Liquid double-reagent kit for measuring free light chains in serum or urine by double-latex method

Abstract

The invention relates to a liquid double-reagent kit for measuring free light chains in serum or urine by a double-latex method. The kit provided by the invention comprises a reagent R1, a reagent R2 and a light chain antigen calibrator with known concentration, wherein the reagent R1 comprises a macromolecular accelerant, a preservative, a surface active agent, a reaction promoter, a stabilizer, an electrolyte and a buffer solution; R2 comprises two types of latex particles with different diameters, wherein the diameters of the latex particles are respectively in ranges from 40nm to 80nm and from 100nm to 200nm; the two types of latex particles are both cross linked with kappa-type or lambda-type anti-FLC (full-load current) polyclonal antibody, and the latex particles comprise the preservative, the surface active agent, the reaction promoter, the electrolyte, the stabilizer and the buffer solution; the light chain antigen calibrator with known concentration comprises the preservative, the electrolyte, the stabilizer, kappa-type or lambda-type FLC antigen and the buffer solution. The kit in the invention has the advantages that the specificity is strong, the sensitivity is high, the linear range is wide, the operation is simple, and the kit is suitable for various full automatic biochemical analyzers.

Description

technical field [0001] The present invention relates to the field of medical immunology, and relates to an immunodetection reagent. Furthermore, the present invention relates to a reagent for measuring free light chains of immunoglobulins in serum or urine. Background technique [0002] Immunoglobulin (Ig for short) is a general term for globulins with antibody activity or chemical structure similar to antibodies. It exists in large amounts in normal human serum and in trace amounts in urine. The Ig molecular structure is a "Y" globulin composed of two heavy chains (Heavy chain, H chain) and two light chains (Light chain, L chain) and disulfide bonds. Human immunoglobulins are divided into IgM, IgG, IgA, IgD, and IgE according to their heavy chains, and the corresponding heavy chains are μ, γ, α, δ, ε; light chains are divided into κ (kappa) and λ (lambda) 2 types, any immunoglobulin contains two light chains of the same type, namely κ type or λ type, and the ratio of the t...

AI Technical Summary

Problems solved by technology

Theoretically, the level of free light chains can reflect the patient's condition and treatment effect in real time; 2. A single measurement of free light chains in urine cannot accurately judge the condition because: under normal circumstances, the increase of FLC in urine It can be detected synchronously in serum and fluid. If the patient with B cell malignant proliferation disease is accompanied by renal failure, the change of light chain in urine cannot be detected, which will lead to misdiagnosis, while the determination of FLC in serum will not be disturbed, which is more diagnostically accurate. precise

Moreover, when using urine as a sample, the patient's 24-hour urine needs to be collected, and the sample size is large and the stability is poor.

[0007] Although studies have shown that the clinical significance of monitoring free light chains in blood is high, the development of determination of free light chains in serum is relatively slow due to the following aspects

One, traditional methods have low sensitivity and cannot be accurately quantified, such as: electrophoresis, immunofixation electrophoresis, etc., the double latex method used in the present invention has a sufficiently high sensitivity; two, specific antibody preparation technology, immunoglobulin in serum The amount of protein is thousands of times that of free light chain. To accurately measure the content of FLC in serum, it is necessary to overcome the interference of a large number of immunoglobulins in serum. The selection of specific antibody is very important. If the selected antibody has poor specificity, it will be different from the intact one. Cross-linking of light chains of immunoglobulins distorts results

Antibodies against the cryptic sites of free light chains prepared in the early stage can specifically recognize and bind to the corresponding free light chains, but the titer of monoclonal antibodies is low, and generally not suitable for immunoturbidimetric methods (latex enhanced method is a kind of immunoturbidimetric method). class, that is, monoclonal antibodies are not suitable for latex-enhanced immune turbidimetry), but now you can make or buy antibodies against multiple hidden sites of free light chains, so it is possible to apply latex-enhanced immune turbidimetry; 3. The content of FLC in the serum of normal human beings is very low, but when the benign or malignant proliferation of B cells occurs, the content of FLC will be dozens of times higher than normal. width

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