Item Brochure
TEST PROCEDURE
Patient specimens and control material must be brought
to room temperature (15° – 30°C; 59° – 86°F) prior to testing.
• Remove the Test Device and the pipette from the
pouch. Place the Device on a flat surface.
• Squeeze the bulb of the pipette and insert the barrel
into the patient sample. Release the bulb and draw
up enough sample to fill the barrel to the line
indicatedon the pipette. Do not overfill.
• Expel the entire contents of the barrel (135µL)
into the sample well of the Test Device. No
drop counting required.
• Discard the pipette in a suitable biohazardous
waste container.
• Read results at 3 minutes.
• Results are invalid after the stated read time.
The use of a timer is recommended.
Two separate black or gray bands — one at “T: Test” and the other at “C: Control” — are visible in the
results window, indicating that the specimen contains detectable levels of hCG. While the intensity of
the test band may vary with different specimens, the appearance of 2 distinct bands should be
interpreted as a positive result.
Negative
If no band appears at “T” and a black or gray band is visible at the “C: Control” position the test
can be considered negative, indicating that a detectable level of hCG is not present.
Invalid
If no band appears at the “C: Control” position, the test is invalid. The test is also invalid if incomplete
or beaded bands appear at either the “T: Test” or “C: Control.” The test should be repeated using
another Test Device.
Note:
The test is valid if the control line appears by the stated read time regardless of whether the sample
has migrated all the way to the end of the sample window.
INTERPRETATION OF TEST RESULTS
Positive
Squeeze the bulb
of the pipette and
draw up enough
sample to fill the
barrel to the line
indicated on the
pipette.
Do not overfill.
Read results at
3 minutes.
3 min.
Positive
Negative
Expel entire
contents of the
barrel into the
sample well of
the test device.
No drop counting
required.
Squeeze the bulb
of the pipette and
draw up enough
sample to fill the
barrel to the line
indicated on the
pipette.
Do not overfill.
Read results at
3 minutes.
3 min.
Positive
Negative
Expel entire
contents of the
barrel into the
sample well of
the test device.
No drop counting
required.