David One Step Teste Gravidez HCG Pregnancy Test Kit with ISO CE FDA Canada Health

• Type: IVD Instrument
• Sensitivity: 10/15/20/25miu/Ml
• Shelf Life: 2.5 Years
• Certification: ISO/CE/FDA/510K
• Specimen: Urine/Serum
• Format: Strip/Cassette/Midstream
• Model NO.: HCG
• Transport Package: Foil Pouch
• Specification: 2.5mm/3mm/4mm/5mm/6mm
• Trademark: David
• Origin: China

Product Description

                                                                       One Step Home Use HCG Pregnancy Test Strip Fertility Test Kit

The One Step hCG test is a rapid test to detect the presence of HCG in urine or serum specimens in a qualitative format sensitive to 15mIU HCG/ml. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated level of HCG in urine or serum. The immunological specificity of the test virtually eliminates cross reactivity interferences from the structurally related glycoprotein hormones hFSH, hLh, hTSH at physiological levels.

PRINCIPLE
The test is a one-step, qualitative, double antibodies sandwich lateral flow immunochromatographic assay. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. Each test device contains mouse monoclonal anti-β-hCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal anti-α-hCG antibody (on the Test Line) and goat anti-mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane.
When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane.
During the test, hCG in the urine specimen reacts with the dye conjugate (mouse anti-β-hCG antibody- colloidal gold conjugate) and forms a complex.  The complex migrates along the membrane to the mouse anti-α-hCG antibody test region (T), and remains captured in the T line.
 

HCG Pregnancy Test

Product name	HCG Pregnancy test
Sensitivity	10 miu/ml;15miu/ml;25miu/ml
Accuracy	more than 99%
Shelf time	24-36 month
OEM time	15-35 days
Certificate	CE/ISO13485/FDA
Specimen	Urine,Serum
Format	Strip /Cassette /Midstream
Size	Strip: 2.5mm/3.0mm/3.5mm/4.0mm/5mm
	Cassette :3mm/4.2mm
	Midstream:4mm/6mm
Usage	Read results within 10-15 minutes