Shenzhen Aivd Biotechnology Co., LTD.

Product Name

Human Chorionic Gonadotropin (HCG) Test Kit (Immunofluorescence Chromatography)

Purpose

To detect the content of HCG in human plasma/serum/whole blood in vitro quantitatively. For Professional Use only.

Principles of Detection

The HCG Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing HCG antibody conjugated with fluorescent microspheres and a control antibody (goat anti-chicken IgY antibody) conjugated with fluorescence microspheres, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another HCG antibody, and the C line is pre-coated with a control line antibody (chicken IgY antibody).

HCG concentration in specimen is positively correlated with the fluorescent density of the microspheres, after the measure and calculation of the quantitative fluorescence immunoassay analyzer, then the analyzer would calculate the concentration of HCG according to the preset calibration curve in the machine and display the result, detection unit is mIU/mL. C line should appear in any cases, which indicates the reaction system is effective.

Storage conditions and shelf life

Store in a sealed aluminum foil bag at 2~30°C. After unpacking the aluminum foil bag under temperature 20~30 ºC , humidity 35~65%, please use it immediately.

Shelf life 18 months.

Applicable instrument

Avid fluorescent immunoanalyzer model: AI-IF 600

Manufacturer& After-Sales Company: Shenzhen Aivd Biotechnology Co., LTD.

Address:C501,Building B5,China Merchants Guangming Science Park, #3009 Guanguang Road, Guangming District, Shenzhen,Guangdong Province, China

Tel: 0755-26165742 Fax:0755-26401805

Specimen collection and preparation

1. Human plasma/serum/whole blood samples can be used for this test.

2. Specimen collection:

Plasma/Serum:

The serum or plasma should be separated by centrifugation immediately after the collection of whole blood. Serum specimens must be collected in standard or vacuum test tubes with serum separating gel.

Specimens can be stored at 2-8°C for 7 days after processing. The specimens frozen at -20°C shouldn't be over 1 month. Multiple freeze-thaw cycles

shouldn't over 3 times.

Whole Blood:

Collect blood specimen into a collection tube containing EDTA or heparin or citric acid, evenly mixed before use. Do not use hemolyzed blood for testing.

Whole blood specimens should be stored at 2-8°C for no more than 4 hours if not test immediately.

3. Do not test patients' samples with severe hemolysis, lipemia and jaundice, all specimens should be treated as infectant.

4. Restore the specimen to 20-30°C before the detection, cryopreserved specimen should be completely thawed, rewarmed and evenly mixed before use.