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Making method of immunochromatographic test paper for detecting premature rupture of fetal membranes

A technology of immunochromatography 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 unsatisfactory sensitivity, specificity and accuracy, inconvenience for obstetric patients, and easy misdiagnosis

Active Publication Date: 2013-06-05
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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  • Making method of immunochromatographic test paper for detecting premature rupture of fetal membranes
  • Making method of immunochromatographic test paper for detecting premature rupture of fetal membranes
  • Making method of immunochromatographic test paper for detecting premature rupture of fetal membranes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[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) Positive detection of fern leaf crystals.

[0064] Healthy control group—(i) Amniotic fluid leakage was not observed before labor;

[0065] (ii) The pH test paper test of the vaginal secretion sample is negative;

[0066] (iii) Negative test for fern leaf crystals.

[0067] Age distribution of experime...

Embodiment 2

[0185] 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.

[0186] 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 making method of immunochromatographic test paper, and concretely relates to a making method of immunochromatographic test paper for detecting the premature rupture of fetal membranes. The preparation method of colloidal gold used in the making method comprises the following steps: heating an aqueous solution of chloroauric acid to boil, adding 2-3mL of an aqueous solution of trisodium citrate having a concentration of 0.5-2g / 100mL under stirring, boiling for 3-10min, cooling, adjusting the pH value to 6.0-7.0 by an aqueous K2CO3 solution to obtain the colloidal gold. The obtained colloidal gold and a mouse anti-human soluble intercellular adhesion molecule-1 monoclonal antibody are used to make a colloidal gold bind pad. The sensitivity and the specificity of the immunochromatographic test paper for detecting premature rupture of fetal membranes obtained through the making method are obviously improved and reach above 97% and above 93% respectively, so the incidence 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): G01N33/577G01N33/558G01N33/544
Inventor 关祥乾胡怀忠
Owner ORIGISSAY BIOLOGICS TECH
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