Procalcitonin (PCT) detection reagent and preparation method thereof
A procalcitonin, single-reagent technology, applied in the field of medical immunodiagnosis, can solve the problems of false negative or false positive test results, influence test precision, difference in production level, etc., achieve simple composition, shorten test time, and simplify operation Effect
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Embodiment 1
[0037] 1) Preparation of latex reagent
[0038] Carboxylated polystyrene microspheres were purchased from JSR Life Sciences, Japan.
[0039] PCT antibody was purchased from Hytest Biotech, Finland.
[0040] EDC was purchased from sigma.
[0041] There are differences between preparation methods 1 and 2 in the combination of surfactants.
[0042] Preparation method 1: Prepare activated latex particles: Take 0.18mL of carboxylated polystyrene microspheres with a particle size of 309nm and a concentration of 10mg / mL, add 3.6mL of 25mM MES with pH6.5, stir for 10min, and add 7.04mg of EDC activator powder After stirring at room temperature for 2.5 hours, the precipitate was collected by centrifugation at 12000 rpm, and the precipitate was resuspended in 1.8 mL of 25 mM MES with pH 6.5.
[0043] Preparation of sensitized latex particles: 0.18 mL of PCT polyclonal antibody with a concentration of 4.0 mg / mL was added to 1.8 mL of 25 mM MES at pH 6.5, and stirred for 1 min to prepa...
Embodiment 2
[0053] Analytical sensitivity of reagents (blank limit)
[0054] Using the reagents in Example 1, select the zero-value calibrator as a blank sample test, and test the concentration on the POCT device. The test was repeated 20 times, and the mean (X) and standard deviation (SD) of the 20 test results were calculated according to the standard curve established in Example 1, and X+2SD was calculated as the analytical sensitivity of the reagent. The test results are shown in Table 1, showing that the analytical sensitivity of Preparation Method 1 is 0.17ng / mL, and the analytical sensitivity of Preparation Method 2 is 0.31ng / mL, indicating that the combination of surfactants can significantly improve the sensitivity of reagent detection . The clinical reference value for the detection of procalcitonin (PCT) is about 0.5 ng / mL, and the analytical sensitivity of the PCT latex-enhanced immune turbidimetric reagent prepared in Preparation Method 1 of the present invention is 3 times ...
Embodiment 3
[0058] Reagent repeatability
[0059] With the single reagent test prepared in Example 1, the PCT concentration is the control substance of the normal value level of about 0.3ng / mL and the control substance of the abnormal value level of the PCT concentration of about 7ng / mL, and the test is repeated 10 times, and the measured value is calculated mean (X) and standard deviation (SD). Calculate the coefficient of variation (CV) according to formula (1). The test results are shown in Table 2. According to the measurement results, the coefficients of variation CV=7.11% and 4.95% are calculated, which meet the technical requirements of reagent CV<10%.
[0060] CV=(SD / X)×100%……………………(1)
[0061] In the formula:
[0062] CV - coefficient of variation;
[0063] SD - standard deviation;
[0064] X - the average value of the measured values.
[0065] Table 2. Repeatability measurement results of Example 1
[0066]
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