Tacrolimus chemiluminescence immunodetection reagent and preparation and detection methods thereof

By using magnetic microparticle immunoassay and chemiluminescence, the problems of low cost and high accuracy in the quantitative determination of tacrolimus have been solved, enabling accurate and precise detection of tacrolimus, reducing production costs and improving detection sensitivity and range.

CN122361791APending Publication Date: 2026-07-10SUZHOU EVERMED BIOMEDICAL CO LTD
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Patent Information

Application Number
CN202411989613.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-31
Publication Date
2026-07-10

AI Technical Summary

Technical Problem

Existing technologies make it difficult to achieve accurate and precise quantitative determination of tacrolimus at low cost, and there are problems with drug toxicity or unclear efficacy due to individual differences.

Method used

Using the competitive method principle, magnetic microparticles are used as the solid phase of the immunoreaction. Combined with chemiluminescence and a fully automated chemiluminescence immunoassay analyzer, the immunoreaction is carried out using fluorescein-labeled anti-tacrolimus monoclonal antibody, tacrolimus-alkaline phosphatase conjugate and magnetic separation reagent, and the intensity of chemiluminescent photons is detected to achieve quantitative determination of tacrolimus.

Benefits of technology

It enables accurate and precise detection of tacrolimus, reduces production costs, improves the analytical precision and sensitivity of detection, has a wide detection range, is easy to operate, and has significant cost advantages.

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Abstract

The invention relates to a tacrolimus chemiluminescence immunodetection reagent and a preparation and detection method thereof, the reagent comprises a first reagent, a second reagent and a magnetic separation reagent, the first reagent is a fluorescein-labeled anti-tacrolimus monoclonal antibody and a buffer solution with pH of 6.0-9.0, and the concentration of the fluorescein-labeled anti-tacrolimus monoclonal antibody is 1.0-5.0 [mu] g / mL; the second reagent is a buffer solution which contains a tacrolimus-alkaline phosphatase conjugate and has a pH value of 6.0 to 9.0, and the concentration of the tacrolimus-alkaline phosphatase conjugate is 0.05 to 0.20 [mu] g / mL; the magnetic separation reagent is a suspension of magnetic particles coated with an anti-fluorescein monoclonal antibody. According to the method, the tacrolimus can be quantitatively detected at lower cost and higher accuracy and precision.
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