Product Manual

inconsistent test results. Such specimens should be clarified by centrifugation prior to assaying.
• If refrigerated, bring specimens to room temperature (18–30°C) prior to testing.
• Frozen specimens must be completely thawed, thoroughly mixed, and brought to room temperature
prior to testing by allowing the specimens to stand at room temperature for at least 30 minutes.
SPECIMEN STORAGE
• If testing will not be performed immediately, the specimens should be refrigerated (2–8°C) for up to 48
hours. Bring specimens to room temperature prior to testing.
• For prolonged storage, specimens may be frozen and stored below –20°C. Frozen specimens must be
completely thawed, thoroughly mixed, and brought to room temperature prior to testing by allowing
the specimens to stand at room temperature for at least 30 minutes. Avoid repeated freezing and
thawing.
• If specimens are to be shipped, they should be packed in compliance with Federal regulations
covering the transportation of etiologic agents. For urine samples, add sodium azide to a
concentration of 0.1% as a preservative and ship by the quickest means possible.
PROCEDURES
PROCEDURAL SUMMARY
The procedure consists of adding the specimen to the sample well in the device and watching for the
appearance of colored lines on the membrane.
PROCEDURAL NOTES
The instructions below must be followed to achieve optimal test reactivity with serum or urine
specimens.
• Allow specimens and the OSOM Ultra hCG Combo Test device to stand at room temperature for at least
30 minutes prior to testing.
• Label the OSOM device with the patient name or control number.
• Allow the dropper to fill with sample. Holding the dropper in a vertical position, add 3 drops of sample
into the Sample Well (S).
• Handle all specimens as if capable of transmitting disease.
• After testing, dispose of the OSOM device and the dropper following good laboratory practices.
Consider each material that comes in contact with specimen to be potentially infectious.
TEST PROCEDURE
STEP 1
For each test, open one OSOM Ultra hCG Combo
Serum/Urine pouch, and label the OSOM device
with the patient ID.
STEP 2
Holding the dropper in a vertical position, add 3 drops
of the sample into the Sample well (S).
STEP 3
Read the results at 3–5 minutes.
Do not interpret the results after 5 minutes.
INTERPRETATION OF RESULTS
Positive
Two pinkish-purple lines, one each at the Test Position (T) and at the Control Position (C). Each of the
following indicates a positive test result.
NOTE: A specimen containing a detectable level of hCG will generate a pinkish-purple line at the Test
Position (T) within 3–5 minutes. The time required to generate the line is dependent on the hCG
concentration in the sample. Some positive results can be read in as early as one minute. To be
interpreted as positive,the pinkish-purple line in the Test Position (T) should be clearly distinguishable
from the background color of the membrane. In strong positive tests, the color intensity of the line at the
Control Position (C) may be much lighter than that of the line at the Test Position (T).
a. Two strong pinkish-purple lines, one each at the Test (T) and Control (C) Positions
b. One strong pinkish-purple line at the Test Position (T) and one light pinkish-purple line at the
Control Position (C).
c. One light pinkish-purple line at the Test Position (T) and one pinkish-purple colored line at the Control
Position (C).