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RequestNotesStatus

User Inquiry:

Yun Zhang <Yun.Zhang@modernatx.com>

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 ?

Status
colourGreen
titleResolved

Dataset wrap
Namemb
Dataset2
hi1styleyellow
hi1column ISBDAGNT
tableidIS table 1

Row

STUDYID

DOMAIN

USUBJID

MBSEQ

MBLNKID

MBTESTCD

MBTEST

MBTSTDTLMBTSTOPOMBCAT

MBORRES

MBSTRESC

MBMETHODVISIT

MBDTC

1

ABC

MB

ABC-01-201

1

HBVP1
Hepatitis B Virus Surface AntigenDETECTION
HBV TRIPLE SCREEN PANEL

POSITIVE

POSITIVE
SCREENING2013-08-26

2

ABC

MB

ABC-01-203

2

HBVP1


Hepatitis B VirusINTERPRETATIONSCREENHBV TRIPLE SCREEN PANEL

ACUTE INFECTION

ACUTE INFECTION
SCREENING2013-08-26

3

ABC

MB

ABC-01-201

3

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

Row

STUDYID

DOMAIN

USUBJID

SPDEVID

ISSEQ

ISLNKID

ISTESTCD

ISTEST

ISCAT

ISORRES

ISORREC

ISMETHOD

VISIT

ISDTC

1

ABC

IS

ABC-01-203

ABC001

1

HBVP1
Microbial-induced AntibodyHEPATITIS B VIRUS SURFACE ANTIGENHBV TRIPLE SCREEN PANELNEGATIVE

SCREENING

2013-08-26

2

ABC

IS

ABC-01-203

ABC001

2

HBVP1


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

SCREENING

2013-08-26

3

ABC

IS

ABC-01-203

ABC001

3

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

SCREENING

2013-08-26
4ABCIS

ABC-01-203

ABC001

4

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

VISIT 1

2013-10-25
5ABCIS

ABC-01-203

ABC001

5

HBVP2


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

VISIT 1

2013-10-25
6ABCIS

ABC-01-203

ABC001

6

HBVP2


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


VISIT 1

2013-10-25
Dataset wrap
Namerelrec
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1ABCMBABC-01-201MBLNID
MANY1
2ABCISABC-01-201ISLNKID
MANY1