Preparation method of immunochromatography test paper for detecting premature rupture of fetal membranes

A technology of immunochromatographic test strips and premature rupture of membranes, which is applied in the direction of measuring devices, analysis materials, instruments, etc., can solve the problems of easy misdiagnosis, unsatisfactory sensitivity, specificity and accuracy, and inconvenience for obstetric patients. Effects of Sensitivity and Specificity Improvement

Active Publication Date: 2013-06-26
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 using sICAM-1 as a detection index provides convenience for obstetric patients, its sensitivity, specificity and accuracy are not ideal, which easily leads to misdiagnosis and is harmful to obstetric patients. it will also be inconvenient

Method used

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  • Preparation method of immunochromatography test paper for detecting premature rupture of fetal membranes
  • Preparation method of immunochromatography test paper for detecting premature rupture of fetal membranes
  • Preparation method of immunochromatography test paper for detecting premature rupture of fetal membranes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] 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);

[0053] Healthy control group: 110 pregnant women with intact membranes before delivery;

[0054] Amniotic fluid sample group: 30 pregnant women with intact membranes undergoing cesarean section.

[0055] Clinical screening criteria for experimental subjects:

[0056] Premature rupture of membranes group—(i) Leakage of amniotic fluid was observed before labor;

[0057] (ii) The pH test paper test of the vaginal secretion sample is positive;

[0058] (iii) Positive detection of fern leaf crystals.

[0059] Healthy control group—(i) Amniotic fluid leakage was not observed before labor;

[0060] (ii) The pH test paper test of the vaginal secretion sample is negative;

[0061] (iii) Negative test for fern leaf ...

Embodiment 2

[0180] 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.

[0181] 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 immunochromatography test paper and particularly relates to a preparation method of immunochromatography test paper for detecting premature rupture of a fetal membrane. A colloidal gold conjugated pad in the preparation method is obtained through the following steps of: adding -1 monoclonal antibodies mouse-anti-human soluble intercellular adhesion molecules in colloidal gold for labeling 20-50 minutes, adding bovine serum albumin for sealing for 20-50 minutes, and centrifugally separating, thus obtaining a separation product, namely a colloidal gold conjugate; dissolving the colloidal gold conjugate in a phosphate buffer solution with pH ranging from 7.2 to 7.4, wherein the phosphate buffer solution contains 10-30mg/100mL of sodium azide; and coating glass fibers with the phosphate buffer solution added with the colloidal gold conjugate, and drying for 8-12 hours at the temperature of 36-38 DEG C, thus obtaining the colloidal gold conjugated pad. According to the immunochromatography test paper prepared by the preparation method, the sensitivity and the specificity are increased remarkably and respectively achieve over 97% and over 93%, so that the occurrence rate of misdiagnosis 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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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558
Inventor 关祥乾胡怀忠
Owner ORIGISSAY BIOLOGICS TECH
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