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Sensitivity
CHECK-MATE urine dip-strips will
detect HCG in urine with concentrations
greater than 25 mIU/ml. The test
has been standardized to World
Health Organisation 1st IRP /
3rd IS 75 / 537.
Materials Provided
Test devices ( test strips )
sealed in an aluminium pouch with
desiccant. Each dip-strip is used
to perform one test only.
Accuracy
Positive correlation of more
than 99% was found testing random
urine samples, as compared to
a commercially available HCG IRMA
(Serono MAIA) kit.
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.
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.
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.
Expected Values
HCG is not normally detected
in the urine of healthy men and
healthy non-pregnant women. The
sensitivity of CHECK-MATE HCG
Urine is 25 mIU/ml (WHO, 1st IRP).
In normal pregnancy, HCG levels
in urine can reach 25 mIU/ml (1st
IRP) as early as 10 days post-conception,
approximately 3 days before the
expected period. CHECK-MATE dip-strips
can therefore be used to determine
pregnancy as early as the first
day of the missed period. HCG
levels continue to increase exponentially
to reach a maximum concentration
in excess of 200,000 mIU/ml at
the end of the first trimester.
Cross Reactivity
HCG-free urine samples containing
500 mIU/ml of the glycoprotein
LH & 1,000 mIU/ml of the glycoproteins
FSH & TSH gave negative results.
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