KSB / Hormone Marker Rapid Test - The Precise Key to Clinical Diagnosis

In the field of in vitro diagnostics, the detection of hormone markers holds irreplaceable and significant value for assisting clinical diagnosis, disease screening, treatment monitoring, and more.

KSB  has been deeply engaged in the research and development and production of hormone marker detection rapid test, and is committed to providing medical professionals with accurate and reliable detection tools.

I. Hormone Markers and Their Clinical Significance

1. LH (Luteinizing Hormone)

Clinical significance: In females, LH works in conjunction with follicle-stimulating hormone (FSH) to regulate the cyclical changes of the ovaries and plays a crucial role in ovulation and corpus luteum formation. Its detection is helpful for diagnosing ovulatory disorders, polycystic ovary syndrome (PCOS), and other gynecological diseases. In males, LH stimulates the interstitial cells of the testis to synthesize and secrete androgens, and can be used to evaluate male gonadal function and assist in the diagnosis of hypogonadism and other conditions.

Normal clinical range: Generally speaking, for adult females, the follicular phase is 2 - 12 U/L, the ovulatory phase is 20 - 100 U/L, and the luteal phase is 2 - 20 U/L; for adult males, it is 1 - 8 U/L. However, different sources may have slightly different definitions of the normal range for LH. For instance, WebMD indicates that for females, the follicular phase is 5 - 25 IU/L, the ovulatory phase is 30 - 100 IU/L, the luteal phase is 4 - 15 IU/L, and the menopausal phase is 30 - 130 IU/L; for males, it is 1.8 - 8.6 IU/L. Other sources suggest that for females, LH is 1.37 - 9 IU/L in the first week of the menstrual cycle, 6.17 - 17.2 IU/L in the second week before ovulation, 1.09 - 9.2 IU/L in the third and fourth weeks, and 19.3 - 100.6 IU/L after menopause; for males, the normal range is 1.42 - 15.4 IU/L.

2. FSH (Follicle Stimulating Hormone)

Clinical significance: During the female menstrual cycle, FSH is mainly responsible for recruiting and selecting dominant follicles and promoting their development and maturation. Measuring FSH levels can be used to assess female ovarian reserve function, predict menopause, and diagnose premature ovarian failure, etc. In males, FSH promotes spermatogenesis. By testing, it can be used to understand male reproductive capacity and identify the causes of infertility.

Normal clinical range: Prepubertal females - follicular phase 5 - 10 IU/L, ovulatory phase 10 - 30 IU/L, luteal phase 4 - 10 IU/L, postmenopausal > 40 IU/L.

3. Testosterone

Clinical significance: It is the main male hormone. In men, it is crucial for the development of reproductive organs, sperm production, and maintaining secondary sexual characteristics. In women, physiological levels of testosterone play a certain role in maintaining sexual desire and bone health. Testosterone testing can be used to diagnose male androgen deficiency and female hyperandrogenism (such as polycystic ovary syndrome).

The normal clinical range: The normal value of testosterone in adult males is generally between 14 - 25.4 nmol/L (equivalent to 300 - 1000 ng/dL), and some sources indicate that the normal value for male testosterone is 260 - 1590 ng/dL; the normal value of testosterone in adult females is usually between 0.7 - 2.8 nmol/L (equivalent to 20 - 80 ng/dL).

4. TSH (Thyroid Stimulating Hormone)

Clinical significance: Secreted by the anterior lobe of the pituitary gland, it can feedback-regulate thyroid function and stimulate the thyroid to synthesize and secrete thyroid hormones. TSH testing is the preferred indicator for thyroid function assessment, enabling early detection of hyperthyroidism or hypothyroidism. It is of great significance for diagnosing thyroid diseases and monitoring the efficacy of thyroid hormone replacement therapy.

The normal clinical range: Generally, it is between 0.4 - 4.0 mIU/L. It varies under different physiological and pathological conditions. For instance, during pregnancy, the normal range becomes narrower.

