High Accuracy HCG Pregnancy Checking Kit 5.5mm Midstream Urine Specimen FDA

High Accuracy HCG Pregnancy Home Fertility Testing Kits, 5.5mm midstream, private use, urine specimen,individual package

INTENDED USE:

The One Step HCG Urine Test is a rapid pregnancy test, which you can easily carry out yourself. It detects the presence of human chorionic gonadotropin (“HCG”), which appears in urine very early during pregnancy. For in vitro self-testing use only. For external use only.

Summary

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum or plasma as early as 7 to 10 days after conception.1,2,3,4 hCG levels continue to rise very rapidly, frequently exceeding 100mIU/ml by the first missed menstrual period,2,3,4 and peaking in the 100,000-200,000mIU/ml range about 10-12 weeks into pregnancy. The appearance of hCG in both the urine and serum or plasma soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. The hCG Pregnancy Rapid Test Cassette is a rapid test that qualitatively detects the presence of hCG in urine or serum or plasma specimen at the sensitivity of 25mIU/ml. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine or serum or plasma. At the level of claimed sensitivity, the hCG Pregnancy Rapid Test Cassette shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.

TEST PRINCIPLE

The hCG Pregnancy Rapid Test Midstream is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum or plasma to aid in the early detection of pregnancy. The test uses two lines to indicate results. The test utilizes a combination of antibodies including a 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 immersing the test cassette in a urine or serum or plasma specimen and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

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.

INTERPRETATION OF 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.

PERFORMANCE

Accuracy

A multi-center clinical evaluation was conducted comparing the results obtained using the HCG Pregnancy Rapid Test Cassette to another commercially available urine hCG Rapid test. The study included 608 urine specimens, and both assays identified 377 negative and 231 positive results. The results demonstrated >99% overall accuracy of the hCG Pregnancy Rapid Test Cassette when compared to the other hCG Rapid Test.