Certified Compliance: Manufactured strictly under ISO 13485 quality management systems, ensuring medical-grade uniformity, complete raw material traceability, and reliable compliance for global distribution.
Home & Self-Testing Friendly: Designed with a minimalist, non-professional "one-step" process, making it an essential and accessible diagnostic tool for home self-testing and elderly care, delivering clear results in just 10–15 minutes.
Product Introduction Copy (Marketing Copy)
【The world's leading expert in rapid diagnostic customization - Your preferred partner for OEM and bulk supply】
In public health screening and large-scale prevention programs, cost-effectiveness and customized services are the keys to success. Our One Step Rapid Test (one-step rapid test kit) series is specifically designed for government tenders, non-governmental organizations (NGOs) procurement, and brand retailers.
Core Strengths
Flexible OEM/ODM Services (Flexible Customization): We offer a comprehensive branding solution, including brand logo embedding, packaging color adjustment, multilingual instructions (such as French, Russian, Portuguese, Arabic, etc.) and card surface silk-screen customization.
Government Bulk Supply Capability: For large-scale public screening needs, we provide highly competitive tiered prices, with sufficient production capacity and rapid logistics response, making us a high-quality supplier for international government bidding projects.
Maximum Packaging Protection: Each test kit is sealed in an independent aluminum foil bag, with powerful desiccants inside to ensure the stability and activity of the reagents in extreme transportation and storage conditions (2-30°C).
Minimalist Operation, Self-testing Friendly: Designed for non-professionals, the "one-step" process yields results within 10-15 minutes, with simple and intuitive interpretation, significantly reducing public health costs.
Quality Compliance: Strictly adhering to IVD production standards, we have a complete quality system certification, ensuring the uniformity and reliability of each batch of products.
Product Specifications
| Category | One Step Rapid Test |
| Methodology | Colloidal Gold Immunochromatography |
| Storage | 2°C – 30°C (36°F – 86°F) |
| Reading Time | 10 – 15 minutes |
| Packaging | 1 test/individual foil pouch; 25/40/50/100 tests/kit available |
| Application | Hospitals, Clinics, Home Self-testing, Government Mass Screening |
| Shelf Life | 24 months |
| Supply Capacity | Supports bulk supply and government procurement bidding |
| Specimen | Depends on test item (Whole Blood / Serum / Urine / Saliva, etc.) |
The Professional OEM/ODM One Step Rapid Test Kit platform by Beijing Jiachuang Jiuhe Global Trade Co., Ltd delivers full-scale contract manufacturing for medical distributors and healthcare brand owners worldwide. This comprehensive Custom Rapid Diagnostic Kit service covers every phase of production, from raw membrane selection to private label packaging. Whether you require an OEM One Step Test Strip for infectious diseases, fertility tracking, drug screening, or chronic biomarkers, our high-capacity facility delivers precise, stable ODM Lateral Flow Assay Kit platforms. We offer flexible, medical-grade manufacturing that transforms your specialized formulations into market-ready diagnostic assets efficiently.
In the fast-moving medical market, expanding your proprietary product line through a dependable Contract Manufacturing Rapid Test partner is a major competitive advantage. The Professional OEM/ODM One Step Rapid Test Kit architecture is built to support companies that want to launch their own branded diagnostics without investing in expensive factory infrastructure.
Our facility adapts seamlessly to your technical needs. When developing a Custom Rapid Diagnostic Kit, our engineers help optimize antigen-antibody conjugation, choice of nitrocellulose membranes, and buffer compositions. This ensures high stability and rapid wicking action across the strip. From simple visual colloidal gold formats to advanced fluorescent readers, each OEM One Step Test Strip is calibrated for reliable precision. Partnering with us gives you access to a turnkey manufacturing supply chain. We manage raw material sourcing, automated cassette assembly, desiccant sealing, and custom packaging. This allows you to launch high-quality B2B Bulk Rapid Test Kits under your own brand name while maintaining strict regulatory compliance.
Full-Scale Private Labeling: Complete freedom over outer box artwork, cassette branding, and multi-language instructions for your Private Label Diagnostic Kit.
Flexible Diagnostic Modalities: Fully adaptable for colloidal gold nanoparticles, latex beads, or advanced fluorescence-based ODM Lateral Flow Assay Kit formats.
