Standardization of Measurement Procedures

The CDC Laboratory/Manufacturer Hormone Standardization (HoSt) Program helps laboratories with lab-developed tests and helps assay manufacturers with calibration. This program assesses the assay performance (bias and imprecision) of the lab or assay manufacturer throughout 1 year.

The program consists of two phases:

Phase 1
The participant receives 40 serum samples with reference value assignments. The serum samples are nonpooled, single donor sera prepared following CLSI protocol C37 (3) from male and female donors. These samples are intended to assess the accuracy of the test and to help in recalibrating the test as needed. Participants who are unable to fully participate in HoSt may obtain the 40 serum sample panel for method evaluation purposes.

Phase 2
After calibration, the participant ships four quarterly challenges (Phase 2A-D) with unknown serum samples for analysis. Values reported from participants on these serum samples are used for bias assessment as described in CLSI guidelines EP9-A2 (4) "Method Comparison and Bias Estimation using Patient Samples." Current acceptable criteria are derived from data on biological variability, the database can be found on the Westgard Website. CDC will consider participants meeting the acceptable mean bias of 6.4%.

CDC HoSt Program provides preliminary reports during the quarterly challenges and technical assistance to resolve potential problems, thus ensuring the participant's long-term success in maintaining standardized testosterone measurements.

All participants will remain anonymous. Only on successful completion of the CDC HoSt program will CDC mention participation publicly.

The CDC HoSt Testosterone program started in January 2010.

• HoSt Standardization of Serum Total Tertosterone Measurements Protocol [PDF - 115 KB]
  Current participant protocol for testosterone.
• HoSt Testosterone Certified Procedures [PDF - 285 KB]
  Updated April 2013

The CDC HoSt Estradiol program is scheduled for launch at the end of 2012.

If you are interested in reference measurement services by the CDC Hormone Standardization Program, please complete the HoSt Standardization Program Information Request Form [PDF - 286 KB] and return it to HoST@cdc.gov.