This example shows trial design and results data for in vitro Neutral Red Cytotoxicity Assay, Relative Absorbance.
Neutral Red Uptake Assay for Mainstream Tobacco Smoke: The neutral red uptake assay provides a quantitative estimation of the number of viable cells in a culture. It is one of the most used cytotoxicity tests with many biomedical and environmental applications. It is based on the ability of viable cells to incorporate and bind the supravital dye neutral red in the lysosomes.
Note that Variable Names and Domain abbreviations may change (have not been checked against existing and are not vetted)
Red Font = has/should have CT
Grey-shaded cells = ignore for now (until we model other tests)
Because a study contains one or more Assays, we have both: STUDYID and ASSAYID
Assumption: Study can have more than one assay type
Assumption: ASSAYID value of ALL means it applies to all assays in the study
Replaced the ASSAYID values of MNT with MNvit (term used in OECD #487) - is this better? This is not a controlled term so we can use anything but what we use in our IG examples are often used in industry implementations so we should use realistic and best practice values as much as possible.
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
Where is TK6 cell type? is this test system (see below)
Row
STUDYID
ASSAYID
DOMAIN
TSSEQ
TSGRPID
TSPARMCD
TSPARM
TSVAL
TSVALNF
1
123
NRU
TS
1
GLPTYP
Good Laboratory Practice Type
FDA
2
123
NRU
TS
2
GLPTYP
Good Laboratory Practice Type
OECD
3
123
NRU
TS
1
STSTDTC
Study Start Date
2022-05-25
4
123
NRU
TS
1
STITLE
Study Title
Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake