Item Brochure

FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY
INTENDED USE
For the qualitative determination of human chorionic gonadotropin (hCG) in urine for
early detection of pregnancy.
SUMMARY AND EXPLANATION OF TEST
The hormone hCG is produced by the placenta
(1)
. Urine hCG provides an early indication of
pregnancy. However, because detectable hCG may be associated with conditions other
than pregnancy
(1,2)
such conditions should be ruled out when diagnosing pregnancy.
PRINCIPLES OF TEST
The OSOM
®
hCG-Urine Test uses color immunochromatographic dipstick technology
with mouse monoclonal and rabbit polyclonal antibodies coated on the nitrocellulose
membrane. The Test Stick is dipped into the urine sample and the sample migrates along
the membrane. If hCG is present in the sample, it will form a complex with the anti-hCG
antibody conjugated color particles. The complex will then be bound by the anti-hCG
capture antibody and a visible blue Test Line along with a red Control Line will appear
to indicate a positive result.
KIT CONTENTS AND STORAGE
Each kit contains 50 (No. 101) Test Sticks in a container and one directional insert. The
Test Sticks must be stored tightly capped at 15° – 30°C (59° – 86°F). Do not use Test Sticks
after expiration date.
MATERIALS REQUIRED BUT NOT PROVIDED
Urine containers and a timer or watch.
PRECAUTIONS
Follow your laboratory safety guidelines in the collection, handling, storage and disposal
of patient specimens and all items exposed to patient specimens
(3)
.
QUALITY CONTROL
If external quality control testing is desired, Control Set Catalog No. 134 may be purchased
separately from Sekisui Diagnostics. Some commercial controls may contain interfering
additives, therefore the use of these controls is not recommended. Test the control in the
same manner as a patient sample. The red Control Line is an internal positive procedural
control; if the test has been performed correctly (e.g. the proper volume of sample was
absorbed into the Test Stick) and the Test Stick is working properly (i.e. the antibodies
and conjugate are active), this indicator will appear. A clear background is an internal
negative procedural control; if the test has been performed correctly and the Test Stick
is working properly, the background will clear to give a discernible result.Quality Control
requirements should be established in accordance with local, state and federal regulations
or accreditation requirements. Minimally, Sekisui Diagnostics recommends that positive and
negative external controls be run with each new lot and with each new untrained operator.
EXPECTED VALUES
Normally, hCG is not detected in urine of healthy men and healthy non-pregnant
women. In normal pregnancy, hCG levels in urine can reach 25 mlU/mL as early as
7 to 10 days post conception, and continue rising to reach a maximum concentration
in excess of 200,000 mlU/mL at the end of the first trimester
(2)
.
LIMITATIONS
• This assay is capable of detecting only whole molecule (intact) hCG, which is the
predominant form of hCG in early pregnancy. It cannot detect the presence of hCG
fragments or free subunits.
• In later term pregnancies (generally beyond the first trimester), occasional urine samples
can contain very high levels of hCG fragments. Therefore, the OSOM hCG Urine Test is
most effective when used for the detection of pregnancy in its earlier stages.
• For diagnostic purposes, hCG test results should always be used in conjunction with
other methods and in the context of the patient’s clinical information (e.g., medical
history, symptoms, results of other tests, clinical impression, etc.). Ectopic pregnancy
cannot be distinguished from normal pregnancy by hCG measurements alone
(4,5)
.
• If the hCG level is inconsistent with, or unsupported by, clinical evidence, results
should also be confirmed by an alternative hCG method. Test results should be
confirmed using a quantitative hCG assay prior to the performance of any critical
medical procedure.
• Interfering substances may falsely depress or falsely elevate results. These interfering
substances may cause false results over the entire range of the assay, not just at
low levels, and may indicate the presence of hCG when there is none. As with any
immunochemical reaction, unknown interferences from medications or endogenous
substances may affect results.
• Infrequently, hCG levels may appear consistently elevated and could be due to,
but not limited to, the presence of the following:
(6 – 9)
Trophoblastic or nontrophoblastic neoplasms: abnormal physiological states that
may falsely elevate hCG levels
(10,11)
. This test should not be used in the diagnosis of
these conditions.
hCG like substances
®
CLIA Complexity: Waived
hCG-Urine Test