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Preparation method of immunochromatographic test strip for detecting premature rupture of membrane

A technology for immunochromatographic test strips and premature rupture of membranes, which can be applied to measurement devices, analytical materials, instruments, etc., can solve the problems of inconvenience of obstetric patients, easy to cause misdiagnosis, unsatisfactory sensitivity, specificity and accuracy, etc.

Active Publication Date: 2013-06-12
ORIGISSAY BIOLOGICS TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although the existing immunochromatographic test paper for detecting premature rupture of membranes with ICAM-1 as a detection index provides convenience for obstetric patients, its sensitivity, specificity and accuracy are not ideal enough, thus easily causing misdiagnosis, which is harmful to obstetric patients. it will also be inconvenient

Method used

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  • Preparation method of immunochromatographic test strip for detecting premature rupture of membrane
  • Preparation method of immunochromatographic test strip for detecting premature rupture of membrane
  • Preparation method of immunochromatographic test strip for detecting premature rupture of membrane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] 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);

[0059] Healthy control group: 110 pregnant women with intact membranes before delivery;

[0060] Amniotic fluid sample group: 30 pregnant women with intact membranes undergoing cesarean section.

[0061] Clinical screening criteria for experimental subjects:

[0062] Premature rupture of membranes group—(i) Leakage of amniotic fluid was observed before labor;

[0063] (ii) The pH test paper test of the vaginal secretion sample is positive;

[0064](iii) Positive detection of fern leaf crystals.

[0065] Healthy control group—(i) Amniotic fluid leakage was not observed before labor;

[0066] (ii) The pH test paper test of the vaginal secretion sample is negative;

[0067] (iii) Negative test for fern leaf crysta...

Embodiment 2

[0187] The control example 1-20 immunochromatographic test papers prepared by different methods were used to detect the clinical samples of vaginal secretions of the same pregnant women respectively, including premature rupture of membranes group and healthy control group, wherein the premature rupture of membranes group was 240 cases, 260 cases in the healthy control group, and the test subjects were all clinically diagnosed and screened using the method in Example 1.

[0188] 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 cotton swab head into 1mL sample diluent (phosphate buffer system), rotate 5 times, squeeze and rotate 2 times against the tube wall to obtain the sample.

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Abstract

The invention discloses a preparation method of an immunochromatographic test strip, and specifically relates to a preparation method of an immunochromatographic test strip for detecting premature rupture of membrane. the preparation of an immunochromatographic membrane in the preparation method is characterized in that a goat anti-human soluble intercellular adhesion molecule-1 polyclonal antibody is taken as a working solution of a detection line, and a goat anti-mouse IgG polyclonal antibody is taken as a working solution of a mass control line; the concentration of the working solution of the detection line is 1.5-2.5 mg / mL, and the concentration of the working solution of the mass control line is 0.5-1.5 mg / mL; and a nitrocellulose membrane is coated with the working solution of the detection line and the working solution of the mass control line, and then is dried at 36-38 DEG C for 8-12 hours to get the immunochromatographic membrane. The sensitivity and the specificity of the immunochromatographic test strip for detecting the premature rupture of membrane are improved obviously to be more than 97% and more than 93% respectively, and thus the occurrence rate of error diagnosis is reduced.

Description

technical field [0001] The invention relates to a preparation method of immunochromatographic test paper, in particular to a preparation method of immunochromatographic test paper for detecting premature rupture of membranes. Background technique [0002] Immunochromatography test paper is a method of using the chromatographic principle to flow the target detection molecules or components in the liquid to be tested to the test line (T line) and quality control line (C line) on the test strip. When the test line changes color The change indicates that the test result is positive, otherwise it is negative. When the color of the quality control line changes, it means that the test result is valid, otherwise it is invalid. [0003] Immunochromatographic test strips are very convenient in detecting or diagnosing certain diseases, so they have been fully used in the detection or diagnosis of various diseases or symptoms, such as early pregnancy test strips. In general, immunochro...

Claims

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Application Information

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IPC IPC(8): G01N33/577
Inventor 关祥乾胡怀忠
Owner ORIGISSAY BIOLOGICS TECH
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