¾ Combined with total PSA, DRE and biopsy findings,
helps to predict the postoperative pathological stage
and grade, and may assist the patient and physician in
making more informed treatment decisions.
¾ Can help differentiate CaP (carcinoma of prostate)
from BPH and reduce unnecessary biopsies.
These are epitopes recognized on the surface of high
molecular weight glycoproteins on the epithelial cells lining
respiratory, gastrointestinal and many other secretory
¾ An epitope associated with a high molecular weight
¾ Originally identified by MAb OC 125
¾ Elevated in ovarian, lung, pancreatic and uterine cancer
¾ Used in differential diagnosis between ovarian cancer
¾ An epitope on mucin type glycoprotein antigen
¾ The antigen is present in normal and malignant epithelial
cells of certain organs — breast, lung, ovary, etc.
¾ Elevated levels are observed in patients with metastatic
Also elevated in chronic hepatitis, liver cirrhosis,
¾ An epitope on sialylated carbohydrate antigen
¾ Present on mucinous type of glycoprotein
¾ Elevated in patients with gastrointestinal cancer
¾ Discrimination between benign and malignant
¾ Complement to CEA in colorectal cancer.
A glycoprotein secreted by the syncytiotrophoblasts of
placenta contains α and β subunits.
In maternal serum found in many forms
¾ Diagnosing trophoblastic disorders
The hCG assays employ different strategies for estimating
hCG from urine (qualitative) and serum (quantitative).
The serum hCG assay measures the intact (whole)
molecule when an antibody or the α-subunit and an
antibody for β-subunit are used in the immunometric
format. This type of assay does not measure free α/ β–
subunit because free subunits cannot form sandwich with
both antibodies. The total β-hCG assay measures both the
intact hCG and free β-subunits. As a tumor marker, a total
It is of utmost importance to check:
¾ Calibrators—calibrated against 3rd IS (WHO)
¾ Calibrator matrix—human serum matrix
¾ Cross reactivity with LH—very little or no cross
ELISA AND CLIA, AS ON RIA TOO.
Summary and Explanation of the Test
Alpha-Fetoprotein (AFP) is a glycoprotein with a
molecular weight of 70 kDA. AFP is normally produced
during fetal development by the hepatocytes, yolk sac
and to a lesser extent by the gastrointestinal tract. Serum
concentrations reach a peak level of up to 10 mg/mL at
12 weeks of gestation. This peak level gradually decreases
to less than 25 ng/mL after 1 year of postpartum. Thereafter,
the levels reduce further to less than 10 ng/mL.
Elevated levels of AFP are found in patients with primary
heptatoma and yolk sac-derived germ tumors. AFP is the
most useful marker for the diagnosis and management of
AFP is also elevated in pregnant women. Presence of
abnormally high AFP concentrations in pregnant women
provides a risk marker for Down syndrome.
AFP has a low clinical sensitivity and specificity as a tumor
marker. Clinically an elevated AFP value alone is not of
diagnostic value as a test for cancer and should only be
used in conjunction with other clinical manifestations
(observations) and diagnostic parameters. AFP levels are
known to be elevated in a number of benign diseases and
conditions including pregnancy and non-malignant liver
diseases such as hepatitis and cirrhosis.
Approximately 97 to 98% of the normal healthy population
has AFP levels less than 8.5 ng/mL. In high risk patients, AFP
values between 100 and 350 ng/mL suggest hepatocellular
carcinoma. Concentrations over 350 ng/mL usually are
Expected values for the AFP ELISA Test System male
and female < 8.5 ng/mL (97–98%).
It is important to keep in mind that establishment of
a range of values which can be expected to be found by
a given method for a population of “normal’-persons is
dependent upon a multiplicity of factors the specificity
of the method, the population tested and the precision of
the method in the hands of the analyst. For these reasons
each laboratory should depend upon the range of expected
method with a population indigeneous to the area in which
CA 15-3 (CARCINOGENIC ANTIGEN 15-3)
Summary and Explanation of the Assay
The MUC-1 antigen is a membrane-anchored mucin-type
glycoprotein present in malignant and normal epithelial
cells of certain organs, e.g. breast, lung, ovary and
pancreas. The apo-protein of the MUC-1 mucin contains
a transmembrane domain, a cytoplasmic domain, and an
extracellular carbohydrate rich domain. The extracellular
domain is characterized by polymorphism with respect
to the number of a 20 amino acid tandem repeat (VNTR
polymorphism). The MUC-1 breast cancer mucin < (CA15-
3 antigen) is secreted from tumor cells and can be used as
a serological marker of breast cancer.
The expiry date of the complete kit is stated on the label
on the outside of the kit box.
Do not use the kit components beyond the expiry date.
No comments:
Post a Comment
اكتب تعليق حول الموضوع