Quality control product for monoclonal immunoglobulin identification and typing and application thereof

Abstract

The invention relates to the technical field of quality control products. The invention provides a quality control product for monoclonal immunoglobulin identification and typing and application thereof. The quality control product comprises a negative quality control product, a positive quality control product and a weakly positive quality control product. The quality control product disclosed by the invention can be used as a standard substance / standard sample for monoclonal immunoglobulin identification and typing detection, a base material and a characteristic value are very close to those of an actual sample, and the quantity is sufficient. The device has good uniformity, stability and applicability, and can meet the quality control requirements of clinical laboratories and the use requirements of general medical laboratories.

Description

Technical Field

[0001] The present invention relates to the technical field of quality control products, and in particular to quality control products for identification and typing of monoclonal immunoglobulins and applications thereof. Background Art

[0002] Immunofixation electrophoresis (IFE) is a detection and analysis method that combines protein zone electrophoresis and immunoprecipitation technology. It is used to detect and identify monoclonal immunoglobulins in body fluids such as blood or urine, and to type them.

[0003] The technical requirements and key selection criteria for quality control products are that the matrix material and characteristic values ​​should be as close as possible to the actual samples and the quantity should be sufficient.

[0004] As the importance of IFE clinical application is increasingly recognized, more and more laboratories are planning to carry out this project. However, inter-laboratory quality evaluation of IFE testing has not yet been carried out, there are no commercialized quality control products for laboratory quality control, and the use of IFE quality control products has not been reported. Summary of the invention

[0005] The purpose of the present invention is to provide a quality control product for the identification and typing of monoclonal immunoglobulins and its application, which can meet the quality control requirements of clinical laboratories and the use requirements of general medical laboratories.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] The present invention provides a quality control product for the identification and typing of monoclonal immunoglobulin, wherein the quality control product comprises a negative quality control product, a positive quality control product and a weak positive quality control product.

[0008] Preferably, the negative control product is prepared by centrifuging blood from healthy people of different sources to obtain serum, and mixing the serum to obtain the negative control product.

[0009] Preferably, the blood comes from 8 to 12 healthy adults, 2.8 to 3.2 mL of blood from each healthy adult, and 1.8 to 2.2 ml of serum is obtained after centrifugation of the blood from each healthy adult;

[0010] The serum is subjected to immunofixation electrophoresis or capillary electrophoresis immunophenotyping or matrix-assisted laser desorption ionization time-of-flight mass spectrometry detection, and is used as a negative quality control product after the detection is normal and negative.

[0011] Preferably, the centrifugation is carried out at 1500-2000×g for 10-15 min.

[0012] Preferably, the preparation method of the positive quality control product is: blood from patients of different sources is centrifuged separately to obtain serum, and the serum is mixed to obtain the positive quality control product.

[0013] Preferably, the blood comes from 8 to 12 sick adults, 2.8 to 3.2 mL of blood from each sick adult, and 1.8 to 2.2 mL of serum is obtained after centrifugation of the blood from each sick adult;

[0014] Preferably, the serum is confirmed to be any combination of IgGλ, IgGκ, IgAλ, IgAκ, IgMλ, IgMκ, IgG, IgA, IgM, κ, and λ positive by immunofixation electrophoresis or capillary electrophoresis immunophenotyping or matrix-assisted laser desorption ionization time-of-flight mass spectrometry before centrifugation, and must contain the five antibodies IgG, IgA, IgM, κ, and λ.

[0015] Preferably, the centrifugation is carried out at 1500-2000×g for 10-15 min.

[0016] Preferably, the weak positive quality control product is prepared by mixing a positive quality control product and physiological saline in a volume ratio of 1:1.8 to 2.2 to obtain the weak positive quality control product.

[0017] The present invention also provides the use of the quality control product in preparing products for identification and typing detection of monoclonal immunoglobulins.

[0018] The present invention provides a quality control product for identification and typing of monoclonal immunoglobulin and its application, wherein the quality control product comprises: a negative quality control product, a positive quality control product and a weak positive quality control product. The quality control product of the present invention can be used as a standard substance / standard sample for identification and typing detection of monoclonal immunoglobulin, and the matrix material and characteristic value are very close to the actual sample, and the quantity is sufficient. It has good uniformity, stability and applicability, and can meet the quality control requirements of clinical laboratories and the use requirements of general medical laboratories. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 Immunofixation electrophoresis pattern: all positive (IgGλ.IgMκ.IgAκ);

[0020] Figure 2 The capillary electrophoresis immunophenotyping pattern is: all positive (IgGλ.IgMκ.IgAκ);

[0021] Figure 3 The matrix-assisted laser desorption ionization time-of-flight mass spectrometry spectrum is: all positive (IgGλ.IgMκ.IgAκ);

[0022] Figure 4 For immunofixation electrophoresis pattern: negative;

[0023] Figure 5 The immunophenotyping pattern by capillary electrophoresis was: negative;

[0024] Figure 6 Matrix-assisted laser desorption ionization time-of-flight mass spectrometry spectrum: negative. DETAILED DESCRIPTION

[0025] The present invention provides a quality control product, which includes: a negative quality control product, a positive quality control product and a weak positive quality control product.

