Abstract
Introduction/Objective
Multiparameter flow cytometry (MFC) is the standard of care for the diagnosis and monitoring of hematopoietic and lymphoid neoplasms. While MFC is a mature technology, new innovations are brought to the market. Such an innovation is the ClearLLab10C, FDA-cleared, 4-tube, 10-color, dry, premixed antibody panels (Beckman Coulter Diagnostics, Brea, California). Our laboratory decided to implement this new reagent system combined with 10-color clinical flow cytometer, Navios EX from the same vendor. This paper describes the clinical validation results for leukemia/lymphoma (LL) evaluation as well as logistical and labor savings in the laboratory.
Methods
Thirty specimens submitted for LL evaluations were tested by our existing 5-color flow cytometer with custom antibody combinations as well as by the Navios EX instrument with the ClearLLab10C product supplemented by additional antibody combinations for intracellular analysis. The validation cases included normal and abnormal cases, representing bone marrows, blood, lymph nodes, and a few other specimens.
Results
There was a complete agreement in the qualitative results.
The new simplified premixed reagents allow for noticeable simplification of inventory and saving in labor. The existing LL antibody cocktails required stocking 41 antibodies. The new platform requires only 4 LL reagents for surface immunophenotyping and we elected to stock additional 8 antibodies for optional intracellular evaluation. The amount of manual pipetting is greatly reduced. One additional advantage of utilizing the new ClearLLab10C is the available electronic and book publication from the vendor illustrating typical results for 24 normal and abnormal specimens analyzed using ClearLLab10C. This resource together with a user-friendly analysis software Kaluza C greatly facilitate interpretation of 10-color results by pathologists, medical technologists, and especially by the pathologists in training.
Conclusion
ClearLLab10C product is a cost-effective and user-friendly solution for laboratories seeking a streamlined MFC and a great reduction of inventory and labor.
Evaluation and validation of a novel 10‐color flow cytometer
