Time resolution immunity fluorescence kit for detecting content of beta-hCG as well as preparation method and application thereof

A time-resolved, immunofluorescent technology, which is applied in measuring devices, biological testing, and analytical materials, can solve the problems of unreported β-hCG content, facilitate sample concentration calculation, avoid product quality investigation, and increase quality control. Effect

Inactive Publication Date: 2014-12-03
ABBOTT DIAGNOSTICS (SHANGHAI) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there is no report on the detection of β-hCG in urine by time-resolved immunofluorescence analysis

Method used

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  • Time resolution immunity fluorescence kit for detecting content of beta-hCG as well as preparation method and application thereof
  • Time resolution immunity fluorescence kit for detecting content of beta-hCG as well as preparation method and application thereof
  • Time resolution immunity fluorescence kit for detecting content of beta-hCG as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] The preparation of embodiment 1 kit

[0068] The preparation method of the above-mentioned kit is as follows:

[0069] 1. Preparation of 200mmol / L pH=6.8±0.1 coating solution

[0070] 35.08g Na 2 HPO 4 12H 2 O, 5.91g NaH 2 PO 4 2H 2 Add O and 9g NaCl to 600ml deionized water, adjust the pH value to 6.8±0.1 with 1N HCl and 1N NaOH, and dilute to 1L.

[0071] Preparation of 2.50mmol / L pH=6.8 blocking protection solution

[0072] 8.77g Na 2 HPO 4 12H 2 O and 3.98 g NaH 2 PO 4 2H 2 O was added to 600ml deionized water, and then 1g BSA (bovine serum albumin), 60g Trehalose (trehalose) and 1g Diazolidinyl Urea (diimidazolidinyl urea) were added in sequence, and the pH value was adjusted to 6.8±0.1 after it was completely dissolved. Set the volume to 1L.

[0073] 3.100mmol / L pH=9.3Eu 3+ Preparation of marking solution

[0074] 2.12g Na 2 CO 3 and 6.72g NaHCO 3 Add it to 600ml of deionized water, adjust the pH value to 9.3±0.1 with 1N HCl and 1N NaOH, and di...

Embodiment 2

[0094] The application of embodiment 2 kit

[0095] The present invention also provides the application method of kit:

[0096]1. Add the β-hCG calibrator and the sample to be tested with concentrations of 0, 15, 25, 37.5, 50, 75 and 100mIU / ml to the microtiter plate coated with anti-β-hCG monoclonal antibody in turn, each The calibrator and the sample to be tested were repeated in three wells, and 50 μl of sample was added to each well, and then 150 μl of analysis solution was added, and incubated with shaking for 30 minutes.

[0097] 2. Dilute the cleaning solution 25 times with deionized water, then wash the microplate with the diluted cleaning solution for 3 times and spin dry.

[0098] 3. Dilute the purified trivalent europium-labeled anti-α-TSH monoclonal antibody 1:100 with the analysis solution, add 200 μl / well to the microtiter plate, and incubate with shaking for 30 minutes.

[0099] 4. Wash the microtiter plate 6 times with 1:25 washing solution and shake dry.

...

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Abstract

The invention discloses a time resolution immunity fluorescence kit for detecting the content of beta-hCG. The time resolution immunity fluorescence kit comprises a box body and a box cover which is arranged above the box body, wherein a separation layer which is used for placing an elisa plate coated by a beta-hCG monoclonal antibody is arranged in the box body; vessel holes for arranging reagent bottles are formed in the box body, and in the vessel holes, a reagent bottle with analysis solution, a reagent bottle with a cleaning solution, a reagent bottle with an enhanced solution, a reagent bottle with a beta-hCG correction product and a reagent bottle with a labeled anti-alpha-TSH monoclonal antibody are placed. In addition, the invention also discloses a preparation method of the kit and application of the kit in detecting the content of beta-hCG. The kit is high in sensitivity, wide in detection range and good in stability. The time resolution immunity fluorescence kit can be full-automatically operated by utilizing a full-automatic time resolution fluorescent immunity analyzer and is simple and time-saving to operate and high in sensitivity reaching up to 0.01mIU/ml, good in accuracy and free from radiation pollution.

Description

technical field [0001] The invention relates to the field of in vitro immunodiagnostic reagents, in particular to a time-resolved immunofluorescence kit for detecting β-hCG in urine, a preparation method and application thereof, to realize quantitative detection of β-hCG content in urine. Background technique [0002] Human chorionic gonadotropin (hCG) is a glycoprotein produced by the syncytiotrophoblast of the placental chorion. The β subunit is a specific antigen, and its structure is different from other anterior pituitary hormones. [0003] Quality is the foundation of a production-oriented enterprise. Many in vitro diagnostic companies that manufacture hCG test pens need to use a standard product containing a certain concentration of β-hCG to perform functional testing of the test pens, so as to confirm whether the test pens meet the standard and whether they can be sold. This is a key quality control point. If the standard product is unqualified, the performance of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/76G01N33/531
CPCG01N33/54366G01N33/54386G01N33/60G01N33/76G01N2333/59G01N2800/36G01N2800/368
Inventor 赵金博张展英周蓓昕
Owner ABBOTT DIAGNOSTICS (SHANGHAI) CO LTD
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