AACC Annual Meeting Meeting - Anaheim, CA - July 25, 2023

Welcome and Introductions
Greg Miller, Virginia Commonwealth University (VCU)
Jesse Seegmiller, University of Minnesota (UMN) Medical School

Dr. Greg Miller, Chair of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Laboratory Working Group (LWG), welcomed the participants to the meeting and asked them to introduce themselves.

The LWG was formed in 2003, with the aim of standardizing the serum creatinine measurement used to determine estimated glomerular filtration rates (eGFRs), which was accomplished in 2010. Subsequently, the LWG began working to standardize urine albumin (UA) measurements. Dr. Miller reviewed LWG publications on UA standardization between 2009 and 2019. Initially, the UA measurement problem was defined, and confounding factors were addressed. The focus then shifted to identifying the infrastructure needed to develop reference measurement procedures (RMPs) and reference materials (RMs) for UA measurements. The National Institute of Standards and Technology (NIST) has been attentive to establishing a UA program and developing RMPs and RMs.

Review of Agreement among Measurement Procedures for UA
Lorin Bachmann, VCU

Dr. Lorin Bachmann explained that the joint NIDDK/International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) LWG for standardization of UA measurement was convened to formally assess the current state of agreement among measurement procedures, assist in the development of RMPs and RMs, evaluate the commutability characteristics of RMs, and establish reference systems to standardize routine measurement procedures.

To characterize the current state of harmonization among UA measurement procedures, a study of 333 native, unadulterated human urine samples was performed. The samples were obtained from among samples submitted during the course of routine patient care. Non-frozen aliquots were measured using 16 manufacturer’s routine measurement procedures. Unadulterated human urine was included in each run as quality-control material to obtain imprecision estimates. Frozen aliquots were measured using liquid chromatography with tandem mass spectrometry (LC-MS/MS).

An error components analysis of the study data showed that assay imprecision—measured as percent analytical coefficient of variation (CV) and inclusive of within-run, between-run, and position effects—was not a significant source of differences among the majority of the measurement procedures. Sample-­specific effects (CV_d) among measurement procedures also were relatively minor, with one exception that likely was due to improper sample handling. The analysis concluded that a major source of the lack of agreement among the measurement procedures was bias, which was measured as the percent difference between routine measurement procedures and measurement by LC-MS/MS. The maximum difference between the highest and lowest measurement procedure median bias exceeded 40 percent, suggesting a lack of agreement among the measurement procedures that was observed across all concentration ranges examined.

Bias characteristics varied for each procedure. The calibrations for the measurement procedures were traceable to a CRM (IRMM-ERM DA470k/IFCC [CRM 470] human serum proteins) or a serum albumin standard prepared in house. The IRMM-ERM DA470k/IFCC material contains other proteins in addition to albumin; both the IRMM-ERM DA470k/IFCC material and the serum albumin standard must be diluted before use for calibration traceability of urine measurement procedures. The study concluded that differences between the materials used for calibration traceability and varying technical implementation approaches could be a source of bias among the measurement procedures. A similar lack of agreement among measurement procedures was observed in data from the 2022 College of American Pathologists (CAP) Accuracy-Based Urine Survey.

Commutability of RMs is evaluated by determining the agreement between results for an RM and results for clinical samples when analyzed by more than one measurement procedure. Preliminary data suggested that the IRMM-ERM DA470k/IFCC materials when diluted to achieve lower albumin concentrations may not be commutable for all measurement procedures. Noncommutability of currently available RMs may also contribute to bias among measurement procedures. Standardization of measurement procedures is needed to enable the use of fixed clinical decision thresholds.

Discussion

• When asked about manufacturer efforts to standardize these assays, Dr. Miller answered that the required tools are not yet available for industry partners. The LWG is developing the RMPs and RMs required for such efforts.
• In response to a question about detecting post-translational modifications (PTMs) of albumin in patients with diabetes or chronic kidney disease (CKD), Dr. Bachmann noted that immunoassays may exhibit variable detection of albumin with PTMs. Dr. Jesse Seegmiller noted that peptides chosen for mass spectrometry (MS)–based assays were not subject to PTMs. Dr. Miller pointed out that PTMs would result in sample-specific effects, which were evaluated by the harmonization study and found to be minimal.

