-
For professional
in vitro
diagnostic use only. Do not use after the
expiration date.
-
The test device should remain in the sealed pouch until
use.
-
All specimens should be considered potentially hazardous
and handled in the same manner as an infectious agent.
-
The test device should be discarded in a proper biohazard container after testing.
Storage and
Stability:
Store as packaged in the sealed pouch at 4-30°C. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration
date.
Specimen Collection and preparation:
A urine specimen must be collected in a clean and dry container. A first morning urine specimen is preferred since it generally contains the highest concentration of hCG; however, urine specimens collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain
a clear specimen for testing.
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.
Procedure:
Materials Provided
Directions for Use:
Allow the test device, urine specimen and/or controls to equilibrate to room temperature (15-30°C) prior to
testing.
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Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
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Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100u1) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration
below.
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Wait for the red line(s) to appear. The result should be read at 3 minutes. It is important that the background is clear before the result
is read.
Note: A low hCG concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes.
Interpretations of
Results:
(Please refer to the illustration above)
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the
test region (T).
NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears
in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
NOTE: The intensity of the red color in the test line region (T) will vary depending on the concentration of hCG present in the specimen. However, neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.
Quality Control:
Internal procedural controls are included in the test. A red line
appearing in the control region (C) is the internal procedural control. It
confirms sufficient specimen volume and correct procedural technique. A
clear background is an internal negative background control. If the test
is working properly the background in the result area should be white to light
pink and not interfere with the ability to read the test result.
It is recommended that a positive hCG control (containing 25250 mlU/mL
mCG) and negative hCO control (containing 0: mlU/mL hCG) be evaluated to verify
proper test performance. It is recommended that federal, state, and local
guidelines be followed.
Limitations:
1.
Very dilute urine specimens, as indicated by a low specific gravity. may not contain representative levels of hCG. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
2.
False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should he collected 48 hours later and tested
3.
Very low levels of hCG (less than 50 m1U/mL) are
present
in
urine specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate 1hr natural reasons (5), a test result that is weakly positive should be confirmed by retesting
with a first morning urine specimen collected 48 hours later.
4.
A number of conditions other than pregnancy, including
trophoblastic disease and certain non-trophoblastie neoplasms
including testicular tumors, prostate cancer, breast cancer lung cancer, cause elevated levels
of
hCG (6-7). Therefore, the presence
of
hCG in urine specimen should not be used to diagnose pregnancy unless
these conditions have been ruled out.
5. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory
funding have been evaluated.
Expected Values:
Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hCG present in their urine and scrum specimens. The amount of hCG will vary greatly with gestational age and between individuals.
The hCG One Step Pregnancy Test Device (Urine) has a sensitivity of 25
mIU/mL, and is capable of detecting pregnancy as early as I day after the first missed menses.
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