Dry type fluorescence immunoassay instrument
A fluorescent immunoassay and dry technology, which is applied in the field of dry immunofluorescence analyzers, achieves the effects of simple operation, high precision and rapid detection.
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Embodiment 1
[0069] Example 1 Appearance
[0070] To the outward appearance of a kind of dry-type fluorescent immunoassay instrument prepared in the present invention, observe with normal or corrected visual acuity and check with feel, find that its outward appearance is flat, without edge, burr; Each adjustment button, button and switch all can work normally, The connector of the connection line should be in good contact; the reader should work normally, and the digital display should be clear and complete.
Embodiment 2
[0071] Example 2 Repeatability
[0072] Repeatability is the degree of agreement between the results of the same sample measured in parallel several times.
[0073] Requirements: The coefficient of variation (CV) of repeated measurements of the instrument is less than or equal to 5%.
[0074] Method: Take C3 and C5 quality control cards as test samples, repeat the test 10 times, and the coefficient of variation (CV) should be less than 5%.
[0075]
[0076] In the formula:
[0077] S = standard deviation of sample test value
[0078] = Average value of sample test values.
[0079] The test results are shown in Tables 1 and 2.
[0080] Table 1: Table of repeatability test results
[0081]
[0082] Table 2: Result display
[0083]
[0084] The results of the repeatability test show that the CV values of the detection repeatability of the fluorescent quality control cards of each concentration of the instrument are far less than 5%, which meets th...
Embodiment 3
[0085] Example 3 Linearity
[0086] Linearity refers to the degree of linear correlation between the calibration value and the measured value of different concentrations.
[0087] Requirements: Use fluorescent quality control cards with different fluorescein concentrations in 5 gradients of C2, C3, C4, C5, and C6 as test samples, measure once each, and compare the actual measured value with the corresponding set of calibration values X , Calculate the linear regression coefficient a (slope) and b (intercept) with the linear regression analysis method, and then calculate the regression value Y#=aX+b, and its linear correlation coefficient R≥0.99. Composition of quality control products: P1 is 20mg / L positive quality control product of CRP, C1-C6 fluorescent quality control cards, the results are shown in Table 3.
[0088] table 3
[0089] serial number
Composition and preparation
quantity
P1
20mg / L CRP
0.5ml / piece
C1
0pmol / ml fluores...
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