Serum or plasma sample diluent and application thereof

Abstract

The invention relates to a serum or plasma sample diluent and application thereof. Particularly, the serum or plasma sample diluent comprises a buffer solution (a), albumin (b) with content of 10-100g / L, alkaline chloride (c) and an optional emulsifier (d), wherein the pH value of the diluent is 6.0-8.0. Compared with the existing human negative mixed serum or plasma and calf serum diluent, the diluent provided by the invention has the characteristics of precise and accurate detection result and long-time stable preservation. The invention also discloses a detection kit containing the diluent and application of the diluent in immunoassay.

Description

technical field [0001] The invention relates to the technical field of biological sample detection, in particular to a serum or plasma sample diluent and its application. Background technique [0002] At present, the new type of automatic immune analyzer can quantitatively determine the presence of serum or plasma samples separately under the condition of no separation due to its simple operation, high degree of automation, fast detection speed, good repeatability, and high precision. Dozens of trace proteins with clinical significance. However, due to methodological limitations (such as the narrow detection linear range of automatic immune analyzers) and biological differences (high concentration of specific proteins in the test samples), many immunological indicators in clinical tests make the test results often Beyond the upper limit of the linear range, a certain proportion of dilution is required to obtain accurate detection results. The automatic immune analyzer dete...

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Problems solved by technology

[0005] In the early years, it was reported that in clinical testing, when the original imported diluent was insufficient, distilled water or saline was used to dilute serum or plasma samples before testing, but distilled water or saline alone could not provide the antigen and antibody needed The optimal reaction conditions of the test results in large deviations, which often affect the diagnosis of clinical diseases

[0006] In 2009, Liu Chengzhong et al. reported that inactivated serum or normal serum with known creatine kinase (CK) concentration was used to dilute and detect the concentration of creatine kinase in serum. In daily work, the dilution of high-value serum with fire-extinguishing serum is easily limited by the need to prepare inactivated serum in advance; while using normal serum with known CK value as the diluent to determine the CK value of high-value serum, the test results need to bring The input CK value is deducted, therefore, the operation result is cumbersome, and there are many inconveniences in clinical detection and diagnosis

However, due to the unstable source of human negative plasma or serum, it is not conducive to medical institutions to use it for a large number of tests; and in different test items, the requirements for human negative serum are not consistent, and it is not convenient to be used as a universal diluent

In addition, whether it is human serum or plasma, or a certain concentration of calf serum, it contains high protein, which is easy to breed bacteria and has poor stability, which is not conducive to long-term storage; Human negative serum or plasma, calf serum is diluted, limited by the detection time, it is often difficult to dilute and mix evenly, resulting in certain deviations in the test results

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