At a glance
The certification process ensures that the method in question is accurate and reliable. Ongoing certification also assures end users that the product stays accurate and reliable. Many clinical laboratories rely on test manufacturers to maintain certified methods.
List of VDSCP certified participants
Certified manufactures are those that meet CDC’s analytical performance criteria. CDC issues certificates for each analytical system evaluated. The date used on the certificate as the “Date of Certification” indicates when the laboratory data were compiled and statistically analyzed at CDC. Certificates for manufacturers expire 1 year after their certification date.
Number of Certificates Issued to Manufacturers by Participant
| Timeframe | Total | Research laboratories | Clinical laboratories | Assay/Kit manufacturers |
|---|---|---|---|---|
| Last 12 months | 19 | 26% | 32% | 42% |
| Last 3 years | 56 | 27% | 20% | 53% |
Total 25-hydroxyvitamin D in Serum
The following laboratories have successfully passed the performance criterion of ±5% mean bias to the CDC and University of Ghent Vitamin D2 and D3 Reference Method and an overall imprecision of <10% over the concentration range of 22-275 nmol/L for total 25-hydroxyvitamin D. Laboratories are awarded certificates for successfully completing bias and imprecision testing using specific methods, reagent lots, calibrator lots and instrumentation. During the year it is the responsibility of the participant to ensure that the results of their method remain consistent over time, throughout the year, between lots, and over the measurement range reported. It is not the intent of the CDC VDSCP to certify each lot of reagents, or to issue certification beyond the measurement range of 22.5-275 nmol/L, at this time.
VDSCP Vitamin D Certified Assays
Certifications from 2020 (Updated September 2024)
VDSCP Vitamin D Certified Procedures
Certifications prior to 2020
Accuracy-Based Monitoring Program (CDC AMP) for hormones
The following clinical and research laboratories have documented traceability to the CDC Clinical Reference Laboratory by meeting performance criteria used by the AMP for total testosterone in males and females (TT) and/or total 25-hydroxyvitamin D (VD).
The following list includes the laboratory name, location of the laboratory, analyte, measurement principle, assay identifier, analysis dates, and the status of the assay in the CDC Hormone Standardization Program (CDC HoSt) and/or the CDC Vitamin D Standarization-Certification Program (CDC VDSCP).
List of Participants Within AMP Performance Criteria
CDC Accuracy-Based Monitoring Program (CDC AMP) List of Participants that are Within Criteria
Contact us
If you have any questions on the List of Certified Participants for VDSCP or the List of AMP Hormones Participants Within Performance Criteria, email: standardization@cdc.gov