The hCG One Step Pregnancy Test Device (Urine) is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 mIU/mL. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, the hCG One Step Pregnancy Test Device (Urine) shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, biLEI and hTSH at high physiological levels.
The hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including mouse monoclonal anti-hCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.
Positive specimens react with the specific colored antibody conjugates and form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will allays appear at the control line region if the test has been performed properly.
The test device contains anti-hCG particles and anti-hCG coated on the membrane.
For professional in vitro diagnostic use only. Do not use after the expiration date.
The test device should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous
and handled in the same manner as an infectious agent.
The test device should be discarded in a proper biohazard container after testing.
Specimen Collection and preparation:
A urine specimen must be collected in a clean and dry container. A first morning urine specimen is preferred since it generally contains the highest concentration of hCG; however, urine specimens collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.
Disposable specimen droppers
Material Required but not provided
Specimen collection container
Directions for Use:
Allow the test device, urine specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100u1) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.
Wait for the red line(s) to appear. The result should be read at 3 minutes. It is important that the background is clear before the result is read.
(Please refer to the illustration above)
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T).
NEGATIVE: One red line appears in the control region (C). No apparent 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.
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.
Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly the background in the result area should be white to light pink and not interfere with the ability to read the test result.
It is recommended that a positive hCG control (containing 25250 mlU/mL mCG) and negative hCO control (containing 0: mlU/mL hCG) be evaluated to verify proper test performance. It is recommended that federal, state, and local guidelines be followed.
1. 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.
2. 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 he collected 48 hours later and tested
3. Very low levels of hCG (less than 50 m1U/mL) are present in urine specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate 1hr natural reasons (5), a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.
4. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastie neoplasms including testicular tumors, prostate cancer, breast cancer lung cancer, cause elevated levels of hCG (6-7). Therefore, the presence of hCG in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.
5. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory funding have been evaluated.
Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hCG present in their urine and scrum specimens. The amount of hCG will vary greatly with gestational age and between individuals.
The hCG One Step Pregnancy Test Device (Urine) has a sensitivity of 25 mIU/mL, and is capable of detecting pregnancy as early as I day after the first missed menses.
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