Custom Assay Development & Innovation (CADI) Services Frequently Asked Questions
Have questions about our Custom Assay Development & Innovation (CADI) services?
View frequently asked questions (FAQs) below to find the answers. Note, sample testing services are only for our Single Molecule Counting (SMC®) platform.
Assay Development Services FAQs
Can we use our own reagents?
Yes, you can provide your own reagents. The CADI scientist on your project will let you know how much of each reagent is necessary and in what format. For example, we typically require antibodies to be purified (no ascites) and free of amines, glycerol, BSA, or other carrier proteins.
Do you require samples from us for assay development?
We typically determine if customer samples are required at the beginning of every project but we sometimes find they are needed at the later stages of assay development. If samples are required, we will work with you to coordinate shipping or procurement.
How do I ship my reagents or samples to you from outside the United States (U.S.)?
Please work with us and your institutional logistic/shipping team to ensure you have the appropriate customs documents required for importing biological materials to the U.S. It is important to choose a shipping company that will store and transport your shipment at appropriate temperatures.
If we use commercially available antibodies in the assay, will you commercialize the kit?
Unless specified in a material service agreement (MSA), we have the option to commercialize new analytes if the reagents are not proprietary.
A MILLIPLEX® assay did not detect all of our samples. Can we transfer the MILLIPLEX® reagents to the SMC® platform to increase sensitivity?
Most ELISA-based assay formats, including the MILLIPLEX® multiplex panels, can be adapted to the SMC® format for enhanced sensitivity.
What is the difference between an SPR and a MILLIPLEX® custom assay?
Our special product release (SPR) panel is a combination of analytes from ≤3 existing panels. A MILLIPLEX® custom assay is a combination of analytes from 4 or more existing panels or any project requiring new analyte development.
When are we invoiced?
The work plan outlines project milestones with go/no-go decisions and invoice points.
What is the intended use of these assays?
All custom products produced by the CADI team are for research use only (RUO) and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.
Are custom assays ISO 9001 certified?
While a number of standard operating procedures (SOPs) are used during assay development, the customizations required for customer-directed assay development are incompatible with ISO 9001. The CADI team does operate at an ISO 9001 certified site and utilizes the infrastructure (quality assurance (QA); environmental, health, and safety (EHS); information technology (IT); and security) covered under that certification.
Sample Testing Services FAQs
Can you advise how samples shipped from outside of the U.S. should be managed?
Please work with us and your institutional logistic/shipping team to ensure you have the appropriate customs documents required for importing biological materials to the U.S. It is important to choose a shipping company that will store and transport your shipment at appropriate temperatures.
Your assay is not currently optimized for our sample type. Can we still send you samples to test?
Yes, we can test non-verified matrices in our assays.
Can you test cell lysates with the SMC® technology?
Yes, but please also send a small sample of your lysis buffer so we can evaluate interference with the assay.
Is your system compatible with whole skin samples?
As long as the samples are lysed and clarified, we accept a variety of tissue types.
What is the required sample volume?
We typically request 500 μL per analyte for duplicate testing but the necessary volume will be confirmed at the project kickoff meeting.
Do you accept diseased and drug-treated samples?
We accept disease state samples and infectious samples on a case-by-case basis after a review by our internal EHS team. In general, we cannot accept Biosafety Level 3 (BSL-3) samples, unknown disease state samples unless they are “apparent healthy/normal”, or viral positive cell culture samples.
Can controls be added to our testing?
Yes, client-prepared controls can be added. We can also prepare controls for an additional charge.
What is the turn-around time for sample testing?
It varies by project size and complexity. Estimated lead times are provided on the work plan and confirmed at the kickoff meeting. Typically, we can assay up to 200 samples per week without any capacity constraints. Expedited service is available for an additional rush charge.
Can we ship samples for you to store until we accumulate a larger batch?
No. Samples will be run as batches once they arrive. After the data review, samples will be discarded or returned.
If there is a leftover sample, can you dispose of this or ship it back?
We either dispose of samples per our SOP or return remnant samples at the clients’ cost.
What does the set-up fee cover?
The set-up fee includes project initiation costs and a confirmatory pretest to ensure the assay meets specifications before client samples are assayed.
What is a sample reconciliation fee?
If the order of samples received does not match the shipping manifest, a sample reconciliation fee is applied to cover the time required to reconcile sample arrangement and ensure samples are logged accurately.
What is a rearray fee?
If clients want their samples to be tested in a different order than how they were shipped, we can rearrange the samples to meet that need if permitted by the plate layout. For example, we can sort samples by donor or treatment dose if the samples were not shipped in that order originally.
For sample testing, if I have less than 30 samples, do I have to pay for a whole plate?
You will pay per sample. Please note every dilution counts as a sample so 15 samples tested in duplicate at two dilution levels equals 30 samples (1 plate).
What quality standards does your lab follow?
We can support your RUO, non-GLP/non-CLIA fit-for-purpose sample testing projects. All internally produced custom and commercial assays used by the CADI team are for research use only (RUO). While SOPs are followed during sample testing, the CADI team does not fall under the site ISO 9001 certificate. We do, however, utilize the infrastructure (QA, EHS, IT, and security) covered under that certification.
What forms of reporting can you do?
Our standard report format is an Excel table; PowerPoint slides may be provided as well depending on the scope of the project. If required, you can also purchase the following options:
- Provide a written report if needed
- Add results onto electronic shipping manifests to preserve the metadata
- Upload results per the client’s Data Transfer Specifications (DTS) to a secure server (assuming the manifest variables match the DTS and we can access the server)
For Research Use Only. Not For Use In Diagnostic Procedures.
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