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Sample dilution composition for detecting sugar antigen 72-4, detection reagent and kit containing detection reagent

A composition and carbohydrate antigen technology, applied in the field of medical testing, can solve the problems of unfavorable improvement of laboratory pipeline, cumbersome calibration operation, narrow linear range, etc., to eliminate the difference between old and new samples, low HOOK risk, and linear range. wide effect

Inactive Publication Date: 2020-02-21
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The commonly used inspection methods in the laboratory for the detection of carbohydrate antigen 72-4 are mainly enzyme-linked immunoassay (ELISA) and chemiluminescence (CLIA). The kit of the method needs to use the calibrator for each experimental operation. The calibration operation is cumbersome and the reaction time is long.
And this method is semi-automatic operation, which is not conducive to the improvement of laboratory inspection pipeline

Method used

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  • Sample dilution composition for detecting sugar antigen 72-4, detection reagent and kit containing detection reagent
  • Sample dilution composition for detecting sugar antigen 72-4, detection reagent and kit containing detection reagent
  • Sample dilution composition for detecting sugar antigen 72-4, detection reagent and kit containing detection reagent

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Example 1 Preparation and use of the kit for the detection of carbohydrate antigen 72-4 1. Preparation of the detection kit for carbohydrate antigen 72-4

[0066] The kit of the invention consists of four components: enzyme conjugate, sample diluent, magnetic bead suspension and calibrator.

[0067] (1) Conventional equipment and reagents

[0068] 1. Enzyme conjugate (packed in a 12mL magnetic bead bottle);

[0069] 2. Sample diluent (packed in a 12mL magnetic bead bottle);

[0070] 3. Magnetic bead suspension (packed in a 4mL magnetic bead bottle);

[0071] 4. Reagent rack (for immobilizing the three components of enzyme conjugate, sample diluent, and magnetic bead suspension);

[0072] 5. Calibrator (packed in 4mL HDPE bottle);

[0073] 6. Calibration card;

[0074] (2) Preparation of enzyme conjugates

[0075] Preparation of enzyme conjugate dilution: use one of the buffer solutions Tris-NaCl, Bis-tris, PBS, MOPS, MES or Taps with a concentration of 0.01-0.1M, ...

Embodiment 2

[0109] Embodiment 2 kit sensitivity assessment

[0110] LoB, LoD, and LOQ were established according to the performance confirmation (establishment) method of the CLSI standard "EP17-A: Evaluation of Detection Limits of Clinical Laboratories". There is no standard substance in this project, and it cannot be traced to SI units. LOQ is not applicable, and the functional sensitivity (FS) is assessed.

[0111] The establishment method is as follows:

[0112] LoB, prepare 5 clinical samples with a value close to 0, repeat 3 times for each sample, do a total of 4 days, and get 60 data; LoD, prepare 5 serial clinical samples with a concentration range of 1 to 4 times LOB, each sample Repeat 3 times, do a total of 4 days, and get 60 data; FS: Using the data in the LoD experiment, 5 concentration samples are measured 3 times a day, a total of 4 days, each sample gets 12 results, and the calculation of each sample Mean, SD and CV%, the concentration to the nearest 20% is the functiona...

Embodiment 3

[0120] Embodiment 3 test kit linear range examination

[0121] According to the method of CLSI standard "EP6-A: Linearity Evaluation of Quantitative Detection Methods", the linear range of this kit was established.

[0122] The establishment method is as follows:

[0123] Take 1 high-value sample H (>300U / mL) and 1 low-value sample L (0.99.

[0124] The result is as attached figure 1 , figure 2 As shown, it can be seen that the linear range of the kit of the present invention can reach 0.3-300 U / mL.

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Abstract

The invention relates to the field of medical examination, and particularly relates to a sample dilution composition for detecting a sugar antigen 72-4, a detection reagent and a kit containing the detection reagent. The kit mainly comprises a magnetic particle suspension coated with a CA72-4 antibody, an enzyme conjugate, a sample diluent and a calibrator. The sample dilution composition can be used for auxiliary diagnosis and postoperative monitoring of tumor diseases such as gastric cancer, ovarian cancer, colorectal cancer, pancreatic cancer and cervical cancer. The kit is short in detection time, and the time of an inspector is greatly saved; the kit adopts a double-antibody sandwich method, is wide in linear range and high in clinical practicability; the kit adopts the specific sample diluent, so that the difference between new and old samples can be eliminated, false positive interference caused by HAMA is effectively reduced, and the detection accuracy of CA72-4 is greatly improved; and the kit adopts a two-step method, so that the risk of HOOK in clinical practice is reduced.

Description

technical field [0001] The invention relates to the field of medical testing, in particular to a sample dilution composition, a detection reagent and a kit containing the detection reagent for the detection of carbohydrate antigen 72-4. Background technique [0002] Carbohydrate antigen CA72-4 (carbohydrate antigen 72-4, CA72-4) is a high molecular weight mucin (molecular weight 220-400KD), discovered in 1981 by Colcher et al. Because it can specifically bind to two monoclonal antibodies B72.3 and CC49, it is called CA72-4. Its epitope is a sialylated oligosaccharide structure. There is a higher positive rate in patients with gastric cancer. It is also expressed in some colon cancers and mucinous ovarian cancers. The serum level of CA72-4 has been found to be elevated in a variety of malignant tumor diseases (including gastric cancer, ovarian cancer, colorectal cancer, pancreatic cancer, gallbladder cancer, breast cancer, cervical cancer, etc.). [0003] The increase of ...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/574G01N33/543
CPCG01N33/54326G01N33/57484G01N33/68G01N2333/705
Inventor 王树亮史小芹刘钊崔小妞付光宇杨增利
Owner AUTOBIO DIAGNOSTICS CO LTD
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