Biomarker Lens

Common biomarkers

  • Hemoglobin
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  • Apolipoprotein B
  • C-Reactive Protein, Cardiac
  • Ferritin
  • Alb/Creat Ratio, Urine
  • Alkaline Phosphatase
  • FSH
  • T4,Free(Direct)

Biomarkers · Chemical

HE4

Primary unit
pmol/L
LOINC codes
55180-4
Tests that measure HE4
Labcorp 4, Quest Diagnostics 1

Ranges

Each lab publishes a reference range for the population groups it tests, usually the middle 95% of results. These intervals describe that population, not an optimal or healthy target. How ranges differ

Quest Diagnostics, HE4, Ovarian Cancer Monitoring 16500

PopulationInterval
Female Premenopausal≤70 pmol/L
Female Postmenopausal≤140 pmol/L

Quest Diagnostics test catalog, 16500

Tests

Check the catalog code, specimen, method and preparation for every test that measures HE4. Select up to five tests to compare them side by side.

Labcorp 4 tests

Single-analyte tests

  • Human Epididymis Protein 4 081700

    Serum · Fasting not stated · Turnaround 1 - 3 days

    Method and collection
    Method
    Electrochemiluminescence Immunoassay (ECLIA)
    Preparation
    No special patient preparations are required.
    Collection
    If red-top tube is used, transfer separated serum to a plastic transport tube.
    Reference notes
    Gender | Range (pmol/L) Male | Not Established Female Age 0 to 39 years | 0.0 – 61.2 40 to 49 years | 0.0 – 63.6 50 to 59 years | 0.0 – 105.2 60 to 69 years | 0.0 – 96.5 >69 years | 0.0 – 96.9 The distribution of HE4 levels determined in 1147 specimens is shown in the table. 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 Female (postmenopausal) | 103 | 97 | 5 | 0 | 1 Benign Conditions Pregnancy | 22 | 21 | 1 | 0 | 0 Benign gynecological disease | 347 | 324 | 18 | 1 | 4 Other benign disease | 108 | 82 | 8 | 7 | 11 Hypertension/CHF | 96 | 75 | 16 | 2 | 3 Cancer Ovarian cancer | 127 | 27 | 18 | 21 | 61 Breast cancer | 46 | 40 | 4 | 2 | 0 Lung cancer | 50 | 29 | 15 | 6 | 0 Endometrial cancer | 116 | 86 | 15 | 4 | 11 Gastrointestinal cancer | 56 | 47 | 8 | 0 | 1 *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 | Progression | No Progression | Total >25% | 76 | 57 | 133 ≤25% | 50 | 171 | 221 Total | 126 | 228 | 354 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 (%) Sensitivity (%) Specificity (%) 10 | 71 | 62 25 | 60 | 75 50 | 43 | 88 75 | 38 | 92 100 | 31 | 95
    Labcorp catalog page
  • Human Epididymis Protein 4 (Serial Monitor) 481700

    Specimen not stated · Fasting not stated · Turnaround 1 - 2 days

Panels that include this biomarker

  • Ovarian Cancer Monitor 081610

    2 analytes · Serum · Fasting not stated · Turnaround 1 - 3 days

    Method and collection
    Method
    HE4: enzyme-linked immunosorbent assay (ELISA); CA 125: electrochemiluminescence immunoassay (ECLIA)
    Collection
    If red-top tube is used, transfer separated serum to a plastic transport tube.
    Labcorp catalog page
  • Ovarian Malignancy Risk (ROMA®) 140045

    4 analytes · Serum · Fasting not stated · Turnaround 1 - 3 days

    Method and collection
    Method
    Electrochemiluminescence Immunoassay (ECLIA)
    Collection
    If a red-top tube is used, transfer separated serum to a plastic transport tube.
    Labcorp catalog page

Quest Diagnostics 1 test

Single-analyte tests

  • HE4, Ovarian Cancer Monitoring 16500

    Serum · Fasting not stated · Turnaround Set up: Mon, Wed, Fri

    Method and collection
    Method
    Chemiluminescent Microparticle Immunoassay (CMIA)
    Collection
    Sample collected in a red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour
    Quest Diagnostics catalog page

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Sources

Verify these ranges and sources

We compile this page from named laboratory catalogs, guidelines and studies. Labs calculate reference intervals from the people they test, for one assay method and one population group, so an interval describes that population rather than an optimal target.

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