One Step Pregnancy Test Strip (Urine)

DUKE One step HCG Pregnancy Rapid Test Kit

One step HCG Pregnancy Rapid Test Kit

The reagent is used to detect the HCG in urine qualitatively according to the principle of double antibody sandwich method.

Human chorionic gonadotropin (HCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization, including protein subunits of α and β. Its function is to stimulate the corpus luteum to continue producing progesterone, to maintain the endometrium suitable for embryo attachment and embryo implantation. In normal pregnancy, HCG can be produced as early as 4 to 5 days after conception, HCG levels continue to rise very rapidly until delivery, peaking in about 8-10 weeks into pregnancy, and fall to normal level 2 weeks after the delivery.

Principle

The one step HCG pregnancy rapid test kit 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 antibodies including a monoclonal HCG-β antibody and goat anti-mouse IgG on the nitrocellulose membrane with colloidal gold marked anti-HCG-α monoclonal antibody as an mark tracer. The reagent is used to detect the HCG in urine according to the principle of double antibody sandwich method and gold immunochromatography assay.

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There is a control line (C) controlling the reaction processs shown on the coated film. Based on test line’s (T) appearance to determine whether the tested sample contains HCG (Human Chorionic Gonadotropin) or not.

Main components

Basic components: sample pad, colloidal marked pad, nitrocellulose membrane, and absorbent paper and PVC board. Colloidal gold marked pad coated with HCG-α monoclonal antibody, nitrocellulose membrane coated with HCG-β monoclonal antibody, control line coated with goat anti-mouse IgG.

Storage and expiry

Store as packaged in the sealed pouch 4-30°C, avoid hot and sunshine, dry place, valid for 2 years, DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.

Sample requirement

Urine. 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 specimen is collected at any time of the day may be used. Urine specimens may be stored at 2-8°C for up to 48 hours prior to assay. For long-term storage, specimen may be frozen and stored below -20°C, the frozen specimens should be fully melted and restore to room temperature and shake before testing. Urine specimens exhibiting visible precipitates should be centrifuged, filtered or allowed to settle to obtain a clear specimen for testing.

Test methods

  1. Instructions must be read entirely before taking the test. Allow the test strip controls to equilibrate to room temperature for 30 minutes (20°C – 30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity: 20%~90%, temp: 10°C-50°C)
  2. Test procedure

Remove the test strip from the sealed pouch, put the end of the test strip printed with arrow into the urine, the interface of the urine should not exceed the max line, take it out after 8-10 seconds and place the test strip on a clean and level surface.

  • Observe the test results immediately within 5 minutes, the results is invalid over 5 minutes.

Results judgment

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: No red bands appear or control line fails to appear. Indicating that the operator error or reagent failure.

DUKE One step HCG Pregnancy Rapid Test Kit

Reference value

The human chorionic gonadotropin rapid test kit has a sensitivity of 25mIU/mL.

Interpretation of results
  1. The reagent only can be used for screening test, just like all qualitative detection reagents.
  2. If the result is still suspected, a first morning urine specimen should be collected 24 to 72 hours later and tested.
Limitations
  1. Concentration of HCG cannot be determined by this qualitative test.
  2. This reagent is designed for the qualitative screening test. A confirmed pregnancy should be made only by a physician after all clinical and laboratory findings have been evaluated.
  3. False negative results may occur when the HCG levels of the ectopic pregnancy are below the sensitivity level of the test. When pregnancy is still suspected, a b-mode ultrasonograph diagnosis is suggested.

Attentions

  1. The test line is significant when the concentration of HCG is high, and the control line may be weak. It is a normal phenomenon
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  3. A number of conditions other than pregnancy, including uterine cancer, hydatidiform mole or menopause, cause elevated levels of HCG and positive results.
  4. If ectopic or normal pregnancy is still suspected, a confirmed pregnancy diagnosis should be made by other methods
  5. If pregnancy is still suspected, a first morning urine specimen should be collected 48 to 72 hours later and tested.
  6. Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
  7. The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.
  8. A small bag of desiccant is in the aluminum foil bag, do not eat.
  9. All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.
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