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0032 (0)16 41 44 07
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0032 (0)16 41 44 07
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TUMOR MARKERS
K221
K231 K222
K223 K224
K225
K205 K226
K227 K228
K232
K221 Total
Prostate Specific Antigen (tPSA) EIA
Prostate specific antigen (PSA) is a serin-like protease with molecular weight
ca. 34 kDa whith was
initially found exclusively in normal prostatic gland as well as in prostatic
fluid and seminal plasma.
Later it was localized also in breast milk and, according to its enzymological
properties, was classified
as human prekallikrein 3. In human serum, most of PSA forms complexes with
serine protease
inhibitor proteins (mostly alpha-1-antichymothripsin, alpha-2-macroglobulin and
antithripsin). A minor
proportion of PSA (free PSA) is circulating outside these complexes.
Elevated serum PSA levels are found in patients with prostatic adenocarcinoma
even at early stages
of the disease. Values of 1000 ng/ml and even more may be found in patients with
profound disease.
Clinical value of this parameter is due to possibility of clinical monitoring
and prognosis of the disease.
Continuous elevation of PSA level is indicative of tumor progression and
ineffective therapy. Nevertheless,
interpretation of the results obtained should be made in the context of other
laboratory and clinical data.
According to data obtained in University of Turku, Finland, the pair of
monoclonal antibodies used in present test
system (PS2-PS6), recognizes both free and complex-bound forms of PSA with equal
affinity (equimolar binding).
Elevations of serum PSA levels are characteristic to prostatic hyperplasia,
inflammation and tumors. Serum
PSA level can be used for monitoring and treatment control of all diseases
involving prostatic tissue,
especially prostatic tumors.
Sample type: serum, plasma
Incubation: 30’/30’/15’, 370С
Control sample: 1
Sample volume: 50 μl
or RT, shaker
Shelf life: 12 months
Sensitivity: 0.3 ng/ml
Calibrators: 5 (0-30 ng/ml)
K231 Free Prostate Specific Antigen
(fPSA) EIA
Additional information valuable for differential diagnosis between benign and
malignant prostate
hyperplasia may be obtained by estimation of free PSA/total PSA ratio. In this
case, age and case
history of patients should be considered: that is, free PSA/total PSA ratio in
patients under 60 years is
to be estimated if total PSA level is above 4 ng/ml while in males over 60 years
where benign prostatic
hyperplasia is common this ratio is rational to be estimated when total PSA
level is above 10 ng/ml.
Besides, it should be kept in mind that significant elevation of total PSA level
may be found in patients
with prostatitis as well as after massage of prostatic gland and the next day
after ejaculation (according
to Xema-Medica data, up to 20 ng/ml and 80 ng/ml, respectively).
Please, note, that free PSA/total PSA ratio should be estimated using EIA kits
of the same manufacturer.
This kit is intended for use with tPSA EIA, Cat.# K221
Sample type: serum, plasma
Incubation: 30’/30’/15’, RT,
Control sample: 1
Sample volume: 50 μl
shaker
Shelf life: 12 months
Sensitivity: 0.1 ng/ml
Calibrators: 5 (0-5 ng/ml)
K222 CA125 EIA
CA125 is an antigen (an epitope) associated with ovarian carcinoma and some
other tumors. Quantitative
determination of CA125 in serum and plasma is used for follow-up of patients
with primary invasive
ovarian carcinoma. The CA125 epitope is found on a heterogeneous group of
glycoproteins with a
high molecular weight (MW 200.000 to over 1.000.000). CA125 can be detected in a
high percentage
of nonmucinous epithelial ovarian tumors. In addition, CA125 is detectable in
some fetal tissues
and in adult tissues in the epithelium of the phallopian tubes, apocrine sweat
glands, breast glands,
endometrium and endocervix. Elevated serum concentrations of CA125 are found in
most patients
with epithelial ovarian cancer, including those with stage 1 disease. CA125
determination is useful for
therapy control and follow-up of ovarian cancer patients treated by any type of
therapy. However, the
CA125 values obtained should always be interpreted in the context of the results
obtained by other
diagnostic procedures.
Internal data obtained by Xema-Medica suggest that serial determination of CA125
may be helpful for
diagnosis of adenocarcinoma development in fibrotic lung tissue in patients with
interstitial lung diseases.
In a present test system, monoclonal antibodies X306 (epitope group A) are used
to capture the
antigen, and monoclonal antibodies X52 (epitope group B) are used as a tracer.
The epitope specificity
of both antibodies were confirmed by an independent expert group (TD1 workshop
2000, International
Society of Oncodevelopmental Biology and Medicine).
Determination of CA125 is not suitable for early diagnosis of malignancies
because elevated CA125 values
may also be found in patients with uterine carcinoma, hepatoma and pancreatic
adenocarcinoma as well
as in non-malignant conditions such as liver cirrhosis, interstitial lung
diseases, severe endometriosis and
during pregnancy.
