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This example shows a report table, trial design, and results data for the in vitro Neutral Red Uptake Cytotoxicity Assay neutral red uptake (NRU) cytotoxicity assay in example study 123.

Expand
titleStudy 123, Sample from Report Table

The following shows the data as it is represented example data for study 123 in a report table for study 123.   This report includes summary statistics (i.e.g. Average, Standard Deviation, Coeff. Var., average, standard deviation, coefficient variation) for each plate and an EC50 value for the entire assay. The grey cells in In the table below, the light grey shading for plate 1 are cells values from wells that do not contain the CHO Hamster cells. NHK cells. The dark grey shading represents the column and row location within the 96-well plate, and in this example the applicant chose to use these column and row locations to assign their REFID values in the RELREF dataset and GT dataset.  

For brevity, the datasets in this example are not comprehensive but are intended to demonstrate a range of proper use. 


Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)




Sample ID

Smoke Regime

Replicate Number

Plate Number

Well Number



Relative Assay Plate Absorbance Readings





Cigarette Smoke Condensate (µg/mL) 

SLS (µg/mL)


EC50 (µg/ml)

0

Well Column:

1

2

3

4

5

6

7

8

9

10

11

12


Well 
Row:

0

10

50

75

100

120

140

160

200

110

200

0



030001

Medium

1

1

1

A

0.046*

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

0.040*



030001

Medium

1

1

2

B

0.048*

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

0.014*



030001

Medium

1

1

3

C

0.005*

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

0.050*



030001

Medium

1

1

4

D

0.049*

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

0.017*



030001

Medium

1

1

5

E

0.047*

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

0.011*



030001

Medium

1

1

6

F

0.032*

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

0.022*



030001

Medium

1

1

7

G

0.044*

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

0.056*



030001

Medium

1

1

8

H

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



*media without cells















030001

Medium

1

2

1

A


93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02




030001

Medium

1

2

2

B


102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02




030001

Medium

1

2

3

C


107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780




030001

Medium

1

2

4

D


104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780




030001

Medium

1

2

5

E


101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02




030001

Medium

1

2

6

F


110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540




030001

Medium

1

2

7

G


104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780




030001

Medium

1

2

8

H


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

 













123

Dataset wrap
Rowcaps
two Types 8 the sponsor's study reference ID is not applicable 912 that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The Study Director is associated with the Test Facility.Rows 23-24 3 for one species (Escherichia coli) with the strain that is tested in this example study.
Rows 1-2:Show
2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP
types apply for this example study. 
Row
3:Shows that
this study was conducted as a GLP study.
Rows 4-5:Show the study start date and study title.
Rows
6-
7:Show
Rows 18-24:Show that this example study includes two different species of bacteria and a total of five strains. 
Rows 18-22:Show that TSGRPID (TSGRPID = 2) has been used to link the information for one species (Salmonella) with four different strains that are tested in this example study.
the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:Shows the applicant's organization.
Row 9:

Shows that the applicant's study reference ID is not applicable.

Rows 10-13:Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The study director is associated with the test facility.
Rows 14-16
:

Show that TSGRPID (TSGRPID=

4) has been used to link the information

  • Assumption: A Trial (study) can have more than one assay type. (this line will be moved to the ts.xpt assumptions page)

on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).

Row 17:

Shows the study type for this study.

Row 18:

Shows that this study includes a Neutral Red Uptake Assay.
Rows 19-20:Show that the species is human and the cell line is NHK in this study.
Dataset2
Dataset2
Expand
titlets.xpt (trial summary, study level parameters)

Row

STUDYID

ASSAYID
Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123
NRU
TS1
GLPTYPGood Laboratory Practice TypeFDA
2123
NRU
TS2
GLPTYPGood Laboratory Practice TypeOECD
3123
TS1
GLPFLGLP FlagY
4123
NRU
TS1
STSTDTCStudy Start Date2022-05-25
4

5123
NRU
TS1
STITLEStudy Title

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

5

6123
NRU
TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6

7123
NRU
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7

8123
NRU
TS1
SSPONSOR

APPLCNT
Sponsor Organization
ApplicantExample
Sponsor
Applicant Inc.
8

9123
NRU
TS1
SPREFID

APREFID
Sponsor
Applicant Study Reference ID
NOT APPLICABLE
9
10123
NRU
TS11TSTFNAMTest Facility NameExample Test Lab Name
10

11123
NRU
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11

12123
NRU
TS11TFCNTRYTest Facility CountryUSA
12

13123
NRU
TS11STDIRStudy DirectorDr. R. Smith
13

14123
NRU
TS1
GLPFLGLP FlagY
4TSTGDNAMTesting Guideline NamePublication No. 07-4519
15
14
123
NRU
TS1
ASTDAssay StandardNIH Publication No. 07-4519
4TSTGDORGTesting Guideline OrganizationNIH
16
15
123
NRU
TS1
ASTDV
4TSTGDVERTesting Guideline
Assay Standard
Version2006-11
16

17123
NRU
TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17

18123
NRU
TS
TS
1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

GNTXAIDGenetic Toxicology Assay IdentifierNRU
19
18
123
NRU
TS1
SPECIESSpecies
Hamster
HUMAN
19

20123
NRU
TS1
TESTSYS

CELLLN
Test System
Cell Line
CHO
NHK
Show the test conditions for the
Dataset wrap
Rows 21-40
Rowcaps
Rows 1-
20
12:Show the test conditions for the set with a short name or SETCD value of
CSC-50b
NRU.
 
The
sponsor
applicant chose this value to represent
plate number 1, well number 1, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Row 17:Shows the value for STRAIN/SUBSTRAIN is NO STRAIN because the well is a media only well, having no CHO Hamster cells. 
test conditions for the entire assay. 
Rows 13-31:Show the test conditions for the set with a short name or SETCD value of CSC-
50
50b.
 
The
sponsor
applicant chose this value to represent plate number 1, well row A, well
number 2
column 3, with a concentration of 50µg/mLof
Cigarette Smoke Condensate
cigarette smoke condensate as shown in the report table for study 123.
Rows 41-60:
  The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.

Rows 32-50:

Show the test conditions for the set with a short name or SETCD value of CSC-50.
 
The
sponsor
applicant chose this value to represent
both wells numbered 7 in
plate number 1, well rows B-G, well column 3 and plate number 2
, with a concentration of 110
, well rows A-H, well column 3. These all have the concentration of 50µg/mLof
Sodium Laurel Sulfate
cigarette smoke condensate as shown in the report table for study 123.
Rows 51-69:Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent plate number 1, well rows B-G, well column 10, and plate number 2, well rows A-H, well column 10. These all have the concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123.