U.S. Department of Health and Human Services

NKDEP Working Group Meeting Summaries

Below are meeting summaries for the Laboratory Working Group and the In Vitro Manufacturers' Forums.

Laboratory Working Group

July 29, 2015 - AACC Annual Meeting- Atlanta, GA

The 2015 Lab Working Group meeting focused primarily on ongoing Urine Albumin (UA) standardization efforts, including efforts to address concentration- and dilution-dependent biases in routine methods, an experimental design to assess freeze-thaw effects, measuring interval recommendations, bias and imprecision goals that should be met by UA measurement procedures, reference measurement procedures and materials, and a plan for UA standardization. A proposed plan to address calibration uniformity for measured glomerular filtration rate (mgfr) based on iohexol clearance measurement was also discussed.

February 5, 2015 - Workshop on Urine Albumin Standardization

The workshop on urine albumin (UA) standardization was convened to: (1) understand the current status of UA measurements; (2) identify measurement procedure limitations to address before standardizing UA measurements, including how the manufacturers need to proceed to address these limitations; (3) develop a plan to standardize UA measurement procedures; and (4) review the use of National Health and Nutrition Examination Survey (NHANES) UA data to improve the diagnostic value of UA in kidney disease, including the relationship between using the NHANES data to develop decision levels and the UA standardization effort.

July 31, 2014 - AACC Annual Meeting- Chicago, IL

The 2014 Lab Working Group meeting focused heavily on Urine Albumin (UA) standardization iIncluding reference materials, reference measurement procedures validation and establishing revised interpretive thresholds for UA. Other topics discussed included the investigation of within person physiologic variability, creatinine performance recommendations, recommendations regarding MDRD vs. CKD-EPI equations for eGFR from creatinine, and standardization of cystatin C measurements and eGFR equations based on cystatin C.

July 31, 2013 - AACC Annual Meeting- Huston, TX

The Lab Working Group discussed creatinine performance recommendations for pediatric ranges, formulas based on creatinine in various medical specialties and the impact of their standardization, standardization of cystatin C measurements and eGFR equations based on cystatin C, and cystatin C education recommendations. In addition, updates were provided on the urine albumin harmonization investigation, NIST reference materials, urine albumin reference measurement procedures validation, and other urine albumin standardization activities.

July 19, 2012 - AACC Annual Meeting- Los Angeles, CA

The Lab Working Group discussed educating clinicians about uncertainty in lab assessment and the status of cystatin C-based, GFR-prediction and CKD-EPI cystatin C equations. Updates regarding urine albumin standardization activities, creatinine method specificity study recommendations, and the IFCC/WASPaLM Task Force were also reported.

July 28, 2011 - AACC Annual Meeting- Atlanta, GA

This meeting provided updates on CKD-EPI and other newer equations, the status of creatinine calibration traceability to IDMS, serum albumin standardization issues, urine albumin (UA) reference procedures, and UA and creatinine reference materials. The status of the serum creatinine method specificity, UA method harmonization, and UA adsorption studies/projects were also reported.

May 16, 2011 - Open Meeting- Belin, Germany

IFCC WG-GFRA Glomerular Filtration Rate Assessment, WG-SAU Standardization of Albumin in Urine Joint Committee with NKDEP Laboratory Working Group Open Meeting 16 May 2011, Conference Center Room 13/14, Berlin, Germany

July 28, 2010 - AACC Annual Meeting- Anaheim, CA

The LWG discussed changes to the NKDEP website, the IFCC's CKD Task Force, the creatinine specificity study, cystatin C standardization, and the urine albumin reference measurement procedure. Also discussed were studies on urine albumin method harmonization, adsorption, and physiological variability.

July 22, 2009 - AACC Annual Meeting- Chicago, IL

This meeting provided an update on urine albumin activities and status reports on the new CKD-EPI equation.

March 4, 2009 - NKDEP LWG, IFCC WG-GFRA, and WG-SAU Conference Call

This meeting was a joint meeting of the NKDEP Laboratory Working Group (LWG) and two International Federation of Clinical Chemistry (IFCC) groups – Standardization of Urinary Albumin (WG-SAU) and Glomerular Filtration Rate Assessment (WG-GFRA), which is headed by Neil Greenberg.

July 30, 2008 - AACC Annual Meeting- Washington, DC

This meeting provided an update on urine albumin activities, and status reports on the revised pediatric equation and activities of NKDEP's working group addressing pharmacy issues.

To request meeting summaries for meetings prior to 2008, please contact us.

In Vitro Manufacturers' Forums

July 31, 2014 - Forum Meeting

This meeting focused heavily on Urine Albumin (UA) standardization including reference materials, commutability assessment of NIST SRMs, reference measurement procedures validation and engaging manufacturer’s in the standardization process. Other topics discussed included creatinine performance recommendations, recommendations regarding MDRD vs. CKD-EPI equations for eGFR from creatinine, current implementation of standardization of cystatin C assays and eGFR reporting based on creatinine and cystatin C equations.

July 31, 2013 - Forum Meeting

This meeting addressed creatinine performance recommendations for pediatric ranges, formulas based on creatinine in various medical specialties and the impact of their standardization, and standardization of cystatin C measurements and eGFR equations based on cystatin C. In addition, updates were provided on the urine albumin harmonization investigation, NIST reference materials, urine albumin reference measurement procedures validation, and other urine albumin standardization activities.

July 19, 2012 - Forum Meeting

This meeting discussed educating clinicians about uncertainty in lab assessment and the status of cystatin C-based, GFR-prediction and CKD-EPI cystatin C equations. Updates regarding urine albumin standardization activities, creatinine method specificity study recommendations, and the IFCC/WASPaLM Task Force were also reported.

July 28, 2011 - Forum Meeting

The Forum addressed CKD-EPI and other newer equations, the status of creatinine calibration traceability to IDMS, serum albumin standardization issues, urine albumin (UA) reference procedures, and UA and creatinine reference materials. The status of the serum creatinine method specificity, UA method harmonization, and UA adsorption studies/projects were also reported.

July 28, 2010 - Forum Meeting

The Forum addressed changes to the NKDEP website, the creatinine specificity study, cystatin C standardization, and the urine albumin reference measurement procedure. Also discussed were studies on urine albumin method harmonization, adsorption, and physiological variability.

July 22, 2009 - Forum Meeting

This meeting provided updates on creatinine standardization, the status of eGFR Reporting,an NKDEP Drug Dosing educational statement for providers, a CKD-EPI eGFR equation and adoption considerations, a new CKiD Study Equation, and the status of Cystatin C standardization.

July 30, 2008 - Forum Meeting

This meeting provided updates on creatinine standardization activities, activities of the working group addressing urine albumin, and activities of the Cystatin C Standardization Working Group (IFCC-EU); the latest on a proposed creatinine specificity study; and a review of revised pediatric content for the NKDEP website.

To request meeting presentations or summaries from meetings prior to 2008, please contact us.

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