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This example shows a report table, trial design and results data for the in vitro Neutral Red Uptake Cytotoxicity Assay in example study 123.

The following shows the data as it is represented in a report table for study 123.  This report includes summary statistics (e.g. Average, Standard Deviation, Coeff. Var.) for each plate and an EC50 value for the entire assay. The grey cells in plate 1 are cells that do not contain the CHO Hamster cells. 

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

10

50

75

100

120

140

160

200

110

200

0



030001

Medium

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*



030001

Medium

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*



030001

Medium

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*



030001

Medium

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*



030001

Medium

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*



030001

Medium

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*



030001

Medium

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*



030001

Medium

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



*media without cells















030001

Medium

1

2

1


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


102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02




030001

Medium

1

2

3


107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780




030001

Medium

1

2

4


104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780




030001

Medium

1

2

5


101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02




030001

Medium

1

2

6


110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540




030001

Medium

1

2

7


104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780




030001

Medium

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

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

Rows 1-2:Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study.
Row 8:Shows that the sponsor's study reference ID is not applicable.
Rows 9-12: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 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.
Rows 23-24:Show that TSGRPID (TSGRPID = 3) has been used to link the information for one species (Escherichia coli) with the strain that is tested in this example study.

ts.xpt

xx.xpt

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 Sponsor Inc.
8123NRUTS1
SPREFIDSponsor Study Reference ID
NOT APPLICABLE
9123NRUTS11TSTFNAMTest Facility NameExample Test 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

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Rows 1-20:Show the test conditions for the set with a short name or SETCD value of CSC-50b. The sponsor chose this value to represent plate number 1, well number 1, with a concentration of 50 µg/mL of 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.
Rows 21-40:Show the test conditions for the set with a short name or SETCD value of CSC-50. The sponsor chose this value to represent plate number 1, well number 2, with a concentration of 50 µg/mL of Cigarette Smoke Condensate as shown in the report table for study 123.
Rows 41-60:Show the test conditions for the set with a short name or SETCD value of CSC-50. The sponsor chose this value to represent both wells numbered 7 in plate number 1 and 2, with a concentration of 110 µg/mL of Sodium Laurel Sulfate as shown in the report table for study 123

tx.xpt

xx.xpt

Row
STUDYID
ASSAYID
DOMAIN
SETCD
SET
TXSEQ
TXPARMCD
TXPARM
TXVAL
1123NRUTXCSC-50bCSC-50-blank1TRTDMINTreatment Duration Minimum47.5
2123NRUTXCSC-50bCSC-50-blank

2

TRTDTRGTreatment Duration Target48
3123NRUTXCSC-50bCSC-50-blank3TRTDMAXTreatment Duration Maximum48.5
4123NRUTXCSC-50bCSC-50-blank4TRTDUTreatment Duration UnitHOURS
5123NRUTXCSC-50bCSC-50-blank5INCBTMPIncubation Temperature37
6123NRUTXCSC-50bCSC-50-blank6INCBTMPUIncubation Temperature UnitC
7123NRUTXCSC-50bCSC-50-blank7WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS540
8123NRUTXCSC-50bCSC-50-blank8HUMIDAtmospheric Relative Humidity  Percent90
9123NRUTXCSC-50bCSC-50-blank9ATMCO2Atmospheric CO2 Percent5
10123NRUTXCSC-50bCSC-50-blank10SPTOBID

Sponsor defined tobacco identifier

CIG01a
11123NRUTXCSC-50bCSC-50-blank11EXPTYP

Exposure Type

Air Liquid Interface
12123NRUTXCSC-50bCSC-50-blank12SAMTYPSample TypeWhole Smoke Conditioned Media
13123NRUTXCSC-50bCSC-50-blank13INTRVNName of the Intervention ArticleTobacco ProdA
14123NRUTXCSC-50bCSC-50-blank14ITVTYPEtype of intervention articlePRODUCT
15123NRUTXCSC-50bCSC-50-blank15ITVCONCintervention concentration50
16123NRUTXCSC-50bCSC-50-blank16ITVCONCUintervention unitug/ml
17123NRUTXCSC-50bCSC-50-blank17STRAINStrain/SubstrainNO STRAIN
18123NRUTXCSC-50bCSC-50-blank18SPDEVIDSponsor defined device identifierPUFFMASTER3k
19123NRUTXCSC-50bCSC-50-blank19DUREFIDSmoking RegimeMedium Intensity Regimen
20123NRUTXCSC-50bCSC-50-blank20SPTOBID

