CE Singclean Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit

(Colloidal Gold)

For Self Testing Specimens: Urine

CE 0123

[PRINCIPLE]

The human chorionic gonadotropin (hCG) pregnancy test kit is a rapid, one-step lateral flow immunoassay for the qualitative delection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG in urine to aid in the early detection of pregnancy for self-testing. It obtained the result from the colored lines.

[PRECAUTIONS]

Please read all the information in this instruction for use before performing the test.

·Do not use after the expiration date printed on the foil pouch.

·Store in a dry place at 4-30°C.Do not freeze.

·Do not use if pouch is torn or damaged.

·Keep out of the reach of children.

·For in vitro diagnostic use.Not to be taken internally.

·Do not open the test foil pouch until you are ready to start the test.

·The used test should be discarded according to local regulations.

[KIT CONTENTS]

·Test strip/ Test cassette /test midstream

·Dropper (for test cassette)

·Desiccant

·Instruction for use

[EQUIPMENT REQUIRED BUT NOT SUPPLIED]

Stopwatch, Disposable specimen container.

[INSTRUCTIONS]

1.Urinate into a clean, dry cup or container.

2.Remove the test strip from the foil pouch and familiarize yourself with the product.

3.Strip: With arrows pointing toward the urine, dip the test strip vertically in the urine for at least 10-15 seconds. Do not pass the maximum line(MAX) on the test strip when dipping the strip into the urine, Remove the test strip from the urine, place it on a non-absorbent flat surface and begin timing. See the illustration below.

Cassette: Hold the dropper vertically and transfer 3 full drops of urine to the specimen well (S) of the test cassette, and then begin timing. Avoid trapping air bubbles in the specimen well (S). See illustration below.

Midstream: Do not urinate on the result window. If you prefer, you can urinate into a clean and dry container, then dip only the absorbent tip of the midstream test into the urine for at least 10-15 seconds. Do not pass the arrow on the midstream when dipping the midstream into the urine. After removing the midstream test from your urine, immediately lay the midstream test on a flat surface with the Result window facing upwards, and then begin timing.

4.As the test begins to work, you may notice a light colored flow moving across the test line region (T) and control line region (C) on the test strip. Read the result at 3 minutes. If no colored line appears, wait 1 minute longer. Some positive results may be observed in 1 minute or less depending on the concentration of hCG. Do not read the result after 10 minutes.

[READING THE RESULTS]

PREGANT

Two distinct colored lines appear. One line should be in the control line region (C) and another line should be in the test line region(T).One line may be lighter than the other; they do not have to match. This means that you are probably pregnant.

NOT PREGNANT

One colored line appears in the control line region (C).No line appears in the test line region (T).This means that you are probably not pregnant.

INVALIID

The result is invalid if no colored line appears in the control line region (C), even if a line appears in the test line region (T). You should repeat the test with a new test kit.

[LIMITATIONS]

1.The human chorionic gonadoptropin (hCG) pregnancy test kit is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hcG can be determined by this test.

2. Very low levels of hCG (less than 50 mU/mL) are present in urine specimens shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.

3.This test reliably detects intact hCG up to 300,000 mlU/mL. lt does not reliably detect hCG degradation products, including free-beta hCG and beta core fragments. Quantitative assays used to detect hCG may detect hCG degradation products and therefore may disagree with the results of this rapid test.

4.This test may produce false positive results. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hCG. Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.

5.This test may produce false negative results. False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested. In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.

6.This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

[PERFORMANCE CHARACTERISTICS]

·Accuracy

A accuracy evaluation was conducted comparing the results obtained using the hCG pregnancy test kit to another commercially available urine membrane hCG test. The study included 160 urine specimens, and both assays identified 89 negative and 71 positive results, The results demonstrated >99% overall accuracy of the hCG pregnancy test kit when compared to the other urine membrane hCG test.

·Sensitivity and Specificity

The hCG pregnancy test kit detects hCG at a concentration of 25mlU/mL or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (500mlU/mL), FSH (1,000mlU/mL), and TSH (1,00ouIU/mL) to negative (0mlU/mL hCG) and positive (25mlU/mL hCG) specimens showed no cross-reactivity.

·Interfering Substances

The following potentially interfering substances were added to hCG negative and positive specimens.

None of the substances at the concentration tested interfered in the assay, and the urine with pH(from 4 to 9) also did not interfere the test result.

Latest version 8.29.04.105 A2 lssued Date: 2020.11.15