Status of the Higher-Order Reference System for Standardization
Jesse Seegmiller, UMN Medical School
Ashley Beasley-Green, NIST

Dr. Seegmiller, Chair of the IFCC Working Group on Standardization of Albumin Assay in Urine (WG­SAU) provided an overview of the reference system, including performance goals, reference materials (RMs), candidate reference measurement procedures (RMPs), and laboratories that are performing RMP testing. Performance goals for clinical laboratory UA measurement were set in 2017 and derived using the biological variability model based on a reasonable estimate of the within-individual coefficient of variation (CV_i). The goal for bias between a clinical laboratory and a (RMP) is ≤13% with CV repeatability ≤6% and CV specimen specific effects ≤6%, which gives an allowable total error of ≤30%.

Dr. Seegmiller shared a diagram of the metrological traceability hierarchy for the calibration of UA clinical laboratory measurement procedures. He pointed out that high purity human albumin RMs include NIST SRM 2925 (0.958 g/L) and the National Metrology Institute of Japan CRM 6202-a (74.3 g/L). These purified UA RMs are intended for use to calibrate LC-MS/MS, but not to calibrate immunoassays. A secondary commutable UA RM is being prepared by NIST. When development of these RMPs and RMs is finalized, manufacturers and other laboratories will be able to standardize their clinical laboratory UA measurement procedures.

Dr. Ashley Beasley-Green described RMs and a candidate RMP developed by NIST for UA standardization. SRM 2925, a buffer solution of albumin, is currently available and used for the calibration of LC-MS/MS procedures for measuring UA. A complete report on characterization of the material is available in a publication (SRM 2925). SRM 2925 is listed in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) Database for Reference Materials (C18RM1). The NIST candidate RMP is a targeted, multiplexed quantitative and qualitative measurement procedure for UA. The NIST candidate RMP is designed to enable value assignment of SRM 3666 albumin in human urine with SRM 2925 used as the calibration material. NIST recently published the procedure to estimate the measurement uncertainty of the candidate RMP.

SRM 3666 is composed of frozen human urine with certified values for endogenous albumin, creatinine, and albumin-to-creatinine (ACR). A complete report on the characterization of the material has been published. The purpose of SRM 3666 is to support the accuracy and global comparability of clinical UA results. SRM 3666 has 4 concentration levels and is currently available. However, the commutability assessment has not been completed and SRM 3666’s suitability for use as a calibrator for immunoassays has not been confirmed.

Dr. Seegmiller highlighted the sequences of albumin peptides (i.e., DLGEENFK, LVNEVTEFAK, QTALVELVK, LVTDLTK, AEFAEVSK, YLYEIAR) measured using his laboratory’s LC-MS/MS candidate RMP. Given the small volume of NIST’s SRM 2925 (i.e., 0.5 mL vial of 0.958 g/L solution), the generation of large lots of calibrators for the LC-MS/MS candidate RMP is not economically feasible. Consequently, SRM 2925 was used to value assign calibrators made by the Advanced Research and Diagnostics Laboratory at University of Minnesota UMN). SRM 2925 derived calibrators (2.98, 5.95, 11.95, 23.93, 48, 96.17, and 195.56 mg/L) were prepared and analyzed in quadruplicate for value assignment. Additionally, in-house calibrators were prepared from Sigma Aldrich’s human serum albumin (A8763) (3, 5, 10, 25, 50, 100, and 200 mg/L) and analysed in quadruplicate. Each peptide was compared to the NIST SRM. The resulting calibration curve was used to value assign the Sigma Aldrich based calibrators. Certain peptides gave unexpectedly low results. A silver-stained polyacrylamide gel was used to examine the albumin material from Sigma Aldrich which was found to contain low–molecular weight fragments that were not present in albumin from other sources. Another source of human albumin will be used for the final set of calibrators for the RMP with values assigned by the same traceability to SRM 2925.

Dr. Seegmiller described comparison studies performed by his group, in which 100 deidentified specimens spanning the ranges of 0–30, 30–300, and >300 mg/L albumin were obtained. All samples were run on a Roche Cobas c501 or a Siemens Dimension Vista and compared to samples analyzed via LC-MS/MS at UMN. Good correlation was observed when comparing the LC-MS/MS results to data from either of the instruments. Preliminary data suggests that standardization should be achievable for clinical laboratory analyzers.

Laboratories at Health Sciences Authority Singapore, Mayo Clinic, NIST, and UMN have each developed UA candidate RMPs and currently are participating in “round robin” testing of exchanged urine samples. The results will be published and submitted to JCTLM for listing of each RMP.

