Kit and method for detecting C1q concentration of complement with nanosized-latex enhancing immune turbidimetry
An immunoturbidimetric and nano-latex technology, which is applied in the field of bioengineering, can solve the problems of complex Clq concentration process and low accuracy of complement, and achieve the effect of high accuracy and simple and convenient process
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Embodiment 1
[0018] 1.1 Applicable instruments
[0019] Semi-automatic and fully automatic biochemical analyzers.
[0020] 1.2 Analysis method
[0021] Enhanced Nanolatex Immunoturbidimetry.
[0022] 1.3 Performance requirements
[0023] 1.3.1 Reagent Appearance
[0024] R1: colorless clear transparent liquid;
[0025] R2: Pale yellow clear liquid or latex suspension.
[0026] 1.3.2 Reagent blank absorbance (A)
[0027] Absorbance (A): R 1 +R 2 ≤0.04A (at a temperature of 37°C; main wavelength 546nm, 600nm (secondary wavelength 700nm)).
[0028] 1.3.3 Precision
[0029] 1.3.3.1 Intra-assay precision
[0030] CV≤10%.
[0031] 1.3.4 Batch-to-batch precision
[0032] Relative range ≤ 10%.
[0033] 1.3.5 Accuracy
[0034] Inaccuracy: within the range of ±10%.
[0035] 1.3.6 Analytical sensitivity
[0036] Absorbance (A)>0.04A.
[0037] 1.3.7 Linearity
[0038] In the range of 50mg / L-400mg / L, the correlation coefficient (γ)≥0.9900.
[0039] 1.3.8 Stability
[0040] The reage...
Embodiment 2
[0043] 2.1 Detection conditions
[0044] 2.1.1 Biochemical analyzer (hereinafter referred to as instrument)
[0045] Hitachi 7060 automatic biochemical analyzer.
[0046] 2.1.2 Working environment temperature
[0047] Room temperature 15-32°C.
[0048] Indoor humidity 45-85% RH.
[0049] 2.1.3 Main measurement parameters and operation steps
[0050] Temperature 37°C; main wavelength 546nm, 600nm (secondary wavelength 700nm), sample or calibrator 3-4μl; R 1 : 240 μl; R 2 : 60 μl, reaction time 10 minutes.
[0051] Method type: two-point endpoint method.
[0052] After adding reagent R1 to the sample or calibrator, incubate at 37°C for 5 minutes, read the first point (A1), add reagent R2, incubate at 37°C for 5 minutes, and read the second point (A2), sample A=A2-A1.
[0053] Result calculation:
[0054]
[0055] 2.1.4 Calibrator
[0056] The calibrator used in this standard is the standard product produced by Nanfang Reagent Factory in Yuhuan County, Zhejiang Provi...
Embodiment 3
[0096] Preparation of reagents
[0097] Take a sample with a content of about 200mg / L, which is sample 4 # , the sample 4 # Prepare 5 test samples with physiological saline or pure water according to the method in the table below. (This sample is ready for use now)
[0098]
[0099] After adding reagent R1 to the sample or calibrator, incubate at 37°C for 5 minutes, read the first point (A1), add reagent R2, incubate at 37°C for 5 minutes, and read the second point (A2), sample A=A2-A1.
[0100] Result instrument calculation:
[0101]
[0102] Through the determination of the above samples, the figure 1 Dose-response curves of complement Clq concentration and absorbance are shown.
[0103] ( figure 1 The curve is based on the OD value of the wavelength of 600nm, and the sub-wavelength of 700nm is for reference only. )
[0104]
[0105] pass figure 1 , measured the serum of 500 cases of normal people, the results are described in the following table, ac...
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