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Rapid
Test Immunoassay Development Quotes
- Rapid
Test Immunoassay Development Quote
- Competitive
Inhibition Rapid Test Immunoassay Development Quote
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:
- Capture antibody and
detection antibody pair.
- Purified analyte.
- Analyte positive
samples.
- Analyte negative
samples.Extraction
buffer.
- Any existing assay
kits or strips for comparative studies.
Phase I: Reagent
Preparation
....
.......
$
Time: 2-4 weeks
- Purification of analyte-specific
monoclonal or polyclonal IgG.
- Affinity purification of
analyte-specific polyclonal IgG.
- Conjugation of analyte-specific
monoclonal IgG (if available) or polyclonal IgG to
colloidal gold.
- Preparation of blocking
buffers.
- Preparation of conjugate
diluents.
- Preparation of
extraction buffers.
Phase II: Selection of
Materials and Assay
Optimization.......
.......$
Time: 4-8 weeks
- Selection of solid
phase membrane for best lateral flow results.
- Selection of absorbent
media for proper sample handling and flow-rate.
- Selection of conjugate
release media for efficient release of colloidal
gold-antibody conjugates.
- Selection of proper
backing material for required rigidity.
- Titration of capture
antibodies and colloidal gold-antibody conjugates to
obtain required sensitivity levels for each analyte.
- Determination of
proper blocking buffer to eliminate nonspecific
background signals.
- 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).
- Comparison of results to
any current standard ELISA results.
- Provide 100 test units
to client for evaluation.
Total Cost
..range
of $30,000 - $100,000
Total Time: 8-14 weeks
SAMPLE
PROPOSAL 2
Competitive Inhibition Rapid Test Immunoassay
Development
Required materials and
reagents from Client:
- Several different
affinity purified PoAb.
- Purified natural analyte.
- Purchased analyte for
use in colloidal gold conjugations.
- Positive samples.
- Negative samples.
- Any current tests for
comparison.
Phase I: Feasibility
Study, Reagent
Preparation..
...
..........$
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.
- Conjugation of the
analyte to colloidal gold in 3 different sizes (3-6
nm, 8-12 nm, and 17-23 nm gold particles).
- Preparation of
blocking buffers.
- Preparation of
conjugate diluents.
- 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.
- Selection of solid
phase membrane for best lateral flow results.
- Selection of absorbent
media for proper sample handling and flow-rate.
- Selection of conjugate
release media for efficient release of conjugate
- Selection of proper
backing material for required rigidity.
- Titration of capture
antibodies and analyte-colloidal gold conjugates to
obtain required sensitivity levels.
- Selection of proper
blocking buffer to eliminate nonspecific background
signals.
- 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.
- Definition and
documentation of assay performance characteristics
essential for optimal assay utility (such as
sensitivity and precision).
- Determination of
cross-reactivity to other molecules, as recommended
by the client.
- Comparison of results
to existing test methods.
- Final adjustments to
the assay protocol.
Phase IV: Production
and Delivery of 10,000
Tests
...............................................$
Time: 4-6 weeks
- Begin pilot scale
manufacturing.
- Quality control
assessment of final components.
- Final assembly,
packaging, and delivery of components for 10,000
rapid test kits.
Total
Cost................................................................................range
of $30,000 - $100,000
Total Time: 15-24 weeks
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