High-sensitivity creatine kinase isozyme quantitative detection test strip

A creatine kinase, quantitative detection technology, applied in measurement devices, instruments, disease diagnosis and other directions, can solve the problems of interference of various factors, high processing requirements, long detection time, etc., to improve detection sensitivity, improve cleaning efficiency, reduce The effect of reaction time

Pending Publication Date: 2020-05-12
NINGBO AUCHEER BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these two detection methods have low sensitivity, require a long detection time, are interfered by various factors, and have high requirements for sample pretreatment.

Method used

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  • High-sensitivity creatine kinase isozyme quantitative detection test strip
  • High-sensitivity creatine kinase isozyme quantitative detection test strip
  • High-sensitivity creatine kinase isozyme quantitative detection test strip

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] see Figure 1-3 , a high-sensitivity creatine kinase isoenzyme quantitative detection test strip, comprising a connection plate 1, a reagent tube integrally formed with the connection plate, the connection plate is divided into a hand-held area 2, a reagent area 3, a washing area 4, In the detection area 5, the upper and lower sides of the handheld area 2 are provided with anti-slip lines 6, the reagent area 3 is provided with a sample reagent tube 7 and a main reagent tube, and the washing area 4 is provided with a washing reagent tube 8. The detection area 5 is provided with a detection reagent tube 9, and the two sides of the reagent area 4 are symmetrically provided with holding notches 10 for easy handling by the user, and the two holding notches 10 are arc-shaped. It is convenient for users to hold with their fingers, which speeds up the work efficiency.

[0020] Preferably, the anti-slip pattern 6 includes a first anti-slip pattern 11 and a second anti-slip patt...

Embodiment 2

[0025] The invention provides a detection method for a high-sensitivity creatine kinase isoenzyme quantitative detection test strip, and the specific steps are as follows:

[0026] 1) Add the sample in the sample reagent well to biotin-labeled creatine kinase isozyme antibody solution (second main reagent tube), acridinium ester-labeled creatine kinase isozyme antibody solution (third main reagent) tube), an immune reaction occurs to form a biotin-creatine kinase isoenzyme antibody-creatine kinase isoenzyme antibody-creatine kinase isoenzyme antibody-acridine ester solution;

[0027] 2) Add biotin-creatine kinase isoenzyme antibody-creatine kinase isoenzyme-creatine kinase isoenzyme antibody-acridine ester solution to streptavidin magnetic particle solution (the first main reagent tube) In the process, a magnetic particle-streptavidin-biotin-creatine kinase isoenzyme antibody-creatine kinase isoenzyme-creatine kinase isoenzyme antibody-acridine ester complex is formed;

[002...

Embodiment 3

[0032]Performance evaluation of test strip of the present invention:

[0033] 1. Linearity: The test strip is based on the concentration value of the standard product (standard products are 0ng / mL, 2ng / mL, 5ng / mL, 10ng / mL, 20ng / mL, 40ng / mL, 60ng / mL, 80ng / mL) is the X-axis, and the signal value of the standard is used as the Y-axis to establish a calibration curve, and calculate the corresponding concentration value according to the signal value intensity of the sample to be tested, such as Figure 4 As shown, the linear equation is y=65764x-183699, R2=0.9945, and the lowest detection limit is 2ng / mL.

[0034] Get the creatine kinase isoenzyme standard substance that concentration is 20ng / ml and carry out 10 tests, utilize linear equation y=65764x-183699, calculate detection concentration value; Detection result is as shown in table 1, and the average value of determination is respectively 20.09ng / ml, the standard deviation was 0.117, and the intra-assay coefficient of variat...

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Abstract

The invention discloses a high-sensitivity creatine kinase isoenzyme quantitative detection test strip which comprises a connecting plate and a reagent tube integrally formed with the connecting plate, the connecting plate is sequentially divided into a handheld area, a reagent area, a washing area and a detection area, antiskid lines are arranged on an upper surface and a lower surface of the handheld area, and a sample reagent tube and a main reagent tube are arranged in the reagent area; a streptavidin magnetic particle solution, a biotin-labeled creatine kinase isoenzyme antibody solution,an acridinium ester-labeled creatine kinase isoenzyme antibody solution, an acidic excitation solution and an alkaline excitation solution are respectively arranged in the main reagent tube; the principle of a double-antibody sandwich method is adopted, meanwhile, an avidin-biotin system is utilized, acridinium ester chemiluminiscence is adopted, the detection sensitivity of the test strip is greatly improved, the reaction time is shortened, and the reagent cost is reduced.

Description

technical field [0001] The invention relates to the technical field of test strips, in particular to a high-sensitivity creatine kinase isozyme quantitative detection test strip. Background technique [0002] The detection of creatine kinase isoenzyme (CK-MB) can be used for the diagnosis and prognosis of acute myocardial infarction (AMI), diagnosis and prognosis of myocarditis, diagnosis of muscle diseases, brain diseases such as cerebral infarction, meningitis, encephalitis and other diseases diagnosis etc. Creatine kinase isoenzymes are of great significance in clinical diagnosis. When various lesions including muscle atrophy and myocardial infarction occur, the level of creatine kinase in human serum increases rapidly. Acid kinase activity is more reliable than doing an EKG. During myocardial infarction, creatine kinase increases within 6 hours of onset, reaches a peak within 24 hours, and returns to normal within 3-4 days. Among them, the creatine kinase isoenzyme CK...

Claims

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Application Information

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IPC IPC(8): G01N33/573G01N21/76
CPCG01N21/76G01N33/573G01N2333/9123G01N2800/10G01N2800/324G01N2800/325
Inventor 周义正唐静陈星星黄丹娣
Owner NINGBO AUCHEER BIOTECHNOLOGY CO LTD
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