How sensitive is
TestPack hCG Combo?
TestPack hCG Combo is sensitive to 25 mIU/ml hCG in
urine or serum.
How accurate is the test?
TestPack hCG Combo has been shown to be > 99%
accurate in clinical trials.
Can plasma be used with the TestPack hCG
Combo test?
No. The test has only been validated for
urine and serum samples only.
Can urine and serum
samples be stored in the fridge/ freezer?
Yes.
Both urine and serum samples can be stored for up to 48 hours
between 2°C and 8°C or up to 3 months if frozen at -20°C. However,
samples must always be brought to room temperature prior to
use.
Can
the test be used directly from the
fridge?
No. although the kit can be stored at 2
- 30°C, it must be allowed to equilibrate at 18 - 30°C for a
minimum of 30 minutes before use.
Do urine samples need
to be collected in containers containing
preservatives?
No. You do not need to add
preservatives to the urine sample. If you want to use a
preservative TestPack hCG Combo
has been validated for use with samples containing 0.1% sodium
azide only.
How soon can
TestPack hCG Combo be used?
TestPack hCG Combo can detect hCG in urine at
concentrations ≥ 25 mIU/ml. On the first day of the expected
period the level of hCG in the urine and serum of a pregnant woman
is expected to range between 50 – 250 mIU/ml.
When is the best time of
day to test?
It is possible to use
TestPack hCG Combo with a urine or serum
sample collected at any time of day. However, a first morning urine
sample will usually contain the highest level of hCG.
How critical is the timing and are
the results stable?
The result must be read 5 minutes
after the sample has been applied to the Sample Well of the
reaction disc, after which time the test should be discarded.
The Patient Bar is very faint,
what does this mean?
Samples containing 5 -
25mIU/ml hCG may produce weak positive results. In such cases a
repeat test is recommended 48 to 72 hours later. However, provided
the Minus Bar is present a weak positive should be recorded as a
valid positive result.
Sometimes the
Patient Bar can be fainter or darker than the Minus Bar. How should
this result be interpreted?
The presence of the
Patient Bar in the Result Window indicates a positive result,
regardless of its intensity compared to the Minus Bar.
What is
the purpose of the Positive On Board Control?
The
Positive On Board Control demonstrates the functionality of the
antibodies that detect hCG. It will always be produced in a valid
test whether or not hCG is present in the sample.
No Minus Bar has appeared in the
Result Window, what does this mean?
The test has not
run correctly. This may occur if the pouch has been opened for too
long prior to the test being carried out. It could also be a
consequence of adding insufficient or excessive sample to the
test.
Will fertility
drugs affect the test result?
Fertility drugs
containing hCG can give misleading results. We recommend that a
pregnancy test is not carried out until at least 14 days have
passed since the administration of these drugs, testing too soon
may give a false positive result.
Do hormonal
contraceptives affect the test?
No. However if a
woman has recently discontinued the use of hormonal
contraceptives her periods may not be regular. In such cases we
recommend testing 19 days after the last unprotected sexual
intercourse.
Can TestPack hCG Combo
be used to detect ectopic pregnancy?
TestPack hCG Combo can be a useful aid in the
diagnosis of ectopic pregnancy, although it cannot distinguish
ectopic pregnancies from normal pregnancies, and since ectopic
pregnancies may produce lower levels of hCG than normal
pregnancies, a positive result may not be seen as early.
If an ectopic pregnancy is suspected, it should always be followed
up with a suitable confirmatory method.