Rapid Response HCG Pregnancy Test represents a breakthrough in simplified pregnancy screening, designed to deliver accurate results without complex procedures. This HCG Rapid Test is single-step diagnostic device and it detects human chorionic gonadotropin in urine samples with remarkable precision, offering sensitivity levels of 25 mIU/mL. Healthcare professionals appreciate its streamlined operation-simply apply the sample and read results in under five minutes. The intuitive design reduces training requirements while maintaining laboratory-grade accuracy above 99%. Each test includes visual confirmation markers that validate proper sample flow, ensuring result reliability. Under strict ISO13485/CE standards, this cost-effective solution helps clinics optimize testing efficiency while providing patients with the swift, dependable answers they need during critical decision-making moments.
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Specimens |
Urine |
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Packing Specification |
1 kit/ box, 5 kits / box, 25 kits/ box |
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Size |
160*55*20mm |
1 kit/ box |
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190*125*30mm |
5 kits / box |
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190*125*70mm |
25 kits / box |
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Shelf life |
2 years |
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Test Time |
Waiting about 5 minutes |
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Certificate |
CE, ISO:13485 |
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OEM |
Acceptable |
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Storage condition |
The kit should be stored at 2-30°C |
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Interpretation of Results
Positive: Two distinct red lines will appear, one in the test region (T) and
another in the control region (C). You can assume that you are pregnant.
Negative: Only one red line appears in the control region (C). No apparent line in the test region (T). You can assume that you are not pregnant.
Invalid: The result is invalid if no red line appears in the control region (C), even if a line appears in the test region (T). In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributor.
NOTE: Clear background in the Result Window can be seen as a basis for effective testing. If the test line is weak, it is recommended that the test be repeated with the first morning specimen obtained 48-72 hours later. No matter how the test results, it is recommended to consult your physician.
PRECAUTIONS
For professional in vitro diagnostic use only.
Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
The extraction reagent solution contains a salt solution if the solution contacts the skin or eye, flush with copious amounts of water.
Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
Read the entire procedure carefully before testing.
FAQ
Q: How does the HCG One Step Rapid Test differ from traditional pregnancy tests?
A: The one-step design simplifies the testing process significantly. Unlike multi-step tests that require separate sample collection and application, this test combines both actions into a single procedure. You simply hold the test strip in the urine stream or dip it into a collected sample for a few seconds. This streamlined approach reduces the chance of user error and makes the test faster and more convenient for both clinical and point-of-care settings.
Q: What does the 25 mIU/mL sensitivity level mean for early detection?
A:A sensitivity of 25 mIU/mL means the test can detect pregnancy when hCG levels reach this concentration in urine. This typically occurs around the time of your expected period, or approximately 14 days after conception. While some tests claim higher sensitivity, the 25 mIU/mL threshold provides an optimal balance between early detection and result accuracy, minimizing the likelihood of false positives from very low hCG fluctuations.
Q:How long should I wait before reading the test results?
A: You should read the results between 5 minutes after applying the sample. Reading too early may give an inaccurate result because the sample needs time to migrate along the test strip and react with the antibodies. However, do not read results after 10 minutes, as evaporation lines may appear and could be mistaken for positive results, leading to confusion.
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