Meet The Experts on DURA Innovation Dry Reagent Technology
Dr. Shankar Pattabhiraman and Shalini Kini answer your questions on DURA Innovations* dry reagent technology, the technology incorporated into DURAClone & ClearLLab reagent portfolios and utilized in the LUCID ^ custom reagent design and RESOURCE$, Δ manufacturing services.
Dr. Shankar Pattabhiraman
Dr. Shankar Pattabhiraman received his Ph.D. degree in human medicine from the Charité Medical University Berlin, Germany. After a post-doctoral fellowship at UCLA, Los Angeles, CA, he spent 10 years as a Research Scientist with INSERM, France, working on the molecular basis of leukemia development. Currently, he is a Technical Product Manager for the Flow Cytometry business unit with Beckman Coulter Life Sciences, where he specializes in the development of multicolor flow cytometry applications for search and clinical use. His main research interests are immunology of infections, and development of clinical flow cytometry techniques.
Shalini Kini
Shalini Kini is Commercial Product Manager for the clinical flow solutions for on-market products. Shalini has 15 years of experience in product development, sales and product management. Prior to joining Beckman Coulter Life Sciences, she held technical, research & Commercial positions in Reametrix, RFCL, Bio-Rad and GE Healthcare Life Sciences. Shalini holds a Master’s in Biotechnology and Management Program from IIM, Bangalore
Do we need to compensate the DURAClone antibodies?
Yes, if you are using more than one color. This depends on the fluorochromes used and how close they are to each other. Additionally, if you compensate for the equivalent liquid reagent panel, then compensation is required for the dry reagent panel. There should be no difference between existing liquid reagent and dry reagent compensation.
Do you have a template ready made for analysis?
Each combination of compensation, flow cytometer and assay is different, so there is no standard template for the reagents, however, a compensation kit is provided with all our reagents. DURAClone off-the-shelf RUO (Research use only) reagents have the lot-matched compensation kits. Our customized reagent services, LUCID and RESOURCE, provide compensation kits, as do ClearLLab reagents. The DURAClone B27# reagent does not require compensation because fluorochromes are well separated.
Can DURAClone dry reagents be used for intracellular staining?
Yes, the efficiency of the DURAClone reagents (DURAClone IM Treg, DURAClone IF T Activation, DURAClone IF T Helper etc.) with intracellular staining has been demonstrated in various publications. Dry reagent technology simplifies the processing time required to get good intracellular staining with DURAClone reagents.1 These are RUO reagents, so we cannot provide and do not have any protocols or validations. The DURAClone panels have been tested with PerFix-nc as given in their IFU (sample data).
What is the regulatory status of DURA Innovations dry reagents?
This depends, based on whether they are for research use only, or for clinical use. The DURAClone portfolio is for research use only, so there is no regulatory guidance for these reagents. Our custom panel design service, LUCID is also for research use only. On the clinical side, ClearLLab 10C panels are CE-IVD and FDA cleared and DURAClone B27 is available for IVD use only in those markets for which it has been registered per applicable regulations.
What kind of lysing solution is recommended for preparing the samples?
Standard lysing solutions can be used with most of the DURA Innovations dry technology reagents, except for those meant for IVD use (IFU mentions the protocols to be used for DURAClone B27, ClearLLab LS and ClearLLab 10C). Any lysing solution can be used with the DURA Innovation dry reagent technology, including Beckman Coulter Life Sciences VersaLyse, IOTest3, PerFix-nc; and ammonium chloride, or others.
ClearLLab 10C panels are designed to include primary antibodies that are linearly oriented as per the Bethesda consensus. Could you give references for the other DURAClone panel designs?
ClearLLab 10C and ClearLLab LS, which are leukemia and lymphoma panels, are both based on the 2006 Bethesda consensus and the WHO panel guidelines. The off-the-shelf DURAClone panels (RUO) have been developed through extensive global collaboration with leading research groups to develop consensus markers for each set of panels. The DURAClone portfolio contains many panels with supporting publications used as the basis and logic for building them.
How long does it take for labs to migrate from liquid cocktails to dry reagents?
This depends on the time taken to validate the pre-lot. When dry reagents are ordered through our custom services, a contract is initially signed with the customer, and a pre-lot is sent to them for validation. After the customer validates the pre-lot of dry reagents in their workflow, they are ready to receive their entire order of reagents specified in the contract. This process typically requires 6-12 weeks.
What is the standard lead time for providing custom dry reagents?
Standard lead time is 8-12 weeks for both LUCID custom reagent design and RESOURCE custom manufacturing services.
We have a Navios flow cytometer with only two lasers and no violet laser. What is the minimum number of tests required to purchase custom reagents?
For our custom service solutions, the minimum order for reagents is 200 tests.
Is there a minimum number of antibodies per panel for custom services?
This is a custom cocktailing service, so one antibody is the minimum.
Can you provide stability data on the validation sample?
No. We cannot make any product claims, including expiration dates, on CMS products. If the lab wants to perform stability testing, they can choose to do this on their own.
Can customers suggest using Abs that are not offered by Beckman Coulter Life Sciences?
Yes. Customers can simply provide us with antibodies and related instructions. Please note that volumes required for some formulated reagents from other vendors may preclude use in dry-down formats.
References
- Pitoiset F, Barbie M, Monneret G, et al. A Standardized Flow Cytometry Procedure for the Monitoring of Regulatory T Cells in Clinical Trials. Cytometry B Clin Cytom. 2018 Sep;94(5):621-626.
* Products under DURA Innovations are intended for both RUO and IVD. Kindly refer to the product specifications for more information.
^ For Research Use Only. Not for use in diagnostic procedures.
$ These products have no regulatory status. Customer is solely responsible for validating them.
Δ This service is currently available only in the United States. If your lab is outside the U.S., consult with your local Beckman Coulter Life Sciences representative about your interest in making this service available in your country.
# DURAClone B27 is available for IVD use only in those markets for which it has been registered per applicable regulations.
