Biotest is an in vitro diagnostics manufacturer producing lateral flow and fluorescence immunoassay rapid tests for professional, laboratory and home use. Our 85,000 m² facility in Hangzhou, China, runs colloidal gold, latex and fluorescent particle platforms under an ISO 13485:2016 MDSAP quality system, supplying CE-marked rapid test kits and OEM/ODM private-label programs to buyers in more than 100 countries.
Hangzhou Biotest Biotech Co., Ltd. is a National High-tech Enterprise founded in 2008 and located in the Yuhang Eco-Industrial Park, Hangzhou. We develop and manufacture immunochromatographic rapid tests and the readers that go with them — from antibody and antigen screening to tumor marker, cardiac marker, inflammation and veterinary panels.
Production is built on our own colloidal gold, latex and fluorescent particle labelling technology, so cut-off values, membrane blocking and conjugation chemistry stay under one roof. That control is what keeps batch-to-batch sensitivity and specificity consistent when you scale from a sample order to a full container.
Ten categories, one quality system. Every category runs on the same membrane, conjugate and QC process, which simplifies mixed orders and keeps documentation consistent.
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Why choose us Our Patent Certification As of December 2023, the company has 230 patented technologies, including 171 domestic patents (9 invention pat
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Why choose us Our Patent Certification As of December 2023, the company has 230 patented technologies, including 171 domestic patents (9 invention pat
Lateral Flow Reader
Why choose us Our Patent Certification As of December 2023, the company has 230 patented technologies, including 171 domestic patents (9 invention pat
Six reasons that come up repeatedly in distributor audits, tenders and OEM projects.
Ten IVD categories from a single manufacturing site means one PO, one set of export documents and one quality agreement instead of five suppliers.
Antigen preparation, antibody labelling and membrane blocking are done internally, backed by 230 patented technologies as of December 2023.
45 NMPA certificates, EU CE certificates covering 603 products and 3 US FDA 510(k) clearances covering 21 tests, with dossier support for your market.
Your brand on the box, our engineering behind it. Packaging design, IFU localisation and kit configuration are handled by a dedicated project team.
An 85,000 m² facility with automated assembly and lot-level traceability keeps sensitivity and specificity stable between the first batch and the hundredth.
Products reach more than 100 countries. In 2015 we acquired Advin Biotechnology in the United States, adding FDA-registered toxicology development to the group.
Format, sample type, shelf life and packaging are fixed by product. The table below covers the parameters common to the range - request the datasheet for cut-off values and performance data on a specific item.
| Product type | Immunochromatographic rapid test (lateral flow) |
|---|---|
| Test formats | Cassette, dip card, strip, midstream, multi-panel cup |
| Sample types | Urine, whole blood / serum / plasma, saliva or oral fluid, nasal and vaginal swabs |
| Detection principle | Sandwich or competitive immunoassay on colloidal gold, latex or fluorescent particles |
| Result reading | Visual (C / T lines) or quantitative with lateral flow / fluorescence reader |
| Time to result | 5 – 15 minutes, depending on analyte |
| Cut-off value | Product-specific, stated in ng/mL on the IFU |
| Shelf life | 18 – 24 months from date of manufacture |
| Storage | 2 – 30 °C, dry, away from direct sunlight; do not freeze |
| Packaging | Individually sealed foil pouch with desiccant; 1, 20, 25, 40 or 50 tests per box |
| Kit contents | Test device, buffer or diluent, dropper, sterile swab, IFU |
| Certification | CE (IVDD 98/79/EC), ISO 13485:2016, US FDA 510(k) for selected tests |
| OEM / ODM | Available - private label, custom packaging, custom panel and cut-off |
| Minimum order | Negotiable; sample orders accepted for evaluation |
| Lead time | 7 – 25 days after deposit, depending on item and quantity |
| Shelf life data | Real-time and accelerated stability reports available on request |
* Specifications vary by product. Values above describe the standard range; the instruction for use supplied with each lot is the binding document.
Six application settings our customers buy for, from judicial screening to veterinary clinics and laboratory workflows.