Sponsor defined tobacco identifier

CIG01a
21123NRUTXCSC-50CSC-501TRTDMINTreatment Duration Minimum47.5
22123NRUTXCSC-50CSC-502TRTDTRGTreatment Duration Target48
23123NRUTXCSC-50CSC-503TRTDMAXTreatment Duration Maximum48.5
24123NRUTXCSC-50CSC-504TRTDUTreatment Duration UnitHOURS
25123NRUTXCSC-50CSC-505INCBTMPIncubation Temperature37
26123NRUTXCSC-50CSC-506INCBTMPUIncubation Temperature UnitC
27123NRUTXCSC-50CSC-507WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS540
28123NRUTXCSC-50CSC-508HUMIDAtmospheric Relative Humidity  Percent90
29123NRUTXCSC-50CSC-509ATMCO2Atmospheric CO2 Percent5
30123NRUTXCSC-50CSC-5010SPTOBID

Sponsor defined tobacco identifier

CIG01a
31123NRUTXCSC-50CSC-5011EXPTYP

Exposure Type

Air Liquid Interface
32123NRUTXCSC-50CSC-5012SAMTYPSample TypeWhole Smoke Conditioned Media
33123NRUTXCSC-50CSC-5013INTRVNName of the Intervention ArticleTobacco ProdA
34123NRUTXCSC-50CSC-5014ITVTYPEtype of intervention articlePRODUCT 
35123NRUTXCSC-50CSC-5015ITVCONCintervention concentration50
36123NRUTXCSC-50CSC-5016ITVCONCUintervention unitug/ml
37123NRUTXCSC-50CSC-5017STRAINStrain/SubstrainCHO
38123NRUTXCSC-50CSC-5018SPDEVIDSponsor defined device identifierPUFFMASTER3k
39123NRUTXCSC-50CSC-5019DUREFIDSmoking RegimeMedium Intensity Regimen
40123NRUTXCSC-50CSC-5020SPTOBID

Sponsor defined tobacco identifier

CIG01a
41123NRUTXSLS-110SLS-1101TRTDMINTreatment Duration Minimum47.5
42123NRUTXSLS-110SLS-1102TRTDTRGTreatment Duration Target48
43123NRUTXSLS-110SLS-1103TRTDMAXTreatment Duration Maximum48.5
44123NRUTXSLS-110SLS-1104TRTDUTreatment Duration UnitHOURS
45123NRUTXSLS-110SLS-1105INCBTMPIncubation Temperature37
46123NRUTXSLS-110SLS-1106INCBTMPUIncubation Temperature UnitC
47123NRUTXSLS-110SLS-1107WAVELGTHSpectrophotometer wavelength in nanometers540
48123NRUTXSLS-110SLS-1108HUMIDAtmospheric Relative Humidity  Percent90
49123NRUTXSLS-110SLS-1109ATMCO2Atmospheric CO2 Percent5
50123NRUTXSLS-110SLS-11010SPTOBID

Sponsor defined tobacco identifier

CIG01a
51123NRUTXSLS-110SLS-11011EXPTYP

Exposure Type

Air Liquid Interface
52123NRUTXSLS-110SLS-11012SAMTYPSample TypeLiquid
53123NRUTXSLS-110SLS-11013INTRVNName of the Intervention ArticleSodium Laurel Sulfate
54123NRUTXSLS-110SLS-11014ITVTYPEtype of intervention articlePOSITIVE CONTROL
55123NRUTXSLS-110SLS-11015ITVCONCintervention concentration200
56123NRUTXSLS-110SLS-11016ITVCONCUintervention unitug/ml
57123NRUTXSLS-110SLS-11017STRAINStrain/SubstrainCHO
58123NRUTXSLS-110SLS-11018SPDEVIDSponsor defined device identifierPUFFMASTER3k
59123NRUTXSLS-110SLS-11019DUREFIDSmoking RegimeMedium Intensity Regimen
60123NRUTXSLS-110SLS-11020SPTOBID

