Dilution being capable of maintaining high stability of enzyme marker solution

Abstract

The invention relates to a diluent being capable of maintaining the high stability of enzyme marker solution and also relates to a method for preparing the diluent and applications thereof. The diluent comprises buffer solution, protein matrix solution, amino acid solution, sugar solution, a specific additive and a preservative. The diluent is a novel enzyme marker solution developed based on thecharacteristics of antibody protein and enzyme protein. With the adoption of the dilution, the stability of enzyme markers in storage and application can be effectively maintained. Tests show that theenzyme marker diluent can be stored at temperature of 37 DEG C for more than one week to fully meet the requirements for the quality of in-vitro diagnostic reagent kits. The diluent can be directly applied to the preparation of the in-vitro diagnostic reagent kits and meet the increasingly growing market demand for the in-vitro diagnostic reagent kits.

Description

technical field [0001] The invention relates to a novel diluent of an enzyme marker. The diluent is used to prepare an enzyme marker solution, which can effectively maintain the stability of the enzyme marker during storage and use, and fully meet the quality requirements of an in vitro diagnostic kit. At the same time, it also relates to the preparation method and application of the diluent of the enzyme marker. Background technique [0002] The immunoassay technique using labeled antigen or antibody is an in vitro ultra-trace analysis technique widely used in modern medicine, biology and other fields. It can accurately measure 10-9-10-15g trace substances, thus solving the problem that other methods cannot The problems solved have greatly promoted the rapid development of various research work and clinical tests in the fields of biology and medicine, and made extraordinary contributions to human scientific progress and health. [0003] Since the invention of radioimmunoas...

AI Technical Summary

Problems solved by technology

[0016] At present, many in vitro diagnostic kits often use concentrated and refrigerated enzyme markers. The concentrated enzyme markers are quite stable. They are often stored at -10°C by adding 30-40% glycerol, but this requires users to reconstitute or dilute them. Prepare your own working solution, which not only increases the workload of the user, but may also cause new operational errors; at the same time, the enzyme marker after simple dilution can only be prepared and used immediately, and the shelf life is short, which is very difficult for research. The work brings a lot of inconvenience; due to the inevitable need to repeatedly freeze and thaw the concentrated enzyme markers during use and storage, in order to solve the problem of enzyme marker stability and improve the quality of in vitro diagnostic kits, high stability It is necessary to study the dilution of the enzyme marker solution

[0017] Most of the current dilutions of enzyme marker solutions include buffer systems (such as PBS phosphate buffer) and BSA (bovine serum albumin), or PBS-tween20, etc. These dilutions are only basic dilutions, and there are still dilutions that need The problem of using up immediately within 12 hours does not protect the enzyme markers to the greatest extent, which is inconvenient to carry out experiments; at the same time, some in vitro diagnostic kits directly have enzyme marker dilutions, but due to The specific composition is not given for commercial reasons, which brings inconvenience to the wide application of in vitro diagnostic kits