What's new in Lab Results CSV/XML import files as of 28 September 2021?

In compliance with TD2021NA the following changes will be available in ADAMS on 28 September 2021 for the Sample Received after 01 April 2021. 

For samples Received after 01 April 2021 when Prohibited substance 19-norandrosterone is selected then:

  1. Estimated concentration of 19-NA (>, ≤) is MANDATORY for 'A' samples:

A dropdown is available with the following values:

        • > 15 ng/mL
        • ≤ 15 ng/mL
        • >10 ng/mL
        • ≤10 ng/mL
  1. Reporting on the presence of THNE is mandatory if concentration of 19-NA > 10 ng/mL.
      • No presence (this is the Default value)

And when 19-NA > 10 ng/mL, one of the following options shall be selected, as applicable: 

      • The level of THNE appears incompatible with that of 19-NA
      • The level of THNE appears compatible with that of 19-NA
  1. Check box GC/C/IRMS 19-NA 19-NE is optional.

When GC/C/IRMS is performed for 19-NA or 19-NE then the checkbox shall be checked and IRMS details shall be entered here. When the check box is checked, the IRMS Table is displayed to record GC/C/IRMS results as follows.  

IRMS table:

        • TC 19-NA: delta and uc values of the TC 19-NA display.
        • TC 19-NE: delta and uc values of the TC 19-NE display. 
        • ERC: Mandatory if 19-NA or 19-NE delta values are entered
        • ERC2: Optional, it is used when the Test result with ERC is positive (AAF) in order to conclude an AAF or ATF.
        • 19-NA/19-NE ratio: Optional numeric value allowed. 
        • Specific comments: Optional check boxes - multi-select is possible
Specific Comments  Specific Code 
Results of the GC/C/IRMS analysis are consistent with the exogenous origin of 19-NA (or 19-NE, if applicable) Consistent_ exogenous_origin_19NA
Results of the GC/C/IRMS analysis are inconclusive or do not meet the criteria supporting an exogenous origin for 19-NA (or 19-NE, if applicable) Inconclusive_ exogenous_origin_19NA
Results of the GC/C/IRMS analysis are consistent with an endogenous origin (i.e. in-situ formation) of 19-NA (or 19-NE, if applicable) Consistent_ endogenous_origin_19NA
19-NA was found in the Sample at an estimated concentration > 10 ng/mL. Tetrahydronorethisterone, a Metabolite of norethisterone, was also detected in the Sample at a concentration that is compatible with that of 19-NA Found_in_the_Sample_19NA
19-NA was found in the Sample at an estimated concentration > 10 ng/mL. Tetrahydronorethisterone, a Metabolite of norethisterone, was also detected in the Sample at a concentration that is NOT compatible with that of 19-NA found_not_compatible_19NA
The 19-NA finding is not consistent with the use of norethisterone not_consistent_norethisterone_19NA

The 19-NA finding is not consistent with pregnancy or the use of norethisterone

Not_consistent_with_pregnancy_19NA
Other (specify in Details concerning Finding) Other_19NA

 

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In Compliance with TD2021DL the following changes will be available in ADAMS on 28 September 2021 for the Sample Received after 01 April 2021.

 It is mandatory to enter the (adjusted) DL if SG > 1.018.

For all Threshold substances the following fields are added in ADAMS: 

  • (adjusted) DL: if applicable (optional)
  • unit drop down: standard unit drop down
 
Following Threshold substances are available in ADAMS: 

