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INTRODUCTION
One Step hCG Pregnancy Test is designed to qualitatively determine elevated human chorionic gonadotropin (hCG) in urine. The result can be read visually in minutes to indicate a positive or negative result for pregnancy.
Test Information: One Step hCG Pregnancy Test (Midstream)
Cat.#:100-17, For Self-Testing
INSTRUCTIONS
(Please read all the information in this leaflet before performing the test.)
Do not use if pouch is torn or damaged.
Do not use after the expiration date.
Do not reuse.
Store in a dry place at temperatures between 2°C-30°C (Celsius) or 35°F to 86°F (Fahrenheit).
Ensure the test foil pouch is at room temperature before opening.
Once open, use as soon as possible.
Keep out of the children's reach.
For in vitro diagnostic use. Not to be taken internally.
TEST PROCEDURE
1. Remove the midstream test from the foil pouch and familiarize yourself with the product.
2. Remove the cap. Save cap.
3. Hold the midstream test by the Handle with the exposed Sampling Tip pointing downward directly into your urine stream for at least 10 seconds until it is thoroughly wet. Note: Do not urinate on the Test Window. If you prefer, you can urinate into a clean and dry container, then dip only the Sampling Tip of the midstream test into the urine for at least 10 seconds.
4. After removing the midstream test from your urine, immediately replace the Cap over the Sampling Tip, lay the midstream test on a flat surface with the Test and Control windows facing upwards, and then begin timing.
5. As the test begins to work, you may notice a light red flow moving across the Test Window. Depending on the concentration of hCG, positive results may be observed in as little as 40 seconds. However, to confirm negative results, the complete reaction time of 5 minutes is required. Do not read the result after 30 minutes.
INTERPRETATION OF RESULT
POSITIVE: Two distinct red lines appear. One line should appear in each control (C) and test (T) regions.
NEGATIVE: One red line appears in the control region (C). No red or pink line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor. (Improper storage conditions such as exposure to heat or expired test device may also contribute to test failure).
Note: The intensity of the red color in the test line region (T) will vary depending on the concentration of hCG present in the specimen. However, neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.
QUESTIONS & ANSWERS
1. Q: How does the test work?
A: The One Step hCG Pregnancy Test detects a hormone in your urine that you body produces during pregnancy (hCG-human chorionic gonadotropin). The amount of pregnancy hormone increases as pregnancy progresses.
2. Q: How soon after I suspect that I am pregnant can I take the test?
A: You can test your urine as early as the first day you miss your period. You can perform the test anytime of the day; however, if you are pregnant, first morning urine contains the most pregnancy hormone.
3. Q: Do I have to test with first morning urine?
A: Although you can test any time of the day, your first morning urine specimen is usually the most concentrated of the day and would have the most hCG in it.
4. Q: How accurate is the test?
A: In both laboratory and consumer clinical studies, the One Step hCG Pregnancy Test has been proved to be 99% accurate.
5. Q: Which factors may affect the test result?
A: Drugs which contain hCG (such as Pregnyl, Profasi, Pergonal, APL) can give a false positive result. Alcohol, oral contraceptives, pain killers, antibiotics or hormone therapies that do not contain hCG should not affect the test result.
6. Q: What should I do if the result shows that I am pregnant?
A: It means that your urine contains hCG and you are probably pregnant. See your health care provider or midwife to confirm that you are pregnant and to discuss the steps you should take.
7. Q: Does the result mean anything other than normal pregnancy if it shows that I am pregnant?
A: A number of medical conditions other than pregnancy, including, ovarian cyst or ectopic pregnancy (pregnancy outside the uterus) can cause elevated levels of hCG.
8. Q: How do I know that the test was run properly?
A: The appearance of a red line in the control window (C) tells you that you followed the test procedure properly and the proper amount of urine was absorbed.
9. Q: What should I do if the result shows that I am not pregnant?
A: It means that no hCG has been detected in your urine and probably you are not pregnant. If you do not start your period within a week of its due date, repeat the test with a new midstream test. If you receive the same result after repeating the test and you still do not get your period, you should see your health care provider.
LIMITATIONS
This test provides a presumptive diagnosis for pregnancy. The user should not take any decision of medical relevance without first consulting her medical practitioner.
A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hCG. Therefore, the presence of hCG in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.
Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
Very low levels of hCG (less than 50 mIU/mL) are present in urine specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.
REFERENCES
1. Batzer FR. "Hormonal evaluation of early pregnancy", Fertil. Steril. 1980; 34(1): 1-13
2. Catt KJ, ML Dufau, JL Vaitukaitis "Appearance of hCG in pregnancy plasma following the initiation of implantation of the blastocyte", J. Clin. Endocrinol. Metab. 1975; 40(3): 537-540
3. Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade "Serum human chorionic gonadotropin levels throughout normal pregnancy", Am. J. Obstet. Gynecol. 1976; 126(6): 678-681
4. Lenton EA, LM Neal, R Sulaiman "Plasma concentration of human chorionic gonadotropin from the time of implantation until the second week of pregnancy", Fertil. Steril. 1982; 37(6): 773-778
5. Steier JA, P Bergsjo, OL Myking "Human chorionic gonadotropin in maternal plasma after induced abortion, spontaneous abortion and removed ectopic pregnancy", Obstet. Gynecol. 1984; 64(3): 391-394
6. Dawood MY, BB Saxena, R Landesman "Human chorionic gonadotropin and its subunits in hydatidiform mole and choriocarcinoma", Obstet. Gynecol. 1977; 50(2): 172-181
7. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross "Ectopic production of human chorionic gonadotropin by neoplasms", Ann. Intern. Med. 1973; 78(1): 39-45
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