BioAssay Works assay-development services allow companies to quickly enter a rapid test market with a minimum investment of resources and time. Our services range from a simple assay-feasibility project to a full-scale development project, including custom manufacturing.
Assay Types
We specialize in developing rapid assays utilizing our deep expertise in gold nanoparticles, including:
- Lateral-flow assays (single/multiple analytes)
- Dipsticks
- Qualitative assays (yes/no)
- Semi-quantitative assays (reader devices)
We have experience working with a large variety of sample types such as saliva, whole blood, serum, tears, urine, feces, biopsy fluids, cell culture supernatant, bacterial broth, etc. and have developed assays for both antibody and antigen detection.
Our Experience Counts
Since 2005, we have successfully developed and manufactured dozens of custom rapid assays for a variety of clients for:
- Human medicine (biomarkers and pathogens)
- Veterinary medicine (infections, fertility)
- Food industry (allergens, bacteria, toxins)
- Pharmaceutical (vaccine production monitoring)
- Industrial monitoring devices
- Biodefense (biowarfare agents)
- Environmental (contaminants)
- Nucleic acid tests
Many of these assays deliver lab-based assay sensitivity in a rapid assay suitable for field or non-laboratory use. We are proud of our track record of developing successful rapid assays for our clients. Let us put this experience to work for you.
Our Technology Makes a Difference
We have four core technologies that we use to help our customers bring lab-based assay sensitivity to point-of-care, rapid assays:
- Ultra-sensitive, concentrated gold-sols that do not use the traditional boiling, reduction process to manufacture the nanoparticles and result in a 15 – 100 O.D. concentrated gold-sol, the foundation for ultra-sensitive assays.
- The unique properties of our concentrated gold nanoparticles enable us to covalently conjugate antibodies, antigens and other ligands. This ensures an optimized and very stable gold conjugate.
- A proprietary gold-ribbon drying process that enhances the release of the gold conjugate from the conjugate pad contributes to an increase in assay sensitivity.
- Our patented C-FLAT® lateral-flow assay platforms (US Patents #7,910,381 and #7,344,893) enable increased assay sensitivity.
Our Process
Clients are in control of each assay-development project and can choose to continue or end the project at any time. Each project is thoroughly documented to help ensure assays can be reproducibly manufactured at the conclusion of the project.
Every project is unique, but most projects follow our three-stage process. Absent an early determination of infeasibility, most assay-development projects proceed to completion.
| Stage 1 - Feasibility | This stage quickly provides insight into whether a rapid test has a reasonable chance for success. |
|---|---|
| Duration | Normally, 8-10 weeks |
| Deliverables | Feasibility Summary Report |
| Client Decision | Proceed to Development, perform additional feasibility work, or end project. |
| Stage 2 - Development | Optimization of various assay components (membrane, gold conjugate pads, wicks, concentrations of assay reagents) is performed. |
|---|---|
| Duration | Normally, 30-40 weeks |
| Deliverables | 50-100 prototypes are developed for client evaluation. The prototypes are further optimized and reflect the insight gained from client evaluation. Development report detailing work performed and final assay design. Verification Summary Report determining if design outputs meet design inputs (limits of detection, specificity, assay duration, etc.) |
| Client Decision | Proceed to Design Transfer stage (Design Freeze), perform additional development work, or end project. |
| Stage 3 - Design Transfer | The process for assay manufacturing is fully documented in preparation for production by BioAssay Works or transfer of non-proprietary components to client or third party for manufacturing. |
|---|---|
| Duration | Normally, 8-10 weeks |
| Deliverables | SOPs for the manufacture and quality control of rapid assays. |
| Client Decision | Who will manufacture test (BioAssay Works, client, third party)? |
Getting Started
Download and fill out our Design Inputs document that captures what you want in an assay. Then contact us at 1-301-874-8888 or at sales@bioassayworks.com to discuss your project. We would be happy to provide you with a customized quote.