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β- Human Chorionic Gonadotropin β-HCG CLIA Test Serum Or Plasma

Brand Name:	Unveil
Model Number:	CI-βHCG
MOQ:	N/A
Price:	negotiation
Supply Ability:	10 M tests/month

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

Product Name:

β- Human Chorionic Gonadotropin( β-HCG) Test Kit (CLIA), Serum Or Plasma, Chemiluminescence Immunoassay

Cat No.:

CI-INS

Principle:

Two-step Chemiluminescence Immunoassay

Specimen:

S/P

Pack:

40T

Shelf Life:

2 Years

Format:

Strip

Certificate:

Storage Temperature:

2-8℃

Cut-Off:

2-10000 MIU/mL

Packaging Details:

40T

Supply Ability:

10 M tests/month

Highlight:

Β- Human Chorionic Gonadotropin CLIA Test

Β- Human Chorionic Gonadotropin Test Kit

Β-HCG Chemiluminescence Immunoassay Test

Product Description

β- human Chorionic Gonadotropin( β-HCG) Test Kit (CLIA), serum or plasma, Chemiluminescence Immunoassay

Product Name:	β- Human Chorionic Gonadotropin( β-HCG) Test Kit (CLIA), Serum Or Plasma, Chemiluminescence Immunoassay
Principle:	Two-step Chemiluminescence Immunoassay
Pack:	40T
Format:	Strip
Storage Temperature:	2-8℃
Cat No.:	CI-INS
Specimen:	S/P
Shelf Life:	2 Years
Certificate:	CE
Cut-Off:	2-10000 MIU/mL

A CLIA test kit for the quantitative determination of β- human Chorionic Gonadotropin (β-HCG) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.

【INTENDED USE】

Theβ- human Chorionic Gonadotropin( β-HCG) Test Kit (CLIA) is intended for quantitative determination of β- human Chorionic Gonadotropin (β-HCG) in human serum or plasma, as an aid in diagnosis of early pregnancy detection and monitoring.

For professional in vitro diagnostic use only.

【SUMMARY】

HCG is a glycoprotein composed of two subunits (α- and β-). The β chain is specific and is responsible for hormone functions. Soon after the fertilized egg is implanted on the uterine wall, the placental trophoblasts begin to secrete HCG. The level of HCG in the blood rises rapidly after conception, which makes HCG a marker for early pregnancy detection and diagnosis.

During pregnancy, HCG can maintain the growth of the corpus luteum and ensure the synthesis of progesterone and . After the HCG in the serum rises to a peak, it drops and then reaches a plateau. The serum in pregnant women is mainly intact HCG. At present, high-sensitivity serum items can be used to quantitatively determine the concentration, which can predict spontaneous abortion 2 and assist in the detection of ectopic pregnancy and multiple pregnancy. The increase of HCG value can be seen in patients with tumors of germ cells, ovary, bladder, pancreas, stomach, lung and liver.

【PRINCIPLE】

The β-HCG CLIA Test Kit uses two-step chemiluminescence immunoassay. In the first step: the sample and the magnetic particles coated with the β-HCG antibody are mixed. After incubation to perform magnetic separation and cleaning. In the second step, add LH antibody alkaline phosphatase-labeled. After incubation to perform magnetic separation and cleaning to remove free enzyme-labeled antibodies.

The third step is to add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of β-HCG in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of β-HCG in the sample.

【REAGENTS】

The reagent strip includes HCG antibody coated with magnetic particles, alkaline phosphatase labeled HCG antibody, wash buffer and substrate solution.

【PRECAUTIONS】

1. For professional in vitro diagnostic use only.

2. Read the entire package insert carefully prior to testing.

3. Do not use after the expiration date indicated on the package.

4. The single reagent strip has been assembled into a ready-to-use unit that cannot be separated.

5. Do not interchange or mix reagents from different batches.

6. Used test materials should be disposed of in accordance with local regulations.

7. Test kits and samples need to be equilibrated to room temperature before testing.

8. It is recommended to use fresh blood. Samples with high-fat chylo, jaundice, and high rheumatoid factor are not recommended and hemolyzed samples are also not recommended.

9. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

10. The test results of this kit are for clinical reference only, clinical diagnosis and treatment of patients should be comprehensively considered in conjunction with their symptoms/signs, medical history, other laboratory tests and treatment responses.

11. Due to methodological or antibody specificity and other reasons, test the same sample with reagent strips from different manufacturers may result in different test results. The results obtained from testing with different reagent strips should not be directly compared with each other, which may cause erroneous medical interpretations.

12. Store and test reasonably in strict accordance with the instructions of the package insert. Keep the reagents away from light, do not turn it over.

13. Theβ- human Chorionic Gonadotropin( β-HCG) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals

【EXPECTED RESULTS】

According to the non-parametric method, this reagent performs a 90% median analysis on the β-HCG test results of 200 normal population samples with a 97.5% confidence level, and the 97.5% percentile concentration value is less than 5.00 mIU/mL.

Due to differences in geography, race, gender, and age, it is recommended that each laboratory establish its own reference value (range).

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products details

β- Human Chorionic Gonadotropin β-HCG CLIA Test Serum Or Plasma

β- Human Chorionic Gonadotropin β-HCG CLIA Test Serum Or Plasma

Β- Human Chorionic Gonadotropin CLIA Test

Β- Human Chorionic Gonadotropin Test Kit

Β-HCG Chemiluminescence Immunoassay Test