One Step hCG Urine Pregnancy Test (Cassette Format)

The 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. Qualitative results in 2-5 minutes 20mIU/ml Sensitivity 99% Accuracy Test any time of day 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.

Intended use

For in-vito detection of hCG in urine, for diagnosis of pregnancy.

How the test works?

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 woman’s missed period. The sensitivity of this test is 20mlU/ml of hCG in urine.

The pouch contains -

1. One test device (Card)
2. One disposable dropper
3. One desiccant (Moister absorbing pouch – Not required for performing the test)

Simple steps to collect the urine sample

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. 

Follow the steps carefully to diagnose pregnancy

1. Take out the test device from the pouch just before you start the test. Do not keep it open for a long period of time.
2. Your test device has a Sample Window (circular), a Result Window marked ‘C’ (Control region) and ‘T’ (Test region).
3. Keep the test device away from fan, drier or breeze of air while performing the test.
4. Keep the test device on a flat surface.
5. Collect the urine sample with the help of the dropper provided.
6. Add exactly 3 full drops of urine sample in the Sample Window.
7. Do not add the urine sample in the Result Window marked with ‘C’ & ‘T’ or any other part of the test device.
8. Do not touch the Result Window of the test device.

 Interpretation of results

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.

Ø      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).

Ø      NEGATIVE RESULT – If only one purple line appears in the Result Window, one at ‘C’.

Ø      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.

• If the test result is negative, it can happen that the period has been miscalculated. Wait for one week and repeat the test.
• Infertility drugs containing hCG will interfere with the results of the test.
• Drinking large amounts of fluids prior to collection of the sample can dilute hCG hormone levels in the urine leading to inaccuracy of the test results.
• Confirm pregnancy by other means before starting endocrinology or any other treatment.
• Dispose of urine specimen, test device and potentially contaminated materials.
• Contaminated, Hemolyzed, turbid specimens should not be used.
• Do not use the test device beyond expiry date.
• Do not reuse a used test device.
• As with all diagnostic tests, only a Registered Medical Practitioner should make a confirmed pregnancy diagnosis.

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? 

A. No

Q. Does other hormones in specimen like LH, FSH, TSH interfere with results?

A. No cross -reactivity, LH (300mlU/ml): FSH (1000mlU/ml), TSH (1000µlU/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.