The Preparation and Use of CDC s Newborn Screening Quality Control Material

Transcription

1 The Preparation and Use of CDC s Newborn Screening Quality Control Material Víctor R. De Jesús, PhD; Joanne V. Mei, PhD; Carla D. Cuthbert, PhD Newborn Screening and Molecular Biology Branch US Centers for Disease Control and Prevention 9 th ISNS International Meeting, Den Haag September 11, 2016 National Center for Environmental Health Division of Laboratory Sciences

2 Services Provided by CDC s Newborn Screening Quality Assurance Program (NSQAP) The only comprehensive quality assurance program using dried blood spots Proficiency testing (PT) Quality control (QC) materials Reference materials Filter paper evaluation Training and consultation NBS translation research Preparation of blood pools Semi-automated blood spot preparation Certification of EQA materials Packaging and shipment to participating labs

3 NSQAP: Proactive External Quality Assurance Proficiency Testing All US RUSP disorders included Participating labs get 3 challenges of 5 blind-coded specimens per year 80% Consensus (US labs) for graded specimens Satisfies EQA requirements for screening labs Internet reporting site for laboratory Results posted and available to participating labs qap_reports.html Follow-up of False Negative (FN) results Proactive follow-up with NSQAP lab scientist Technical assistance and technology transfer to NBS labs Assistance to ensure analytic validity and utility of screening tests Assayed QC materials 14 QC programs 61 markers RUSP: US Recommended Uniform Screening Panel

4 Assayed QC Materials Available through NSQAP

5 Essential Properties of Quality Control Materials DBS materials intended to monitor reliability of a test system and help minimize reporting of incorrect results. Can be used to: Estimate test precision Detect systematic analytical deviations due to reagent and/or instrument variation Must simulate patient specimen composition matrix effect Must be stable under the same patient specimen storage and shipping conditions Must be homogeneous These QC Materials are NOT meant to be used as calibrators US FDA. Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material.

6 Using Quality Control Materials Kit QC versus CDC QC QC monitor methods over time Document trends in method performance Identify problems so that corrective actions can be taken quickly Kit QC primary QC, comes with commercial reagents Run on every plate or every assay CDC QC EXTERNAL QC Supplemental materials, not for every day use Should be run periodically to assess method changes

7 NSQAP QC Material Preparation How do we do it?

8 When we say that we process buckets of blood to make EQA materials We mean it!!

9 Steps involved in QC Dried Blood Spot Production NSQAP prepares, certifies and distributes more than 500,000 QC DBS each year

10 QC Certification Sheet: Downloadable from NSQAP web site Data elements include: Expiration date Enrichment levels Certified (assayed) values Instructions for participants

11 QC Certification Sheet Data Elements

12 QC Certification Sheet Data Elements

13 QC Certification Sheet Data Elements

14 QC Certification Sheet Data Elements Note:The values provided in the above tables are for reference use only. The mean value and confidence limits (CL) are determined by CDC for each quality control (QC) lot. Each participating laboratory must establish its own mean valuesand CL for its test method with these QC materials. Temporary estimates of mean values and CL can be determined after 10 successive, independent measurements. Slazyk WE, Hannon WH. Quality assurance in the newborn screening laboratory. In: Therrell BL Jr, editor. Laboratory methods for neonatal screening. Washington (DC): American Public Health Association, 1993: Temporary estimates of mean values and CL can be determined after 10 successive, independent measurements.

15 NSQAP Annual Report

16 NSQAP QC Data Analysis and Participant Feedback QC data are evaluated 2 times per year Data sorted by method Mean, SD, slopes Reports on web site

17 Summary NSQAP QC materials are intended to monitor reliability of a test system and help minimize reporting of incorrect results NSQAP QC materials are NOT calibrators Participation in NSQAP QC programs enhances analytical reliability, and enables method comparisons by participants and manufacturers NSQAP is a comprehensive resource for laboratory services

18 CDC Resources and Contacts NSMBB Branch Office Carla Cuthbert PhD, FACMG Newborn Screening Quality Assurance Program (NSQAP) Joanne V. Mei, PhD TSH, T4, 17OHP, Cystic Fibrosis, Sickle Cell Disease, Total Galactose, HIV and Toxoplasma antibodies TREC and LSD PT Programs, Data Management and Program Administration Biochemical Mass Spectrometry Laboratory (BMSL) Victor R. De Jesus, PhD Amino Acids, Succinylacetone, Acylcarnitines, X-ALD, MSUD, GAMT, MMA-HCY, CAH MS/MS Biotinidase, GALT, G6PD, Filter Paper Evaluations Newborn Screening Translation Research Initiative (NSTRI) Robert Vogt, PhD TREC and LSD reference materials Development of DBS reference materials for candidate conditions Molecular Quality Improvement Program (MQIP) Suzanne Cordovado, PhD Continuous quality improvement for molecular methods in DBS Quality assurance for specific mutations involved in newborn disorders Data Management Team (DMT) Sherri Zobel Irene Williams LoNeka Shockley

19 Thank you for your attention! Newborn Screening Saving Lives. Promoting Healthier Babies. Protecting our Future. For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone: CDC-INFO ( )/TTY: Visit: Contact CDC at: CDC-INFO or The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Environmental Health Division of Laboratory Sciences