Sample type: serum, plasma
Incubation: 60’/15’, 370С
Control sample: 1
Sample volume: 50 μl
Calibrators: 6 (0-400 U/ml)
Shelf life: 12 months
Sensitivity: 5.0 U/ml
K223 CA19-9 EIA
CA19-9 or sialyl-Lewis is an antigen (an epitope) associated with tumors of the
gastrointestinal tract, such
as pancreatic, liver, stomach and colorectal carcinoma. Quantitative
determination of CA19-9 in serum and
plasma is helpful in monitoring of patients where such tumors have been
diagnosed, especially together with
determination of carcinoembryonic antigen (CEA, Xema-Medica Cat# K224).
Increasing levels of CA 19-9
may indicate a progression of disease or poor therapeutic response while
decreasing values point to the
efficacy of treatment. However, the CA19-9 values obtained should always be
interpreted in the context
of the results obtained by other diagnostic procedures.
Determination of CA19-9 is not suitable for early diagnosis of malignancies
because elevated CA19-9
values may also be found in patients with pancreatitis, cystic fibrosis as well
as liver cirrhosis and other
severe hepatic diseases, especially accompanied by cholestasis as the antigen is
excreted with bile. Some
individuals lack the enzyme responsible for synthesis of sialyl-Lewis antigen
and therefore cannot respond
by antigen elevation even to progressive tumor growth.
Sample type: serum, plasma
Incubation: 30’/30’/15’, 370С
Control sample: 1
Sample volume: 50 μl
Calibrators: 5 (0-240 U/ml)
Shelf life: 12 months
Sensitivity: 2.0 U/ml
K224 Carcinoembryonic antigen (CEA) EIA
New 1 step version
Carcinoembryonic antigen (CEA) represents a family of heavily glycosylated
glycoproteins with MW
180-200 kDa which is expressed and secreted by normal human gastrointectinal
mucosa.
Serum CEA elevation may serve as the early laboratory marker of relapsing or
metastatic colon or rectal
carcinoma. Elevated serum CEA is observed in many other adenocarcinomas,
including mammary,
gastric, pulmonary, esophageal and ovarian; in some of these patients serum CEA
may be used
for disease monitoring.
In blood circulation, there are some substances showing high degree of
similarity to CEA (NCA, NCA2); this
fact requires the use of highly specific anti-CEA reagents. In the present test
system, we use for capturing
CEA the monoclonal antibody 1C6 directed towards domain A3/B3, epitope Gold
group I, confirmed
independently (TD8 workshop, 2000, International Society of Oncodevelopmental
Biology and Medicine).
Due to high prevalence of serum CEA elevation in benign diseases (mucosal
inflammations), this test
system is not recommended for screening for malignant tumors.
Sample type: serum, plasma
Incubation: 30’/30’/15’, 370С
Control sample: 1
Sample volume: 50 μl
Calibrators: 6 (0-64 ng/ml)
Shelf life: 12 months
Sensitivity: 1.0 ng/ml
K225
Alpha-Fetoprotein (AFP) EIA
New 1 step version
Alpha-fetoprotein (AFP) is a glycoprotein with a MW ca. 65 kDa which is secreted
by fetal liver and
yolk sac. AFP represents the main protein of fetal serum while being found in
trace quantities in adults.
Serum AFP quantitative determination is used in primary diagnostics and
monitoring of hepatocellular
liver cancer, trophoblastic tumors of testicles and ovary as well as theratomas
and theratocarcinomas.
Quantitative determination of AFP in serum of pregnant women or in amniotic
fluid during week 15-20
of gestation is widely used for laboratory screening of Down syndrom and defects
of spinal cord.
Sample type: serum, plasma
Incubation: 60’/15’, 370С
Control sample: 1
Sample volume: 50 μl
Calibrators: 5 (0-200 U/ml)
Shelf life: 12 months
Sensitivity: 2.0 U/ml
K205 Human
Chorionic Gonadotropin (HCG) EIA
Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by
trophoblastic cells
of placenta. A molecule of HCG consists of two noncovalently bound subunits:
alpha- and beta-HCG.
Beta-subunit is specific for HCG hormone. Determination of HCG is widely used
for early diagnosis
of pregnancy. Multiple pregnancy results in correspondent elevation of serum
HCG, while ectopic
pregnancy and placental insufficiency cause decreased serum HCG levels.
Determination of HCG in serum during second trimester is used for pregnancy
monitoring, especially
in screening for Down syndrome, along with other laboratory tests (AFP and
Estriol).
Serum HCG is also a laboratory marker of trophoblastic tumors -
chorionepitheliomas, some seminomas
and theratomas. Serial determination of serum HCG may be used for therapy
monitoring in these
cancers. The present test system uses beta chain specific monoclonal antibody
XK27 as the capture,
and alpha-chain specific monoclonal antibody XK77 as the tracer; therefore only
the whole intact HCG
molecule is detected.
Sample type: serum, plasma
Incubation: 30’/30’/15’, 370С
Control sample: 1
Sample volume: 50 μl
Calibrators: 6 (0-200 IU/ml)
Shelf life: 12 months
Sensitivity: 2.5 IU/ml
K232
Thyroglobulin (TG) EIA
New kit!