Substance class

Substance Name

Specific Code

S3. Beta-2 Agonists

formoterol greater than the Decision Limit

formoterol greater than the Decision Limit

S3. Beta-2 Agonists

(EQAS only) formoterol equal to or less than the Decision Limit

(EQAS only) formoterol equal to or less than the Decision Limit

S3. Beta-2 Agonists

salbutamol greater than the Decision Limit

salbutamol greater than the Decision Limit

S3. Beta-2 Agonists

(EQAS only) salbutamol equal to or less than the Decision Limit

(EQAS only) salbutamol equal to or less than the Decision Limit

S6. Stimulants

cathine greater than the Decision Limit

cathine greater than the Decision Limit

S6. Stimulants

(EQAS only) cathine equal to or less than the Decision Limit

(EQAS only) cathine equal to or less than the Decision Limit

S6. Stimulants

ephedrine greater than the Decision Limit

ephedrine greater than the Decision Limit

S6. Stimulants

(EQAS only) ephedrine equal to or less than the Decision Limit

(EQAS only) ephedrine equal to or less than the Decision Limit

S6. Stimulants

methylephedrine greater than the Decision Limit

methylephedrine greater than the Decision Limit

S6. Stimulants

(EQAS only) methylephedrine equal to or less than the Decision Limit

(EQAS only) methylephedrine equal to or less than the Decision Limit

S6. Stimulants

pseudoephedrine greater than the Decision Limit

pseudoephedrine greater than the Decision Limit

S6. Stimulants

(EQAS only) pseudoephedrine equal to or less than the Decision Limit

(EQAS only) pseudoephedrine equal to or less than the Decision Limit

S7. Narcotics

total morphine greater than the Decision Limit

total morphine greater than the Decision Limit

S7. Narcotics

(EQAS only)total morphine equal to or less than the Decision Limit

(EQAS only) morphine equal to or less than the Decision Limit

S7. Narcotics

total morphine greater than the Decision Limit and ratio of total morphine to total codeine is equal or higher than 2.0 and total codeine is not higher than 5 ug/mL

total morphine greater than the Decision Limit and ratio of total morphine to total codeine is equal or higher than 2.0 and total codeine is not higher than 5 ug/mL

S7. Narcotics

(EQAS only) total morphine greater than the Decision Limit but lower than the concentration of ethylmorphine, and/or the ratio of total morphine to total norethylmorphine is NOT higher than 20

(EQAS only) total morphine greater than the Decision Limit but lower than the concentration of ethylmorphine, and/or the ratio of total morphine to total norethylmorphine is NOT higher than 20

S7. Narcotics

total morphine greater than the Decision Limit and greater than the concentration of ethylmorphine, and the ratio of total morphine to total norethylmorphine is higher than 20

total morphine greater than the Decision Limit and greater than the concentration of ethylmorphine, and the ratio of total morphine to total norethylmorphine is higher than 20

S7. Narcotics

(EQAS only) total morphine greater than the Decision Limit but lower than the concentration of ethylmorphine, and/or the ratio of total morphine to total norethylmorphine is NOT higher than 20

(EQAS only) total morphine greater than the Decision Limit but lower than the concentration of ethylmorphine, and/or the ratio of total morphine to total norethylmorphine is NOT higher than 20

S8. Cannabinoids

Carboxy-THC greater than the Decision Limit

Carboxy-THC greater than the Decision Limit

S8. Cannabinoids

(EQAS only) Carboxy-THC equal to or less than the Decision Limit

(EQAS only) Carboxy-THC equal to or less than the Decision Limit

S2. Peptide Hormones, Growth Factors, Related Substances and Mimetics

human Chorionic Gonadotrophin (hCG) greater than the Decision Limit for LC-MS/MS

human Chorionic Gonadotrophin (hCG) greater than the Decision Limit for LC-MS/MS

S2. Peptide Hormones, Growth Factors, Related Substances and Mimetics

(EQAS only) human Chorionic Gonadotrophin (hCG) equal to or less than the Decision Limit for LC-MS/MS

(EQAS only) human Chorionic Gonadotrophin (hCG) equal to or less than the Decision Limit for LC-MS/MS

S2. Peptide Hormones, Growth Factors, Related Substances and Mimetics

human Chorionic Gonadotrophin (hCG) greater than the Decision Limit for immunoassays

human Chorionic Gonadotrophin (hCG) greater than the Decision Limit for immunoassays

S2. Peptide Hormones, Growth Factors, Related Substances and Mimetics

(EQAS only) human Chorionic Gonadotrophin (hCG) equal to or less than the Decision Limit for immunoassays

(EQAS only) human Chorionic Gonadotrophin (hCG) equal to or less than the Decision Limit for immunoassays

 

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In Compliance with TD2021CG/LH the following changes will be available in ADAMS on 28 September 2021 for the Sample Received after 01 April 2021.

Labs shall enter  “Adjusted Concentration (SG > 1.018) (IU/L)” value for LH Analysis, if:

  • “Sample Specific Gravity (Initial Testing Procedure)” is greater than 1.018;
    AND
  • LH-Analysis result is either “PAAF” or “ATF”.

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In compliance with TD2021EPO the following changes will be available in ADAMS on 28 September 2021 for the Sample Received after 1 May 2021.

For the following substances 

  • erythropoietin (EPO)
  • methoxy polyethylene glycol-epoetin beta (CERA)
  • darbepoetin (dEPO)
  • EPO-Fc

If the Result is an AAF or ATF, then one or multiple ERA Analytical Method(s) applied during the confirmation procedure shall be indicated in the Lab Results (see checkboxes in example below): 

ERA Analytical Method

Specific Code

IEF-PAGE

IEF-PAGE

SDS-PAGE

SDS-PAGE 

SAR-PAGE

SAR-PAGE

Other (such as LC-MS)

Other

 

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The following changes will be available in ADAMS on 28 September 2021 for the Sample Received after 1 April 2021.

