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Lupus anticoagulant confirmation kit (coagulation method)

A lupus anticoagulant and reagent technology, applied in the field of clinical diagnosis, can solve the problem of no "gold standard"

Pending Publication Date: 2020-09-25
SHANGHAI SUNBIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The most recent guidelines issued by CLSI (American Clinical and Laboratory Standards Institute) in 2014 state that there is currently no "gold standard" (international standard) for evaluating and comparing LA assays

Method used

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  • Lupus anticoagulant confirmation kit (coagulation method)
  • Lupus anticoagulant confirmation kit (coagulation method)
  • Lupus anticoagulant confirmation kit (coagulation method)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Effects of Different Phospholipids on the Sensitivity of Confirmation Kits

[0038] The present invention has compared soybean lecithin and bovine cephalin, and the concentration is 30 μ g / mL, and formula is as follows:

[0039] 50mM Tris-HCl buffer at pH 7.30, 30μg / mL soybean lecithin / bovine cephalin, 0.2U / mL viper venom activator RVV-X, 25mM calcium chloride, 2μg / mL polybrene, 1% PEG6000;

[0040] At the same time, NPP (NPP, normal pooled plasma, normal pooled plasma) and LA positive samples were detected, and soybean phospholipids were found to have better sensitivity. The results are shown in Table 1.

[0041] Table 1

[0042]

[0043]

Embodiment 2

[0044] Embodiment 2: the impact of different metal ions on the sensitivity of the kit

[0045] Table 2 is respectively based on the formula of embodiment 1 (soybean lecithin) with different concentrations of Zn 2+ , Mn 2+ 、Cu 2+ 、Ni 2+ The results obtained by the confirmation reagent of the present invention for detecting NPP and LA positive plasma are compared with the simultaneous detection of imported kits, wherein each metal salt is its chloride, but not particularly limited.

[0046] Table 2

[0047]

[0048] It can be seen from Table 2 that adding Mn 2+ Salt or Zn 2+ After adding salt, the sensitivities of the reagents all increased, and with the increase of the concentration, the sensitivities were also higher. Join Cu 2+ Salt and Ni 2+ After adding salt, the sensitivity of the reagent decreased significantly, and the sensitivity decreased more obviously as the concentration increased.

Embodiment 3

[0049] Example 3: Comparison of clinical sample detection between the kit of the present invention and the imported kit

[0050] Based on the comparison results of the metal ions in Example 2, the confirmation kit of the present invention with the addition of 0.4mM zinc chloride and the imported kit were used to measure 200 clinical samples at the same time. The negative and positive results detected by the two kits are shown in Table 3. .

[0051] table 3

[0052]

[0053] The negative coincidence rate of this kit calculated according to the above table=90 / (90+16)×100%=84.9%, the positive coincidence rate=90 / (90+4)×100%=95.7%, the total coincidence rate= (90+90) / 200×100%=90%, and the rank sum test shows that the detection difference between the two kits has no statistical significance, indicating that the diagnostic sensitivity of the kit of the present invention has reached the imported reagent standard.

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Abstract

The invention relates to the technical field of clinical diagnosis, and particularly discloses a lupus anticoagulant confirmation reagent based on a dRVVT method. The confirmation reagent comprises abuffer solution, soyabean lecithin, viper venom activator RVV-X, calcium, a heparin neutralizer and a stabilizer. The lupus anticoagulant confirmation reagent (kit) of the coagulation method is provided on the basis of the principle of the dRVVT method, and comprises a buffer solution, soybean phospholipid, viper venom activator RVV-X, calcium, a heparin neutralizer, a preservative, a stabilizer and Zn<2+> salt or Mn <2+> salt. By adding metal ions Zn<2+> and Mn<2+> into the confirmation reagent, the sensitivity of the confirmation reagent is improved, so that the detection accuracy of the reagent is improved.

Description

technical field [0001] The invention relates to the technical field of clinical diagnosis, in particular to a lupus anticoagulant confirmation kit based on the dRVVT method. Background technique [0002] Lupus anticoagulants (Lupus anticoagulants, LA) is a phospholipid-dependent pathological circulating anticoagulant substance, which is a heterogeneous immunoglobulin of IgG or IgM. It mainly interferes with the phospholipid-dependent coagulation process by binding to β2-glycoprotein Ⅰ (β2-glycoprotein Ⅰ, β2-GPI), human prothrombin (PT) and other phospholipid complexes, prolonging the coagulation time. LA is named after it was first discovered in patients with systemic lupus erythematosus (SLE). It can be seen in various autoimmune diseases such as antiphospholipid syndrome (APS), SLE, connective tissue diseases, and APS. Patients with arteriovenous thrombosis are closely associated with risk of morbid pregnancy. LA detection can not only predict the occurrence of thrombus,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/86G01N33/68
CPCG01N33/86G01N33/6854
Inventor 谢永华管瑞静
Owner SHANGHAI SUNBIO TECH
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