Synonyms
|
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Allscripts (AEHR) Order Name
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Human Epididymis Protein 4 ( HE4 )
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Sunrise Clinical Manager (SCM) Order Name
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HE4 Ovarian Cancer
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Clinical Info
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The assay is used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical findings used for monitoring ovarian cancer.
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Specimen Type
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Blood
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Container
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Gold Top Tube
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Collection Instructions
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Container/Tube: Red top to Gold top Tube
Specimen: 0.8 mL serum (0.4 mLmin)
Transport Temperature: Refrigerated
Stability: 5 Days Room Temperature
14 Days Refrigerated or Frozen
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Transport Instructions
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Refrigerated
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Specimen Stability
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5 Days Room Temperature
14 Days Refrigerated or Frozen
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Methodology
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Electrochemiluminescence Immunoassay (ECLIA)
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Days Performed
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Performing Laboratory
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LabCorp
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CPT
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86305
LOINC Code: 55180-4
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PDM
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5963010
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Result Interpretation
Gender
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Range (pmol/L)
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Male
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Not Established
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Female
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Age
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0 to 39 years
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0.0 – 61.2
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40 to 49 years
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0.0 – 63.6
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50 to 59 years
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0.0 – 105.2
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60 to 69 years
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0.0 – 96.5
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>69 years
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0.0 – 96.9
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The distribution of HE4 levels determined in 1147 specimens is
shown in the table.
Distribution of HE4 Assay Values
| |
Apparently Healthy
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Female (premenopausal)
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Number of Subjects
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76
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0−150 pMol
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72
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150.1−300 pMol
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3
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300.1−500 pMol
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0
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>500 pMol
|
1
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Female (postmenopausal)
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Number of Subjects
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103
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0−150 pMol
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97
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150.1−300 pMol
|
5
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300.1−500 pMol
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0
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>500 pMol
|
1
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Benign Conditions
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Pregnancy
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Number of Subjects
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22
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0−150 pMol
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21
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150.1−300 pMol
|
1
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300.1−500 pMol
|
0
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>500 pMol
|
0
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Benign gynecological disease
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Number of Subjects
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347
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0−150 pMol
|
324
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150.1−300 pMol
|
18
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300.1−500 pMol
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1
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>500 pMol
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4
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Other benign disease
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Number of Subjects
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108
|
0−150 pMol
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82
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150.1−300 pMol
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8
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300.1−500 pMol
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7
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>500 pMol
|
11
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Hypertension/CHF
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Number of Subjects
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96
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0−150 pMol
|
75
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150.1−300 pMol
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16
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300.1−500 pMol
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2
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>500 pMol
|
3
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Cancer
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Ovarian cancer
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Number of Subjects
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127
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0−150 pMol
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27
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150.1−300 pMol
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18
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300.1−500 pMol
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21
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>500 pMol
|
61
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Breast cancer
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Number of Subjects
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46
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0−150 pMol
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40
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150.1−300 pMol
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4
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300.1−500 pMol
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2
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>500 pMol
|
0
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Lung cancer
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Number of Subjects
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50
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0−150 pMol
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29
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150.1−300 pMol
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15
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300.1−500 pMol
|
6
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>500 pMol
|
0
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Endometrial cancer
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Number of Subjects
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116
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0−150 pMol
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86
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150.1−300 pMol
|
15
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300.1−500 pMol
|
4
|
>500 pMol
|
11
|
Gastrointestinal cancer
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Number of Subjects
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56
|
0−150 pMol
|
47
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150.1−300 pMol
|
8
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300.1−500 pMol
|
0
|
>500 pMol
|
1
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Distribution of HE4 Assay Values
| |
Number of Subjects
|
0−150 pMol
|
150.1−300 pMol
|
300.1−500 pMol
|
>500 pMol
|
Apparently Healthy
|
Female (premenopausal)
|
76
|
72
|
3
|
0
|
1
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Female (postmenopausal)
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103
|
97
|
5
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0
|
1
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Benign Conditions
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Pregnancy
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22
|
21
|
1
|
0
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0
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Benign gynecological disease
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347
|
324
|
18
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1
|
4
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Other benign disease
|
108
|
82
|
8
|
7
|
11
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Hypertension/CHF
|
96
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75
|
16
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2
|
3
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Cancer
|
Ovarian cancer
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127
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27
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18
|
21
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61
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Breast cancer
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46
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40
|
4
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2
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0
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Lung cancer
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50
|
29
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15
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6
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0
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Endometrial cancer
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116
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86
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15
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4
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11
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Gastrointestinal cancer
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56
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47
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8
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0
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1
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*In this study, 94.4% of the healthy female subjects had an HE4
assay value ≤150 pMol.
Monitoring of disease status in patients diagnosed with
ovarian cancer.
The effectiveness of the HE4 EIA as an aid in monitoring of
disease status in ovarian cancer patients was determined by
assessing changes in HE4 levels in serial serum samples from 80
patients compared to changes in disease status. A study involving a
total of 354 pairs of observations was undertaken with an average
number of 4.4 observations per patient. A positive change in HE4
was defined as an increase in the value that was at least 25%
greater than the previous value of the test. This level of change
takes into account the variability of the assay and the biological
variability. Sixty percent or 76/126 of the patient samples with a
positive change correlated with the disease progression, while 75%
or 171/228 of the patient serial samples with no significant change
in HE4 value correlated with no progression. The total concordance
was 70% or 247/354. The following table presents the data in a 2 x
2 format.
Change in Disease State per Sequential Pair
Increase in HE4 Concentration
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>25%
|
Progression
|
76
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No Progression
|
57
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Total
|
133
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≤25%
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Progression
|
50
|
No Progression
|
171
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Total
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221
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Total
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Progression
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126
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No Progression
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228
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Total
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354
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Change in Disease State per Sequential Pair
Increase in HE4 Concentration
|
Progression
|
No Progression
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Total
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>25%
|
76
|
57
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133
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≤25%
|
50
|
171
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221
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Total
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126
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228
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354
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The following table shows the resulting sensitivities and
specificities of the HE4 EIA compared to the disease status at
various changes in HE4 EIA concentrations.
• Sensitivity is represented as a concordance of the HE4
EIA to progression of disease.
• Specificity is represented as a concordance of the HE4
EIA to no progression of disease.
Percent Change In HE4 Concentration
(%)
|
10
|
Sensitivity
(%)
|
71
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Specificity
(%)
|
62
|
25
|
Sensitivity
(%)
|
60
|
Specificity
(%)
|
75
|
50
|
Sensitivity
(%)
|
43
|
Specificity
(%)
|
88
|
75
|
Sensitivity
(%)
|
38
|
Specificity
(%)
|
92
|
100
|
Sensitivity
(%)
|
31
|
Specificity
(%)
|
95
|
Percent Change In HE4 Concentration
(%)
|
Sensitivity
(%)
|
Specificity
(%)
|
10
|
71
|
62
|
25
|
60
|
75
|
50
|
43
|
88
|
75
|
38
|
92
|
100
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31
|
95
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Forms
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