Human epididymis protein 4
CLINICAL SIGNIFICANCE
HE4 belongs to the family of whey acidic 4-disulfide center (WFDC) proteins, which has suspected trypsin inhibitor properties. The HE4 gene (also known as WFDC2) located on chromosome 20q1213.1 encodes 14 homologous genes, consisting of 5 Composed of exons and 4 introns, the HE4 gene encodes a 13KD protein.
The HE4 test has the highest sensitivity in diagnosing ovarian cancer, especially in the early stages of the disease. The combined use of HE4 and CA125 is more accurate in predicting malignant tumors than either alone. Its sensitivity and specificity are 76% and 95%, respectively. It is reported that HE4 is expressed in normal tissues of respiratory tract epithelial cells and germ cells. Although there is no tissue specificity, a large number of chip studies have confirmed that HE4 is one of the most effective markers of ovarian cancer. This item cannot be used as an indicator for ovarian cancer screening.
SENSITIVITY
When the sample concentration is 140pmol/L, the absorbance change should ≥ 0.0100.
LINEARITY
In the range of [30,800] pmol/L, the linearity correlation coefficient r ≥ 0.990. In the range of [30,200]pmol/L, the absolute deviation should ≤ ±30pmol/L; In the range of [200,800] pmol/L, the relative deviation should ≤15%.
PRECISION
a)Repeatability(N=20)
|
|
Mean(pmol/L) |
CV(%) |
|
Level1 |
110.3 |
4.10 |
|
Level 2 |
320.8 |
3.50 |
b)Intermediate precision(N=80)
|
|
Mean(pmol/L) |
CV(%) |
|
Level1 |
108.6 |
5.32 |
|
Level 2 |
319.2 |
3.83 |
INTERFERENCES
Dissolve the following substances into a serum sample with a basic concentration of about 200±20 pmol/L for determination. The effect of Hemoglobin ≤200 mg/dL, Intralipid ≤250 mg/dL, Bilirubin ≤40 mg/dL,RF ≤250 IU/mL is less than 10%.