HERNANDEZ, ANALYN B.

BSMT4
CANCER ANTIGEN 125
MEANING, INTENDED USED, RISK
RESULTS
It is a large, glycosylated, mucin-like protein that is
used clinically as a marker for ovarian cancer.
This marker is not unique to ovarian marker
because is is also found in the normal ovary as
well as on the other tissues including the :

● Pleura
● Pericardium
● Peritoneum
● Epithelial tissues of colon
● Pancreas
● Lungs
● Kidney
● Prostate
● Breast
● Endocervix ● Stomach
● Endometrium ● gallbladder
● Fallopian tube

These tests are used to monitor certain cancers during and after treatment. It is
considered as the best marker for ovarian cancer. It has multiple applications to the disease,
ranging from screening and diagnosis to prognosis and monitoring response to therapy.
Serum CA 125 levels greater than 35 kU/L are considered to be above normal. Although
90% of women with ovarian cancer stages II and IV have elevated CA 125 the screening of this
marker is not recommended for the general population because it lacks sensitivity and
specificity. It is only seen in 50 % to 60 % of women with stage I ovarian cancer, therefore
generalized screening would miss about half of the women During the period when the disease
is most treatable.

SUMMARY AND EXPLANATION OF TEST

CA blood tests measure the amount

of a protein called CA 125 ( cancer antigen
125) in the blood. CA 125 levels are high in
many women with ovarian cancer. The
ovaries are pairs of female reproductive
glands that store ove (eggs) and make
female hormones. Ovarian Cancer
happens when there is uncontrolled cell
growth in a woman’s ovary.
High CA-125 level can be a sign of
other conditions besides ovarian cancer,
this test is not used to screen women at low
risk for the disease. It is usually done on
women already diagnosed with ovarian cancer. This can help to find out if the cancer treatment
is working, or if the cancer has come back after the patient's finished treatment.

Marker Cancer Uses Normal Noncancerous Comments

Sources condition with
Elevation

CA 125 Ovarian Screening Ovaries and Endometriosis Increases

adenocarcino Diagnosis various other pelvic can occur
ma Prognosis tissues inflammatory during
Monitoring disease, menstruation
uterine . Screening
fibroids, and only is
pregnancy recommend
ed for
women with
a family
history of
ovarian
cancer.

BIOLOGICAL PRINCIPLE OF THE PROCEDURE

The CA 125 assay is useful for monitoring the response to therapy for patients with
epithelial ovarian cancer. Serial testing for patient CA 125 values should be used in conjunction
with other clinical methods for monitoring ovarian cancer. Elevations may be observed in
patients with nonmalignant disease. A CA 125 assay result should not be interpreted as
absolute evidence of the presence or absence of malignant disease.

REFERENCES RANGES, INTERPRETATION, COLLECTION AND PANEL

● The reference ranges of CA 125 is 0-35 unit/mL (0-35 kU/L)

Interpretation

If the patient is being treated for ovarian cancer, she may be tested several times
throughout her treatment. If testing shows that the CA 125 level has gone down, it usually
means that the cancer is responding to treatment. If the levels go up or stay the same, it means
that the cancer is not responding to the treatment.
If the patient has finished her treatment for ovarian cancer , high CA 125 levels may
mean that the cancer came back.
If the patient is not being treated for ovarian cancer and her results show a high CA 125
level it can be a sign of cancer. But, it may also be a sign of noncancerous condition such as :

● Endometriosis, a condition in which tissue that normally grows inside the uterus also
grows outside the uterus. It can be very painful. It may also make it harder to get
pregnant.
 ● Pelvic inflammatory disease (PID), an infection of a woman's reproductive organs. It's
usually caused by a sexually transmitted disease, such as gonorrhea or chlamydia.
● Uterine fibroids, noncancerous growths in the uterus
● Liver disease
● Pregnancy
● Menstruation, at certain times during your cycle

Collection and Panel

A CA-125 blood test involves taking a small sample of blood, typically from a vein in the
arm. The following will occur:

● First, a healthcare provider will clean and disinfect the area with an antiseptic.
● Then, they’ll wrap an elastic band around your upper arm so your veins swell with blood.
● Once they find a vein, they’ll gently insert the needle into the vein. They’ll collect the
blood in a small tube attached to the needle.
● After enough blood has been drawn, they’ll remove the needle and cover the puncture
site to stop any bleeding.
● The blood sample will then be sent to a laboratory for analysis.

● Once the laboratory has your results, your doctor will schedule an appointment to
discuss them with you.

