One Step Pregnancy Test Strip, Cassette and Midstream (urine) / HCG Pregnancy Rapid Test

• Type: IVD Instrument
• Transport Package: Carton
• Trademark: DIAGNOS
• Origin: China
• Model NO.: strip, cassette and midstream
• HS Code: 3822001000

Product Description

Strip

INTRODUCTION

One step pregnancy test strip is a test kit for the determination of HCG (Human Chorionic Gonadotropin) in urine specimens. This test kit is used to obtain a visual qualitative result for early detection of pregnancy. 

STORAGE AND STABILITY

The test kits can be stored at room temperature (18 to 30ºC) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION

1.  For in vitro diagnostic use only.
2.  Do not use test kit beyond expiry date.
3.  The test device should not be reused.




Cassette
INTRODUCTION

One Step Cassette Style HCG Urine Pregnancy Test is a test kit for the determination of HCG (Human Chorionic Gonadotropin ) in urine specimens. This test kit is used to obtain a visual, qualitative result for early detection of pregnancy.

TEST PROCEDURE

1. To begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.                                   
2. Draw 0.15ml (about 3 drops) sample into the pipette, and dispense it into the sample well on the cassette.
3. Wait for the colored bands to appear. Depending on the concentration of HCG in the test specimen, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 minutes) is required. Do not read results after 10 minutes.

INTERPRETATION OF RESULTS

Negative: Only one color band appears on the control region. No apparent band on the test region. There is no pregnancy.
Positive: Distinct color bands appear on the control and test regions. Both test line and control line indicates that you are pregnant. Color intensity of the test bands may vary. Different stages of pregnancy have different concentrations of HCG hormone.
Invalid:  No visible band at all. Repeat test with a new test kit.

STORAGE AND STABILITY

The test kit can be stored at room temperature (18 to 30ºC) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION

1.       For in vitro diagnostic use only.
2.       Do not use test kit beyond expiry date.
3.       The test device should not be reused.

Midstream
Introduction

The One Step HCG (human  chorionic gonadotrophin) 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. 

HOW DOES IT WORK?

Human chorionic gonadotropin (HCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone.
When urine specimen is dropped into a midstream, capillary action carries the specimen to migrate along the membrane. When HCG in the sample reaches the Test Zone region of the membrane, it will form a colored line. Absence of this colored line suggests a negative result.
To serve as a procedure control, a colored line will appear at the Control Zone region, if the test has been performed properly.

CONTENT OF THE TEST KIT

1.          One pouch containing a reaction midstream and a desiccant. The desiccant is for storage purposes only, and is not used in the test procedures.
2.          Leaflet with instructions for use.

WHAT ELSE DO YOU NEED?

1.        A clean, dry, plastic or glass container to collect the urine.
2.        Timer (watch or clock)

PRECAUTIONS

1.          This kit is for external use only. Do not swallow.
2.          Discard after first use. The test midstream cannot be used more than once.
3.          Do not use test kit beyond expiry date.
4.          Do not use the kit if the pouch is punctured or not well sealed.
5.          Keep out of the reach of children. 

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