Sponsor defined tobacco identifier

CIG01a

Dataset Debug Messages

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Rows 1-2:Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study.
Row 1:Shows the REFID of 123NRU that indicates the entire assay.
Rows 2, 5, 8, 9:Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3b, 1-3, 1-10, 2-10).
Rows 3-4, 6-7, 10-11:Show REFID values that the sponsor chose, in this case, to represent the plate number (1 or 2), column (1 - 10), and row (A-G) of the 96-well plate.
Rows 3-4:Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units within the parent Trial Set of 1-3b.
Rows 6-7:Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units within the parent Trial Set of 1-3b.
Rows 10-11:Show the REFIDs 1-10-G and 2-10-G that indicate two experimental units within the parent Trial Set of 1-3b.
$titleHtml

relref.xpt.xpt

Row

STUDYID

ASSAYID

SETCD

REFTYPE

REFID

PARENT

LEVEL

1123NRUALLASSAY123NRU
1
2123NRU

CSC-50b

TRIAL SET1-3b123NRU2
3123NRU

CSC-50b

EXPERIMENTAL UNIT1-3-A1-3b3
4123NRU

CSC-50b

EXPERIMENTAL UNIT1-3-H1-3b3
5123NRUCSC-50TRIAL SET1-3123NRU2
6123NRUCSC-50EXPERIMENTAL UNIT1-3-B1-33
7123NRUCSC-50EXPERIMENTAL UNIT1-3-C1-33
8123NRUSLS-110TRIAL SET1-10123NRU2
9123NRUSLS-110TRIAL SET2-10123NRU2
10123NRUSLS-110EXPERIMENTAL UNIT1-10-G1-103
11123NRUSLS-110EXPERIMENTAL UNIT2-10-G2-103
$warningHtml

Dataset Wrapper Debug Message

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$warningHtml

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).

  • row 161: This shows the EC50 result value for the entire assay (the SETCD, EUID, and OBUID are null).


Rows 1, 4:  These data are not shown in the report table but included here for completeness of the NRU assay.

RowSTUDYIDASSAYIDDOMAINGTSEQREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRT (coll. summ. result type)GTSTRESCGTSTRESNGTSTRESU
1123NRUGT11-3-BABSORBAbsorbance Reading1.7 (0.0 - 2.0)

1.71.7
2123NRUGT21-3-BBKCABSBackground Corrected Absorbance Reading

1.6




1.61.6
3123NRUGT31-3-BRELABSRelative Absorbance Reading77.7%
77.777.7%
4123NRUGT41-3-CABSORBAbsorbance Reading1.8 (0.0 - 2.0)

1.81.8
5123NRUGT51-3-CBKCABSBackground Corrected Absorbance Reading

1.7




1.71.7
6123NRUGT61-3-CRELABSRelative Absorbance Reading77.4

77.477.4
7123NRUGT71-3RELABSRelative Absorbance Reading 78.2%MEAN78.278.2%
8123NRUGT81-3RELABSRelative Absorbance Reading 2.9%STANDARD DEVIATION2.92.9%
9123NRUGT91-3RELABSRelative Absorbance Reading 3.6
COEFFICIENT OF VARIANCE3.63.6
10123NRUGT101-10-GABSORBAbsorbance Reading0.7

0.70.7
11123NRUGT111-10-GBKCABSBackground Corrected Absorbance Reading

0.6




0.6


0.6



12123NRUGT111-10-GRELABSRelative Absorbance Reading8.57

8.578.57
13123NRUGT121-10RELABSRelative Absorbance Reading

8.94

%MEAN

8.94

8.94


14123NRUGT131-10RELABSRelative Absorbance Reading

2.72

%

STANDARD DEVIATION

2.72

2.72


15123NRUGT141-10RELABSRelative Absorbance Reading

30.5


COEFFICIENT OF VARIANCE

30.5

30.5


16123NRUGT152-10-GABSORBAbsorbance Reading0.9




17123NRUGT162-10-GBKCABSBackground Corrected Absorbance Reading

0.8







18123NRUGT172-10-GRELABSRelative Absorbance Reading6.30

6.306.30
19123NRUGT182-10RELABSRelative Absorbance Reading

5.91

%MEAN

5.91

5.91


20123NRUGT192-10RELABSRelative Absorbance Reading

0.83

%

STANDARD DEVIATION

0.83

0.83


21123NRUGT202-10RELABSRelative Absorbance Reading

14.1


COEFFICIENT OF VARIANCE

14.1

14.1


22123NRUGT21123NRUEC50Effective Concentration of 50 Percent Cytotoxicity123ug/ml
123123ug/ml
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