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Magnetic bead time resolution fluorescence immunoassay quantitative determination cTnI (cardiac troponin I) kit

A time-resolved fluorescence and immunoquantitative technology, applied in biological testing, measuring devices, analytical materials, etc., can solve the problems of delayed doctor diagnosis and treatment, susceptibility to interference, long detection time, etc., achieve large Stokes shift and improve detection range , Easy and fast operation

Inactive Publication Date: 2018-07-27
GUANGZHOU BIOKEY HEALTH TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, MYO has a short half-life and reaches the peak early, but its specificity is poor and it is easily disturbed, resulting in false positive test results; CK-MB has better specificity, but its half-life is longer than that of MYO, and it takes longer to report the condition, which delays the doctor's diagnosis. and treatment
cTnI is currently the gold standard for the diagnosis of myocardial infarction. At present, the methods for detecting cTnI mainly include colloidal gold method and fluorescence immunochromatography, but these methods generally have shortcomings such as low sensitivity and poor accuracy; long time

Method used

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  • Magnetic bead time resolution fluorescence immunoassay quantitative determination cTnI (cardiac troponin I) kit
  • Magnetic bead time resolution fluorescence immunoassay quantitative determination cTnI (cardiac troponin I) kit
  • Magnetic bead time resolution fluorescence immunoassay quantitative determination cTnI (cardiac troponin I) kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] In this example, the magnetic bead time-resolved fluorescence immunoquantitative detection kit for cTnI consists of a reagent strip and a cTnI calibrator.

[0028] Wherein, the shape of the reagent strip is fan-shaped, and 1 to 13 holes are arranged sequentially from left to right. The 1st and 2nd holes are test holes, the 3rd and 4th holes are fluorescent marker holes, the 6th and 7th holes are cleaning solution holes, the 8th and 9th are sample diluent holes, the 12th are enhancement solution holes, the 5th and 10th holes are , 11,13 are preparatory holes. A magnet can be stored between the 1st and 2nd wells for magnetic separation experiments. The 1st and 2nd wells can store a liquid volume of 300 μl; the 3rd and 4th wells can be disassembled from the entire reagent strip to become independent components, which is convenient for fluorescent markers. Pack and store. The 3rd, 4th, and 5th wells can store a liquid volume of 400 μl; the 6th and 7th wells can store a li...

Embodiment 2

[0060] The making and detection of embodiment 2 reagent strips

[0061] The reagent strips in this example, semi-finished products are assembled through the following procedures: 50 μL cTnI immunomagnetic beads, 100 μL europium-labeled cTnI antibody, 2000 μL cleaning solution, 2000 μL cleaning solution, 400 μL enhancement solution, and then seal it with a sealing film machine, and the sealing film is coated with product information identifications that can be scanned and identified by an automatic fluorescence detection analyzer, including enterprise standard curves, batches, production dates, and expiration dates. The finished reagent strips, the packaged cTnI calibrator and other accessories are assembled into a kit.

[0062] Sample testing:

[0063] ①Add sample:

[0064] Put the sample or calibrator to be tested into the loading system of the automatic instrument, insert the reagent strip into the reagent strip slot, and the instrument will automatically identify the prod...

Embodiment 3

[0075] The comparison of embodiment 3 and commercially available kit

[0076] Commercially available high-sensitivity troponin-I assay kit (chemiluminescent microparticle immunoassay) (Abbott Trading Co., Ltd.) and the method in Example 1 are used to detect serum samples (cTnI concentration range in the sample is 0.05~50ng / mL) repeated three times to verify the correctness of the detection results of the kit of the present invention, the results are shown in Table 1 below.

[0077] Table 1 Sample test results

[0078]

[0079] Compared with commercially available reagents, the deviation of this reagent is less than ±10%, and the detection result of this reagent is accurate and reliable.

[0080] Adopt commercially available high-sensitivity troponin-I assay kit (chemiluminescent microparticle immunoassay) (Abbott Trading Co., Ltd.) and the reagents in Example 1 to detect 100 cases of clinical serum samples, and the test results are shown in figure 1 ,Table 2.

[0081] T...

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Abstract

The invention discloses a magnetic bead time resolution fluorescence immunoassay quantitative determination cTnI kit. The cTnI kit comprises an immunomagnetic bead coating a cTnI monoclonal antibody,a cTnI standardized product solution, an europium-marked cTnI monoclonal antibody solution, washing liquid and enhancement liquid. The immunomagnetic bead coating the cTnI monoclonal antibody is a covalent conjugate of a superpara magnetic bead modified by a functional group and with the diameter being 1-3 microns and the cTnI monoclonal antibody. The kit has the high sensibility, the sensibilityof cTnI is 0.05ng / mL, and a blood serum (plasma) does not need to be diluted; the determination time is short, and a report can be resulted within 30 minutes; the demanding amount of the sample is less, and only 100 microliters are needed for one-time sample loading; and the kit is equipped with a full-automatic time resolution immune analysis meter, operation is easy, and labor is saved.

Description

technical field [0001] The invention relates to the technical field of in vitro reagent detection, in particular to a magnetic bead time-resolved fluorescence immunoquantitative detection kit for cTnI. Background technique [0002] Troponin is a regulatory protein of striated muscle contraction, present in cardiac muscle and skeletal muscle, composed of three subunits, namely TnI, TnC and TnT. The three subunits form a complex that plays an important regulatory role in muscle contraction and relaxation. TnI is an inhibitory subunit of actin and has three subtypes: fast skeletal muscle isoform (fTnI), slow skeletal muscle isoform (sTnI) and cardiac muscle isoform (cardiac troponin I, cTnI). Among them, the molecular mass of myocardial cTnI is 23.9kD, including 210 amino acid residues. Elevated cTnI content can be used as an important serological indicator for the diagnosis of acute myocardial infarction (AMI). [0003] The incidence of acute myocardial infarction has conti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/6887
Inventor 李根平解巧丽
Owner GUANGZHOU BIOKEY HEALTH TECH CO LTD
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