Home Up Feedback Contents Search Sell your Prod. Meet us News           

 
Home • Up

Tumor Markers

 

Home

GENTAUR

+32 1658 9045

or

0032 (0)16 41 44 07

+32 1650 9045

[email protected]

Av. de l' Armée 68

B-1040 Brussels

BELGIUM

France

tel 01 43 25 01 50

fax01 43 25 01 60

9, rue Lagrange

75005 Paris

Italia

tel 02 36 00 65 93

fax 02 36 00 65 94

20135 Milano

Deutschland

tel +32 1658 9045

fax +32 1650 9045

Polska

Tel 058 710 33 44

Fax 00 32 16 50 90 45

ul. Grunwaldzka 88A/2

81-771 Sopot

日本

tel +81 78 386 0860

fax +81 78 306 0296

Minaatojimaminami-manchi

Chuo-ku, Kobe

065-0047

Österreich
+43720880899

Canada Montreal
+15149077481

Česká republika Praha
+420246019719

Danmark
+4569918806

Finland Helsset
+358942419041

Ελλάς Αθήνα
+302111768494

Magyarország Budapest
+3619980547

Ireland Dublin
+35316526556

Luxembourg
+35220880274

Nederland
+31208080893

Norge Oslo
+4721031366

Polska Warszawa
+48223988221

Sverige Stockholm
+46852503438

Schweiz Züri
+41435006251

US New York
+17185132983

Other Countries
0032 (0)16 41 44 07


 

 

 

 

 

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


 

 

Copyright © 2002 GENTAUR Molecular Products
Last modified: 05/29/09