Urine Pregnancy Test Strip Kits Home use

HCG Pregnancy Test Strip Kits is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

Features: 

• Fast read within 5 minutes
• High accuracy over 99.6%
• Easy use at home
• Long Shelf life

Urine Pregnancy Test Strip Insert

INTENDED USE

One Step HCG Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection  of pregnancy by both professional and home users.

SUMMARY AND EXPLANATION

One Step HCG Urine Pregnancy Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. During pregnancy, the placenta produces HCG after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, urine contains higher the levels of HCG at concentrations of 25mIU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mIU/ml. 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.

PRINCIPLE

The HCG assay is a rapid one-step test based on immunochromatographic technology. A membrane with an absorbent pad over a strip of fiber glass paper is impregnated with a colloidal conjugate of gold particles and monoclonal antibodies to HCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the HCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-HCG monoclonal antibodies affixed on the test zone (“T”) will bind the HCG-gold conjugate complex, forming a pink line (“T”). Any sample will cause a pink colored line to appear in the control zone (“C”). This line is formed by the binding of polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly.

CONTENTS

Each box contains: the pouch and the operating instruction. Each pouch contains: the Pregnancy Test Strip and the Desiccant.

STORAGE AND STABILITY

The test kit can be stored at room temperature (4℃-30℃) in the sealed pouch to the date of expiration.

The test kits should be kept away from direct sunlight, moisture and heat. Do not freeze.

PRECAUTIONS

1. FOR IN-VITRO DIAGNOSTIC USE ONLY (IVD), NOT for internal
2. Read directions for use carefully before performing this Perform each step exactly as described.
3. Do not use beyond the expiration date marked on the foil
4. Each one step HCG pregnancy Test can only be used once; do not re-use the one step HCG pregnancy Test
5. Do not use the Test if the foil pouch is
6. Once the foil pouch has been opened, the Test should be used
7. Discard each one step HCG pregnancy Test after use. Treat urine samples and used test devices as if they were potentially infectious. Avoid contact with
8. KEEP OUT OF REACH OF CHILDREN.

MATERIALS REQUIRED BUT NOT PROVIDED

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TEST PROCEDURE

1.  SAMPLE COLLECTION AND HANDLING

To perform this test, collect a urine sample into a clean and dry container. Urine samples collected first thing in the morning are ideal because they generally contain higher concentration of HCG. However, urine samples collected at any time of the day may also be used.

2.  TO CARRY OUT THE TEST

Absorbent cotton  Test line    Control line

DIRECTIONS FOR USE

• Bring the sealed pouch to room
• Remove the strip from the foil
• Immerse the strip into the urine with the arrow end pointing toward the urine Do not cover the urine over the MAX (maximum) line.
• Take the  strip  out  of  the  cup  after  a

minimum of 15 seconds and lay it flatly on a non-absorptive, clean surface.

• Read the result in 5
• Discard the test device after a single

Depending on the concentration of HCG in the urine sample, positive results may be seen within 40 seconds. Wait the full five minutes to confirm the result. Do not read the one step HCG pregnancy Test after 5 minutes as this may give an incorrect test result.

This is a single use test. Please safely dispose of the strip, regard this as infectious material and dispose of the test appropriately after use.

3.   HOW TO READ THE RESULT

Positive: If two pink/purple colored lines appear on the one step HCG pregnancy Test, one in the control area and one in the test area, then this means HCG has been detected in the urine and there is a strong possibility of pregnancy. The lines seen may be faint and one line may be lighter than the  other;  however  this  is still a positive result. The lines do not have to match in strength or color.

Negative: If one colored pink/purple line appears in the control area on the one step HCG pregnancy Test and there is no line in the test area, then this indicates a negative result. This means no HCG has been detected in the urine. This indicates you are either not pregnant or you have tested too early. If you are not sure repeat the test in 48 hours.

Invalid: If no lines appear anywhere on the control zone, the test is invalid and repeat the test using another strip.

Invalid Test Results can be caused by:

• The absorbent tip not being wetted
• Reading the test result too early or too A 5 minutes reaction time is required.

For further information, see LIMITATIONS OF THE PROCEDURE

4.   QUALITY CONTROL

Built in Quality Control Features:

The appearance of a line in the control area indicates that the one step HCG pregnancy Test is performing properly and serves as a procedural control. It is recommended that a positive hCG control (containing 25-250mIU/mL hCG) and a negative hCG control (containing 0mIU/mL hCG) are evaluated to verify proper test performance when a new shipment of tests is received.