Detection kit for premature rupture of fetal membranes and preparation method thereof

A detection kit and a technology for premature rupture of membranes, applied in biological testing, material inspection products, etc., can solve the problems of high requirements for operators, need to operate instruments, and low sensitivity, and achieve high sensitivity, simple operation, and specificity Good results

Inactive Publication Date: 2013-06-26
安徽深蓝医疗科技股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent application 200620083734.1 discloses a disposable premature rupture of membranes pH test paper diagnostic stick, but its sensitivity is not high, and it is easy to cause false negatives
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Method used

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  • Detection kit for premature rupture of fetal membranes and preparation method thereof
  • Detection kit for premature rupture of fetal membranes and preparation method thereof
  • Detection kit for premature rupture of fetal membranes and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0026] The preparation method of the premature rupture of membranes detection kit includes two major steps: the configuration of the treatment solution and the preparation of the kit, and the specific steps are as follows:

[0027] 1) Preparation of treatment solution

[0028] Preparation of A gold standard pad treatment solution: Tris-Hcl (10mM, PH=7.4)+0.5%PVP+0.5%TW-20

[0029] Preparation of B sample pad treatment solution: Tris-Hcl (0.1MPH=9.0)+1%PVP+1.0%S17+0.8%Casein+0.3%TritonX-100

[0030] C spot membrane antibody dilution preparation: PBS {PB (10mM, PH = 7.4), 0.85% NaCl}

[0031] Preparation of D-labeled antibody diluent: PB (10mM, PH=7.4)

[0032] Preparation of E colloidal gold complex dilution: PB (10mM, PH=7.4)+20% sucrose+1%BSA

[0033] 2) Preparation of the kit

[0034] A treatment of membrane materials:

[0035] a. Treatment of sample pad: The sample pad (SB08) used by generals is soaked with the prepared treatment solution. After fully soaking, it can b...

Embodiment

[0058] By adopting the aforementioned method of use, the verification test of 200 routine clinical samples has been carried out to the premature rupture of membranes detection kit (insulin-like growth factor binding protein-1 detection kit) (colloidal gold immunochromatography) of the present invention, and the control group adopts traditional The standard for the diagnosis of premature rupture of membranes is to use pH test paper to detect the pH of the vaginal secretions > 7 or to see fern-shaped crystals in the vaginal secretions directly under the microscope and to see a small amount of liquid flowing out of the cervix in vaginal speculum examination. The results showed that there was no significant difference between the test product and the control group, and the test product reached the gold standard result of clinical diagnosis.

[0059]

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Abstract

The invention discloses a detection kit for premature rupture of fetal membranes, which comprises a detection test paper strip or a test paper card for premature rupture of fetal membranes, a buffer and a cotton swab, the test paper strip or the test paper card comprise a detection zone (T) coated with anti-human insulin-like growth factor binding protein-1 monoclonal antibody 1 and a quality control zone (C) coated with anti-mice polyclonal antibody and colloidal gold coated with anti-human insulin-like growth factor binding protein-1 monoclonal antibody 2. The preparation method of the kit comprises the following steps: preparing a treating liquid, preparing the kit, preparing a colloidal gold compound, spraying metal, cutting, assembling, cutting, packaging and the like. The detection kit for premature rupture of fetal membranes has the advantages of good specificity, high sensitivity, rapid and simple detection, and no pain in a usage process, and can be used for self-test in household and test on bed.

Description

technical field [0001] The invention relates to the field of detection kits, in particular to a detection kit for premature rupture of membranes and a preparation method. Background technique [0002] The rupture of fetal membranes before labor is called premature rupture of fetal membranes (prom), which is a common complication in obstetrics, and its incidence rate is about 10% in domestic reports. Prom complicated by intrauterine infection can lead to premature birth and perinatal death, and is one of the important causes of maternal and child illness and death. [0003] In the prior art, using the gold standard is an accurate method for diagnosing premature rupture of membranes, that is, injecting a dye (such as methylene blue) into the amniotic cavity of a pregnant woman, and if there is infected and colored liquid flowing out of the vagina, it can be diagnosed as fetal membranes Premature rupture, but the gold standard detection is difficult to operate clinically and c...

Claims

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Application Information

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IPC IPC(8): G01N33/68
Inventor 张超陈奉玲洪莲
Owner 安徽深蓝医疗科技股份有限公司
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