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Specimen Collection
For optimal results it is best
to test the first urine voided
in the morning because it contains
the greatest concentration of
HCG. However, specimen urine collected
anytime during the day can be
used. Specimens can be stored
at 2 o C to 8 o C for up to 48
hours, or below -20 o C for at
least 3 months. Specimens should
not be frozen and thawed repeatedly.
Thawed specimens should be inverted
several times just prior to testing.
Urine samples containing excessive
bacterial contamination should
not be used.
Test Procedure
- If urine specimen, or the
dip-strips have been stored
in the refrigerator, allow them
to warm to room temperature
before testing.
- Use a new CHECK-MATE dipstrip
for each sample.
- Remove the dipstrip from the
pouch. Label the back of the
CHECK-MATE with the patient's
name or control identification.
• NOTE: Only touch the
strip on the end with the solid
blue tape.
• Contact with other parts
of the strip may affect the
performance of the test.
- Dip strip into the sample
of urine upto the blue line
indicated by the arrows for
5 seconds.
- Results will appear after
1 - 5 minutes.
- Do not read the test after
15 minutes.
Precautions
- For in-vitro diagnostic use.
- Do not use the reaction units
after the expiry date.
- All patient samples should
be handled as if they were capable
of transmitting disease.
Limitations
As in the case of any other diagnostic
procedures, the results obtained
from this kit must be used only
as an adjunct to other information
available to the physician. A
normal pregnancy cannot be distinguished
from an ectopic pregnancy based
on HCG levels alone. Positive
results from very early pregnancy
may later prove negative due to
natural termination of pregnancy.
This is estimated to occur in
50% of all conceptions. It is
recommended that weak positive
results be re-tested with a fresh
urine sample 48 hours later. Patients
with trophoblastic and non-trophoblastic
disease, or specimens with a high
Rheumatoid Factor ( RF ), may
have elevated HCG levels, therefore
the possibility of HCG secreting
neoplasms should be eliminated
prior to the diagnosis of pregnancy.
A negative result obtained with
a urine specimen collected from
a very early pregnancy may be
due to an extremely low concentration
of HCG. If pregnancy is still
suspected, a test should be repeated
on a fresh specimen obtained about
2 days later. If a urine specimen
is too dilute (i.e., low specific
gravity), it may not contain a
representative urinary HCG concentration.
If a negative result is obtained
with a low specific gravity specimen
and pregnancy is still suspected,
a first morning specimen should
be obtained and re-tested. After
an extended period of time, negative
results obtained with the recommended
timing may become weakly positive.
This may be due to a level of
HCG less than 25 mlU/ml. If pregnancy
is still suspected, a repeat test
is suggested in after 48 hours.
In rare cases one pink line may
appear 1 cm from the edge of the
solid blue tape indicating a positive
result with a very high concentration
of HCG.
Quality Control
A built-in control is included
in the test. In addition, in accordance
with good laboratory practice,
negative and positive controls
should be used with each assay.
Such controls are available commercially.
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