External Quality Assessment: Choosing an EQA program University of Nairobi/University of Washington Peadiatrics Research Laboratory John Gatimu University of Nairobi/University of Washington Research Laboratory
External Quality Assessment (EQA) Labs need to evaluate the various EQA programs to identify one that best suits SOPs Study protocols EQA specimens should be analyzed the same way patient samples are analyzed Applicable to a wide range of clinical laboratory assays
Analyzing Flow Cytometry Samples Using FACS Calibur samples can be gated automatically or manually In general, good correlation between automatic and manual gating Differences indicate a problem In our lab only a small number of samples require manual gating
Objective To identify an EQA program that best suits our laboratory’s SOPs and study protocols
Objectives cont and Methodology Measured objectives by: 1. Evaluating percent change in absolute CD3, CD4 and CD8 cell count between gating methods 2. Analyzing statistical differences in SD intervals (SDI) from automated vs manual gating using a paired t-test 3. Obtaining failure rate from each company Compared 10 EQA specimens from 2 companies Used FACS Calibur SOPs
Patient samples: Similar Counts Between Gating Method Automated gated Manual gated 929 931 440 441 457 462
EQA Samples: Differences Between Gating Method Automated gated Manual gated 1121 1521 757 718 733 344
Results: Manual Gating results in increased absolute counts
Results: Using True Mean Derived from Company Company A : Lymphocyte Subset Auto gated Manual gated P value CD4 0.32 SDI 0.10 SDI 0.0095 CD3 3.10 SDI -0.417 SDI 0.0002 CD8 4.98 SDI -0.66 SDI 0.0001 Company B Lymphocyte Subset Auto gated Manual gated P value CD4 -0.09 SDI 0.06 SDI 0.6529 CD3 -0.22 SDI -0.31 SDI 0.0200 CD8 0.66 SDI 0.12 SDI 0.0005
Results: Percent Failure rate Percent of tests > 2SD of true mean Automated gating Lymphocyte Subset Company A Company B P value CD4 0% 10% 0.3506 CD3 70% 0.0051 CD8 90% 0.0000
Summary and Conclusion Differences were noted for: Percent change in absolute CD3, CD4 and CD8 counts after manual gating SDIs Failure rate Labs should evaluate specimens from various EQA programs in order to identify one that best suits the labs SOPs and study protocols This process is applicable to other clinical laboratory tests
Barbara Lohman-Payne Judd Walson CFAR Tanja Hart UW Amy Liu KEMRI Acknowledgements Barbara Lohman-Payne Judd Walson Tanja Hart Amy Liu Michele Merkel Nick Bright Anna Wambugu CFAR UW KEMRI UoN BD