Commutability Assessment Plan for NIST SRM 3666 Albumin and Creatinine in Frozen Human Urine
Ashley Beasley-Green, NIST
Greg Miller, VCU

Dr. Beasley-Green shared the commutability assessment plan for SRM 3666. Phase I of the study will involve an external collaborator’s (Virginia Commonwealth University) acquiring single-donor human urine specimens and performing routine clinical assays for albumin and creatinine for each sample. For this portion of the study, NIST will provide sample vials and NIST labels. Additionally, NIST will value assign the albumin and creatinine content in each clinical sample. Phase II of the commutability study will involve NIST’s preparing a Material Transfer Agreement (MTA) for all participants, which will be necessary for data and specimen sharing and for including participant names in the study publication. The NIST team will provide study partners with the study sample set (clinical specimens and SRM 3666). When the study partners have analyzed their samples and returned their data, NIST will return the data to the study participants and publish the full study.

Dr. Miller reviewed the protocol for the commutability assessment of SRM 3666. He introduced a model of the maximum uncertainty that can be contributed by noncommutability in a calibration hierarchy. The model assigns an uncertainty allowance to several standard sources of uncertainty (e.g., certified RM [CRM], CRM noncommutability, in vitro diagnostic medical device [IVD-MD] end-user calibrator, clinical laboratory measurements using an IVD­MD), which contribute to a quantifiable combined standard uncertainty allowance. The maximum allowable combined standard uncertainty for the patient sample results is used to derive allowable limits for the contributing uncertainties. This model recently was published by the IFCC Working Group on Commutability in Metrological Traceability (Clin Chem 2023;69:966-75) and will be used for deriving the criteria for the commutability assessment.

If the allowable noncommutability bias is assumed to have any value, the bias will have a random distribution among various IVD-MDs that are being assessed. The distribution will be rectangular, and the standard deviation of the distribution can be described by the formula W/2*√3, where W is the width of the distribution (the maximum and minimum allowable noncommutability bias). Based on previous work, the maximum allowable uncertainty of clinical samples (umax_CS) has been determined to be 8.5 percent, which gives a maximum uncertainty for noncommutability bias (umax_NC) of 3.2 percent as 3/8 of the umax_CS. The calculated maximum allowable noncommutability bias (MANCB) is 5.5 percent as √3⋅ umax_NC, and thus, the MANCB for SRM 3666 is plus or minus 5.5 percent.

For the experimental design, SRM 3666 with four different concentrations of UA and similar levels of creatinine will be tested. Clinical samples will be chosen to cluster around each of the four UA concentrations. The protocol will involve one run with each SRM level measured in three positions distributed among 48 clinical samples (a ratio of one SRM per four clinical samples), with each sample measured in triplicate. Participating IVD platforms are anticipated to include Abbott Alinity, Beckman AU, Beckman Unicel DxC, Mindray BS-800m, Roche Cobas c503, Siemens BN, Siemens Atellica, Siemens Dimension EXL, and Ortho Vitros. These platforms were chosen based on the number of participants in CAP and international External Quality Assessment programs and the availability of SRM 3666 and clinical samples. The commutability assessment procedures will be based on IFCC publications on differences in bias and calibration effectiveness. Next steps will include virtual meetings with participating IVD manufacturers to review the final protocol and logistics. Dr. Miller anticipated that materials will be shipped to manufacturers in March 2024, and NIST will arrange the MTAs and shipping.

Dr. Miller asked for feedback about the experimental design:

• Can three replicates be made from a single sample cup to reduce dead volume?
• Can Jaffe methods be eliminated in a similar protocol for a creatinine commutability assessment?
• Should point-of-care devices be included in the study?

Discussion

• Dr. Miller pointed out that although SRM 3666 will soon be available for purchase, the use of this material by manufacturers is not recommended until the commutability study is complete.
• A participant pointed out that samples can be read in triplicate to reduce the use of reagents and materials. He wondered whether this approach would be acceptable in the commutability assessment and also recommended the use of sample cups that minimize dead volume. Dr. Miller responded that this procedure would be acceptable if preanalytical bias (e.g., evaporation of the samples) is controlled.
• Other participants noted that wash steps should be considered in between repeated sampling from a single cup and that repeated sampling will affect the sequence of the samples. The maximum time that the samples will spend on the analyzers and the sequence of the samples should be defined in the protocol.
• Dr. Miller emphasized that enzymatic methods for creatinine measurement are preferred by many over the Jaffe method, which is not as reliable in patients with diabetes. He noted that it would be preferable to include the Jaffe method in the commutability study, but concerns are being raised about the amount of material that would be required for both assays. A participant pointed out that current clinical guidelines were developed using a mixture of Jaffe and enzymatic methods.
• The group agreed that point-of-care devices would not be included in the study.
• The group discussed the different ranges of albumin that instruments can measure. Dr. Miller pointed out that manufacturers should not be diluting the samples for a commutability study.