Broad Specimen Optimization: Tailored to work flawlessly with human whole blood, serum, plasma, urine, saliva, or swab-extracted analytes.
Scalable Production Capacity: High-throughput automated lines ensure stable delivery of B2B Bulk Rapid Test Kits during sudden market spikes.
Strict Confidentiality Protocols: Full intellectual property (IP) protection secured by robust, enforceable Non-Disclosure Agreements (NDAs).
The core asset of our Professional OEM/ODM One Step Rapid Test Kit service is our deep expertise in lateral flow chemistry and microfluidic dynamics. Creating a stable Custom Rapid Diagnostic Kit requires balancing membrane porosity, sample viscosity, and conjugate release rates.
A key challenge in Point of Care Test Development is maintaining batch-to-batch consistency. Our laboratory uses high-precision dispensing equipment to coat antibodies onto the OEM One Step Test Strip matrix. Whether spraying capture lines for qualitative screens or quantitative assays, we tightly control environmental humidity and strip drying cycles. This attention to detail prevents test-line bleed and reduces background noise, delivering clear visual readouts and clean contrast.
Manufacturing a Private Label Diagnostic Kit involves serious regulatory responsibilities. Our production facilities operate under strict ISO 13485 quality management systems. This ensures that every ODM Lateral Flow Assay Kit we produce maintains full raw material traceability. We provide complete technical documentation to support your local product registrations and clearance protocols.
| Customization Component | Available OEM/ODM Specifications & Options |
| Product Platform Name | Professional OEM/ODM One Step Rapid Test Kit |
| Primary Test Formats | Cassette, Uncut Sheet, Dipstick, or Midstream |
| Detection Technologies | Colloidal Gold, Latex Nanoparticles, Fluorescent Dots |
| Target Assay Types | Infectious Disease, Fertility, Toxicology, Cardiac Markers |
| Sample Matrix Support | Whole Blood / Serum / Plasma / Urine / Saliva / Swab |
| Custom Branding Areas | Laser-Etched Cassette Logo, Printed Pouches, Custom Boxes |
| Analytical Performance | Custom Sensitivity and Specificity Targets Available |
| Storage Specifications | Room Temperature Stability (2°C – 30°C) |
| Regulatory Support | ISO 13485 Compliant Manufacturing Facility |
| Lead Manufacturing Origin | Beijing Jiachuang Jiuhe Global Trade Co., Ltd |
Global Medical Distributors: Expand your regional footprint with a customized, proprietary line of B2B Bulk Rapid Test Kits.
National Public Health Programs: Source large quantities of a custom OEM One Step Test Strip tailored to specific epidemic tracking needs.
OTC Retail Pharmacies: Launch high-margin, store-branded consumer kits for fertility or wellness screening.
Veterinary & Agricultural Labs: Create specialized Point of Care Test Development models for livestock disease screening.
Choosing our Contract Manufacturing Rapid Test platform gives healthcare wholesalers and corporate diagnostic brands deep economic and operational benefits:
Minimized Capital Expenditures: Skip the multimillion-dollar cleanroom construction and equipment maintenance costs by utilizing our established infrastructure.
Accelerated Time-to-Market: Leverage our pre-optimized ODM Lateral Flow Assay Kit designs to cut your R&D cycles by months.
Stronger Competitive Moat: Owning a Custom Rapid Diagnostic Kit protect your business from local price wars, giving you full control over wholesale pricing margins.
For standard parameters using our stock materials, initial OEM One Step Test Strip samples can be prepared for evaluation within 2 to 4 weeks. Complex or completely new Point of Care Test Development projects may take longer depending on antigen sourcing.
Yes. Our contract manufacturing team regularly works with client-supplied biological materials. We can run small pilot batches to test your materials on our automated assembly lines.
MOQs vary depending on the product format (uncut sheets vs. finished cassettes) and packaging complexity. Please contact our B2B team at Beijing Jiachuang Jiuhe Global Trade Co., Ltd for a precise breakdown based on your project scope.
Certified Compliance: Manufactured strictly under ISO 13485 quality management systems, ensuring medical-grade uniformity, complete raw material traceability, and reliable compliance for global distribution.
Home & Self-Testing Friendly: Designed with a minimalist, non-professional "one-step" process, making it an essential and accessible diagnostic tool for home self-testing and elderly care, delivering clear results in just 10–15 minutes.