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Request Notes Status 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 ?
mb.xpt
mb.xpt
mb.xpt
Row
STUDYID
DOMAIN
USUBJID
MBSEQ
MBLNKID
MBTESTCD
MBTEST
MBTSTDTL MBTSTOPO MBCAT MBORRES
MBSTRESC
MBMETHOD VISIT MBDTC
1
ABC
MB
ABC-01-201
1
HBVP1 Hepatitis B Virus Surface Antigen DETECTION HBV TRIPLE SCREEN PANEL POSITIVE
POSITIVE SCREENING 2013-08-26 2
ABC
MB
ABC-01-203
2
HBVP1
Hepatitis B Virus INTERPRETATION SCREEN HBV TRIPLE SCREEN PANEL ACUTE INFECTION
ACUTE INFECTION SCREENING 2013-08-26 3
ABC
MB
ABC-01-201
3
HBVP2 Hepatitis B Virus Surface Antigen DETECTION HBV TRIPLE SCREEN PANEL POSITIVE
POSITIVE VISIT 1 2013-10-25 4
ABC
MB
ABC-01-203
4
HBVP2 Hepatitis B Virus INTERPRETATION SCREEN HBV TRIPLE SCREEN PANEL ACUTE INFECTION
ACUTE INFECTION VISIT 1 2013-10-25
$warningHtml
xx.xpt
is.xpt
xx.xpt
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 Antibody HEPATITIS B VIRUS SURFACE ANTIGEN HBV TRIPLE SCREEN PANEL NEGATIVE SCREENING
2013-08-26 2
ABC
IS
ABC-01-203
ABC001 2
HBVP1
Microbial-induced IgM Antibody HEPATITIS B VIRUS CORE ANTIGEN HBV TRIPLE SCREEN PANEL POSITIVE SCREENING
2013-08-26 3
ABC
IS
ABC-01-203
ABC001 3
HBVP1 Microbial-induced Total Antibody HEPATITIS B VIRUS CORE ANTIGEN HBV TRIPLE SCREEN PANEL POSITIVE SCREENING
2013-08-26 4 ABC IS ABC-01-203
ABC001 4
HBVP2 Microbial-induced Antibody HEPATITIS B VIRUS SURFACE ANTIGEN HBV TRIPLE SCREEN PANEL NEGATIVE VISIT 1
2013-10-25 5 ABC IS ABC-01-203
ABC001 5
HBVP2
Microbial-induced IgM Antibody HEPATITIS B VIRUS CORE ANTIGEN HBV TRIPLE SCREEN PANEL NEGATIVE VISIT 1
2013-10-25 6 ABC IS ABC-01-203
ABC001 6
HBVP2
Microbial-induced Total Antibody HEPATITIS B VIRUS CORE ANTIGEN HBV TRIPLE SCREEN PANEL POSITIVE
VISIT 1
2013-10-25
$warningHtml
relrec.xpt
$titleHtml
relrec.xpt
Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID 1 ABC MB ABC-01-201 MBLNID MANY 1 2 ABC IS ABC-01-201 ISLNKID MANY 1
$warningHtml