted for 68% of the data in the group, and the data distributed within X ± 2SD range accounted for the overall 95%, the data distributed in the range of X ± 3SD accounts for 99% of the total. When we require the test result to be qualified within the range of X ± 2SD, 95% of the data may be qualified. The accuracy of the human ELISA kit refers to how close the measurement result is to the true value (or target value). Accuracy cannot be expressed in numbers, and is often measured by inaccuracy. The degree of deviation between the measurement result and the target value is called deviation, which indicates the inaccuracy of the test.
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