Product Manual

Negative
Only one pinkish-purple line, at the Control Position (C).
NOTE: In the absence of hCG, or in the case that the hCG concentration is below the detection limit of
the test, there will be no apparent line at the Test position. The control line at the Control Position should be
clearly readable.
Invalid
A distinctive colored line at the Control Position (C) should always appear. The test is invalid if no Control
line forms.
NOTE: If there is no distinct pinkish-purple line visible at the Control Position, the test is inconclusive. If there
is a suspected procedural error made by the user, the result should be considered inconclusive. It is
recommended that in this case the test be repeated or a fresh specimen be obtained and tested. A
Control line should always appear. The absence of a pinkish-purple line at the Control Position means the
test is invalid and should be repeated with a new test device.
LIMITATIONS
• As with any assay employing mouse antibodies, the possibility exists for interference by human
anti-mouse IgG antibodies (HAMA) in the sample. Similarly, specimens from patients who have been
routinely exposed to animals or to animal serum products may contain heterophile antibodies which
may cause erroneous results.
• Elevated hCG levels have been reported in patients with both gestational and nongestational
trophoblastic diseases.
8, 9, 10
The hCG of trophoblastic neoplasms is similar to that found in
pregnancy, so these conditions, including choriocarcinoma and hydatidiform mole, should be ruled
out before pregnancy is diagnosed.
• An extremely low concentration of hCG during the early stage of pregnancy can give a negative
result. In this case, another specimen should be obtained at least 48 hours later and tested.
• The hCG level may remain detectable for several weeks after normal delivery, delivery by cesarean
section, spontaneous abortion, or therapeutic abortion.
11
• The hCG level in the case of spontaneous abortion may be very low and eventually decrease. The test
is highly sensitive, and specimens which test positive during the initial days after conception may later
be negative due to natural termination of the pregnancy. Natural termination occurs in 22% of
clinically unrecognized pregnancies and 31% of pregnancies overall.
12
Subsequent testing of a new
urine or serum sample after an additional 48 hours is recommended in order to confirm that the hCG
level is rising as indicated in a normal pregnancy.
• The concentration of hCG may be very low in the case of ectopic pregnancy.
13
A suspected ectopic
pregnancy may be further evaluated using a quantitative hCG assay.
• Very high levels of hCG may exist in certain pregnancies and pathological conditions
(e.g., choriocarcinoma and hydatidiform mole). This may weaken the signal line.
• The physician should evaluate data obtained from this kit in light of other clinical information.
• Samples which contain excessive bacterial contamination or have been subjected to repeated
freezing and thawing should not be used because such specimens can give spurious results.
• Urine samples collected after consumption of a large amount of fluids may contain a lower hCG
concentration. If such a sample is negative, a first morning specimen should be obtained and
retes ted.
• In rare occasions, persistent low levels of hCG present in men and in nonpregnant women
(concentrations 3 to 100 mIU/mL) may result in positive results.
14,15
USER QUALITY CONTROL
INTERNAL CONTROL: Each OSOM Ultra hCG Combo Test device has a built-in control. The Control line
is an internal positive procedural control. A distinct reddish-purple Control line should appear at C
position indicating an adequate sample volume is used, the sample and reagent are wicking on the
membrane, and the test reagents at the Control line and the conjugate-color indicator are reactive.
In addition, the clearing background in the Result window is considered as an additional procedural
control by providing a distinct readable result. This may be considered an internal negative
procedural control. If background color appears in the Result window which interferes with your
ability to read the test result and obscure the formation of the control band, your result may be
invalid. If the problem persists, contact Sekisui Diagnostics Technical Service at 800-332-1042 (US
Customers only)
EXTERNAL CONTROL: External controls may also be used to assure that he reagents are working
properly and that the assay procedure is followed correctly. It is recommended that a control be