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Rapid HCG Pregnancy Test (strip/ cassette/ midstream) with CE & ISO Certificated

Shenzhen Jgoal Prototype Co.,Ltd | Updated: May 04, 2017


Basic Info

Model NO.: Strip, Cassette, Midstream

Application: for Diagnosis

Certificate: CE0123, ISO13485, ISO14001, ISO9001

Accuracy: 99.96%

Specification: CE & ISO

Type: Biological Diagnostic Reagents

Form: Strip, Cassette, Midstream

Specimens: Urine

Trademark: TrusCare Medical / OEM

Origin: Shenzhen

Product Description

Rapid HCG Pregnancy Test


Specifications


Features:

1. Fast to test

2. Easy to operate

3. Sensitive and accurate result

4. Competitive price

Product Description


Rapid HCG Pregnancy Test Devices:


INTRODUCTION

HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration in urine. The concentrations of HCG in urine and serum continue to rise during the first trimester of pregnancy to as high as 100, 000mIU/ml. HCG appears in serum and urine shortly after conception, and continues to increase during the early stages of pregnancy, making it an excellent indicator for the detection of pregnancy.


PRINCIPLE

The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control region. During the test, urine specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence or absence of HCG.


STORAGE

The kits should be stored at temperature 4-30° C in the sealed pouch for the duration of the shelf life.


PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use after expiration date.

3. Test device should remain sealed until use.


REAGENTS AND MATERIALS PROVIDED

1. Rapid HCG S/U Test Card

2. Disposable sample pipet

2. Instruction for use


SPECIMENS COLLECTION

Urine:

1. The urine specimens must be collected in a clean dry container either plastic or glass without preservatives. No centrifugation or filtration of urine is required. Specimens collected at any time may be used. However the first morning urine generally contains the highest concentration of the hormone.

2. If specimens can not be tested within 3 days of collection, they should be stored refrigerated at 2-8 degree.



Packaging Detail

1. strip: 100tests/box,5000tests/carton

2. cassette:50tests/box,2500tests/carton

3. midstream:50tests/bag,2000tests/carton