TD2021EAAS Changes to Lab Results

 

As of 1 April 2021, Labs will be required to enter some of the confounding factors with an estimated concentration in the comments section of Lab Results in ADAMS until the TD2021EAAS functionalities are available on 13 April 2021. 

 

Instructions to report Confounding Factors between 1st April to 13th April in ADAMS:

  1. When option “Y” is selected for the following Confounding Factors:  
    • Ethyl Glucuronide: Est. concentration should be entered as shown below (no change) 
    • 5a-reductase inhibitors: 4-hydroxy-dutasteride, 6-hydroxy-dutasteride or carboxy-finasteride must be entered as a comment in the “Analysis Details/Explanation/Opinion field along with the estimated concentration. 
    • Ketoconazole or similar: Ketoconazole or Miconazole or Fluconazole must be entered as a comment in the “Analysis Details/Explanation/Opinion field along with the estimated concentration.
  2. There is no change for reporting Anti-Estrogens between April 1st and 13th
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In compliance with TD2021EAAS the following changes will become effective in ADAMS on 13 April 2021. 

EQAS Forms: 

  • It will be possible to enter confirmed values for Steroidal profile variables in the EQAS form, a “Confirm” button will be available.  

Lab Result and EQAS Forms: 

  • The uncertainty field (uc) is empty when the value of the associated steroidal profile variable is either -1 or -2 
  • Confounding Factors:  
      • The list of confounding factors displayed depends on the “Date Received by Lab” field in both the Lab Result and EQAS forms. Confounding factors will only be displayed after the field “Date Received by Lab” is entered.  
      • New Confounding Factors are added to the Lab Results/EQAS. 
      • For Lab Results and EQAS received after 13 April 2021, the estimated concentration of confounding factors is mandatory if the option “Y” is selected, according to the table below. 

Name  

Unite of measure  

Specific Code  

Comments  

Ethyl Glucuronide 

ug/mL 

ethylglucuronide_est 

New Specific Code is effective as of 13 April 2021. 

The Ethyl Glucuronide with the present Specific Code “ethylglucuronide” is effective until 13 April 2021. 

Estimated Concentration required  

Carboxy-finasteride  

ng/mL 

carboxyfinasteride 

Estimated Concentration required 

4-hydroxy-dutasteride  

ng/mL 

4-hydroxy-dutasteride 

Estimated Concentration required 

6-hydroxy-dutasteride  

ng/mL 

6-hydroxy-dutasteride 

Estimated Concentration required 

Ketoconazole  

ng/mL 

ketoconazole_est  

Estimated Concentration required 

Fluconazole  

ng/mL 

fluconazole 

Estimated Concentration required 

Miconazole  

ng/mL 

miconazole 

Estimated Concentration required 

Anti-estrogenic substances  

 

anti_estrogens_sub  

 

 

Other  

 

other 

Optional  

 

      • Confounding Factors 5a-reductase inhibitors, Ketoconazole or similar and Anti-estrogens: 
          • For samples received after 13 April 2021, these confounding factors will no longer be applicable.  
          • Samples received before 13 April 2021 still require their presence. 

 

CSV/XML imports and batch updates 

  • When steroidal variable value is “-1” or “-2”, the value of uncertainly (uc) must be empty.  
  • When the sample is received after 13 April 2021: 
    • The new mandatory Confounding Factors and their Estimated Concentration are required.

CSV Format:

      • “CF_conc” is mandatory when “CF_presence” is True. 
      • “CF_conc_confirmed” is mandatory when “CF_presence_confirmed”  is True.  
      • “Unit” is not required anymore.

XML format:

        • "Concentration" is mandatory when “presence” is True.
        • "ConcentrationConfirmed” is mandatory when “presenceConfirmed” is True. 
    • Confounding factor specific code anti_estrogens_sub is mandatory.
    • Confounding factor specific code other is optional.
  • When sample is received between 1st and 13 April and Estimated Concentration is required Labs shall update the following Confounding Factors with the Estimated Concentration:
      • carboxy-finasteride 
      • 4-hydroxy-dutasteride
      • 6-hydroxy-dutasteride
      • Ketoconazole with Specific Code ketoconazole_est
      • fluconazole
      • miconazole  
  • When sample is received before 13 April 2021 Labs shall submit the following Confounding Factors with the specific code below:
      • Anti-estrogens with Specific Code anti_estrogens
      • Ketoconazole or similar with Specific Code ketoconazole
      • Ethyl Glucuronide with Specific Code ethylGlucuronide 

 

 

 

  

 

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