IVD CE certificate HCG Pregnancy test kit HCG one step test Midstream urine  specimen

Intended Use of HCG Test Midstream

The hCG Rapid Test Midstream is a rapid, self-performing, qualitative immunoassay for the determination of human chorionic gonadotropin (hCG) in urine specimen at 20 mIU/ml or above.

Principle of HCG Test Midstream

The hCG Rapid Test Midstream is a qualitative, solid phase, two-site sandwich immunoassay (5-6) for the detection of human chorionic gonadotropin (hCG) in urine. This test utilizes the principle of immuno-chromatography, a unique two-site immunoassay on a membrane. As the test sample flows through the membrane assembly within the test device, the colored anti-hCG-colloidal gold conjugate binds with the hCG in the sample. This complex moves further on the membrane to the test region where it is immobilized by the anti-hCG coated on the membrane leading to formation of a pink colored line which confirms a positive test result. Absence of this colored line in the test region indicates a negative test result.

The unreacted conjugate and unbound complex form a pink line, if any move further on the membrane and are subsequently immobilized by the anti-mouse antibodies coated on the membrane at the control region. This control line serves to validate the test results.

Catalog and detail information of HCG Test Cassette ( Urine)

Procedure of HCG Test Midstream using

1. To begin testing, open the sealed pouch by tearing along the notch. Remove test device--midstream from the pouch.

2. Hold the round end of cover with one hand. Use the other hand to pull out the midstream cap and expose the absorbent.

3. Point the absorbent tip downward; place the absorbent tip in urine stream for at least 3 seconds to be thoroughly wet. Do not urinate passed the arrow mark. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 3 seconds

.4. Re-cap the device and wait for color bands to appear. Read the result in five minutes. Do not read results after more than 5 minutes.

HOW TO READ THE RESULTS?

Negative (not pregnant) :Only one color band appears in the Control Zone. No apparent band on the Test Zone. This indicates that no pregnancy has been detected.

Positive (pregnant) : Distinct color bands appear in the Control and Test Zones. It indicates that you are pregnant. The color intensity of the test bands may vary since different stages of pregnancy have different concentrations of HCG hormone.

Invalid:No visible band at all, or there is a visible band only in the test region and not in the control region. Repeat with a new test kit. If test still fails, please contact the distributor or the store, where you bought the product, with the lot number.

NOTE: if the color in the Test Zone is weak, it is recommended that the test be repeated in 48 hours.

INTERPRETATION OF RESULTS

1. Negative: Only one color band appears on the Control region. No apparent band on the Test region. There is no pregnancy.

2. Positive: Distinct color bands appears on the Control and Test regions. Both Test line and Control line indicate that you are pregnant. Color intensity of the Test bands may vary. Different stages of pregnancy have different concentrations of HCG hormone.

3. Invalid: No visible bang at all. Repeat test with a new test kit.

STORAGE AND STABILITY

The test kits can be stored at room temperature (18 to 30℃) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use test kit beyond expiry date.

3. The test device should not be reused.

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