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Kit for clinical detection of abnormal prothrombin

A prothrombin, abnormal detection technology, applied in the field of medical testing, can solve the problems of inconvenient use, high price, short validity period, etc., and achieve the effects of avoiding detection errors, wide detection range and strong specificity

Inactive Publication Date: 2019-01-15
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The calibrators of Fuji’s kit are freeze-dried, which is inconvenient to use and has a short validity period (9 months)
At the same time, as an imported kit, its price is relatively expensive and the cost is relatively high

Method used

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  • Kit for clinical detection of abnormal prothrombin
  • Kit for clinical detection of abnormal prothrombin
  • Kit for clinical detection of abnormal prothrombin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Preparation of kits for clinical detection of abnormal prothrombin

[0029] 1. Prepare sealing solution

[0030] The sealing solution is prepared from 0.01 M PBS buffer solution with pH 7~8, which contains 1~3‰ (w / v) preservative (Proclin300, MIT, Bro, IPBC or NaN 3 One or a mixture of two or more of them), 1~3% (w / v) protein stabilizer (one or two or more of casein, fish gelatin or bovine serum albumin can be used) and 0.1 ~1% (w / v) glycerin.

[0031] 2. Prepare enzyme conjugate dilution

[0032] The enzyme conjugate is prepared by 0.05 M Tris-NaCl buffer solution with pH 7~8, which contains 1~3‰ (w / v) preservative (Proclin 300, MIT, Bro, IPBC or NaN can be used 3 1~3% (w / v) protein stabilizer (one or more mixtures of casein, fish gelatin or bovine serum albumin can be used) and 0.1 ~0.5‰ of carmine pigment.

[0033] 3. Prepare sample diluent

[0034] The sample diluent is prepared by 0.01 M PBS buffer solution with pH 7~8, which contains 1~3‰ (w / v) pre...

Embodiment 2

[0049] Embodiment 2 Sensitivity assessment of the kit of the present invention

[0050] LoB, LoD, and LoQ were established in accordance with the performance confirmation (establishment) method of the CLSI standard "EP17-A: Evaluation of Clinical Laboratory Detection Limits". Items that cannot be strictly traced to SI units do not establish LoQ, but establish the functional sensitivity (FS) of the kit.

[0051] Limit of Blank (LoB): Prepare 5 clinical samples with a value close to 0, repeat 3 times for each sample, do a total of 4 days, get 60 data, and calculate LoB according to the calculation method of EP17-A.

[0052] Limit of detection (LoD): Prepare 5 serial clinical samples with a concentration range of 1 to 4 times the LOB, repeat 3 times for each sample, and do a total of 4 days to obtain 60 data, and calculate the LoD according to the calculation method of EP17-A.

[0053] Functional sensitivity (FS): Using the data in the LoD experiment, 5 concentration samples wer...

Embodiment 3

[0057] Embodiment 3 The precision assessment of the kit of the present invention

[0058] Three batches of reagents were taken for precision experiments, and high / low value quality control products were used for assessment respectively, and the variation of the measured concentration was calculated 20 times for each measurement. The measurement results are shown in Table 2 below, and the results show that the coefficients of variation are all less than 6%.

[0059] Table 2 Kit precision

[0060]

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Abstract

The invention discloses a kit for clinical detection of abnormal prothrombin. The kit comprises a magnetic particle PIVKA-II calibration product, magnetic particle suspension coated with PIVKA-II antibodies, magnetic particle PIVKA-II enzyme conjugate and sample diluent. The principle of a sandwich method is adopted to detect. Magnetic particles are coated with the PIVKA-II antibodies. Horseradishperoxidase labeled PIVKA-II antibodies are adopted to prepare the enzyme conjugate. An antibody-antigen-antibody multienzyme complex is formed through an immunological reaction. The complex catalyzesa luminescent substrate to emit photons, and the intensity of photoluminescence is proportional to the content of PIVKA-II. Operation is simple and convenient, sensitivity is high, specificity is high and the detection range is wide. The calibration product in the kit is liquid, and therefore detection errors due to the re-solubilization of calibration product are avoided, detecting results are more accurate, and clinical application is facilitated. The kit can be adopted in early diagnosis of hepatocellular carcinoma, monitoring of disease progression, evaluation of therapeutic effect and the like.

Description

technical field [0001] The invention relates to the field of medical testing, in particular to a kit for clinical detection of abnormal prothrombin. Background technique [0002] Prothrombin is a single-chain glycoprotein of 579 amino acid residues synthesized by the liver, with a molecular weight of 72kDa. From the N-terminus, there is a Gla region, two loop regions, and a protease region. The N-terminus of the prothrombin precursor peptide chain contains 10 glutamic acid residues, which are converted into 10 γ-carboxyglutamic acid residues under the catalysis of vitamin K-dependent γ-glutamyl carboxylase , forming prothrombin. When vitamin K deficiency, presence of vitamin K antagonists, altered membrane receptors, increased prothrombin prothrombin, gamma-glutamate carboxylase deficiency, failure of hepatocytes to uptake low-density lipoprotein, cells during epithelial-mesenchymal transition Skeleton changes may cause one or more glutamic acid residues in the Gla region...

Claims

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Application Information

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IPC IPC(8): G01N33/535G01N33/543G01N21/76G01N33/573G01N33/68
CPCG01N21/763G01N33/535G01N33/54326G01N33/573G01N33/68
Inventor 渠文涛史小芹马雷周金龙刘雅奇郑业焕渠海付光宇吴学炜
Owner AUTOBIO DIAGNOSTICS CO LTD
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