Obtaining Certification

Summary of NGSP Criteria

The NGSP offers three types of certification, manufacturer method certification, Level I Laboratory Certification and Level II Laboratory Certification. The certification process includes the exchange of 40 patient samples and an assessment of agreement analysis. A certificate of traceability to the Diabetes Control and Complications Trial (DCCT) Reference Method is issued to any manufacturer or laboratory that successfully completes the certification process. The certificate is effective for 1 year and is specific to the reagents and instrumentation used during certification.

The process consists of a 40 sample comparison with a Secondary Reference Laboratory (SRL; see list of SRLs under “Laboratory Network Members”). To begin the process, and for any further information, contact the NGSP Network Coordinator (Littler@health.missouri.edu). You will then need to choose an SRL and arrange for sample shipment to or from the SRL. If you have completed the process before and already know which SRL you will be working with, you may contact the SRL directly. Complete all the analyses following the enclosed instructions and send the data by e-mail (Excel file attachment) to the network coordinator.

Summary of Certification Criteria
Certification
Type
# samples
compared
Certification Criterion
Monitoring (yes / no)
Monitoring
Protocol
Cost
(basic cert.)
Manufacturer
40
37 of 40 results within ± 6%
No
-
$3500
Level I Lab
40
38 of 40 results within ± 6%
Yes
10 Samples Quarterly
$5000
Level II Lab
40
37 of 40 results within ± 6%
No
-
$3500

 

Certification Packets

Downloadable certification packets and forms are available here.