Accuracy-based proficiency testing for estradiol measurements

Details

• Alternative Title:
  Clin Biochem
• Personal Author:
  Cao, Zhimin Tim ; Rej, Robert ; Vesper, Hubert ; Astles, J. Rex
• Description:
  Objectives:
  
  Accuracy of estradiol measurements is important but conventional proficiency testing (PT) cannot assess accuracy when possibly non-commutable samples are used and method peer-group means are the targets. Accuracy-based assessment of estradiol measurements is needed.
  
  Design and Methods:
  
  Five serum samples were prepared from single donors, frozen, and distributed overnight to 76 New York State Department of Health (NYSDOH)-certified laboratories. Participants analyzed samples for estradiol. The biases of group means were assessed against the Centers for Disease Control and Prevention (CDC)-defined targets, evaluated using the Hormone Standardization Program (HoSt) E2 performance criterion of ±12.5 %. Each laboratory’s performance was evaluated using total allowable error (acceptance limits) of target ±25 % or ±15 pg/mL (55 pmol/L) (whichever was greater, NYSDOH), target ±30 % (Clinical Laboratory Improvement Amendments [CLIA]), and target ±26 % (minimal limit based on biological variation [BV]).
  
  Results:
  
  The biases (range) were 34 % (−17 % to 175 %), 40 % (−33 % to 386 %), 16 % (−45 % to 193 %), 5 % (−27 % to 117 %), and 4% (−31 % to 21 %), for samples at estradiol of 24.1, 28.4, 61.7, 94.1, and 127 pg/mL, or 89, 104, 227, 345, and 466 pmol/L, respectively. Large positive method/analytical systematic biases were revealed for 9 commonly used method/analytical systems in the United States at low estradiol concentrations. Of the 9 analytical systems, 0, 0, 3, 7 and 6 met the HoSt criterion for the samples with estradiol at the five respective concentrations. PT evaluation showed that 59 %, 69 % and 87 % of laboratories would receive a PT event passing (satisfactory) score when the CDC-defined target and a criterion of NYSDOH, CLIA or BV was used, respectively. However, >95 % laboratories would obtain PT passing score if method peer-group means were used as targets regardless of the criterion used.
  
  Conclusions:
  
  Improvement in accuracy of estradiol measurements is needed, particularly at low estradiol concentrations. Accuracy-based PT provides unambiguous information about the accuracy of methods/analytical systems.
  
  
• Subjects:
  Clinical Laboratory Services Humans Laboratories Laboratories, Clinical Laboratory Proficiency Testing Reference Standards United States
• Keywords:
  Accuracy Estradiol Proficiency Testing Standardization
• Source:
  Clin Biochem. 124:110700
• Pubmed ID:
  38043696
• Pubmed Central ID:
  PMC11261451
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  124
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:4ac682cca6e1354765098cf6714e3f1f6e649a1a971a186146797376d6d1ea12bc3f4cd7fda7a52cc51fa75103a7f1200a90b74567a350958ee5777f9653005d
• Download URL:
  https://stacks.cdc.gov/view/cdc/159336/cdc_159336_DS1.pdf
• File Type:
  [PDF - 718.92 KB ]