Patients need to test if they have a higher risk factor for ovarian cancer. She may at a
higher risk if she :

● Have inherited a gene that puts you at higher risk of ovarian cancer. These genes are
known as BRCA 1 and BRCA 2.
● Have a family member with ovarian cancer.
● Previously had cancer in the uterus, breast, or colon.

NORMAL AND ABNORMAL RESULTS

CS 125 LEVELS (unit/mL) Potential Cancer

0-35 (normal) Unlikely to have cancer. 99 % of the time, it

means no cancer

< 35 (high) Possible Cancer. More test will be needed for

diagnosis
High levels of CA 125 don’t necessarily confirm the presence of ovarian cancer. CA 125 level
may be elevated due another condition like:
● Uterine fibroids
● Endometriosis
● Pelvic inflammatory disease
● Pregnancy
● Menstruation
INSTRUMENT PROCEDURE, PREPARATION OF ANALYSIS, SPECIMEN
STORAGE, SHIPPING

Instrument Procedure
COBAS E 411
● To run the patient specimen
● Start with the Workplace
● Click the test selection test
● New Sequence number
● Enter the position
● Enter the patient ID
● Select the test CA 125
● Save

Preparation for Analysis, Specimen Storage and Shipping

● Only human serum (including serum collected in separator tubes [SST]) or plasma
(collected in tripotassium EDTA, sodium heparin, or lithium heparin collection tubes) may
be used.
● Do not use grossly hemolyzed specimens.
● Do not use heat-inactivated specimens.
● Serum and plasma specimens should be free of fibrin, red blood cells or other particulate
matter.
● If testing will be delayed more than 24 hours, remove serum or plasma from the clot,
serum separator, or red blood cells. Specimens may be stored for up to 7 days at 2-8°C
prior to being tested. If testing will be delayed more than 7 days, serum or plasma should
be stored frozen at -20°C or colder.

LIMITATION OF THE PROCEDURE

● The assay is unaffected by icterus (bilirubin < 1129 μmol/L or < 66 mg/dL), hemolysis
(Hb < 2.0 mmol/L or < 3.2 g/dL), lipemia (Intralipid < 2000 mg/dL) and biotin (< 287
nmol/L or < 70 ng/mL).
Criterion: Recovery within ± 10 % of initial value.
Samples should not be taken from patients receiving therapy with high biotin doses (i.e.
> 5 mg/day) until at least 8 hours following the last biotin administration.
● Patients with confirmed ovarian carcinoma may have pretreatment CA 125 assay values
in the same range as healthy individuals. Elevations in circulating OC 125 defined
antigen may be observed in patients with nonmalignant disease. For these reasons, a
CA 125 assay value, regardless of level, should not be interpreted as absolute evidence
for the presence or absence of malignant disease. The CA 125 assay value should be
used in conjunction with information available from clinical evaluation and other
diagnostic procedures. The CA 125 assay should not be used as a cancer screening
test.
LINEARITY, SENSITIVITY, SPECIFICITY

The sensitivity and specificity of CA125 is known to be poor. It is only raised in

approximately 50% of stage 1 epithelial ovarian cancers and in 75–90% of patients with
advanced disease. False positive results have been noted in many medical disorders, both
malignant and benign.This lack of specificity has been widely investigated and CA125 has now
been shown to be an effective marker for many diseases other than ovarian cancer.

METHOD OF COMPARISON
A comparison of the Elecsys CA 125 II assay (y) with Fujirebio Diagnostics CA 125 II RIA (x)
using clinical samples gave the following correlations.
Number of samples measured: 139

Passing/Bablok Linear regression

7 = 0.93x + 5.57 y= 0.96x + 5.82

T= 0.81 R = 0.981
The sample concentrations were between approximately 4 and 500 U/mL.

BIOMARKER DISEASE
● Ovarian Cancer

Reference
● Immunology and serology in laboratory medicine / Mary Louise Turgeon. 4th ed. c2009.
● : Immunology and serology in laboratory medicine / Mary Louise Turgeon. 5th ed
● https://labogids.sintmaria.be/sites/default/files/files/ca_125_ii_2018-03_v2.pdf
● https://emedicine.medscape.com/article/2087557-overview
● https://www.google.com/search?q=ca+125+ovarian+cancer&rlz=1C1BNSD_enPH1000P
H1000&source=lnms&tbm=isch&sa=X&ved=2ahUKEwje3s3EmPb5AhWvsFYBHazwDA
AQ_AUoAXoECAEQAw&biw=1366&bih=600&dpr=1#imgrc=y0-0rasYA7LWSM&imgdii=7
H6tgwjzld3d0M
● https://www.healthline.com/health/ca#results
● https://medlineplus.gov/lab-tests/ca-125-blood-test-ovarian-cancer/
● https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1770590/