Sample Specific Gravity (Confirmation Procedure) is mandatory for B, B2 sample in the Urine Lab Results.

 

 

 

CSV File: 

Optional Fields
Field Column header Description
Estimated concentration of 19-NA (>, ≤)

prohibited_substance_estconcentration [index]

 

Mandatory under the Prohibited Substance 19-norandrosterone. 

Possible values: (Specific codes):

  • > 15 ng/mL
  • <= 15 ng/mL
  • > 10 ng/mL
  • <= 10 ng/mL
Presence of THNE

presence_THNE_compatible[index]

Presence_THNE_incompatible[index] 

Required under the Prohibited Substance 19-norandrosterone when Estimated concentration of 19-NA > 10 ng/mL.  

When both THNE are empty or FALSE is selected for any of them then “No presence” is selected in the Lab Results.

Values :TRUE, FALSE. empty 

 

GC/C/IRMS 19-NA 19-N

GC_C_IRMS_19NA_19NE[index]

Optional for Prohibited Substance 19-norandrosterone. 

Required when GC/C/IRMS 19-NA 19-N was performed.

Value: TRUE , FALSE , blank

19-NA/19-NE ratio  prohibited_substance_19NA_19NE_ratio [index] 

Optional for Prohibited Substance 19-norandrosterone.

 Numeric positive value

Target Compounds under 19-norandrosterone

TC_substance[index] 

TC_substance_variable_code[Index]

TC_substance_variable_d_value[Index]

TC_substance_variable_u_value[Index]

Mandatory to select one Target Compound when GC/C/IRMS 19-NA 19-N is selected.

TC_Substance code :

  • 19-norandrosterone

TC_substance_variable_code: 

  • 19NA 
  • 19NE

TC_substance_variable_d_value  ,TC_substance_variable_u_value: Numeric values

Example:

TC_substance[1]=19-norandrosterone

TC_substance_variable_code [1]=19-NA

TC_substance_variable_d_value [1]= -27

TC_substance_variable_u_value [1]=0.06

TC_substance_variable_code [2]=19-NE

TC_substance_variable_d_value [2]= -28

TC_substance_variable_u_value [2]=0.07

Endogenous Reference Compound under 19-norandrosterone

ERC_substance_variable_code [Index]

ERC_substance_variable_d_value [Index]

ERC_substance_variable_u_value[Index]

ERC2_substance_variable_code[Index]

ERC2_substance_variable_d_value[Index]

ERC2_substance_variable_u_value[Index]

Mandatory to select ERC values when GC/C/IRMS 19-NA 19-N is selected.

ERC_substance_variable_code: specific code of the Endogenous Reference Compound variable for IRMS.

Possible values:

Pregnanediol (PD), 5α-androst-16-en-3α-ol (16-en), 11β-hydroxyandrosterone (11-OHA), 11-ketoetiocholanolone (11-O-Etio), Androsterone (Androsterone), Pregnanetriol (PT)

 

ERC_substance_variable_d_value: δ(0/00) decimal value or integer as per ADM2 settings for the variable.

ERC_substance_variable_u_value: uc (0/00) decimal value or integer as per ADM2 settings for the variable. 

ERC2_substance_variable_code is optional. 

ERC2_substance_variable_d_value  is required when ERC2_substance_variable_code is entered.

ERC2_substance_variable_u_value is required when ERC2_substance_variable_code is entered. 

Example:

ERC_substance_variable_code [1]=16-en
ERC_substance_variable_d_value [1]= -27
ERC_substance_variable_u_value [1]=0.06
ERC2_substance_variable_code [1]=PT
ERC2_substance_variable_d_value [1]= -28
ERC2_substance_variable_u_value [1]=0.08

Specific comments

consistent_exogenous_origin_19NA[index]

inconclusive_exogenous_origin_19NA[index]

consistent_endogenous_origin_19NA[index]

found_in_the_sample_19NA[index]

Found_Not_Compatible_19NA[index]

not_consistent_norethisterone_19NA[index]

not_consistent_with_pregnancy_19NA[index]

other_19NA[index]

Required when GC/C/IRMS 19-NA 19-N is selected for the Prohibited Substance.

Value: True , False , Empty 

More than one specific comments is possible.  

(Adjusted) DL

prohibited_substance_DL[index]

prohibited_substance_DL_unit[index]

The (Adjusted) DL value for the prohibited substance for the sample Received after 01-April 2021.

prohibited_substance_DL_unit[index] is mandatory when a value exist in prohibited_substance_DL[index]. 

