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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Improving the understanding, detection, and management of kidney disease.

Meeting Minutes – Manufacturers' Forum
July 22, 2009

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Kidney Disease Education Program (NKDEP) Manufacturers Forum
AACC Annual Meeting — Chicago, IL

Participants: Greg Miller (Chair), Lorin Bachmann, David Bunk, Johanna Camara, Christa Colbbaert, Paul D'Orazio, John Eckfeldt, James Fleming, Mary Lou Gantzer, Matthew Gnezda, Neil Greenberg, J. Mark Herlan, Yoshihisa Itoh, Chandra Jain, Graham Jones, Hans-Joachim Kytzia, Yemmi Lemma, Jack Levine, Bob Maher, Andrei Malic, Ezio Marelli, Leigh Ann Milburn, Andrew Narva, Eileen Newman, Mauro Panteghini, Thomas Pisani, Max Robinowitz, Mary Robinson, Fabio Rota, Kazuhiko Sameshima, Heinz Schimmel, George Schwartz, Sari Tikanoja, Dave Torrens, Reba Wright, Fawn Xie, Esther Yang, Ichimaru Yasuyuki, Ingrid Zegers

Meeting Minutes

1. Status of Creatinine Standardization from IVD Manufacturer Survey — Greg Miller

Status of Creatinine Standardization from IVD Manufacturer Survey — Greg Miller

2. Status of eGFR Reporting from the College of American Pathologists Survey — Greg Miller

3. NKDEP Drug Dosing Educational Statement for Providers — Lesley Stevens

4. CKD-EPI eGFR Equation and Adoption Considerations — Lesley Stevens

There are limitations with the MDRD equation if the eGFR is > 60. The CKD-EPI study developed a better equation to estimate GFR using data from studies in which there was a measured GFR and included patients with and without CKD. The new equation shows greater accuracy across the GFR range; and in particular, it has improved agreement with measured GFRs > 60. This equation was applied to the NHANES population to evaluate the effect of the new equation on the burden of CKD in the US. Using the new equation, the burden of CKD was reduced from 26 to 23 million. The CKD-EPI results were just published and NKDEP is not making a recommendation regarding the equation at this time; rather there will be a period of validation to determine its impact on the field. In the interim, the LWG intends to develop information on this equation to be posted to the NKDEP website in the next few months.

5. CKiD Updated Schwartz Equation Currently on the NKDEP Web Calculator Page for Standardized Creatinine Methods — George Schwartz

See below

6. New CKiD Study Equation Uses Creatinine, Urea, Cystatin — George Schwartz

7. Cystatin C Standardization Status — Greg Miller for Anders Grubb (Chair, IFCC WG-SCC)

The project has successfully prepared secondary reference material which is pooled human serum to which a recombinant cystatin product has been added. The value assignment is complete and they are beginning the commutability study. It is estimated that the product will be available in 2010. Also, a large study is planned to generate an equation using standardized cystatin C methods. There will be a notification through the IRMM website when the product is available, and the LWG will make an announcement when the product is available.

8. Status of Work in Progress — Greg Miller

a. Serum creatinine method specificity (IFCC WG-GFRA, LWG, Neil Greenberg)

Refer to written summary circulated with the agenda for the following:

b. Urine albumin reference material (Yoshi Itoh, JSCC)

Development of a urine albumin reference material is being sponsored by the Japanese government and estimated to be available in 2-3 years.

c. Urine creatinine and albumin reference materials (David Bunk, Karen Phinney, NIST)

NIST will develop a reference material for urine creatinine and albumin. A task force to determine parameters for this material was created today; it is estimated that a product will be developed in about 2 years.

d. Urine albumin IDMS candidate reference procedure (John Lieske, Mayo Clinic and David Bunk, NIST)

e. Urine albumin biological variability study (Mary Robinson, CDC)

f. Urine albumin adsorption study (Mary Robinson, CDC)

Want to investigate problems with adsorption of albumin to containers for collection and analysis.

g. Urine albumin method harmonization study (Lori Bachman, LWG)

h. Urine albumin molecular forms study (Glen Hortin, LWG)

Questions:

Page last updated: March 1, 2012