Performance of RMPs for UA
Greg Miller, VCU

Status report on the extent of equivalence assessment between four laboratories

Dr. Miller described the protocol for measuring the extent of the equivalence of results among the UA candidate RMPs developed by the Health Sciences Authority Singapore, Mayo Clinic, NIST, and UMN. The protocol consists of eight individual human urine samples provided by Health Sciences Authority Singapore, which were frozen at −80° Celsius and had approximate UA concentrations of 20, 30, 30, 30, 90, 100, 150, and 200 mg/L. The samples were demonstrated to be commutable with clinical samples. The samples will be thawed and mixed per a specified procedure, and UA will be measured for four independent aliquots of the sample. Each laboratory will follow its standard operating procedure for the UA RMP. Calibration will be traceable to SRM 2925, and laboratories with clinical IVD-MDs will measure UA in duplicate using those systems. Results are expected by November 2023, and publications will be developed to support JCTLM nominations for each RMP in 2024.

Assessing the Clinical Impact of Standardizing UA Measurement Results
Jenna Norton, NIDDK

Dr. Jenna Norton discussed study plans to demonstrate the clinical and public health impacts of standardized UA measurements. She explained that UA is used routinely in clinical practice to help assess disease severity and guide treatment and is one of the strongest predictors of kidney and cardiovascular outcomes. Existing UA measurements show more than 40 percent bias across methods. Dr. Norton and colleagues hypothesized that bias in UA assessment affects CKD surveillance and treatment. They asked whether different UA measurement procedures affect the understanding of the population prevalence of CKD and how the lack of UA measurement standardization was affecting clinical care (e.g., CKD diagnosis and staging, assessing response to therapy, risk prediction).

Examining these questions involves two proposed approaches: one for public health surveillance and one for clinical care. To simulate the potential effects of various UA measurement procedure biases on national CKD prevalence estimates, we propose to use laboratory data from the National Health and Nutrition Examination Survey (NHANES) conducted from 2001 to 2020. NHANES UA measurements will be categorized by ranges based on clinical classification values. The full range of positive and negative biases found in prior research (Bachman 2014, et al.) will be applied to the data to observe the effects at a population level and the various resulting possibilities for population prevalence of CKD. The biases will be applied to various clinical scenarios to understand potential impacts on diagnosis, staging, and risk prediction using common risk assessment methods (e.g., end-stage renal disease progression prediction equation, mortality prediction equation).

Dr. Norton and colleagues in the Division of Kidney, Urologic, and Hematologic Diseases are soliciting input related to the study proposal from program staff at the National Institutes of Health. Dr. Norton requested feedback and suggestions from the LWG meeting participants.

Discussion

• In response to a question about the NHANES study, Dr. Norton confirmed that the UA measurements consist mainly of spot assays on randomly collected urine. The data set includes a series of 24-hour urine samples that were collected during a single visit, as well as ACR data.
• The meeting participants discussed the measurement procedure used to measure UA in the NHANES study until 2020, which was an in-house fluorescent amino assay and not a commonly used IVD manufacturer’s method.
• Dr. Miller pointed out that results from this study will be beneficial for demonstrating to regulators that UA standardization will have a strong effect on patient care.

Timeline for Implementing a UA Standardization Activity
Greg Miller, VCU

Dr. Miller shared the anticipated timeline for standardizing UA measurement procedures. He noted that manufacturers should maintain the current UA calibration hierarchies for the time being and plan to implement the NIDDK LWG/IFCC WG-SAU higher-order reference system when it becomes available.

The timeline is planned as follows:

• September–November 2023—Finalize the commutability protocol for NIST SRM 3666 with participating IVD manufacturers and complete the MTA with manufacturers participating in the commutability assessment.
• November 2023—Complete the extent-of-equivalence assessment for the RMPs.
• March–April 2024—Perform the commutability assessment experiments for NIST SRM 3666.
• April–May 2024—Meet with the U.S. Food and Drug Administration regarding the recalibration submissions.
• May 2024—Submit the RMPs to JCTLM (a 1-year process).
• July 2024—Present the program for standardizing UA measurements at the American Association for Clinical Chemistry/Association for Diagnostics & Laboratory Medicine symposium, assuming the program is accepted.
• January 2025—Educate the community regarding the effects of recalibration.
• May 2025—Begin recalibration of UA IVD-MDs by IVD manufacturers and submit SRM 3666 to JCTLM.

Dr. Miller shared several options for implementing the UA standardization. Manufacturers can obtain and split clinical urine samples with one of the RMP laboratories, using the clinical samples as calibrators for the manufacturer’s selected measurement procedure and reassigning values to working calibrators and end-user calibrators. Alternatively, manufacturers can use the results from the split urine samples to determine a correction function to apply to the working calibrator(s) or to the end-user calibrator(s). A third option is for manufacturers to obtain SRM 3666 (once its commutability with clinical samples is confirmed) and use this material as a calibrator for their selected measurement procedure, reassigning values to the working calibrator(s) or to the end-user calibrator(s).

Progress and Utilization of Cystatin C
Joseph Vassalotti, National Kidney Foundation (NKF) and Icahn School of Medicine at Mount Sinai

Dr. Joseph Vassalotti provided an update on progress in the utilization of cystatin C testing to assess eGFR. In 2021, the NKF and the American Society of Nephrology (ASN) Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases released a report outlining a new race-free approach to estimating clonerular filtration rate (eGFR) for diagnosing kidney disease. In the report, the NKF–ASN Task Force recommended adopting the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) eGFR creatinine equation, which estimates kidney function without a race variable. The task force also recommended increased use of cystatin C combined with eGFR from serum creatinine as a confirmatory assessment of GFR or kidney function.

Despite greater availability and improvements in standardization, the cystatin C assay is not available across all clinical chemistry laboratories. The use of laboratory measurement procedures for cystatin C is challenged by several barriers, including that the majority of laboratories send out the test to a referral lab; reimbursement uncertainties; low primary clinician understanding; and outstanding research questions to precisely define the population for which cystatin C should be tested and how the results should be interpreted. In general, testing with cystatin C will be useful when additional precision in GFR is needed or when non-GFR determinants of creatinine are present. The 2023 Medicare reimbursement rates are $18.52 for cystatin C, compared with $5.12 for creatinine. Moreover, reimbursement for creatinine (but not cystatin C) is facilitated by inclusion in the basic ($8.46) and comprehensive ($10.46) metabolic panels. Although these individual differences are quite small, the national cumulative impact could be substantial, with approximately 250 million serum creatinine tests performed in the United States annually. Cystatin C testing has no Medicare National Coverage Determination and is subject to decisions of the 12 local Medicare Administrative Contractors. Overall, eGFR from serum creatinine remains the clinical standard worldwide for routine clinical practice.

The NKF is promoting awareness of the use of the 2021 CKD EPI creatine and combined equations using informative flyers, online courses, and online and mobile eGFR calculators. An American Association for Clinical Chemistry/NKF Guidance Document on Improving Equity in Chronic Kidney Disease Care was released in 2023 and includes Table 3, describing the non-GFR determinants of serum creatinine and cystatin C. A 2023 update of the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for the evaluation and management of CKD will soon be released. The KDIGO document likely will provide more definitive recommendations to inform the indications for cystatin C testing and interpretation in the clinical context.

Discussion

• Dr. Seegmiller commented that some clinicians recommended keeping the creatinine and cystatin C measurements separate. Dr. Vassalotti agreed that much of the emphasis has been placed on the combined equation; the separate measurements can be clinically informative. For example, the cystatin C–only equation may be the optimal way to assess kidney function in certain settings when creatinine is confounded by non-GFR determinants. Three equations with either biomarker alone and with the combination of creatinine and cystatin C are currently recommended.
• Several participants commented that the CAP data shared in the presentation are highly selective. Out of hundreds of thousands of laboratories with Clinical Laboratory Improvement Amendments certification, only several thousand participate in CAP surveys, with an overrepresentation of academic laboratories that are likely early adopters of the recommended equations.

Summary and Follow-Up Items
Greg Miller, VCU

Dr. Miller reviewed key action items:

• Schedule meetings with the participants in the commutability study, discuss points raised in the current meeting, and work toward a uniform protocol in the next several months.
• Complete the RMP round robin by November 2023.
• Submit the RMPs to JCTLM by spring of 2024.

Adjournment

Dr. Miller thanked the participants for attending and adjourned the meeting at 3:40 p.m. PDT.

