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RequestNotesStatus

User Inquiry: Yun Zhang <Yun.Zhang@modernatx.com>

From Yun: Hepatitis B screening panel includes Hepatitis B surface antigen, Hepatitis B Surface antibody, Hepatitis B core antibody. If those tests are only done at screening and not related to study interest disease.

If following IG 3.3 , all those 3 tests are mapped to MB. If following IG 3.4, will only antigen map to MB , those 2 antibody tests are mapped to IS ? But in this way the same panel test would be separated in two domains.  Do you have any suggestions ? Here is the link to the test:

https://testdirectory.questdiagnostics.com/test/test-guides/TS_HBVScreen/hbv-screen-panel-with-reflexes


2024-02-22 team notes - we also talked about making a new variable called “Panel Testing” which would apply to all the specimen-based domains. In recent years we have seen other panel tests that would required tests to be mapped to, for instance, GF and MB. It would be nice to have a standard variable dedicated to grouping related records from the same panel test, instead of having to rely on CAT or linking variables.

Status
colourGreen
titleResolved
2024-02-22: Jordan sent the mockup example back to Yun.


Action Item:

  •  Jordan needs to add this to Example Collection.
Dataset wrap
Namemb
Dataset2
hi1styleyellow
hi1column ISBDAGNT
tableidIS table 1
Dataset wrap
titlelb.xpt
Namemb
Rowcaps
Rows 1-2:Show the screening, followed by confirmatory detection of Influenza A virus RNA in a nasal specimen by Rapid PCR test.
Row 3:Shows viral load of the previously detected Influenza A virus RNA.
Dataset2

Row

STUDYID

DOMAIN

USUBJID

MBSEQ

MBGRPID

MBLNKID

MBTESTCD

MBTEST

MBTSTDTLMBTSTOPOMBCAT

MBORRES

MBORRESU

MBSTRESC

MBSTRESNMBSTRESUMBSPECMBLOC
MBMETHOD
VISITNUM
VISIT

MBDTC

1

ABC

MB

ABC-01-

001

201

1

1INFARNAInfluenza A RNADETECTIONSCREENMICROBIOLOGYYESYESYESMUCUSNOSTRIL

RAPID PCR

1SCREEN2018-06-01
HBVP1
Hepatitis B Virus Surface AntigenDETECTION
HBV TRIPLE SCREEN PANEL

POSITIVE

POSITIVE
SCREENING2013-08-26

2

ABC

MB

ABC-01-

001

203

3

2

1

HBVP1

INFARNAInfluenza A RNADETECTIONCONFIRMMICROBIOLOGYYESYESYES

log 10 IU/mL

MUCUSNOSTRIL

RAPID PCR

1SCREEN

Hepatitis B VirusINTERPRETATIONSCREENHBV TRIPLE SCREEN PANEL

ACUTE INFECTION

ACUTE INFECTION
SCREENING2013-08-26
2018-06-01

3

ABC

MB

ABC-01-

001

201

1

3

2INFARNAInfluenza A RNA

VIRAL LOAD

QUANTIFYMICROBIOLOGY4.5log 10 copies/mL4.54.5log 10 copies/mLMUCUSNOSTRIL

QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION

1SCREEN2018-06-01

Option 1 - for the quantification 2nd step, use --TSTOPO since we already proposed controlled terminology

Note: if I remember correctly we specifically avoided the term "quantification" because the test can be "semi, pseudo, or fully quantitative", we found this term just toooo vague.

HBVP2
Hepatitis B Virus Surface AntigenDETECTION
HBV TRIPLE SCREEN PANEL

POSITIVE

POSITIVE
VISIT 12013-10-25

4

ABC

MB

ABC-01-203

4

HBVP2
Hepatitis B VirusINTERPRETATIONSCREENHBV TRIPLE SCREEN PANEL

ACUTE INFECTION

ACUTE INFECTION
VISIT 12013-10-25
Dataset wrap
Dataset2
hi1styleyellow
hi1column ISBDAGNT
tableidIS table 1
Dataset wrap
titlelb.xpt
Namemb
dataset2

Row

STUDYID

DOMAIN

USUBJID

SPDEVID

ISSEQ

ISGRPID

ISLNKID

ISTESTCD

ISTEST

ISBDAGNTISTSTOPO
ISCAT

ISORRES

ISORRESU

ISORREC

ISSTRESC

ISSTRESN

ISSTRESU

ISMETHOD

VISITNUM

VISIT

MBDTC

ISDTC

1

ABC

MB

IS

ABC-

001

01-203

ABC001

1

1
HBVP1
Anti

Microbial-
microbial IgM AntibodySARS-CoV-2SCREENMICROBIOLOGYYESYESYESEIA1SCREEN2018-06-012ABCMBABC-00131Anti-microbial IgM AntibodySARS-CoV-2QUANTIFYMICROBIOLOGY350Titer350350

Titer

EIA1SCREEN2018-06-01
induced AntibodyHEPATITIS B VIRUS SURFACE ANTIGENHBV TRIPLE SCREEN PANELNEGATIVENEGATIVE

SCREENING

2013-08-26

2

ABC

IS

ABC-01-203

ABC001

2

HBVP1


Microbial-induced IgM AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELPOSITIVEPOSITIVE

SCREENING

2013-08-26

3

ABC

IS

ABC-01-203

ABC001

3

HBVP1
Microbial-induced Total AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELPOSITIVEPOSITIVE

SCREENING

2013-08-26
4ABCIS

ABC-01-203

ABC001

4

HBVP2
Microbial-induced AntibodyHEPATITIS B VIRUS SURFACE ANTIGENHBV TRIPLE SCREEN PANELNEGATIVENEGATIVE

VISIT 1

2013-10-25
5ABCIS

ABC-01-203

ABC001

5

HBVP2


Microbial-induced IgM AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELNEGATIVENEGATIVE

VISIT 1

2013-10-25
6ABCIS

ABC-01-203

ABC001

6

HBVP2


Microbial-induced Total AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELPOSITIVEPOSITIVE


VISIT 1

2013-10-25
Dataset wrap
Namerelrec
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1ABCMB
MBLNID
MANY1
2ABCIS
ISLNKID
MANY1

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