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This example shows sample raw data, trial design and results data for in vitro Neutral Red Uptake Cytotoxicity Assay. 

Expand
titleStudy 123, Report Table

Image Added

The following shows the tabulated data as it is represented in a report for this study.  This report includes summary statistics (e.g. Average, Standard Deviation, Coeff. Var.)

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)


EC50 (µg/ml)

0

10

50

75

100

120

140

160

200

110

200

0


1-1

030001

A

1

1

1

0.046

0.046*0.039*0.012*0.030*0.003*0.057*0.032*0.003*0.050*0.044*

0.040


1-1

030001

A

1

1

2

0.048

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

0.014


1-1

030001

A

1

1

3

0.005

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

0.050


1-1

030001

A

1

1

4

0.049

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

0.017


1-1

030001

A

1

1

5

0.047

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

0.011


1-1

030001

A

1

1

6

0.032

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

0.022


1-1

030001

A

1

1

7

0.044

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

0.056


1-1

030001

A

1

1

8

0.056

0.013*0.040*0.008*0.013*0.002*0.029*0.018*0.006*0.016*0.024*

0.046


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



*non-treated control wells














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



EC50 (µg/ml). Effective concentration at 50% cytotoxicity.  (using a specific sigmoidal equation = model). (could also be EC20 or EC30, EC70, etc.)













123

to.xpt

do.xpt

...

Expand
titlets.xpt (trial summary, study level parameters)
  • 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

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123NRUTS1
GLPTYPGood Laboratory Practice TypeFDA
2123NRUTS2
GLPTYPGood Laboratory Practice TypeOECD
3123NRUTS1
STSTDTCStudy Start Date2022-05-25
4123NRUTS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay


5123NRUTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123NRUTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123NRUTS1
SSPONSORSponsor OrganizationExample Applicant Inc.
8123NRUTS1
SPREFIDSponsor Study Reference ID
NOT APPLICABLE
9123NRUTS11TSTFNAMTest Facility NameExample Tox Testing Lab Name
10123NRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123NRUTS11TFCNTRYTest Facility CountryUSA
12123NRUTS11STDIRStudy DirectorDr. R. Smith
13123NRUTS1
GLPFLGLP FlagY
14123NRUTS1
ASTDAssay StandardNIH Publication No. 07-4519
15123NRUTS1
ASTDVAssay Standard Version2006-11
16123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake
18123NRUTS1
SPECIESSpeciesHamster
19123NRUTS1
TESTSYSTest SystemCHO

...

OU
Expand
titleou.xpt Observational and Experimental Units Domain


Image Added

ou.xpt. Observational and Experimental Units domain

Experimental unit - The unit to which the treatment is applied, eg. Test tube

Observational unit - The unit on which the response is measured. (This may not be the same as the experimental unit.)

relref.xpt

Row

STUDYID

ASSAYID

SETCD

REFID

PARENT

LEVEL

1123NRUALL123NRU
1
2123NRU
RowSTUDYIDASSAYIDDOMAINSETCD (from TX)

EUID

OBUID

1123NRU
CSC-501-3
-B
123NRU
1-3-B
2
3123NRU
OU
CSC-501-3-
C
B1-3
-C
3
4123NRU
OUSLS
CSC-
110
501-
11
3-
G
C1
-11-G4
-33
5123NRUSLS-1101-10123NRU2
6123NRU
OU
SLS-1102-
11-G
10123NRU2
7123NRUSLS-1101-10
2-11
-G
expand
1-103
8123NRUSLS-1102-10-G2-103
Expand
titlegt.xpt (similar to LB)
titlegt.xpt (similar to LB)

cells growing in plate, treat cells in the plate, then add NRU dye, then extract NRU (the OBUID) dye and transfer to another plate (put in spectrophotometer & read)..  

      Image Removed  Image RemovedImage Removed

3B and 3C now (change pictures)

  • row 161: This shows the EC50 result value for the entire assay (the SETCD, EUID, and OBUID are null).
RowSTUDYIDASSAYIDDOMAIN
SETCDEUID OBUID
GTSEQREFID
GTSEQ
GTTESTCDGTTESTGTORRESGTORRESUGTCOLSRT (coll. summ. result type)GTSTRESCGTSTRESNGTSTRESU

123NRUGT
CSC-501-3-B
11-3-B
11-3-B
ABSORBAbsorbance Reading1.7 (0.0 - 2.0)

1.71.7

123NRUGT
CSC-50
21-3-B
2
BKCABSBackground Corrected Absorbance Reading

1.6




1.61.6

123NRUGT
CSC-50
1-
3
-B
1-3-B
3
RELABSRelative Absorbance Reading77.7%
77.777.7%

123NRUGT
CSC-50
41-3-
B1-3-B4RELABSRelative Absorbance Reading 78.2%MEAN78.278.2%123NRUGT
CABSORBAbsorbance Reading1.8 (0.0 - 2.0)

1.81.8




5
CSC-50
1-3-
B1-3-B5RELABSRelative Absorbance Reading 2.9%STANDARD DEVIATION2.92.9
CBKCABSBackground Corrected Absorbance Reading

1.7




1.71.7
%


123NRUGT
CSC-50
61-3-
B1-3-B6
CRELABSRelative Absorbance
Reading 
Reading
3
77.
6COEFFICIENT OF VARIANCE3.6
4

77.477.4
3.6


123NRUGT7
EC50Effective Concentration of 50 Percent Cytotoxicity123ug/ml123123
1-3RELABSRelative Absorbance Reading 78.2%MEAN78.278.2%




81-3RELABSRelative Absorbance Reading 2.9%STANDARD DEVIATION2.92.9%




91-3RELABSRelative Absorbance Reading 3.6
COEFFICIENT OF VARIANCE3.63.6




101-10-GABSORBAbsorbance Reading0.7

0.70.7




111-10-GBKCABSBackground Corrected Absorbance Reading

0.6




0.6


0.6



80123NRUGT111-10-GRELABSRelative Absorbance Reading8.57

8.578.57




121-10RELABSRelative Absorbance Reading

8.94

%MEAN

8.94

8.94






131-10RELABSRelative Absorbance Reading

2.72

%

STANDARD DEVIATION

2.72

2.72


...


141-10RELABSRelative Absorbance Reading

30.5


COEFFICIENT OF VARIANCE

30.5

30.5






152-10-GABSORBAbsorbance Reading0.9








162-10-GBKCABSBackground Corrected Absorbance Reading

0.8







160123NRUGT172-10-GRELABSRelative Absorbance Reading6.30

6.306.30
ug/ml


123NRUGT
CSC-50
18
1-
2-
C1-2-C1
10RELABSRelative Absorbance Reading
77

5.

477.477.4

91

%MEAN

5.91

5.91

...80



123NRUGT
SLS-1101
19
1-11-G1-11-G
2-10RELABSRelative Absorbance Reading
8.57ug/ml8.578.57ug/ml

0.83

%

STANDARD DEVIATION

0.83

0.83

......160



123NRUGT
SLS-110
202-
11-G2-11-G1
10RELABSRelative Absorbance Reading
6

14.

30ug/ml6.306.30

1


COEFFICIENT OF VARIANCE

14.1

14.1

ug/ml


161123NRUGT21
7
123NRUEC50Effective Concentration of 50 Percent Cytotoxicity123ug/ml
123123ug/ml