The World's Leading New Technology for Premature Rupture of Membranes Diagnosis
Research Background
Premature Rupture of Membranes (PROM) refers to the rupture of membranes that occurs in pregnant women before labor. When the gestational period is ≥ 37 weeks, the occurrence of premature rupture of membranes is called full-term premature rupture of membranes (PROM), with an incidence rate of 10%. When the gestational period is ≤ 37 weeks, the occurrence of premature rupture of membranes is called preterm premature rupture of membranes (PPROM), with an incidence rate of 2% - 20%. Among them, the incidence rate of premature rupture for single fetus is 2% - 4%, and for twin fetuses is 7% - 20%. Premature rupture of membranes is one of the most common complications in the perinatal period. Its pregnancy outcome is related to the gestational age at the time of membrane rupture. If not detected and handled in a timely manner, it can cause serious adverse consequences for pregnant women, fetuses, and newborns, such as preterm birth, maternal and infant infections, fetal lung dysplasia, cord prolapse, fetal deformity, serious neonatal diseases and postpartum endometritis. Currently, there is no non-invasive gold standard for the detection of membrane rupture in domestic and international clinical practice for maternal and infant complications caused by premature rupture of membranes. The most commonly used methods include vaginal fluid pH measurement, vaginal posterior fornix effusion examination, and vaginal fluid smear fern-like crystal examination. Although vaginal effusion examination is direct evidence for diagnosing premature rupture of membranes, not every patient with premature rupture of membranes has obvious effusion, and the examination is relatively troublesome and has poor patient acceptance. Vaginal fluid pH determination can show false positive results when there is alkaline urine, blood, semen, or vaginal inflammation in the vaginal fluid. Vaginal fluid smear fern-like crystal examination may show false positive results due to easy contamination of glass slides by fingerprints, semen, and cervical mucus. Dried swabs or specimens contaminated by blood may cause false negative results, and the requirements for inspectors are high. In addition, when there is a small amount or high-level membrane rupture, it is difficult to obtain accurate diagnostic results only relying on the above methods.
Project Introduction
01
A biotechnology company was founded in early spring of 2010. It is a high-tech biotechnology company with independent intellectual property rights and master core technologies, integrating the research and development, production and promotion of clinical diagnostic reagents. At its establishment, it showed a strong development momentum. It has multiple original patents for rapid diagnostic markers of premature rupture of membranes and can widely be used in a rapid detection kit for clinical detection of premature rupture of membranes. It adheres to the responsibility of human health and pursues superior quality and high reputation.
02
Soluble intercellular adhesion molecule-1 (soluble intercellular adhesion molecule-1, sICAM-1) is shed from the extracellular membrane components by protease cleavage. The concentration of sICAM-1 in amniotic fluid is extremely high. When the membranes rupture, the amniotic fluid will leak into the vagina, resulting in a significant increase in the concentration of sICAM-1 in vaginal fluid. However, the background concentration of sICAM-1 in vaginal fluid is very low when the membranes are intact. Therefore, this product uses the sICAM-1 detection kit for pregnant women during pregnancy (colloidal gold method) (trade name: Yuyikang) to qualitatively detect soluble intercellular adhesion molecule-1 in vaginal secretions of pregnant women during pregnancy for the diagnosis of premature rupture of membranes. Using the principle of colloidal gold immunochromatography, human sICAM-1 is detected. The gold-labeled mouse anti-human ICAM-1 monoclonal antibody captures sICAM-1 in the sample to be tested in the sample pad area to form an ICAM-1/monoclonal antibody complex and flows from the adsorption area to the test area. After binding with the goat anti-human ICAM-1 polyclonal antibody pre-solidified in the test area of the test card, it is fixed in the insoluble carrier and forms a visible red test line at the test line (T line), indicating that the sample contains a high concentration of sICAM-1, suggesting amniotic fluid leakage. The quality control line (C line) is used to show whether the detection kit is functioning normally. When the goat anti-mouse IgG polyclonal antibody captures the gold-labeled mouse anti-human ICAM-1 monoclonal antibody, the quality control line shows red.
Technical Advantages
Non-invasive and pollution-free, simple operation
This product is tested by taking vaginal posterior fornix secretions. It is non-invasive and pollution-free, easy to use, does not require inspection instruments, and is operated by doctors, nurses and midwives. The results are available in 3 - 6 minutes, and the judgment is simple. Its sensitivity is as high as 99.53%, specificity is 95.99%, and accuracy is 97.42%, which can significantly reduce the missed diagnosis rate. This test can provide rapid diagnosis for clinical doctors, improve work efficiency and protect the health of mothers and infants.
This product can be used for the diagnosis of typical and atypical premature rupture of membranes in clinical practice, the diagnosis of full-term and preterm premature rupture of membranes, and has excellent discriminatory diagnostic value for increased vaginal fluid caused by vaginal inflammation, increased fluid on the outer genital area caused by urinary incontinence, and physiological increase in vaginal fluid. It can also be used for the screening of high-risk pregnant women with premature rupture of membranes (such as: having gynecological inflammation; the age of pregnant women < 18 years old or > 35 years old; vaginal bleeding; bad lifestyles such as smoking and excessive drinking; a history of premature rupture of membranes; amniocentesis or frequent sexual life in the third trimester; excessive amniotic fluid, multiple pregnancies, abnormal fetal positions, etc.; uterine deformity, placental abruption, incompetent cervix; having acute upper respiratory tract infection, hypertension, hyperthyroidism and other diseases; multiple abortions or premature delivery histories; deficiency of nutrients such as vitamin C, copper and zinc; combined with diabetic patients; severe cough, severe constipation, etc.; high mental stress during pregnancy, etc.) to diagnose atypical premature rupture of membranes (high-level or tiny rupture) and avoid missed diagnosis affecting the health of the fetus and the mother, thereby avoiding doctor-patient disputes.
Financing Plan
At present, the company is undergoing equity restructuring. The estimated value in 2025 is 200 million yuan. If interested, please contact.
