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Kit for detecting premature rupture of membrane, and preparation method thereof

A technology of premature rupture of membranes and kits, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve the problems of deviation of measurement results, unsatisfactory sensitivity and specificity of detection results, small rupture of membranes, etc.

Active Publication Date: 2013-08-28
ORIGISSAY BIOLOGICS TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although the existing immunochromatographic test paper for detecting premature rupture of membranes using sICAM-1 as a detection index provides convenience for obstetric patients, it is only a qualitative detection method in itself, and it is not as good as a quantitative detection method in determining There is a certain degree of deviation in the results, which can easily lead to misjudgments, resulting in unsatisfactory sensitivity and specificity of the test results; especially for the vaginal amniotic fluid flow caused by small rupture of membranes and high rupture in the occurrence of premature rupture of membranes For smaller obstetric patients

Method used

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  • Kit for detecting premature rupture of membrane, and preparation method thereof
  • Kit for detecting premature rupture of membrane, and preparation method thereof
  • Kit for detecting premature rupture of membrane, and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0056] Taking outpatients and inpatients of West China Second Hospital of Sichuan University as the experimental subjects, the experimental subjects were divided into premature rupture of membranes group, healthy control group and amniotic fluid sample group according to the existing detection methods.

[0057] Premature rupture of membranes group: 110 pregnant women with premature rupture of membranes (including 80 cases of full-term premature rupture of membranes and 30 cases of preterm premature rupture of membranes);

[0058] Healthy control group: 110 pregnant women with intact membranes before delivery;

[0059] Amniotic fluid sample group: 30 pregnant women with intact membranes undergoing cesarean section.

[0060] Clinical screening criteria for experimental subjects:

[0061] Premature rupture of membranes group—(i) Leakage of amniotic fluid was observed before labor;

[0062] (ii) The pH test paper test of the vaginal secretion sample is positive;

[0063] (iii) ...

Embodiment 2

[0166] A total of 40 kits of control examples 1-8 prepared by different methods were used to detect the same clinical samples of vaginal secretions of pregnant women, including premature rupture of membranes group and healthy control group, wherein the premature rupture of membranes group 500 cases, and 500 cases of healthy control groups, the test subjects were all clinically diagnosed and screened using the method in Example 1. Among them, more than 70% of the premature rupture of membranes group were obstetric patients with small or high rupture of the membranes and small vaginal amniotic fluid flow.

[0167]Sample collection: Pregnant women were taken in the bladder lithotomy position (lying in the supine position, with the lower limbs flexed separately, exposing the vulva), after peeping through the vagina, a disposable sterile cotton swab was inserted into the posterior fornix of the vagina, and rotated 5 times to sample. Insert the tip of the cotton swab into 1mL sample...

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Abstract

The invention discloses a detection kit and a preparation method thereof, specifically elates to a kit for detecting premature rupture of membrane and a preparation method thereof. The kit comprises a multi-cell plate and reagents, wherein the reagents comprise: A, a magnetic microsphere suspension, wherein the magnetic microspheres are prepared by co-cross-linking hydroxylation magnetic microspheres with a diameter of 0.5-2 mum, N-hydroxysulfo succinic acid amide and carbodiimide, and a concentration of the magnetic microspheres in the suspension is 75-85 / muL; B, phycoerythrin-labeled streptavidin and a biotin-labeled antibody detection solution, wherein the biotin is N-hydroxy succinic acid imino ester, the antibody is mouse anti-human soluble intercellular adhesion molecule-1 monoclonal antibody, and a concentration of the biotin-labeled antibody is 1.7-2 mg / mL; and C, a soluble intercellular adhesion molecule-1 protein standard substance and a standard substance dilution solution. The kit provides significantly increased sensitivity and specificity for the detection result of premature rupture of membrane so as to reduce diagnostic error incidence rate, wherein the sensitivity and the specificity can respectively achieve more than 99% and 98%.

Description

technical field [0001] The invention relates to a detection kit and a preparation method thereof, in particular to a detection kit for premature rupture of membranes and a preparation method thereof. Background technique [0002] The kits used in medicine are a complete set of reagents necessary for the analysis or detection of certain parameters, such as disease diagnosis kits, nucleic acid extraction and recovery kits, bacterial identification kits, etc. Most of the existing kits use quantitative detection methods, relatively speaking, the detection kits are more accurate than the qualitative detection methods of immunochromatography test paper. [0003] Rupture of fetal membranes (Rupture of Fetal Membrane, referred to as ROM) may occur at any time during pregnancy, and rupture of fetal membranes that occurs before labor is called premature rupture of membranes (PROM). The incidence of PROM after term (after 37 weeks of gestation) is about 10%, and the incidence of PROM ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/531
Inventor 关祥乾胡怀忠
Owner ORIGISSAY BIOLOGICS TECH
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