HCG Rapid Medical Diagnostic Women's Health Blood Test Kit by TRFIA analyzer

High sensitivity cFDA approved SAA Quantitative Detection Kit (TRFIA)

【Intended use】

For Medical Professional Use Only!

This kit is suitable for quantitative determination of total β-hCG in human serum / plasma / whole blood in vitro.

Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by trophoblast cells of the placenta, it is an excellent marker of pregnancy, doubling every 1.5-3 days in the first six weeks. hCG concentrations in healthy and non-pregnant individuals were low, cannot even be detected. hCG structure is similar to pituitary hormone FSH( follicle stimulating hormone), TSH( thyroid stimulating hormone) and LH( luteinizing hormone, and these hormones contain the same α subunits. But because β subunits are different, they are given immunological and biological specificity. Enzyme linked immunosorbent assay (ELISA),Fluorescence immunochromatography,chemiluminescence analysis, Qualitative analysis of colloidal gold early pregnancy test paper.

【Testing principles】

The β-hCG detection kit is a time-resolved fluorescence immunochromatographic technique for quantitative determination of β-hCG concentrations in blood samples. Mix the sample buffer and blood samples, then add them to the reagent card. The β-hCG in the sample is coupled with fluorescent microspheres on the marker pad β-hCG monoclonal antibodies bind to form a complex, by capillary chromatography to the nitric acid fiber membrane containing β-hCG other specific antibody detection band, and was captured to form a double antibody sandwich complex.As a result, the more β-hCG in the sample, the more complex accumulation on the detection band. The excess unreacted fluorescent microspheres continued to be chromatographic to the control line. After the reagent strip is excited, the fluorescence intensity on the detection line reflects the content of the captured β-hCG in the sample. After the detection and calculation of the time-resolved fluorescence immune-analyzer, the concentration of β-hCG in the sample was quantitatively reflected.

【Main components】

1. β-hCG test kit: contains 20 people /50 people reagent card, IC card 1, manual 1, sample detection liquid 20 people /50 people.

The reagent card consists of plastic casings and test strips, Test strips are made of sample pads, marker pads, mainly fiberglass, fluorescent probe (0.5% solid content of microspheres) of mouse β-hCG monoclonal antibody, 1:40 Dilution, detection membrane (mainly made of cellulose nitrate membrane), sprayed with mouse anti-human β-hCG monoclonal antibody (1.0 mg/mL) and sheep anti-mouse immunoglobulin G (IgG) polyclonal antibody (1.0 mg/mL), absorbent paper and polystyrene (PVC) plywood. The main component of the sample buffer was saline, proclin300.

3. Do not exchange different batch numbers.

4. Storage conditions and expiry date?

The kit is stored in 2℃~8℃, valid for 18 months. If the use period of printing on the package is not exceeded, the product can be stored stably at temperature (20℃~30℃) for 30 days. The temperature change during transportation (<37℃) has no effect on product quality. The reagent strip and the sample detection solution are used in one-to-one mode, that is, a reagent strip is matched with a bottle of sample detection solution to detect a sample. After unsealing, it can be stabilized for 1 hour at room temperature. Under normal humidity and light conditions, store and use according to the above requirements.