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MB Examples

Created by Jordan Li, last modified on Apr 08, 2021

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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.

mb.xpt

mb.xpt

Row	STUDYID	DOMAIN	USUBJID	MBSEQ	MBGRPID	MBTESTCD	MBTEST	MBTSTDTL	MBTSTOPO	MBCAT	MBORRES	MBORRESU	MBSTRESC	MBSTRESN	MBSTRESU	MBSPEC	MBLOC	MBMETHOD	VISITNUM	VISIT	MBDTC
1	ABC	MB	ABC-001	1	1	INFARNA	Influenza A RNA	DETECTION	SCREEN	MICROBIOLOGY	YES		YES	YES		MUCUS	NOSTRIL	RAPID PCR	1	SCREEN	2018-06-01
2	ABC	MB	ABC-001	3	1	INFARNA	Influenza A RNA	DETECTION	CONFIRM	MICROBIOLOGY	YES		YES	YES	log 10 IU/mL	MUCUS	NOSTRIL	RAPID PCR	1	SCREEN	2018-06-01
3	ABC	MB	ABC-001	1	2	INFARNA	Influenza A RNA	VIRAL LOAD	QUANTIFY	MICROBIOLOGY	4.5	log 10 copies/mL	4.5	4.5	log 10 copies/mL	MUCUS	NOSTRIL	QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION	1	SCREEN	2018-06-01

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

is.xpt

is.xpt

Row	STUDYID	DOMAIN	USUBJID	ISSEQ	ISGRPID	ISTESTCD	ISTEST	ISBDAGNT	ISTSTOPO	ISCAT	ISORRES	ISORRESU	ISSTRESC	ISSTRESN	ISSTRESU	ISMETHOD	VISITNUM	VISIT	MBDTC
1	ABC	IS	ABC-001	1	1		Anti-microbial IgM Antibody	SARS-CoV-2	SCREEN	MICROBIOLOGY	YES		YES	YES		EIA	1	SCREEN	2018-06-01
2	ABC	IS	ABC-001	3	1		Anti-microbial IgM Antibody	SARS-CoV-2	QUANTIFY	MICROBIOLOGY	350	Titer	350	350	Titer	EIA	1	SCREEN	2018-06-01

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The LB drug tox screen example of TSTPOP.

Row 1:	Shows Cannabinoids are screened.
Row 2:	Shows the previously detected Cannabinoids are further confirmed in the subject.
Row 3:	Shows the quantification of the Cannabinoids.

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lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBGRPID	LBSEQ	LBTESTCD	LBTEST	LBTSTOPO	LBCAT	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSPEC	LBMETHOD	LBLOINC	LBDTC	VISITNUM	VISIT
1	ABC	LB	ABC-001-001	1	1	CANNAB	Cannabinoids	SCREEN	DRUG TOXICITY	POSITIVE		POSITIVE	POSITIVE		URINE	KINETIC MICROPARTICLE IMMUNOASSAY	19287-2	2013-02-16	1	Week 1
2	ABC	LB	ABC-001-001	1	2	CANNAB	Cannabinoids	CONFIRM	DRUG TOXICITY	250	ug/L	POSITIVE			URINE	MASS SPECTROMETRY	19289-8	2013-02-16	1	Week 1
3	ABC	LB	ABC-001-001	1	3	CANNAB	Cannabinoids	QUANTIFY	DRUG TOXICITY	271	ug/L	271	271	ug/L	URINE	GC/MS	19291-4	2013-02-16	1	Week 1

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The IS ADA example using TSTPOP.

Row 1:	Shows the screening of the presence of ADA to DRUG AZ-007.
Row 2:	Shows the confirmation of the previously detected ADA to DRUG AZ-007.
Row 3:	Shows the quantification of the said ADA from the screen and confirmatory steps.

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is.xpt

Row	STUDYID	DOMAIN	USUBJID	ISSEQ	ISREFID	ISGRPID	ISTESTCD	ISTEST	ISBDAGNT	ISTSTOPO	ISCAT	ISSCAT	ISORRES	ISORRESU	ISSTRESC	ISSTRESN	ISSTRESU	ISSPEC	ISMETHOD	VISITNUM	VISIT	ISDTC
1	ABC	IS	ABC-002	1	V555	1	ADA_BAB	Binding Antidrug Antibody	DRUG AZ-007	SCREEN	ANTIDRUG ANTIBODIES	HUMORAL IMMUNITY	POSITIVE		POSITIVE			SERUM	ELECTROCHEMILUMINESCENCE IMMUNOASSAY	1	VISIT 1	2017-07-27
2	ABC	IS	ABC-002	2	V555	1	ADA_BAB	Binding Antidrug Antibody	DRUG AZ-007	CONFIRM	ANTIDRUG ANTIBODIES	HUMORAL IMMUNITY	POSITIVE		POSITIVE			SERUM	ELECTROCHEMILUMINESCENCE IMMUNOASSAY	1	VISIT 1	2017-07-27
3	ABC	IS	ABC-002	3	V555	1	ADA_BAB	Binding Antidrug Antibody	DRUG AZ-007	QUANTIFY	ANTIDRUG ANTIBODIES	HUMORAL IMMUNITY	50	titer	50	50	titer	SERUM	ELECTROCHEMILUMINESCENCE IMMUNOASSAY	1	VISIT 1	2017-07-27

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IS NSV Metadata

Variable	Label	Type	Role	Origin
ISTSTOPO	Test Operational Objective	text	Non-Standard Record Qualifier	CRF

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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