Publish Time: 2026-01-05 Origin: Bioteke
In the world of In Vitro Diagnostics (IVD), innovation is often measured by how much it simplifies the user experience without sacrificing accuracy. For decades, urine-based testing has been the undisputed standard for at-home pregnancy detection. However, Bioteke Corporation is challenging this 70-year-old status quo with its groundbreaking Saliva Pregnancy Test Kit.
As we move into 2026, Bioteke’s patented technology is not just a "new product"—it is a strategic pivot for distributors and healthcare providers looking to lead the IVD market.
It is a common misconception that HCG (Human Chorionic Gonadotropin) is only present in urine or blood. In reality, HCG is a glycoprotein that enters the bloodstream and permeates various bodily fluids, including saliva.
Bioteke’s kit utilizes a High-Sensitivity Chromatographic Immunoassay. This double-antibody sandwich method allows for the qualitative detection of HCG levels as low as $5 mIU/mL.
Bioteke has successfully completed rigorous clinical trials, proving that saliva-based detection can match the reliability of traditional methods.
| Feature | Bioteke Saliva Test Specification |
| Sensitivity | 99% |
| Specificity | 100% |
| Detection Limit (LoD) | 5 mIU/mL (Ultra-Early Detection) |
| Result Time | Positive in as fast as 20s; Final confirmation in 5-10 mins |
| Sample Type | Human Saliva (Non-invasive) |
Traditional urine tests require a private bathroom and, often, a "first-morning" sample for maximum accuracy. The Bioteke Saliva Test removes these barriers. Whether at work, traveling, or in a social setting, users can test discreetly without needing a restroom.
By eliminating the need for urine collection cups or "mid-stream" maneuvers, Bioteke offers a cleaner, more dignified experience. This non-invasive approach is particularly appealing to the modern, health-conscious consumer who prioritizes wellness and convenience.
With a sensitivity of 5 mIU/mL, our test can detect pregnancy as early as 7–10 days after conception, providing answers even 3 days earlier after the missed period.
For EU B2B partners, regulatory compliance is the ultimate trust signal. While the product already carries the CE Mark and ISO 13485 certification, Bioteke is currently in the advanced stages of applying for EU IVDR (In Vitro Diagnostic Regulation 2017/746) self-test certification.
What does this mean for distributors?
Future-Proofing: IVDR is the most stringent diagnostic standard in the world. Being ahead of this curve ensures that Bioteke products will remain on shelves long after older "IVDD" products are phased out.
Retail Expansion: Once the self-test certification is finalized, it opens doors to every major pharmacy chain and retail outlet across the EU.
As a open, innovative supplier in IVD manufacturing, Bioteke offers more than just a product; we offer a partnership. We provide:
OEM/ODM Services: Tailored packaging and branding for your specific market.
Regulatory Support: Assistance with local registrations and clinical data requirements.
Supply Chain Stability: High-volume manufacturing capacity from our ISO-certified facilities.
The shift toward non-invasive diagnostics is inevitable. Bioteke’s Saliva Pregnancy Test Kit is at the forefront of this revolution, combining patented innovation with clinical-grade accuracy.
Are you ready to bring the next generation of pregnancy testing to your market?
Contact Bioteke Today for Wholesale Inquiries and Clinical Reports.