A kit for detecting premature rupture of membranes

A technology of premature rupture of membranes and kits, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of deviation of measurement results, sensitivity and specificity of detection results are not ideal, and it is easy to cause misjudgment and other problems

Active Publication Date: 2015-09-30
ORIGISSAY BIOLOGICS TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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.

Method used

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  • A kit for detecting premature rupture of membranes
  • A kit for detecting premature rupture of membranes
  • A kit for detecting premature rupture of membranes

Examples

Experimental program
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Effect test

Embodiment 1

[0078] 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 method.

[0079] 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);

[0080] Healthy control group: 110 pregnant women with intact membranes before delivery;

[0081] Amniotic fluid sample group: 30 pregnant women with intact membranes undergoing cesarean section.

[0082] Clinical screening criteria for experimental subjects:

[0083] Premature rupture of membranes group—(i) Leakage of amniotic fluid was observed before labor;

[0084] (ii) The pH test paper test of the vaginal secretion sample is positive;

[0085] (iii) P...

Embodiment 2

[0240] The control examples 1-20 kits 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 was 500 cases , healthy control group is 500 examples, and the test object adopts the method for embodiment 1 to carry out clinical diagnosis and screening.

[0241] 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 diluent (containing bovine serum albumin with a mass fraction of 15, 0.05% sodium azide and 10mmol / L PBS), rotate 5 times, squeeze and rotate 2 times against the tube wall, G...

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Abstract

The invention discloses a detection kit and particularly relates to a kit for detecting premature rupture of fetal membranes. The kit comprises a nitrocellulose membrane and the following reagents: (A) membrane sealing solution, (B) mouse anti-human soluble intercellular adhesion molecule-1 monoclonal antibody detection solution, (C) washing solution, (D) goat anti-mouse IgG polyclonal antibody detection solution marked by horse radish peroxidase, and (E) chromogenic substrate diaminobenzidine solution. The kit disclosed by the invention detects the premature rupture of the fetal membranes by adopting a qualitative detection manner; the manufacturing cost and the use cost are both obviously reduced; meanwhile, compared with immune chromatography test paper for qualitative detection, the kit can effectively improve the sensitivity and the specificity of detection results of the premature rupture of the fetal membranes, and the sensitivity and the specificity reach more than 99% and more than 96% respectively, so that the occurrence rate of misdiagnosis is reduced.

Description

technical field [0001] The invention relates to a detection kit, in particular to a detection kit for premature rupture of membranes. 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, when the kits use quantitative detection methods, the box generally contains detection standards. At the same time, the detection process will also include the detection of several standard products. Therefore, kits using quantitative detection are generally expensive in terms of production cost or use cost, but their quantitative detection results are more accurate than qualitative detection methods of immunochromatographic test strips. [0003] Rupture of fetal membranes (Rupture of Fetal Membrane, refe...

Claims

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Application Information

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