Judicial and public security screening, workplace testing, rehabilitation centres and harm-reduction programs. Urine, saliva and oral fluid formats covering 66 substances, including fentanyl, tramadol and synthetic cannabinoids.
Hospital outpatient departments, CDC and blood-centre screening for HIV, HBsAg, HCV and syphilis, plus fever panels for dengue and malaria in endemic regions.
OB/GYN clinics, IVF centres and pharmacy retail: pregnancy and ovulation prediction, fertility hormone panels and vaginal infection screening for home and professional use.
Emergency department chest-pain triage with cTnI, CK-MB and Myo, and community screening programs using AFP, CEA and PSA tumor marker tests.
Companion animal clinics, livestock farms and quarantine stations: canine and feline infectious disease, hormone and inflammation testing at the point of care.
Small and mid-size laboratories that need quantitative results: fluorescence immunoassay analyzers with matching cartridges, calibration cards and LIS-ready output.
Four buying models. Each one comes with its own documentation set, packaging options and commercial terms.
Mixed-category orders, protected territory and marketing material so you can open a market without managing five supplier relationships.
Your label, your IFU, your panel. A dedicated project engineer follows the order from artwork approval to first-article inspection.
Volume supply for ministries of health, NGOs and screening campaigns, with the paperwork tenders ask for and a stable production slot.
Point-of-care tests plus the reader, controls and training that make quantitative testing practical outside a central laboratory.
Seven controlled stages, each with a release gate. Nothing moves to the next stage without a QC signature.
Antigen, antibody, membrane, conjugate and card stock are tested on arrival; only released lots enter production.
Colloidal gold, latex or fluorescent particles are conjugated and qualified against reference standards.
Test and control lines are dispensed, dried and inspected for line position and intensity.
Lamination, card cutting and cassette or strip assembly on automated lines in a controlled environment.
Individual foil pouching with desiccant, seal integrity check and lot coding for traceability.
Sensitivity, specificity, precision, cross-reactivity and appearance tested against the product specification.
Retained samples enter the stability program; QA reviews the batch record and releases the lot.
Quality management system and product certificates for the rapid test range. Scans can be supplied as PDF on request for tender and registration files.
85,000 m² of production, QC laboratory and controlled storage in the Yuhang Eco-Industrial Park - registered capital of 106 million RMB.
We are a manufacturer. Hangzhou Biotest Biotech Co., Ltd. was founded in 2008 and operates an 85,000 m² facility in the Yuhang Eco-Industrial Park, Hangzhou, covering R&D, production, QC and export in one site.
The quality system is certified to ISO 13485:2016 and audited under MDSAP. Products hold EU CE certificates issued under IVDD 98/79/EC, 45 NMPA certificates, and 3 US FDA 510(k) clearances covering 21 tests. Certificate numbers and scopes are listed in the Certifications section above.
Yes. OEM and ODM projects are standard work for us: private-label boxes, custom pouches, localised IFU, custom panel combinations and custom cut-off values. Artwork approval and first-article samples are completed before mass production.
MOQ is negotiable and depends on the item and packaging. Sample orders are accepted for evaluation. Production lead time is typically 7–25 days after deposit and artwork confirmation; larger or mixed orders are scheduled individually.
Yes, evaluation samples are available for most items. Buyers normally cover the courier cost, and the sample charge is refundable against the first bulk order.
Rapid tests ship at ambient temperature - no cold chain is required. Products should be stored at 2–30 °C, kept dry and away from direct sunlight, and must not be frozen. Shelf life is 18–24 months from the manufacturing date.
Yes. We provide technical files, IFU and label content, performance and stability reports, and certificate copies for registration dossiers. For markets with specific formatting requirements our regulatory team adapts the documents.
Raw materials are released only after incoming testing; every batch goes through in-process checks, finished-product sensitivity and specificity testing, and retained-sample stability monitoring. Batch records are traceable to the component lots used.
Tell us the analytes, formats and target market. You will get a quotation, the matching datasheets, certificate copies and a realistic lead time - no obligation.
