One Step hCG Urine Pregnancy Test (Cassette Format)
One-Step hCG Urine Pregnancy Tests are qualitative immunoassays for
detecting human Chorionic Gonadotropin (hCG) hormone in urine.
Enables detection of hCG for pregnancy as early as on the 1st day of a
woman's missed period.
These tests are
easy to use, versatile and produce very fast results.
With a built in test control, results appear as either single
(negative) or double (positive) bands.
The One-Step hCG Pregnancy Test has a sensitivity of 20mlU/ml
and is therefore an effective aid in detecting early pregnancy.
For in-vito detection of hCG in
urine, for diagnosis of pregnancy.
When a woman becomes pregnant, her body produces a hormone called hCG (human
Chorionic Gonadotropin). This hormone appears in the urine. The secretion of
this hormone increases throughout the first trimester. This is a highly
sensitive rapid test for the detection of hCG in urine. Pregnancy can be
diagnosed as early as the first day of a womans missed period. The
sensitivity of this test is 20mlU/ml of hCG in urine.
The urine sample is to be
collected in a clean and dry container. Rinse the container with water till it
is free of soap / detergent. Soap / detergent might interfere with the results
of the test. For optimal results, first urine sample of the day is
preferred. However, randomly collected fresh urine sample may also be used.
Once you finish addition of the urine sample, you can observe the urine sample flowing across the Result Window. Observe the Result Window for appearance of lines and interpret the result. The lines start appearing within few seconds after the sample flows across the Result Window.
ุ POSITIVE RESULT - If two distinct purple lines appear in the Result Window, one a C and one at T. (Result for strong positive urine sample appears within 2 minutes).
ุ NEGATIVE RESULT If only one purple line appears in the Result Window, one at C.
INVALID RESULT If no lines appear in the Result Window with
distinct color, it is recommended to repeat the test.
Read the result within 10
minutes. Do not interpret the result after 10 minutes. Appearance of test lines
after 10 minutes may not have any significance. If you want to confirm, discard
the used test device and repeat the above test with a fresh test device and
fresh sample after 24 hours.
Frequently asked questions
Q. Why is hCG needed ? And when and how does it produce the best results?
A. When a woman is pregnant, her body (placenta) produces the special pregnancy hormone hCG (human Chorionic Gonadotropin). The hCG, one step pregnancy Test detects hCG in the urine as early as on the first day of a missed period in case of a woman having regular menstrual cycle prior to the missed period.
Q. Is early morning urine the best sample for testing?
A. Yes, the first morning urine sample contains the highest concentration of hCG, due to lack of fluid intake during sleep. 7-10 days after the missed period , however, hCG concentration is high enough to be detected with hCG at any time of the day.
Q. If I see two bands, but one band is darker than the other, should I interpret the results as positive?
A. Yes, this should be interpreted as a Positive Result. Development of 2 lines, irrespective of the intensity of the lines, is to be interpreted as positive.
Q. Can the result change after standing for a certain length of time?
A. A positive Result will not change after the test is completed in 3 minutes. However, in order to prevent any incorrect, results, the test should not be interpreted after 10 minutes.
Q. If the is positive, what do I do?
A. If the test result is positive with the hCG, pregnancy should be confirmed after all clinical & laboratory findings have been evaluated, as done for all other diagnostic test.
Q. If test result is negative, what do I do?
A. A negative result means that no pregnancy hormones (hCG) has been detected and there is no pregnancy . If the woman does not menstruate within a week, then she may have miscalculated the day her period was due. Repeat the test. If second test is still negative and she still has not menstruated, she may consult a specialist/gynecologist.
Q. Can I get a false or misleading result?
A. This should not happen if the instructions in the product insert are followed correctly, to avoid procedural & handing errors, following are few other reasons for getting a false results-
Use of very dilute urine sample, as indicated by a low specific gravity, may not contain representative levels of hCG.
False negative results may occur when the levels of hCG are below 20mlU/ml. When pregnancy is still suspected, a first morning urine sample should be collected 48 hours later and tested.
False results may be observed due to Natural Termination of Pregnancy which is very common in India (in more than 50% of the cases), during the 1st trimester.
Certain rare medical conditions can also cause a false result, including trophoblastic disease, testicular tumors, prostate cancer, breast cancer, lung cancer which causes elevated levels of hCG.
Q. Any drugs? Do they affect performance of the hCG?
A. Only if the drug after in questions hCG. Test should be performed after 7-14days after the last hCG injection (in case of infertility treatment)
Q. Do antibiotics or oral contraceptive pills affect the test?
Q. Does other hormones in specimen like LH, FSH, TSH interfere with results?
A. No cross -reactivity, LH (300mlU/ml): FSH (1000mlU/ml), TSH (1000ตlU/ml).
Q. How about Extra-Uterine Pregnancy?
A. In Extra-Uterine Pregnancy, (Ectopic Pregnancy) hCG levels increase slowly and hence if the test is done when hCG levels exceed 20mlU/ml, the hCG will detect Extra -Uterine Pregnancy.