[0026] In the present invention, the preparation method of the negative quality control product is: blood from healthy people from different sources is centrifuged separately to obtain serum, and the serum is mixed to obtain the negative quality control product.

[0027] In the present invention, the blood is preferably derived from 8 to 12 healthy adults, 2.8 to 3.2 mL of blood from each adult, and 1.8 to 2.2 ml of serum is obtained after centrifugation of the blood of each adult. It is further preferably derived from 10 healthy adults, 3 mL of blood from each healthy adult, and 2 ml of serum is obtained after centrifugation of the blood of each healthy adult.

[0028] The serum is subjected to immunofixation electrophoresis or capillary electrophoresis immunophenotyping or matrix-assisted laser desorption ionization time-of-flight mass spectrometry detection, and is used as a negative quality control product after the detection is normal and negative.

[0029] In the present invention, the centrifugation is preferably performed at 1500-2000×g for 10-15 min, and more preferably at 1750×g for 12-13 min.

[0030] In the present invention, the method for preparing the positive quality control product is preferably: blood from patients of different sources is centrifuged separately to obtain serum, and the serum is mixed to obtain the positive quality control product.

[0031] In the present invention, the blood is derived from 8 to 12 sick adults, 2.8 to 3.2 mL of blood from each sick adult, and 1.8 to 2.2 mL of serum is obtained after centrifugation of the blood from each sick adult. It is further preferably derived from 10 sick adults, 3 mL of blood from each sick adult, and 2 mL of serum is obtained after centrifugation of the blood from each sick adult.

[0032] In the present invention, the serum is preferably confirmed as any combination of IgG.λ, IgG.K, IgA.λ, IgA.K, IgM.λ, IgM.K, IgG, IgA, IgM, K, and λ positive by immunofixation electrophoresis or capillary electrophoresis immunophenotyping or matrix-assisted laser desorption ionization time-of-flight mass spectrometry before centrifugation, which must include the five antibodies IgG, IgA, IgM, K, and λ.

[0033] In the present invention, the centrifugation is preferably performed at 1500-2000×g for 10-15 min, and more preferably at 1750×g for 12-13 min.

[0034] In the present invention, the preparation method of the weak positive quality control product is preferably: mixing the positive quality control product and physiological saline in a volume ratio of 1:1.8 to 2.2 to obtain the weak positive quality control product, and further preferably: mixing the positive quality control product and physiological saline in a volume ratio of 1:2 to obtain the weak positive quality control product.

[0035] The present invention also provides the use of the quality control product in preparing products for identification and typing detection of monoclonal immunoglobulins.

[0036] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0037] Example 1

[0038] A method for preparing quality control product

[0039] (1) Blood from 8 healthy adults of different sources was collected, 2.8 mL per person, and centrifuged at 1500 × g for 5 min. 1.8 mL of serum was obtained from each adult. The serum was subjected to immunofixation electrophoresis and mixed after being tested as normal negative or polyclonal negative to obtain a negative control product.

[0040] (2) Blood from eight adults with the disease was collected from different sources, 2.8 mL per person, and centrifuged at 2000 × g for 3 min. 1.8 mL of serum was obtained from each adult. The serum was subjected to immunofixation electrophoresis to confirm any combination of IgGλ, IgGκ, IgAλ, IgAκ, IgMλ, IgMκ, IgG, IgA, IgM, κ, and λ positive. The serum samples must contain serum samples positive for the five antibodies IgG, IgA, IgM, κ, and λ. The positive quality control samples were obtained after mixing.

[0041] (3) Mix the positive quality control product and normal saline in a volume ratio of 1:1.8 to obtain a weak positive quality control product.

[0042] Example 2

[0043] A method for preparing quality control product

[0044] (1) Blood from 12 healthy adults of different sources was collected, 3.2 mL per person, and centrifuged at 2000 × g for 3 min. 2.2 mL of serum was obtained from each adult. The serum was subjected to capillary electrophoresis immunophenotyping test. The serum that tested normal negative or polyclonal negative was mixed to obtain a negative control product;

[0045] (2) Blood from 12 adults with the disease was collected from different sources, 3.2 mL per person, and centrifuged at 1500 × g for 5 min. 2.2 mL of serum was obtained from each adult. The serum was subjected to capillary electrophoresis immunophenotyping and confirmed to be any combination of IgGλ, IgGκ, IgAλ, IgAκ, IgMλ, IgMκ, IgG, IgA, IgM, κ, and λ positive. The serum samples must contain IgG, IgA, IgM, κ, and λ positive serum samples. The positive quality control samples were obtained after mixing.

