Innovative Colloidal Gold Quantitative Testosterone Detection

I. Clinical Significance of Testosterone Testing: A Core Indicator for Health Management

Testosterone, as a core androgen, plays multiple physiological roles in the human body:

- Male health: Maintaining sexual function, muscle mass, bone density, and metabolic balance; diagnosing hypogonadism, erectile dysfunction, and testicular dysgenesis.

- Female health: Assisting in the diagnosis of polycystic ovary syndrome (PCOS), hirsutism, and evaluating hyperandrogenemia.

According to statistics, PCOS affects 5-10% of women of childbearing age worldwide, with over ten million patients in China. Meanwhile, the prevalence of late-onset hypogonadism (LOH) in men over 40 years old is as high as 40%, highlighting the urgent need for testing.

II. Limitations of Existing Detection Technologies

The current mainstream methods all have their drawbacks:

1. ELISA method: It takes 1.5 hours for detection, relies on laboratory equipment, and is suitable for scientific research but difficult to popularize.

2. Chemiluminescence/time-resolved fluorescence method: It requires fully automatic instruments, is costly, and is limited to large hospitals.

3. Mass spectrometry (LC-MS/MS): Although it can perform multi-index joint detection (such as testosterone and androstenedione), the equipment is expensive and the pretreatment process is complex, making it only feasible in hospitals.

Therefore,  a simple, fast and economical solutions are urgently needed in primary care and home settings.

III. Breakthrough Product: Colloidal Gold Quantitative Testosterone Detection Kit

Our company has launched the first colloidal gold quantitative testosterone detection kit. Relying on the colloidal gold technology platform and combined with the colloidal gold quantitative detection instrument, it achieves an extremely simple operation of "sample in - result out" by obtaining the signal of the detection line.

Technical Principles

- Nano-gold labeled antibody: Colloidal gold particles are combined with testosterone antibodies to form specific conjugates.

- Competitive immunochromatography: Testosterone in the sample competes with the gold-labeled antibody to bind to the detection line (T line), and the signal intensity of the T line is negatively correlated with the testosterone concentration.

- Signal quantification: The signal is captured by a portable reader, and the concentration is accurately calculated (detection limit as low as 0.25 ng/mL).

Disruptive Advantage

IV. Comprehensive Services Empowering Industry Partners

To accelerate the popularization of technology, our company offers full-chain support:

1. Technology Transfer

- Core Process Packages: Nano-gold labeling process, antibody pairing solutions, test strip assembly technology;

- Adapted to Multiple Scenarios: Supports whole blood, plasma, and serum sample testing.

2. OEM/ODM Processing

- Flexible Customization: Offer single-person  strips or uncut sheets; can be adjusted to qualitative, semi-quantitative and quantitative reagents.

- Quality Control Assurance: Comply with CE/IVD standards, and stability verification (12-months storage period at 2-30℃).

V. Conclusion: Redefining the "Speed" and "Accessibility" of Testosterone Testing

Colloidal gold quantitative technology has liberated testosterone detection from laboratories to bedside, home and field scenarios. The "golden window" of 15 minutes helps doctors make quick decisions and enables patients to manage themselves. In the future, we will continue to promote the in-depth application of this technology in the fields of women's health and reproductive health, and work with global partners to build a precise health ecosystem.

For any inquiries, please feel free to contact below: 

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

#IVD  #KSB  # Hormone # rapid test  # testosterone #OEM