5. AMH (Anti-Müllerian Hormone)

Clinical significance: Secreted by granulosa cells of small ovarian follicles, it is an excellent indicator for evaluating the ovarian reserve function of women. AMH levels are relatively stable and not affected by the menstrual cycle, which can more accurately reflect the number of primordial follicles in the ovaries. It can be used to predict the age of menopause, assess ovarian responsiveness in assisted reproductive technology, and provide key evidence for the evaluation of female fertility.

The normal clinical range: Generally speaking, the normal value of AMH in women is between 2 - 6.8 ng/mL. A value greater than 6.8 ng/mL may suggest polycystic ovary syndrome, while a value less than 2 ng/mL may indicate a decline in ovarian reserve function.

6. Progesterone

Clinical significance: It is a key hormone for maintaining pregnancy. Its secretion increases during the luteal phase of the female menstrual cycle, providing a suitable environment for the proliferation and secretion of the endometrium and the implantation of the fertilized egg. Detection of progesterone can be used to assist in the diagnosis of early pregnancy, assess luteal function, predict the risk of miscarriage, etc. It is of great value in the diagnosis and management of gynecological endocrine diseases and pregnancy-related diseases.

The normal clinical range: For women of childbearing age, the follicular phase is 0.2 - 0.4 ng/ml, the ovulatory phase is 8.5 - 32.2 ng/ml, the early pregnancy period is 20 - 30 ng/ml, the mid-pregnancy period is 50 - 100 ng/ml, and the late pregnancy period is 100 - 400 ng/ml.

7. PRL (Prolactin)

Clinical significance: Secreted by the anterior lobe of the pituitary gland, its main physiological function is to promote breast development and milk secretion. PRL testing can be used to diagnose pituitary prolactinomas, hyperprolactinemia and other diseases, which may cause menstrual disorders, amenorrhea, infertility and other symptoms.

Normal clinical range: 3 - 25 ug/L for women of childbearing age.

II. KSB R&D Product Information

The hormone marker detection reagents produced by KSB have the following outstanding features:

1.Precise and reliable: 

Utilizing the colloidal gold quantitative and fluorescence immunoassay detection platform, and subject to a strict quality control system, it ensures the high accuracy and repeatability of the test results, providing a solid basis for clinical diagnosis.

2. Comprehensive Coverage: 

The test kits cover a wide range of hormone markers including LH, FSH, testosterone, TSH, AMH, progesterone, PRL, etc., meeting the diverse clinical scenarios and diagnostic needs, and assisting medical institutions in comprehensively assessing the endocrine status of patients.

3. Easy operation: 

The reagents are easy to use and the detection process is efficient, with results available within 20 minutes.

4. Strong stability: 

The products have been specially formulated and optimized in production processes, ensuring a long validity period and good stability under specified storage conditions. This guarantees consistent performance across different batches and usage cycles of the reagents.

5. CE Certification: 

All products have obtained CE certification and can be sold in the European Union and neighboring regions that recognize CE.

III. Services We Can Provide

1.Recruiting Agents:

We sincerely invite agents from all over the country who are passionate about the field of in vitro diagnostics to join us. We offer comprehensive market promotion support, professional training systems, competitive product prices and profit margins. Let's work together to create a bright future.

2.Technology Development: 

We have a strong R&D team that can continuously develop new hormone biomarker detection reagents and related detection technologies based on market demands and customer feedback, dedicated to providing more innovative solutions for clinical diagnosis.

3. Technology transfer: 

Provide mature technology transfer services for partners in need, helping them achieve localized production and quality control of hormone marker detection reagents, and promoting technology sharing and industrial upgrading.

4.OEM Service: 

We have professional OEM production capabilities and can customize the production of hormone biomarker detection reagents based on specific customer requirements and brand demands, meeting the personalized market strategies of different customers.

With a professional technical team and high-quality products and services, Kangshengbao Company has always been at the forefront of the in vitro diagnostic reagent industry. We look forward to working with you to promote the wide application of hormone marker detection in the field of medical diagnosis, improve the level of medical services, and benefit a large number of patients.

for any inquiries, please feel free to contact below: 

info@ksbbiotech.com / candy.liang@ksbbiotech.com 

#IVD  #KSB  # Hormone # rapid test