HCG Weekly Pregnancy Test

Intended use

HCG Weekly Pregnancy Test is a rapid visual immunoassay for the semi-quantitative detection of human chorionic gonadotropin in human urine specimens. HCG Weekly Pregnancy Test is intended for using as an aid to estimate pregnant weeks.

Introduction

Human chorionic gonadotropin (hCG), a glycoprotein hormone secreted by viable placental tissue during pregnancy, is excreted in urine approximately 20 days after the last menstrual period. hCG levels rise rapidly, reaching peak levels after 60-80 days. The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for the early detection and confirmation of pregnancy. The HCG concentration increases with the increase of gestational weeks. So the HCG concentration can helps to determine the gestational weeks.

Procedure

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.

2. Add 3 drops of specimen (approximately 120 µL) directly into the specimen well (S) and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the result area in the device.

3. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

NOTE: Low hCG concentrations may produce very weak T lines after a prolonged period of time. Therefore, do not interpret the result after 10 minutes.

Interpretation of Results

	NOT PREGNANT: Only one colored band appears, in the control region (C). No apparent colored band appears in the test regions 1, 2 and 3.
	PREGNANT 1 TO 2 WEEKS: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (1).
	PREGNANT 2 TO 3 WEEKS: Three colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test regions (1 and 2).
	PREGNANT 3 WEEKS OR MORE: Four colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test regions (1, 2 and 3).
	INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The intensity of color in the test region (1, 2 and 3) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive.

2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

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