Description
One Step hCG Single Test
Kit
A rapid,
one step test for the qualitative detection of human chorionic
gonadotropin (hCG) in urine.
INTENDED USE
The One
Step hCG Single Test Kit is a rapid chromatographic immunoassay for
the qualitative detection of human chorionic gonadotropin (hCG) in
urine to aid in the early detection of pregnancy.
SUMMARY
Human
chorionic gonadotropin (hCG) is a glycoprotein hormone produced by
the developing placenta shortly after fertilization. In normal
pregnancy, hCG can be detected in both urine and serum as early as
7 to *0 days after conception. hCG levels continue to rise very
rapidly, frequently exceeding **0 mIU/mL by the first missed
menstrual period, and peaking in the **0,******0,**0 mIU/mL range
about ****2 weeks into pregnancy. The appearance of hCG in both
urine and serum soon after conception, and its subsequent rapid
rise in concentration during early gestational growth, make it an
excellent marker for the early detection of pregnancy.
The One
Step hCG Single Test Kit is a rapid test that qualitatively detects
the presence of hCG in urine specimen at the sensitivity of *5
mIU/mL. The test utilizes a combination of monoclonal and
polyclonal antibodies to selectively detect elevated levels of hCG
in urine. At the level of claimed sensitivity, the One Step hCG
Single Test Kit shows no cross-reactivity interference from the
structurally related glycoprotein hormones hFSH, hLH and hTSH at
high physiological levels.
PRINCIPLE
The One
Step hCG Single Test Kit is a rapid chromatographic immunoassay for
the qualitative detection of human chorionic gonadotropin (hCG) in
urine to aid in the early detection of pregnancy. The test utilizes
a combination of antibodies including a monoclonal hCG antibody to
selectively detect elevated levels of hCG. The assay is conducted
by getting the urine specimen migrating on the test strip and
observing the formation of colored lines. The specimen migrates via
capillary action along the membrane to react with the colored
conjugate.
Positive
specimens react with the specific antibody-hCG colored conjugate
to form a colored line at the test line region of the membrane.
Absence of this colored line suggests a negative result. To serve
as a procedural control, a colored line will always appear at the
control line region if the test has been performed properly.
REAGENTS
The test
kit contains anti-hCG particles and anti-hCG coated on the
membrane.
PRECAUTIONS
For
professionalin vitro
diagnostic use only.
Do not use after the
expiration date.
The test 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 kit should be
discarded in a proper biohazard container after
testing.
STORAGE AND STABILITY
Store as
packaged in the sealed pouch at ***0°C. The test is stable through
the expiration date printed on the sealed pouch. The test must
remain in the sealed pouch until use. DO NOT FREEZE. Do not use
beyond the expiration date.
SPECIMEN COLLECTION AND
PREPRATION
Urine assay
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.
Specimen Storage
Urine
specimens may be stored at **8°C for up to *8 hours prior to
testing. For prolonged storage, specimens may be frozen and stored
below **0°C. Frozen specimens should be thawed and mixed before
testing.
PROCEDURE
Materials provided
Test
kit
Package
insert
Materials
required but not provided
Specimen
collection container
Timer
DIRECTIONS FOR USE
Allow the
test kits, urine specimen and/or controls to equilibrate to room
temperature (*5°**0°C) prior to testing.
Midstreams
1. Remove the
midstream test from the foil pouch.
2. Remove the Cap.
3. Hold the midstream test by
the Thumb Grip with the exposed Absorbent Tip pointing downward
directly into your urine stream for at least *0 seconds until it is
thoroughly wet. See the illustration below.
4. Note: Do
not urinate on the Test and Control windows. If you prefer, you
can urinate into a clean and dry container, then dip only the
Absorbent Tip of the midstream test into the urine for at least *0
seconds.
5. After
removing the midstream test from your urine, immediately replace
the Cap over the Absorbent Tip, lay the midstream test on a flat
surface with the Test and Control
windows facing upwards, and then begin timing.
As the
test begins to work, you may notice a light red flow moving across
the window. Wait 3 minutes for the red line(s) to appear. If
no red line appears, wait one minute longer. Some positive results
may be observed in 1 minute or less depending on the concentration
of hCG. Do not read the result after *0 minutes.
Cassettes
1. Remove
the test device from the sealed pouch and use it as soon as
possible.
2. Place
the test device on a clean and level surface. Hold the dropper
vertically and transfer 3 full drops of urine (approx.**0μL) to the
specimen well (S) of the test device. Start the timer.
3. Wait
for the colored line(s) to appear. Read results at 3 minutes. Do
not read the result after *0 minutes.
Strips
1. Remove the strip
from the sealed pouch. Label the strip with patient or control
identifications.
2. Immerse the strip
into the urine with the arrow end pointing toward the urine. Do not
cover the urine over the MAX (maximum) line. You may leave the
strip in the urine or you may take the strip out after a minimum of
*5 seconds in the urine and lay the strip flatly on a
non-absorptive clean surface.
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 *0 minutes.
INTERPRETATION AND RESULTS
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 kit. 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 **-**0 mIU/mL
hCG) and a negative hCG control (containing "0" mIU/mL hCG) be
evaluated to verify proper test performance.
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 *8
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 be collected *8 hours later and
tested.
3 Very
low levels of hCG (less than *0 mIU/mL) are present in urine
specimen shortly after implantation. However, because a significant
number of first trimester pregnancies terminate for natural reasons
, a test result that is weakly positive should be confirmed by
retesting with a first morning urine specimen collected *8 hours
later.
4 A
number of conditions other than pregnancy, including trophoblastic
disease and certain non-trophoblastic neoplasms including
testicular tumors, prostate cancer, breast cancer, and lung cancer,
cause elevated levels of hCG. Therefore, the presence of hCG in
urine 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 findings 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 serum
specimens. The amount of hCG will vary greatly with gestational age
and between individuals.
The One
Step hCG Single Test kit has a sensitivity of *5 mIU/mL, and is
capable of detecting pregnancy as early as 1 day after the first
missed menses.
PERFORMANCES CHARACTERISTICS
Accuracy
A
multi-center clinical evaluation was conducted comparing the
results obtained using the One Step hCG Test to another
commercially available urine membrane hCG test. The study included
**0 urine specimens: both assays identified *2 negative and *8
positive results. The results demonstrated **0% overall agreement
(for an accuracy of > *9%) of the One Step hCG Test when
compared to the other urine membrane hCG test.
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