rapid pregnancy HCG test strip

Product Overview

Description

 

INTENDED USE

One Step cT hCG Test Cassette is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

SUMMARY AND EXPLANATION

Human Chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization.  During normal pregnancy, hCG can be detected in urine as early as 7 days following conception, doubling every 1.3 to 2 days. At the time of the last missed menstrual period, urine hCG levels are about 100mIU/ml with peak levels of 100,000 to 200,000mIU/ml seen at the end of the first trimester. The presence of hCG soon after conception and its subsequent increase in concentration during early gestational growth make it an ideal marker for the early detection of pregnancy.

PRINCIPLE

One Step cT hCG Test Cassette is a rapid qualitative assay for the detection of hCG in urine. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the hCG in the test samples with an extremely high degree of sensitivity. In less than 5 minutes, levels of hCG as low as 25mIU/ml can be detected.

As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone (“T” area) and produces a pink-purple coloured band when the hCG concentration is greater than 25mIU/ml.  In the absence of hCG, there is no line in the positive reaction zone.  Unbound conjugate binds to the reagents in the control zone (“C” area), producing a pink-purple band, demonstrating that the reagents are functioning properly.

REAGENTS

The test cassette contains anti-hCG particles and anti-hCG coated on the membrane.

MATERIALS PROVIDED 

• Test cassettes

• Disposable specimen droppers

• Package insert

MATERIALS REQUIRED BUT NOT PROVIDED

• Specimen collection container

• Timer

STORAGE AND STABILITY

Store test cassettes at 4~ 30°C (room temperature). Keep in dry, dark place. Avoid sunlight. The test is stable until the date imprinted on the pouch label.

WARNING

For in vitro diagnostic use only

1. Read directions for use carefully before performing this test. Pay attention to the position of the C and T lines.

2. Do not use beyond the labeled expiration date.

3. Do not reuse the test cassette. Discard responsibly after use.

4. Do not use if pouch is damaged or opened.

5. Do not touch the membrane located within the window.

6. Once the pouch is opened, the test cassette should be used immediately. Prolonged   exposure to ambient humidity will cause product deterioration.

7. Treat urine samples and used cassettes as if they are potentially infectious. Avoid contact with skin

ASSAY PROCEDURE

1. Determination of Test Date

 The test can be used from the first day after a missed period.

2. Specimen Collection and Handling

One Step cT hCG Test Cassette is formulated for use with fresh urine specimens. The test should be used right after the specimen collection. Urine cup should be used to collect specimens, and the urine does not require any special pretreatment.  

3. Test Procedure

1. Remove the test cassette from its foil wrapper by tearing along the slice.

2. Using the urine dropper, withdraw the urine sample from the specimen cup and slowly dispense 3 drops (approximately 120uL) into the circular sample well, being careful not to overfill the absorbent pad.

3. Read results within five minutes.

DO NOT INTERPRET RESULT AFTER 10 MINUTES.

4. Discard the test cassette after single use in an appropriate place.

4. Interpretation of Results  

Negative:

If only one pink line appears in the control area, you can assume that your patient is not pregnant.  

Positive:

If two pink lines appear one in the control area and one in the test area, you can assume that your patient is pregnant.

Invalid:

If no red line appears in the control area (C), even if a line appears in the test area (T). You should repeat the test with a new test.

 

 

 

 

 

QUALITY CONTROL

Built in Quality Control Features

After addition of the sample these coloured bands migrate along the membrane at the leading edge of the dye conjugate and are “removed” from the test device completely.

 

When the test is complete, you will see a pink-purple coloured band in the “C” area of the test strip on negative samples and a pink-purple coloured band in the “T” and “C” area on positive samples. The appearance of the CONTROL band indicates that the test strip is performing properly and serves as a procedural control.