Exemple:
"2.3"

"IU/L"

Adjusted Concentration (SG > 1.018) (IU/L)“ under “Concentration (IU/L) 

lh_adj_concentration

 

This column is required for the sample Received after 01-April 2021 only when specific_gravity is > 1.018
 and 
LH-Analysis is either PAAF or ATF.

ERA Analytical Method

PS_PAGE_Analytical_MethodA[index]

PS_PAGE_Analytical_MethodB[index]

PS_PAGE_Analytical_MethodC[index]

PS_PAGE_Analytical_MethodD[index]

 Apply to the following substances from 01 May 2021:  

  • erythropoietin (EPO)
  • methoxy polyethylene glycol-epoetin beta (CERA)
  • darbepoetin (dEPO)
  • EPO-Fc

Specific Code of ERA Analytical Method for the prohibited substance [index] shall be reported. 

  • IEF-PAGE
  • SDS-PAGE 
  • SAR-PAGE
  • Other

Example: 
PS_PAGE_Analytical_MethodA[1]=SDS-PAGE
PS_PAGE_Analytical_MethodB[1]=SAR-PAGE

XML File: 

Data Element Description
Estimated concentration of 19-NA (>, ≤)

Required under substance when Substance is 19-norandrosterone. 

Possible values: 

  • > 15 ng/mL
  • <= 15 ng/mL
  • > 10 ng/mL
  • <= 10 ng/mL

Example : 

<estConcentration>> 15 ng/mL</estConcentration>

<estConcentration>&#60;= 15 ng/mL</estConcentration>

<estConcentration>>10 ng/mL</estConcentration>

<estConcentration>&#60;=10 ng/mL</estConcentration>

 

Presence of THNE

Required under the substance when Substance is 19-norandrosterone.Default value is No presence. 

Example: 

<presenceTHNE>

<presenceTHNEIncompatible>true</presenceTHNEIncompatible>
</presenceTHNE>

GC/C/IRMS 19-NA 19-NE

Optional under Substance, when CG/C/IRMS performed for 19-norandrosterone then must be True. 

19-NA/19-NE ratio 

Optional under substance with decimal value .

Target Compounds under 19-norandrosterone

When Date_ Received is after 01-April-2021 and GC/C/IRMS 19-NA 19-NE is true then the new Target Compounds can be entered under substances 19-norandrosterone with Specific code between brackets : 

  • 19-NA(19NA)
  • 19-NE(19NE)

<code>: specific code of the IRMS Target Compound variable.

<value>: δ (0/00) decimal value or integer as per ADM2 settings for each variable. Mandatory if a Target Compounds code is included for the same code.

<uc>: uc (0/00) decimal value or integer as per ADM2 settings for each variable. Mandatory if a Target Compound is included for the same code. 

Endogenous Reference Compound under 19-norandrosterone

Required Fields under substance 19-norandrosterone when GC/C/IRMS 19-NA 19-NE is true :

<endogenousReferenceCompound>: mandatory when  GC/C/IRMS 19-NA 19-NE is true. 

<endogenousReferenceCompound2>: optional

For each Endogenous Reference Compounds must entered the following values:  

<code>: specific code of the Endogenous Reference Compound variable for IRMS.

 <value>: δ(0/00) decimal value or integer as per ADM2 settings for the variable.

<uc>: uc (0/00) decimal value or integer as per ADM2 settings for the variable. 

 

Specific comments

Required under substance when substance is 19-norandrosterone and GC/C/IRMS 19-NA 19-NE is true.

codes can be: 

  • inconclusive_exogenous_origin_19NA
  • consistent_endogenous_origin_19NA
  • found_in_the_sample_19NA
  • found_not_compatible_19NA
  • not_consistent_norethisterone_19NA
  • not_consistent_with_pregnancy_19NA
  • other_19NA
(Adjusted) DL

This is optional and available under the Threshold substances when Date_Received is after 01 April 2021.

When adjusted DL value is entered then adjusted DL Unit is mandatory. 

 

Adjusted Concentration (SG > 1.018) (IU/L)“ under “Concentration (IU/L) 

This is required only when sample received after 01-April-2021 and specific gravity is > 1.018
 and LH-Analysis is either PAAF or ATF. 

ERA Analytical Method

It is optional for the following substances for the sample Received after 01 May 2021: 

  • erythropoietin (EPO)
  • methoxy polyethylene glycol-epoetin beta (CERA)
  • darbepoetin (dEPO)
  • EPO-Fc

The multiple value is allowed : 

  • IEF-PAGE
  • SDS-PAGE 
  • SAR-PAGE
  • Other

XSD File

  • "found_not_compatible_19NA" is added under Specific comments in the V3 of 'Labresults Sep 2021-V3.XSD' file. 
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