Item Brochure

A red Control Line but no blue Test Line is a negative result and the sample contains no
detectable hCG.
Invalid
If after 5 minutes, no red Control Line appears, or background color makes reading
the red Control Line impossible, the result is invalid and the test should be repeated
with a new Test Stick.
INTERPRETATION OF TEST RESULTS
Positive
A blue Test Line and a red Control Line is a positive result and the sample contains hCG.
Note that the blue line can be any shade of blue, and can be lighter or darker than the
line in the picture.
Negative
TEST PROCEDURE
Urine collected anytime may be used. Urine specimens may be refrigerated (2° – 8°C;
36° – 46°F) and tested within 48 hours. Urine specimens and control material must be at
room temperature (15° – 30°C; 59° – 86°F) prior to testing.
Absorbent End
Sample Line
Result Window Handle End
• Remove Test Stick(s) from the container;
re-cap container immediately.
• Dip the Absorbent End of the Test Stick
into the sample up to the Sample Line
for at least 3 seconds.
• Remove the Test Stick from the sample.
Place it on a clean, fl at, dry disposable
surface such as a paper towel.
• Read results. Positive results can be read
as soon as the red Control Line appears.
Confi rm negatives at 5 minutes. Results
read after 5 minutes are invalid.
Sample Line
Note:
False results may
occur if urine
level goes above
Sample Line.
• Because of the high degree of sensitivity of the assay, specimens tested as
positive during the initial days after conception may later be negative due to
natural termination of the pregnancy. Overall, natural termination occurs in 22%
of clinically unrecognized pregnancies and 31% of other pregnancies
(12)
. In the
presence of weakly positive results, it is good laboratory practice to sample and
test again after 48 hours.
• If the test band appears very faint, it is recommended that a new sample be
collected 48 hours later and tested using another OSOM
®
hCG Urine Test Stick.
• Dilute urine specimens may not have representative levels of hCG.
• Detection of very low levels of hCG does not rule out pregnancy
(6)
, as low levels
of hCG can occur in apparently healthy, nonpregnant subjects
(13,14)
. Additionally,
post-menopausal specimens may elicit weak positive results due to low hCG levels
unrelated to pregnancy. In a normal pregnancy, hCG values double approximately
every 48 hours
(15)
. Patients with very low levels of hCG should be sampled and tested
again after 48 hours, or tested with an alternative method.
5 min