Kevin Abbott, M.D., M.P.H. (by Zoom)
Program Director, Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
kevin.abbott@nih.gov

Lorin Bachmann, Ph.D., DABCC
Chair, IFCC Working Group for Standardization of Albumin in Urine
Associate Professor, Department of Pathology
Co-Director, Clinical Chemistry Laboratory
Virginia Commonwealth University
lorin.bachmann@vcuhealth.org

Ashley Beasley-Green, Ph.D.
Staff Scientist, Biomolecular Measurement Division
National Institute of Standards and Technology
ashley.beasley@nist.gov

Johanna Camara, Ph.D.
Research Chemist
National Institute of Standards and Technology
johanna.camara@nist.gov

Jian Dai, Ph.D., FAACC, FCACB
Director
Mindray
j.dai@mindray.com

Jamie P. Deeter
Senior Director of Scientific Affairs
Roche Diagnostics GmbH
jamie.phillips.jp1@roche.com

Joris Delanghe, Ph.D.
Professor, Department of Clinical Chemistry
University Hospital Ghent
joris.delanghe@ugent.be

Silvia Ferre, Ph.D. (by Zoom)
Senior Director
National Kidney Foundation
silvia.ferre@kidney.org

James Fleming, Ph.D., FACB
Vice President and Director, Scientific Affairs
Laboratory Corporation of America
jim_fleming@labcorp.com

Debbie Gipson (by Zoom)
Program Officer and Senior Scientific Officer for Precision Kidney Clinical Trials
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
debbie.gipson@nih.gov

Harvey Kaufman, M.D. (by Zoom)
Medical Director, Business Development
Quest Diagnostics
harvey.w.kaufman@questdiagnostics.com

Anthony Killeen, M.D., Ph.D.
Professor, Department of Laboratory Medicine and Pathology
Director of the Advanced Research and Diagnostics Laboratory
University of Minnesota Medical Center
kille001@umn.edu

Horst Klima
Manager, Research and Development
Roche Diagnostics
horst.klima@roche.com

Qinde Liu, Ph.D. (by Zoom)
Consultant Scientist
Health Sciences Authority, Singapore
liu_qinde@has.gov.sg

Soha Mahmoud, Ph.D. (by Zoom)
Manager, Scientific Collaborations
QuidelOrtho
soha.mahmoud@orthoclinical diagnostics.com

Greg Miller, Ph.D.
Chair, Laboratory Working Group
Professor, Department of Pathology
Co-Director, Clinical Chemistry Laboratory
Director, Pathology Information Systems
Virginia Commonwealth University
greg.miller@vcuhealth.org

Tetsuya Nejime, Ph.D. (by Zoom)
Department Head
Serotec Company, Ltd
t-nejime@serotec.co.jp

Jenna Norton, Ph.D., M.P.H. (by Zoom)
Program Director
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
jenna.norton@nih.gov

Denise O’Meara, M.S.
Staff Development Scientist
Beckman Coulter Diagnostics
domeara@beckman.com

Afshin Parsa, M.D., M.P.H. (by Zoom)
Program Director
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health

Meda Pavkov, M.D., Ph.D. (by Zoom)
Medical Epidemiologist
Centers for Disease Control and Prevention
mpavkov@cdc.gov

Karen Phinney, Ph.D.
Group Leader, Biomolecular Measurement Division
National Institute of Standards and Technology
karen.phinney@nist.gov

Terry Rice
Manager of Development Science
Beckman Coulter Diagnostics
trice@beckman.com

David W. Seccombe, M.D., Ph.D., FRCPC (by Zoom)
Managing Director
Canadian External Quality Assessment Laboratory (CEQAL)

Jesse Seegmiller, Ph.D.
Associate Professor, Department of Laboratory Medicine and Pathology
University of Minnesota Medical School
jseegmil@umn.edu

Neha Shah, M.S.P.H. (by Zoom)
Scientific Program Analyst
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
neha.shah2@nih.gov

Robert Star, M.D. (by Zoom)
Director, Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
robert.star@nih.gov

Hwee Tong Tan, Ph.D. (by Zoom)
Senior Scientist
Health Sciences Authority, Singapore
teo_tang_lin@has.gov.sg

Tang Lin Teo, Ph.D. (by Zoom)
Division Director
Health Sciences Authority, Singapore
tang_lin@has.gov.sg

Joseph Vassalotti, M.D. (by Zoom)
Chief Medical Officer, National Kidney Foundation
Clinical Professor, Icahn School of Medicine at Mount Sinai
josephv@kidney.org