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

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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

2. 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

3. 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 u_c values of the TC 19-NA display.
      • TC 19-NE: delta and u_c 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

4. In the Test Report, the details are displayed under the “Results / Résultats” section:

In the Test Report, the details are displayed under the “Results/Résultats” section : 

When Test-Results is AAF then: “This result constitutes an Adverse Analytical Finding for the presence of the substance in the Sample.” is displayed.

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”.

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): 

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.

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_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_19NA_19NE[index]

Optional for Prohibited Substance 19-norandrosterone. 

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

Value: TRUE , FALSE , blank

Optional for Prohibited Substance 19-norandrosterone.

 Numeric positive value

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

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

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]. 

Example:
"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.

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

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>

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

Example: 

<presenceTHNE>

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

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

Optional under substance with decimal value .

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. 

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. 

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

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. 

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. 

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