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Rapid Test Sample Proposals

Rapid Test Immunoassay Development Quotes


Introduction


In addition to microtiter plates, immunoassays are also configured as rapid tests, such as a home pregnancy test. Like microtiter plate assays, rapid tests use antibodies to react with antigens and can be developed as MoAb-PoAb sandwich formats, competitive inhibition formats, and antigen-down formats. With a rapid test, the antibody or antigen reagents are bound to porous membranes, which react with positive samples while channeling excess fluids to a non-reactive part of the membrane.


Rapid immunoassays commonly come in 2 configurations: a lateral flow test where the sample is simply placed in a well and the results are read immediately; and a flow through system, which requires placing the sample in a well, washing the well, and then finally adding an analyte-colloidal gold conjugate. The results can then be read after a few minutes. One sample is tested per strip or cassette.


Because rapid tests are faster than microtiter plate assays, require little sample processing, are often cheaper, and generate yes/no answers without using an instrument, they are often used in the field by non-laboratory people testing whole samples. However, rapid immunoassays are not as sensitive nor can they be used to accurately quantitate an analyte. (Self-monitoring of blood glucose levels by diabetics is considered quantitative rapid testing, however, immunoassay technology is not used for these tests.) All rapid immunoassay tests can be converted to a microtiter plate assay, but not all microtiter plate assays can be converted to a rapid test.


If the target analyte and necessary antibodies are available, assay development generally costs between $30,000 - $100,000 and usually takes 4-8 months. Proposals are often broken down into 4 phases, which detail time and cost estimates. Payments are often structured with a front fee of 30% of the estimated total, and milestone payments disbursed thereafter, which can be paid after each phase or monthly.


Once the test has been developed, up to 10,000 complete rapid test kits can provided to the client for evaluation. Rapid test have an expected shelf life of 12 to 18 months, and can be contained in a rugged plastic case. A cost quote for manufacturing will be provided once the test has been finalized and all components are known. This cost may range between $0.50 - $5.00 USD per test (with a minimum manufacturing charge of $2,000).


These sample proposals are meant to answer basic questions, and to act as project guidelines. Depending on your specific project, the amount of antigen required may vary, conjugations may be necessary, the antibody may need to be purified, sample preparation steps may be necessary, and the length of time for the project will vary. In order to answer some of your questions, or to prepare a specific quote for your project, please review the Assay Development Questionnaire, and then contact us. All prices are in US dollars.

Sample Proposal 1


Rapid Test Immunoassay Development
Required materials and reagents from Client:

  1. Capture antibody and detection antibody pair.
  2. Purified analyte.
  3. Analyte positive samples.
  4. Analyte negative samples.Extraction buffer.
  5. Any existing assay kits or strips for comparative studies.

Phase I: Reagent Preparation


Time: 2-4 weeks

  1. Purification of analyte-specific monoclonal or polyclonal IgG.
  2. Affinity purification of analyte-specific polyclonal IgG.
  3. Conjugation of analyte-specific monoclonal IgG (if available) or polyclonal IgG to colloidal gold.
  4. Preparation of blocking buffers.
  5. Preparation of conjugate diluents.
  6. Preparation of extraction buffers.

Phase II: Selection of Materials and Assay Optimization.......…………….......$
Time: 4-8 weeks

  1. Selection of solid phase membrane for best lateral flow results.
  2. Selection of absorbent media for proper sample handling and flow-rate.
  3. Selection of conjugate release media for efficient release of colloidal gold-antibody conjugates.
  4. Selection of proper backing material for required rigidity.
  5. Titration of capture antibodies and colloidal gold-antibody conjugates to obtain required sensitivity levels for each analyte.
  6. Determination of proper blocking buffer to eliminate nonspecific background signals.
  7. Development of user-friendly test protocol for field use.

Phase III: Assay Validation

Time: 2 weeks
Definition and documentation of assay performance characteristics essential for optimal assay utility (such as sensitivity and precision).

  1. Comparison of results to any current standard ELISA results.
  2. Provide 100 test units to client for evaluation.

Total Cost: $30,000 - $100,000

Total Time: 8-14 weeks

Sample Proposal 2


Competitive Inhibition Rapid Test Immunoassay Development
Required materials and reagents from Client:

  1. Several different affinity purified PoAb.
  2. Purified natural analyte.
  3. Purchased analyte for use in colloidal gold conjugations.
  4. Positive samples.
  5. Negative samples.
  6. Any current tests for comparison.

Phase I: Feasibility Study, Reagent Preparation

Time: 3-4 weeks

Each polyclonal will be assessed for its ability to bind analyte-colloidal gold conjugates. Upon completion of Phase I, all reagents will be prepared.

  1. Conjugation of the analyte to colloidal gold in 3 different sizes (3-6 nm, 8-12 nm, and 17-23 nm gold particles).
  2. Preparation of blocking buffers.
  3. Preparation of conjugate diluents.
  4. Assessment of each PoAb to bind the analyte-colloidal gold.

Phase II: Feasibility Study, Selection of Rapid Test Materials and Assay Optimization


Time: 4-8 weeks

All antibodies that successfully bind the analyte-colloidal gold conjugate will be used during this phase. The antibodies will be examined individually and in combinations. Phase III will begin when the required sensitivity level is reached.

  1. Selection of solid phase membrane for best lateral flow results.
  2. Selection of absorbent media for proper sample handling and flow-rate.
  3. Selection of conjugate release media for efficient release of conjugate
  4. Selection of proper backing material for required rigidity.
  5. Titration of capture antibodies and analyte-colloidal gold conjugates to obtain required sensitivity levels.
  6. Selection of proper blocking buffer to eliminate nonspecific background signals.
  7. Development of a user-friendly test protocol for field use.

Phase III: Assay Optimization and Validation


Time: 4-6 weeks

Upon completion of Phase III, the assay and assay protocol will be complete. All documentation will be in place for manufacturing and the assay will be in its final form.

  1. Definition and documentation of assay performance characteristics essential for optimal assay utility (such as sensitivity and precision).
  2. Determination of cross-reactivity to other molecules, as recommended by the client.
  3. Comparison of results to existing test methods.
  4. Final adjustments to the assay protocol.

Phase IV: Production and Delivery of 10,000 Tests


Time: 4-6 weeks

  1. Begin pilot scale manufacturing.
  2. Quality control assessment of final components.
  3. Final assembly, packaging, and delivery of components for 10,000 rapid test kits.

Total Cost: $30,000 - $100,000

Total Time: 15-24 weeks

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