Human chorionic gonadotropin (HCG) Rapid Test

Short Description:

  • CE and ISO 13485 Certificate
  • Approval OEM/ODM
  • Component
  • Desiccant  1 pc/ per pouch
  • Instruction 1 pc/box

Product Detail

Product Tags


The hCG Pregnancy Midstream Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy

[Detection principle]

The hCG Pregnancy Midstream Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test uses two lines to indicate results. The test line utilises a combination of antibodies including monoclonal hCG antibody to selectively detect elevated levels of hCG. The control line is composed of goat polyclonal antibodies and colloidal gold particles. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of coloured lines. The specimen migrates via capillary action along the membrane to react with the coloured conjugate. Positive specimens react with the specific antibody hCG coloured conjugate to form a red line at the test line region of the membrane. Absence of this red line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

 [Product composition]

  • (50 bags/ box)
  • urine cup ( 50 pc/box)
  • Desiccant (1pc/bag)
  • Instruction ( 1 pc/box)

Please read the operating instructions carefully before testing, and restore the test card and the sample to be tested to room temperature of 2–30℃.

  • The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. 
  • All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. The used test should be discarded according to local regulations.
  • Hold the midstream test by the capped Thumb Grip with the exposed Absorbent Tip pointing downward directly into your urine stream for at least 10 seconds until it is thoroughly wet. See the illustration opposite. Note: Do not urinate either on theTest or Control windows. If you prefer, you can urinate into a clean and dry container, then dip only the Absorbent Tip of the midstream test into the urine for at least 10 seconds


[Result judgment]

POSITIVE: Two distinct red lines appear*. One line should be in the control line region (C) and another line should be in the test line region (T).

NOTE: The intensity of the colour in the test line region (T) may vary depending on the concentration of hCG present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered positive.

NEGATIVE: One red line appears in the control line region (C). No apparent coloured line appears in the test line 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. If the problem persists, discontinue using the test kit immediately and contact your local supplier.

[Storage and expiration]
This product should be stored at 2 ℃–30℃ dry place away from light and not frozen; Valid for 24 months. See the outer package for the expiration date and batch number.

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