Item Brochure

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.
Expel entire
contents of the
barrel into the
sample well of
the test device.
No drop counting
required.
Read results at
5 minutes for serum.
Read results at
3 minutes for urine.
3 min.
5 min.
Positive
Negative
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.
Expel entire
contents of the
barrel into the
sample well of
the test device.
No drop counting
required.
Read results at
5 minutes for serum.
Read results at
3 minutes for urine.
3 min.
5 min.
Positive
Negative
Serum
Serum specimens should be obtained aseptically in tubes without anticoagulants. Plasma specimens
are not suitable and should not be used for the OSOM hCG Combo Test. Serum specimens may be stored
at 2° – 8°C (35° – 46°F) for up to 48 hours before testing. However, if testing is delayed beyond 48 hours, the
serum specimens (separated from the clot) should be frozen at -20°C (-4°F) or colder. Frozen specimens
may be stored for up to 1 year. The frozen specimens should be thawed, mixed, and brought to room
temperature 15° – 30°C (59° – 86°F) before testing.
QUALITY CONTROL
Internal Quality Control
Several procedural controls are incorporated into each OSOM hCG Combo Test for routine quality checks.
The same labeled conjugate antibody results in the appearance of both the test and the control
bands. The appearance of the control band in the results window is an internal positive procedural
control which validates the following:
Test System: The appearance of the control band assures that the detection component of both
the test line and control line is intact, that adequate sample volume was added and that adequate
capillary migration of the sample has occurred. It also verifies proper assembly of the Test Device.
Operator: The appearance of the control band indicates that an adequate volume of fluid was added
to the sample well for capillary migration to occur. If the control band does not appear at the read
time, the test is invalid.
The clearing of the background in the results area may be documented as a negative procedural control.
It also serves as an additional capillary flow control. At the read time, the background should appear
white to light gray and not interfere with the reading of the test. The test is invalid if the background fails
to clear and obscures the observation of a distinct control band.
If the control band fails to appear with a repeat assay, do not report patient results. Contact Sekisui
Diagnostics for technical service: Tel [phone] (U.S. Customers only)
External Quality Control
Sekisui Diagnostics recommends that external hCG controls be run with each new lot, and with each
new untrained operator. The OSOM hCG Urine Control (Catalog Number 134) or the OSOM hCG Serum
Control (Catalog Number 138) are designed for this purpose. Quality Control requirements should be
established in accordance with local, state and federal regulations or accreditation requirements.
PROCEDURAL NOTES
• If specimen has been stored refrigerated, allow it to warm to room temperature before use.
• Several tests can be run at the same time. Use a new pipette with each test to avoid
contamination errors.
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 indicated on 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:
3 minutes for urine
5 minutes for serum
Strong positive results may be observed sooner.
• Results are invalid after the stated read time.
The use of a timer is recommended.