[0046] (3) Mix the positive quality control product and normal saline in a volume ratio of 1:2.2 to obtain a weak positive quality control product.

[0047] Example 3

[0048] A method for preparing quality control product

[0049] (1) Blood samples from 10 healthy adults of different origins were collected, 3 mL per person, and centrifuged at 1750 × g for 4 min. 2 mL of serum was obtained from each adult. The serum was tested by matrix-assisted laser desorption ionization time-of-flight mass spectrometry. The serum samples that were detected as normal negative or polyclonal negative were mixed to obtain negative quality control samples.

[0050] (2) Blood from 10 adults with the disease from different sources was collected, 3 mL per person, and the blood was centrifuged at 1750 × g for 4 min. 2 mL of serum was obtained from each adult. The serum was tested by matrix-assisted laser desorption ionization time-of-flight mass spectrometry and confirmed to be any combination of IgGλ, IgGκ, IgAλ, IgAκ, IgMλ, IgMκ, IgG, IgA, IgM, κ, and λ positive. The serum samples must contain serum samples positive for the five antibodies IgG, IgA, IgM, κ, and λ. The positive quality control samples were obtained after mixing.

[0051] (3) Mix the positive quality control product and normal saline in a volume ratio of 1:2 to obtain a weak positive quality control product.

[0052] Test example

[0053] Figure 1.2.3 are respectively the positive quality control product spectra measured when the quality control product of the present invention is applied to the three detection methods of immunofixation electrophoresis, capillary electrophoresis immunophenotyping and capillary electrophoresis immunophenotyping for monoclonal immunoglobulin identification and typing.

[0054] Figure 4 .5.6 are respectively the negative quality control product spectra measured when the quality control product of the present invention is applied to the three detection methods of immunofixation electrophoresis, capillary electrophoresis immunophenotyping and capillary electrophoresis immunophenotyping for monoclonal immunoglobulin identification and typing.

[0055] Note: Figures 1 to 6 These 6 spectra include 3 positive and 3 negative, which are the positive or negative spectra obtained by the same positive or negative quality control product in three detection methods.

[0056] As can be seen from the above embodiments, the present invention provides a quality control product and its application, wherein the quality control product includes: a negative quality control product, a positive quality control product and a weak positive quality control product. The quality control product of the present invention can be used as a standard substance / standard sample for the identification and typing detection of monoclonal immunoglobulins, and the matrix material and characteristic values ​​are very close to the actual samples, and the quantity is sufficient. It has good uniformity, stability, and applicability, and can meet the quality control requirements of clinical laboratories and the use requirements of general medical laboratories.

[0057] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A quality control product for identification and typing of monoclonal immunoglobulins, characterized in that: The quality control products include: negative quality control products, positive quality control products and weak positive quality control products.

2. The quality control product according to claim 1, characterized in that: The preparation method of the negative quality control product is: blood from healthy people from different sources is centrifuged separately to obtain serum, and the serum is mixed to obtain the negative quality control product.

3. The quality control product according to claim 2, characterized in that: The blood comes from 8 to 12 healthy adults, 2.8 to 3.2 mL of blood from each healthy adult, and 1.8 to 2.2 ml of serum is obtained from the blood of each healthy adult after centrifugation; The serum is subjected to immunofixation electrophoresis or capillary electrophoresis immunophenotyping or matrix-assisted laser desorption ionization time-of-flight mass spectrometry detection, and is used as a negative quality control product after the detection is normal and negative.

4. The quality control product according to claim 3, characterized in that: The centrifugation is performed at 1500-2000×g for 10-15 min.

5. The quality control product according to claim 1, characterized in that: The preparation method of the positive quality control product is: blood from patients of different sources is centrifuged separately to obtain serum, and the serum is mixed to obtain the positive quality control product.

6. The quality control product according to claim 5, characterized in that: The blood comes from 8 to 12 sick adults, with 2.8 to 3.2 mL of blood from each sick adult. After centrifugation of the blood from each sick adult, 1.8 to 2.2 mL of serum is obtained.

7. The quality control product according to claim 6, characterized in that: Before centrifugation, the serum is confirmed by immunofixation electrophoresis or capillary electrophoresis immunophenotyping or matrix-assisted laser desorption ionization time-of-flight mass spectrometry to be any combination of IgG.λ, IgG.K, IgA.λ, IgA.K, IgM.λ, IgM.K, IgG, IgA, IgM, K, and λ positive, which must include the five antibodies IgG, IgA, IgM, K, and λ.

8. The quality control product according to claim 7, characterized in that: The centrifugation is performed at 1500-2000×g for 10-15 min.

9. The quality control product according to claim 1, characterized in that: The weak positive quality control product is prepared by mixing a positive quality control product and physiological saline in a volume ratio of 1:1.8 to 2.2 to obtain the weak positive quality control product.

10. Use of the quality control product according to any one of claims 1 to 9 in the preparation of products for identification and typing of monoclonal immunoglobulins.

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