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

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

  • 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
  • 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 applicant designations as specified in the trial design.
  • 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
  • Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
  • Smoke fraction?  is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
  • Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
1123NRUTXCSC-50CSC-501TRTDMINTreatment Duration Minimum47.5
2123NRUTXCSC-50CSC-502TRTDTRGTreatment Duration Target48
3123NRUTXCSC-50CSC-503TRTDMAXTreatment Duration Maximum48.5
4123NRUTXCSC-50CSC-504TRTDUTreatment Duration UnitHOURS
5123NRUTXCSC-50CSC-505INCBTMPIncubation Temperature37
6123NRUTXCSC-50CSC-506INCBTMPUIncubation Temperature UnitC
7123NRUTXCSC-50CSC-507WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS540
8123NRUTXCSC-50CSC-508HUMIDAtmospheric Relative Humidity  Percent90
9123NRUTXCSC-50CSC-509ATMCO2Atmospheric CO2 Percent5
10123NRUTXCSC-50CSC-5010SPTOBID

Sponsor defined tobacco identifier

CIG01a
11123NRUTXCSC-50CSC-5011EXPTYP

Exposure Type

Air Liquid Interface
12123NRUTXCSC-50CSC-5012SAMTYPSample TypeWhole Smoke Conditioned Media
13123NRUTXCSC-50CSC-5013INTRVNName of the Intervention ArticleTobacco ProdA
14123NRUTXCSC-50CSC-5014ITVTYPE
(CT e.g, Product, positive control, negative control, vehicle control, solvent control)
type of intervention articlePRODUCT 
15123NRUTXCSC-50CSC-5015ITVCONCintervention concentration50
16123NRUTXCSC-50CSC-5016ITVCONCUintervention unitug/ml
17123NRUTXCSC-50CSC-5017STRAINStrain/SubstrainCHO
18123NRUTXCSC-50CSC-5018SPDEVIDSponsor defined device identifierPUFFMASTER3k
19123NRUTXCSC-50CSC-5019DUREFIDSmoking RegimeMedium Intensity Regimen
20123NRUTXCSC-50CSC-5020SPTOBID

Sponsor defined tobacco identifier

CIG01a
21123NRUTXSLS-110SLS-1101TRTDMINTreatment Duration Minimum47.5
22123NRUTXSLS-110SLS-1102TRTDTRGTreatment Duration Target48
23123NRUTXSLS-110SLS-1103TRTDMAXTreatment Duration Maximum48.5
24123NRUTXSLS-110SLS-1104TRTDUTreatment Duration UnitHOURS
25123NRUTXSLS-110SLS-1105INCBTMPIncubation Temperature37
26123NRUTXSLS-110SLS-1106INCBTMPUIncubation Temperature UnitC
27123NRUTXSLS-110SLS-1107WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS540
28123NRUTXSLS-110SLS-1108HUMIDAtmospheric Relative Humidity  Percent90
29123NRUTXSLS-110SLS-1109ATMCO2Atmospheric CO2 Percent5
30123NRUTXSLS-110SLS-11010SPTOBID

Sponsor defined tobacco identifier

CIG01a
31123NRUTXSLS-110SLS-11011EXPTYP

Exposure Type

Air Liquid Interface
32123NRUTXSLS-110SLS-11012SAMTYPSample TypeLiquid
33123NRUTXSLS-110SLS-11013INTRVNName of the Intervention ArticleSodium Laurel Sulfate
34123NRUTXSLS-110SLS-11014ITVTYPE
(CT e.g, Product, positive control, negative control, vehicle control, solvent control)
type of intervention articlePOSITIVE CONTROL
35123NRUTXSLS-110SLS-11015ITVCONCintervention concentration200
36123NRUTXSLS-110SLS-11016ITVCONCUintervention unitug/ml
37123NRUTXSLS-110SLS-11017STRAINStrain/SubstrainCHO
38123NRUTXSLS-110SLS-11018SPDEVIDSponsor defined device identifierPUFFMASTER3k
39123NRUTXSLS-110SLS-11019DUREFIDSmoking RegimeMedium Intensity Regimen
40123NRUTXSLS-110SLS-11020SPTOBID

Sponsor defined tobacco identifier

CIG01a


relref.xpt

Row

STUDYID

ASSAYID

SETCD

REFID

PARENT

LEVEL

1123NRUALL123NRU
1
2123NRUCSC-501-3123NRU2
3123NRUCSC-501-3-B1-33
4123NRUCSC-501-3-C1-33
5123NRUSLS-1101-10123NRU2
6123NRUSLS-1102-10123NRU2
7123NRUSLS-1101-10-G1-103
8123NRUSLS-1102-10-G2-103

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).
RowSTUDYIDASSAYIDDOMAINGTSEQREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRT (coll. summ. result type)GTSTRESCGTSTRESNGTSTRESU

123NRUGT11-3-BABSORBAbsorbance Reading1.7 (0.0 - 2.0)

1.71.7

123NRUGT21-3-BBKCABSBackground Corrected Absorbance Reading

1.6




1.61.6

123NRUGT31-3-BRELABSRelative Absorbance Reading77.7%
77.777.7%

123NRUGT41-3-CABSORBAbsorbance Reading1.8 (0.0 - 2.0)

1.81.8




51-3-CBKCABSBackground Corrected Absorbance Reading

1.7




1.71.7

123NRUGT61-3-CRELABSRelative Absorbance Reading77.4

77.477.4

123NRUGT71-3RELABSRelative 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

123NRUGT182-10RELABSRelative Absorbance Reading

5.91

%MEAN

5.91

5.91



123NRUGT192-10RELABSRelative Absorbance Reading

0.83

%

STANDARD DEVIATION

0.83

0.83



123NRUGT202-10RELABSRelative Absorbance Reading

14.1


COEFFICIENT OF VARIANCE

14.1

14.1


161123NRUGT21123NRUEC50Effective Concentration of 50 Percent Cytotoxicity123ug/ml
123123ug/ml














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