Saliva liquefied sugar chain antigen determination kit and preparation method thereof

Abstract

The invention discloses a saliva liquefied sugar chain antigen determination kit, which comprises a latex reagent, and the latex reagent comprises a first KL-6 monoclonal antibody latex reagent and asecond KL-6 monoclonal antibody latex reagent; latex microspheres are activated by an activation buffer solution with a pH value of 5.5-6.0, then the pH value is adjusted to 7.0-7.4 to obtain a firstactivated microsphere solution, and the first activated microsphere solution is coupled with a first KL-6 monoclonal antibody to obtain a first coupling reaction solution; latex microspheres are activated with an activation buffer solution with the pH value of 6.5-7.0, then the pH value is adjusted to 7.5-8.0 to obtain a second activated microsphere solution, and the second activated microsphere solution is coupled with the second KL-6 monoclonal antibody to obtain a second coupling reaction solution; and the first coupling reaction solution and the second coupling reaction solution are respectively sealed, and solid-liquid separation is carried out to obtain solid resuspension, so as to obtain the first KL-6 monoclonal antibody latex reagent and the second KL-6 monoclonal antibody latex reagent. The kit is high in accuracy, wide in linear range and beneficial to large-scale production.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a kit for assaying sialolyzed sugar chain antigens and a preparation method thereof. Background technique [0002] In recent years, with the continuous development of various medical examination techniques, especially the wide application of lung imaging such as high-resolution CT in clinical practice, the accuracy of early diagnosis of ILD patients has been improved, but no substantial progress has been made in the treatment of ILD. Some patients have poor prognosis and high mortality. Early diagnosis and treatment can improve the prognosis of patients. Therefore, in addition to lung CT, lung function, blood gas analysis, bronchoscopy and lung biopsy, which have been clinically used in the diagnosis of ILD, serological tests related to the development and prognosis of ILD are also available. It has become a research hotspot, among which salivary sugar chain antigen-6 (KL-6) is cons...

AI Technical Summary

Problems solved by technology

A number of studies in recent years have reported that high-level expression of KL-6 may be associated with interstitial lung disease (ILD), acute lung injury, radiation pneumonitis, viral pneumonia, drug-associated interstitial pneumonia, tumors and other diseases. The role may be to promote the proliferation and migration of fibroblasts, thereby affecting the occurrence and development of fibrosis

[0004] At present, the methods widely used clinically to detect KL-6 by latex immunoturbidimetric assay are: (1) Method 1: Mix the two monoclonal antibodies first, and then activate the coupling together; however, the accuracy and precision of this method are both low. Not high; because each monoclonal antibody has its own suitable activation and coupling conditions, if two monoclonal antibodies are placed under the same conditions and activated and coupled together, the most suitable performance of each monoclonal antibody cannot be displayed, thereby affecting Accuracy and Precision

(2) Method 2: Conjugate two monoclonal antibodies to large latex and small latex respectively to increase linearity and sensitivity. Although this method uses two monoclonal antibodies coupled to large and small latex (same conditions), although the sensitivity and linear range can be increased, However, the process involves multiple centrifugation and ultrasonic steps, which is not conducive to scale-up production

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