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 - indicates potential for CT code lists
green font - links to other domains
The following shows the tabulated data as shown in the report for this study:
Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)
Run-Port Number
Sample ID
Smoke Fraction
Replicate Number
Plate Number
Well Number
Relative Assay Plate Absorbance Readings
Cigarette Smoke Condensate (µg/mL)
SLS (µg/mL)
10
50
75
100
120
140
160
200
110
200
1-1
030001
A
1
1
1
100
83.0
56.7
29.5
13.0
8.57
4.44
1.76
13.7
0.547
1-1
030001
A
1
1
2
107
77.7
65.7
30.2
15.6
9.79
5.41
2.49
8.09
0.791
1-1
030001
A
1
1
3
98.6
77.4
57.7
35.8
8.09
7.36
3.22
0.791
6.38
0.061
1-1
030001
A
1
1
4
94.9
81.5
38.2
31.2
7.60
5.17
3.22
0.791
5.17
0.304
1-1
030001
A
1
1
5
111
78.1
64.5
32.9
8.82
5.90
2.74
1.28
10.3
0.547
1-1
030001
A
1
1
6
96.6
76.2
48.0
26.8
7.84
4.20
2.74
1.52
8.09
4.93
1-1
030001
A
1
1
7
105
77.9
58.2
28.3
8.09
4.68
1.76
0.547
8.57
1.76
1-1
030001
A
1
1
8
95.2
74.0
47.2
24.4
8.57
3.71
3.47
0.304
11.2
0.791
Average
101
78.2
54.5
29.9
9.70
6.17
3.37
1.19
8.94
1.22
Std. Dev.
6
2.9
9.4
3.6
2.95
2.19
1.12
0.72
2.72
1.58
Coeff. Var.
5.8
3.6
17.2
11.9
30.4
35.5
33.1
61.0
30.5
129.9
1-1
030001
A
1
2
1
93.4
74.0
56.0
35.1
11.8
8.70
5.10
1.98
5.34
1.02
1-1
030001
A
1
2
2
102
75.2
53.3
35.1
11.8
7.74
5.58
3.66
5.34
1.02
1-1
030001
A
1
2
3
107
79.0
55.0
26.5
10.1
6.06
3.66
1.74
7.02
0.780
1-1
030001
A
1
2
4
104
80.2
55.3
29.8
8.94
3.90
3.66
1.50
6.30
0.780
1-1
030001
A
1
2
5
101
75.7
54.1
26.7
4.86
4.38
1.26
1.02
6.30
1.02
1-1
030001
A
1
2
6
110
85.7
67.7
26.0
5.34
4.62
3.42
1.50
6.30
0.540
1-1
030001
A
1
2
7
104
77.8
64.9
27.7
8.22
3.18
2.46
1.02
6.30
0.780
1-1
030001
A
1
2
8
103
71.6
58.9
25.5
9.42
4.14
3.90
1.26
4.38
0.780
Average
103
77.4
58.1
29.0
8.82
5.34
3.63
1.71
5.91
0.840
Std. Dev.
5
4.4
5.3
4.0
2.63
1.97
1.37
0.86
0.83
0.170
Coeff. Var.
4.6
5.6
9.2
13.6
29.8
36.9
37.6
50.0
14.1
20.2
Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
Assumption: A Trial (study) can have more than one assay type
Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
Row
STUDYID
ASSAYID
DOMAIN
TSSEQ
TSGRPID
TSPARMCD
TSPARM
TSVAL
TSVALNF
1
123
ALL
TS
1
GLPTYP
Good Laboratory Practice Type
FDA
2
123
ALL
TS
2
GLPTYP
Good Laboratory Practice Type
OECD
3
123
ALL
TS
1
STSTDTC
Study Start Date
2022-05-25
4
123
ALL
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
During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
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)
needs to be allowed to vary down to the well level / result level
Row
STUDYID
ASSAYID
DOMAIN
SETCD
SET (what sponsor calls it)
TXSEQ
TXPARMCD
TXPARM
TXVAL
1
123
NRU
TX
1-1-A
(plate-col-row in the 96-well plate)
CSC-10
(through SLS-200)
PLATENUM. (e.g., 1 or 2)
1
1
2
123
NRU
TX
1-1-A
CSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate