Certification of HoSt Analytical Performance
To be used for patient care and public health, laboratory tests must meet certain requirements for accuracy and precision. With the HoSt certification program, CDC evaluates whether laboratory tests for testosterone and estradiol meet these analytical performance criteria.
The following is the process for HoSt certification:
- CDC provides participants with 10 serum samples every quarter for four quarters. Participants are unaware of the testosterone and estradiol concentrations in these samples.
- Participants follow a specific protocol to analyze samples, and report results to CDC.
- CDC takes participants’ data, reported from four consecutive quarters, and compares it to the actual concentration determined with CDC’s reference method.
- CDC calculates the accuracy of participants’ data using the protocol published by the Clinical Laboratory and Standards Institute.
- Participants receive a comprehensive report about the assessment. Laboratory tests that meet bias and precision analytical performance criteria receive a certificate, and are listed on the HoSt list of certified labs for testosterone or estradiol.
Current Analytical Performance Criteria for Certification
| Analyte | Accuracy | Precision |
|---|---|---|
| Testosterone1 | ±6.4% mean bias | <5.3%** |
| Estradiol2 | ±12.5% bias if >20 pg/mL, ±2.5 pg/mL bias if ≤20 pg/mL |
<11.4%** |
- Yun YM et al. ClinChem 2012
- Vesper et al. Steroids 2013
- Stockel et al. Clin Chem Acta 2009
** criteria included in performance report but not currently used for certification
Certificates are valid for one year and can be renewed by re-enrolling in the program. Enrollments can be done at any time throughout the year.
To enroll in the program, contact Standardization@cdc.gov.