Key points
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 HoSt certified participants
Certified manufactures are those that meet CDC’s analytical performance criteria. CDC issues certificates for each certified 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.
After meeting acceptance analytical performance for four consecutive quarters, a participant is certified. The certification is valid for one year. After four consecutive quarters, participants are evaluated quarterly for certification.
Testosterone in serum
The following laboratories have successfully passed the performance criterion ±6.4% mean bias to the CDC Testosterone Reference Method over the concentration range of 2.50-1,000 ng/dL. Laboratories are awarded certificates for successfully completing bias 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 HoSt Program to certify each lot of reagents, or to issue certification beyond the measurement range of 2.50-1,000 ng/dL, at this time.
HoSt Total Testosterone Certified Assays Certifications from 2020 (Updated September 2024)
HoSt Testosterone Certified Procedures Certifications prior to 2020
Estradiol in serum
The following laboratories have successfully passed the performance criteria of ±12.5% mean bias (for samples >20 pg/mL) and ±2.5 pg/mL absolute bias (for samples ≤20 pg/mL) to the CDC Estradiol Reference Method in serum over the concentration range of 1.92-209 pg/mL. Laboratories are awarded certificates for successfully completing bias 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 HoSt Program to certify each lot of reagents, or to issue certification beyond the measurement range of 1.92-209 pg/mL, at this time.
HoSt Estradiol Certified Assays Certifications from 2020 (Updated September 2024)
HoSt Estradiol 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
Contact us
If you have any questions on the List of Certified Participants for HoSt or the List of AMP Hormones Participants Within Performance Criteria, email: standardization@cdc.gov