From puberty through menopause, a woman's reproductive organs are constantly changing through the normal processes of sexual activity, pregnancy and aging, and sometimes disease and injury. Gynecology is the medical practice dealing with the health of the female reproductive systems (vagina, uterus, and ovaries) and the breasts. Gynecologic disorders are disorders that affect the female reproductive system. Common types of gynecologic disorders include polycystic ovary syndrome (PCOS), endometriosis, uterine fibroids, vaginitis, and menstrual disorders.
PCOS - the most common cause of anovulatory infertility. Women with PCOS are at higher risk for several conditions, including metabolic syndrome, type 2 diabetes, cardiovascular disease, obesity, obstructive sleep apnea, mood disorders, endometrial hyperplasia, and endometrial cancer.
Endometriosis - affects about 10% of women of reproductive age and contributes significantly to the development of pelvic adhesions, infertility, ectopic pregnancy, and chronic pelvic pain.
Uterine Fibroids (leiomyomata) - represent the most common benign gynecologic tumor in women and are associated with an array of detrimental health effects including abnormal uterine bleeding, pelvic pain, infertility, miscarriage, and preterm labor.
Vaginitis - a term used to describe any disorder that causes swelling or infection of both the vulva and the vagina. Common types of vaginitis include noninfectious vaginitis, bacterial vaginosis, yeast infections, and sexually transmitted forms of vaginitis.
Menstrual Disorders - abnormal menstrual bleeding impacts quality of life due to irregular or excessive bleeding and can herald underlying gynecologic pathologies such as the presence of endometrial polyps, uterine fibroids, or anovulatory conditions.
Some gynecologic diseases are self-limited, while others cause infertility or life-threatening infection or bleeding if left untreated. Therefore, prompt and accurate diagnosis is important for appropriate life-saving treatment and for the preservation of fertility. Different tests and techniques have been developed for the diagnosis of gynecological diseases. Firstly, the symptoms and physical examinations are done. Secondly, the gold standard has been the visual inspection by laparoscopy followed by histological confirmation. The histological analysis involves a biopsy that removes a piece of tissues from cervix, vagina, and vulva for examination under a microscope. Thirdly, the imaging techniques, including ultrasonography, computed tomography (CT), and magnetic resonance imaging (MRI), can be performed to narrow the differential diagnosis. Moreover, noninvasive diagnostic tests that are developed for biomarkers analysis in samples such as serum or plasma, urine, endometrial, or menstrual fluid are useful.
Non-invasive diagnostic tests based on the measurement of disease markers or infectious pathogens with IVD immunoassays is useful to aid in the diagnosis of gynecological diseases. These IVD immunoassays use antibodies/antigens that specific for the analytes and generate quantitative information in a sensitive and rapid manner. So far, various immunoassay platforms have been developed, including ELISA (enzyme-linked immune-sorbent assay), LFIA (lateral flow immunoassay), CLIA (chemiluminescent immunoassay), immunohistochemistry, etc.
Development of biomarker-specific IVD immunoassays is a time-consuming, resource-intensive effort. Particularly, the use of high-quality elements, antibodies, and antigen, is of great importance to achieve high sensitivity and accuracy. Creative Biolabs has built a versatile IVD platform to provide custom biomarker-specific IVD antibody development services as well as one-stop IVD immunoassay development services to global clients. Based on our years of experience, we offer flexible support in different phases of the IVD project, including assay design, raw material selection, working protocol establishment, assay validation, and kit manufacturing. For more information, please click the links below:
We focus on various biomarkers as follows:
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