Hcg Level Test Strips Manufacturing Procedure

a)  Pre-coat the specific anti-hCG antibody with gold conjugated particles and non-specific IgG with gold conjugated particles and buffer salts on the label pad.

b)  Use the sprayer to dispense specific anti-hCG antibody with gold conjugated particles and non-specific IgG with gold conjugated particles and buffer salts onto the membrane.

c)  Assemble the membrane, label pad, absorbent pad and sample pad on the plastic backing.

d)  Cut the plastic backing into strips of selected size.

     e)  Lay the strip into the plastic cassette, then pack the cassette, dropper and a desiccant packet. (for model Cassette)

f)  Test the device according to QC procedure and release the finished product.

Urine Pregnancy Test Strip Storage and Stability

Store as packaged in the sealed pouched at room temperature (2-30℃). The kit is stable within the expiration date printed on the labeling.

Once open the pouch, the test strip should be used within 1 hours. Prolongedexposure to ambient humidity will cause product deterioration.

Hcg Pregnancy Strip Test Procedure

  2.Immerse the test strip in the urine sample with printed sample end pointing toward the urine for at least 10 seconds. Be sure the sample level is below the marked sample line (MAX) on test strip.

  3.Take the strip out and lay the strip flatly on a non-absorptive clean surface. 4.Wait for red lines to appear. The test should be read in approximately 3-5 minutes. Do not interpret results after 5 minutes.

Pregnancy Strip Test 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 be obtained after 48-72 hours and tested again, or consulting your physician.

Negative: Only a single red line appears in the control region (C). No apparent red or pink line appears in the test region (T). Negative test results 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 nor the rate of increase in hCG can be determined by this qualitative test.