Pregnancy
Kit
What is Pregnancy Test Kit?
For rapid detection of Human Chronic Gonadotropin (hcg) in
urine specimen. Usually, a pregnancy test is done by
evaluating the urine. Secreted by the developing plancenta
shortly after implantation, hcg can be detected in the Urine
and the, serum of a pregnant women. The results are shown
withinn minutes.
Human Chorionic Gonadotropin (hcg) is a glycoprotein
hormone secreted by placenta shortly after egg
fertilization. hcg can be detected in the urine or serum of
a patient as early as 6 to 15 days after conception.
Storage an Atability
The test card can be stoned at room temperature max 30º
C, in the sealed pouch till expiry date mentioned on the
package.
Contents of the kit
- Test Device (Card)
- Dropper
- Blue Silica Gel
How to use
The urine sample to be collected in clean and dry
containder, either plastic or glass. The urine sample should
preferably first morning urine as specimen, since it
contains the highest concentration of hormones.
Put the card on smooth surface switch off the fan. Put 3
drops on the kit. The results may likely to be shown in 40
seconds. However, to confirm negative results the 5 minutes
are required.
Interpretion of Results
- Positive
Two distinct pink-coloured bands appear, one in the
Test Region (T) and other in the control region (C).
- Negative
Only one pink-coloured appear in the Control region
(C).
- Invalid
A total absence of pink-coloured bands in both regions
is indications of procedural error and the sample may be
repeated with a Fresh Test Device.
Limitations
- A Numbers of conditions other than pregnancy,
including trophoblastic disease and certain
non-trophoblastic neoplasms, cause levels of hcg.
- If a urine specimen is too dilute (i.e. low specific
gravity) it may not contain representative levels of
hcg.
- As with all diagnostic tests, a definite clinical
diagnosis should not be based on the results of a single
test.
Quality Control
It is recommended that two levels of positive control
specimens and one negative control specimen be used with
each new kit, for validation of results and quality control
procedures.
Performance Characteristic
- Sensitivity and specificity
The CORE-G hcg detects urine hcg concentrations grater
than 10 mlu/ml as indicated by the appearance of a
colour band at the test region.