Enabling Clinical Decisions and Outcomes through Increasing Accuracy of Lab Results
Ability to make good treatment decisions relies on accurate test results and directly impacts the quality of patient care and satisfaction. Consistent, reproducible and standardized processes enable the timely release of relevant and quality data to clinicians.
Standardization Supports Accuracy
Provided in a ready-to-use single-test tube format, BD OneFlow™ reagents increase accuracy in results by minimizing operational mistakes and risk for testing repetition. Built on the standards defined by the EuroFlow™ Consortium, the pre-defined 8-color reagent panels provide high diagnostic utility delivering accurate and reproducible results to clinicians, ultimately providing consistency of patient outcomes across care venues.
Using the EuroFlow ALOT antibody panel, “Analysis of the 466 well-characterized BCP-ALL, T-ALL and AML cases, excluding AUL/MPAL samples (n=17), highlighted excellent discrimination of BCP-ALL from both AML and T-ALL.” 1
Results from the clinical trial showed that the BD OneFlow™ ALOT gave an overall agreement of 100% (93 of 93) in orienting patients into lymphoid (44 of 44 concordant) and non-lymphoid (49 of 49 concordant) lineages when compared with the EuroFlow system. Furthermore, interpretation of the BD OneFlow™ clinical trial results was highly concordant to diagnostic truth derived from a composite of patient history and lab findings.
The EuroFlow “LST detected aberrant B-, T-, or NK-cells immunophenotypes in 149/150 (99.4%) of B-CLPD and in 78/83 (94%) of T/NK-CLPD with an overall frequency of 97.4%." 1 Results from the clinical trial study show that the BD OneFlow™ LST in combination with the BD OneFlow B-CLPD T1 gave 100% (101 of 101) overall agreement in classifying patients as having CLL (54 of 54 concordant) and in identifying patients with other B-cell chronic lymphoproliferative diseases (47 out of 47 concordant) when compared with the EuroFlow system. Furthermore, interpretation of the BD OneFlow™ results was highly concordant to diagnostic truth.
The EuroFlow “PCD panel was able to detect and fully characterize the immunophenotype of aberrant plasma cells or their normal/reactive counterparts in all the samples tested (100), as also assessed by routine diagnostic protocols performed in parallel.” 1
"The most important pitfalls in immunophenotyping of leukemia and leukaemic lymphomas are...misdiagnosis and overinterpretation." 2
Data accuracy and reproducibility are eansured by the use of ready-to-use BD OneFlow™ Setup and BD OneFlow™ Assay-Specific software templates, supported by BD FACSDiva software and designed on the basis of the EuroFlow™ analysis procedure.
A suite of available beads allows for delivering data standardization, accuracy and reproducible results:
- BD FACSDiva™ CS&T IVD beads standardize setup and monitoring for consistent performance and guarantee reproducibility with Application Setting
- BD OneFlow™ Setup beads ensure data accuracy and reproducibility by providing assay-specific target values, as per EuroFlow™ SOPs 3
- BD™ FC Beads provide consistency in results, eliminating variability when using cells for compensation
- J.J.M. van Dongen, L. Lhermitte, S. Böttcher, et al on behalf of the EuroFlow Consortium (EU-FP6, LSHB-CT-2006-018708). EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia 2012, 26 (9): 1908-75.
- J.C.Kluin-Nelemans, E.R.van Wering, C.E. van der Schoot, H.J.Adriaansen, M.B. van’t Veer, J.J.M. van Dongen and J.W.Gratama on behalf of the Dutch Co-operative Study Group on Immunophenotyping of Haematological Malignancies (SIHON). SIHONSCORE: a scoring system for external quality control of leukemia/lymphoma immunophenotyping measuring all analytical phases of laboratory performance; Br.J.Heamatology 2001, 112: 337-343
- T Kalina, J Flores-Montero, VHJ van der Velden, et al on behalf of the EuroFlow Consortium (EUFP6, LSHB-CT-2006-018708). EuroFlow standardization of flow cytometer instrument settings and immunophenotyping protocols; Leukemia 2012, 26 (9): 1986-2010.