Accurate One Step Dipstick Test
Pregnancy Test Strip (Urine)

This Accurate One Step Dipstick Test is Pregnancy Test Strip. It is used to test the Urine for Pregnancy.

Intended Use: The hCG Pregnancy Test Strip is a rapid, one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid of the early detection of pregnancy. The test is intended for in vitro diagnostic self-testing.

Principle: The hCG Pregnancy Test Strip adopts the principles of double antibody sandwich method and immunochromatography to test the human chorionic gonadotropin (hCG) in the urine. The membrane is pre-coated with anti-hCG antibodies in the test region (T) and anti-mouse antibodies in the control region (C). During testing the urine sample reacts with the colored conjugate (mouse anti-hCG antibody colloidal gold conjugate) which has been pre-coated on the test strip. The mixture then migrates upward on the membrane to react with anti-hCG antibodies in the test region and generate a red line. Presence of the red line indicates a positive result, while its absence indicates a negative result. Regardless of the presence of hCG, a the mixture continues to migrate across the control regions, a red line at the region will always appear. The presence of this red line serves as verification for sufficient sample volume and proper flow and as a control for the reagents.

Warning and Precautions: 

• For in vitro diagnostic use only
• Do not use after the expiry date.
• The Test strip should remain in the sealed pouch until use. Do not use if the pouch is damaged or opened
• Read directions for use carefully before performing this test.
• Avoid skin, eyes or clothing contact with test area.
• As with all diagnostic tests, a confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated. 
• Do not reuse the test strip, Discard it in the dustbin after single use.
• All urine specimens and used strip should be considered potentially infectious and avoided contact with skin. 

Storage and Stability: 

•  Store as packaged in the sealed pouched at room temprature (4 – 30°C). The kit is stable within the expiration date printed on the labeling.
• Once open the pouch, the test strip should be used within 1 hour. Prolonged exposure to the ambient humidity will cause product deterioration.

Specimen: The urine specimen must be collected in a clean, dry plastic or glass container. The first morning urine is perferred since it generally contains the highest concentration of hCG. However, urine collected at any time of the day may be used. Urine specimens may be stored at 2-8°C for upto 48 hours prior to assay. 

Test Procedure: Read the entire procedure carefully prior to performing any test 
* Allow test strip and urine samples to equilibrate to room temperature (20-30°C) prior to testing.
* Remove the hCG pregnancy test strip from foil pouch. Use strip as soon as possible but within 1 hour after removal from pouch specially if the room temperature is more than 30°C and in high humidity environment. 
* Immense the test strip in the urine sample with printed sample level is below the marked sample line (MAX) on test strop. 
* Take the strip out an lay the strip flatly on a non-absorptive clean surface. 
   Wait for the red lines to appear. The test should be read in approximately 3-5 minutes.
   Do not interpret results after 5 minutse.

Interpretation of Results

Positive: Two distinct red lines will appear, One in the test region (T) and one in the control region (C). Positive test results are possible but not definitive for the diagnosis of pregnancy. It is strongly recommended that an additional urine specimen should be obtained after 48-72 hours and tested again or consulting your physician. 
Negative: Only single red line appears in the control region (C). No apparent red or pink line appears in the test region (T). Negative test result mean that you may not be pregnant. However, you should re-test with the first morning specimen obtained 48-72 hours later. 
Invalid: Control band fails to appear which means improper testing procedures or deterioration of reagents probably occurred. In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributor. 
Notes: The shade of red color in the test region (T) will vary depending on the concentration of hCG present. However, neither the quantitative value not the rate of increase in hCG can be determined by this qualitative test.