|
SPECIMEN COLLECTION
AND PREPARATION
The urine specimen must be collected
in a clean, dry
container. Specimens collected randomly may be used. However,
the first morning urine generally contains the highest concentration
of hormone. Urine specimens may be refrigerated (2° - 8°C)
and stored up to 72 hours prior to assay. If specimens are refrigerated,
they must be equilibrated to room temperature before testing.
DIRECTIONS FOR USE
1. Allow specimen and test strip to
reach room temperature (20° to 30°C) prior to testing.
2. Remove the test strip from the sealed foil pouch (test strip
must be used within 10 minutes of opening package).
3. Hold the test strip at the top in a vertical position with
the arrows pointing downward. Lower the test strip into the urine
specimen. Do not immerse the test strip beyond the "Stop
Line". (See illustration.)
4. Leave the test strip immersed until saturated, approximately
20 seconds. (Never put more than one test strip into urine at
the same time.)
5. Remove the test strip from the sample.
6. Set aside for about one minute.
7. Read the result.
INTERPRETATION OF RESULTS
The test is negative only if one band
appears in the Control Zone. The test is positive if two colored
bands appear. One colored band will appear in the Specimen Zone
and one in the Control Zone. Any colored band in the Specimen
Zone should be considered positive. The colored band in the Control
Zone may be lighter or darker in color than the Specimen Zone
band. The test is invalid if no band appears in the Control Zone
even if a colored band appears in the Specimen Zone. This can
be caused by not immersing the test strip for 20 seconds or by
immersing it beyond the "Stop Line". Try immersing
the strip again. If it still doesn't work, repeat the test
using a new test strip, making sure the test strip is not immersed
beyond the "Stop Line". |
|
QUALITY CONTROL
Each test includes a built in quality and procedural control.
Correct procedural technique and test strip performance is confirmed
when a colored band appears at the Control Zone of the membrane.
LIMITATIONS
False negative results may occur when levels of hCG are below
the sensitivity level of the test. When pregnancy is still suspected,
a first morning urine should be collected 48 hours later and
tested. Elevated levels of hCG may be found in trophoblastic
disease, choriocarcinoma, and embryonal cell carcinoma. Islet
cell tumors may also produce hCG as well as other carcinomas.
Elevated levels of hCG may remain several weeks following normal
pregnancy conclusion, delivery by cesarean section, spontaneous
or therapeutic abortion.
Ectopic pregnancies may produce very low levels
of hCG. If this condition is suspected further testing using
a quantitative assay may be desirable.
EXPECTED VALUES
Negative results are expected in healthy
non-pregnant women and healthy men. Healthy pregnant women have
hCG present. The amount will vary greatly with gestational age
and between individuals. First morning urine specimens approximate
hCG levels which reach 5 to 50 mIU/ml within 1 week of gestational
age. Tests can detect pregnancy as early as 1 day after a missed
menses.
PERFORMANCE CHARACTERISTICS
Accuracy: Proven over 99% accurate in
clinical trials.
SENSITIVITY AND SPECIFICITY
Detects hCG concentrations of 20 mIU/ml
and greater.
PRECAUTIONS
1. The test strip should remain in the
sealed pouch until ready for use. Once the sealed pouch has been
opened, the test is good for 90 days only.
2. All urine specimens should be considered potentially hazardous
and handled in the same manner as an infectious waste agent.
3. The test strip should be discarded in a proper container after
testing.
STORAGE AND STABILITY
The test strips should be stored at room
temperature (15° to 30° C) for the duration of the shelf-life.
The test strip must remain in the foil wrap until ready for use.
Once the pouch has been opened the test strips are good for 90
days only.
BACK to test
page
|