Thyroglobulin (TG) is a high MW (ca. 650-700 kDa) glycoprotein synthesized by
the thyroid epithelial
cells. In normal thyroid gland, TG is secreted to the follicular lumen and
undergoes iodination of tyrosine
residues leading to formation of thyroid hormones (T3 and T4). Minor quantities
of TG penetrate
to the circulation in normal donors. Synthesis of TG is regulated by hormones
(TSH, TRH, exogenous
thyroid therapy).
In differentiated thyroid carcinoma, serial determination of serum TG is used
for post-treatment
monitoring. An elevation of serum TG in such patients indicates a presence of
residual thyroid tissue,
relapse or metastatic growth of the tumor. The elevated serum TG are also
observed in benign thyroid
diseases, e.g. thyroiditis, hyperthyroidism and non-toxic goiter. The monitoring
of serum TG is also
used for prognostic evaluation of thyrostatic treatment of Graves’ disease.
Sample type: serum, plasma
Incubation: 60’/15’, RT, shaker
Control sample: 1
Sample volume: 50 μl
Calibrators: 5 (0-400 ng/ml)
Shelf life: 12 months
Sensitivity: 3.0 ng/ml
EIA kits for
quantitative detection of MUC1 antigen (Mammary carcinoma monitoring)
K226 M12 (CA 15.3) EIA
K227 M22 EIA (analogous to МСА, Roche)
K228 M20 EIA (analogous to BR 27.29, Biomira)
MUC1 is a heterogenous glycoprotein with a molecular mass ca. 300-450 kD. The
main epitope of
MUC1 determined in all three systems is a unique immunodominant peptide motif
TRPAPGS. Elevation
of serum MUC1 is associated with mammary carcinomas. Quantitative determination
of MUC1 in serum
and plasma is helpful in monitoring of patients with such tumors to estimate the
course of the disease,
effectiveness of its treatment and to reveal reccurence or metastases. However,
MUC1 values obtained
should always be interpreted in context of results obtained by other diagnostic
and clinical procedures.
Apart from mammary carcinomas, MUC1 levels in blood may rise in lung tumors,
prostate cancer,
ovarian carcinomas, gastro-intestinal tumors. Elevation of MUC1 level in blood
can be also found in
benign tumors of the mammary gland and the ovary, endometriosis, hepatitis,
liver cirrhosis and lung
fibrosis. Pregnancy and lactation may also cause elevation of MUC1 level in
serum.
To estimate effectiveness of surgical treatment, we recommend to use all three
systems (M12, M22,
M20) before and after resection; the one showing the most pronounced
post-surgery decline should be
then used for further monitoring.
K226 M12 (CA 15.3)
EIA
This kit is designed on “heterogeneous sandwich” principle. Two antibodies are
used: one is fixed on
a solid phase and used to capture an antigen while the other is labeled with a
marker enzyme and
used as a conjugate. Such kits are the most specific ones but have low
sensitivity (not more than 75%
- even in patients with a stage III MC). Besides, CA 15.3 level may be
significantly elevated in some
non-malignant states – such as interstitial lung diseases.
NOTE: those patients received murine monoclonal antibodies for radioimaging or
immunotherapy may
develop high titered anti-mouse antibodies (HAMA). The presence of these
antibodies gives false results
in the present assay. Sera from HAMA positive patients should be treated by
depleting adsorbents
before assaying.
Sample type: serum, plasma
Incubation: 30’/30’/15’, RT,
Control sample: 1
Sample volume: 50 μl
shaker
Shelf life: 12 months
Sensitivity: 1.5 U/ml
Calibrators: 5 (0-250 U/ml)
K227 M22
(analogous to MCА, Roche)
The M22 kit is based on a principle of “homogeneous sandwich” – i.e., the same
monoclonal antibody
(X19) recognizing the peptide determinant TRPAPGS is used both to capture
antigen on the solid phase
and to detect it by enzymatic reaction. Such systems (e.g., MCA, Roche) may give
a higher percentage of
false-positive results compared to kits based on competitive or “heterogeneous
sandwich” principles.
NOTE: Those patients received murine monoclonal antibodies for radioimaging or
immunotherapy may
develop high titered anti-mouse antibodies (HAMA). The presence of these
antibodies gives false results
in the present assay. Sera from HAMA positive patients should be treated by
depleting adsorbents
before assaying.
Sample type: serum, plasma
Incubation: 30’/30’/15’, RT,
Control sample: 1
Sample volume: 50 μl
shaker
Shelf life: 12 months
Sensitivity: 1.5 U/ml
Calibrators: 6 (0-100 U/ml)
K228 M20
(analogous to BR 27.29, Biomira)
The M20 kit is based on a principle of competitive immunoassay. The labeled
monoclonal antibody X19
recognizing the peptide determinant TRPAPGS binds the natural purified mammary
carcinoma-derived
antigen on the solid phase. Such test systems (e.g., BR27.29 developed by
Biomira) may give a higher
sensitivity for tumor specific forms of MUC1 compared to kits based on sandwich
principle.
Sample type: serum, plasma
Incubation: 60’/15’, 370С
Control sample: 1
Sample volume: 50 μl
Calibrators: 6 (0-50 U/ml)
Shelf life: 12 months
Sensitivity: 1.2 U/ml
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