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FSH Test Kit CLIA Ovarian Diseases Double Antibody Sandwich Method 0.50-200 MIU/ML

Name: FSH Test Kit CLIA Ovarian Diseases Double Antibody Sandwich Method 0.50-200 MIU/ML
Brand: Hangzhou AllTest Biotech CO.,LTD
SKU: CI-FSH
Price: Negotiable USD
Availability: InStock

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

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

Product Name:

FSH Test Kit (CLIA), Ovarian Diseases,Double Antibody Sandwich Method,0.50-200 MIU/mL

Cat No.:

CI-FSH

Principle:

Double Antibody Sandwich Method

Specimen:

S/P

Pack:

40T

Shelf Life:

2 Years

Format:

Strip

Certificate:

Storage Temperature:

2-8℃

Cut-Off:

0.50-200 MIU/mL

Packaging Details:

40T

Supply Ability:

10 M tests/month

Highlight:

Chemiluminescence Immunoassay FSH Test Kit

CLIA FSH Test Kit

200 MIU/ML FSH Test Kit

Product Description

FSH Test Kit (CLIA), ovarian diseases,Double Antibody Sandwich Method,0.50-200 mIU/mL

Product Name:	FSH Test Kit (CLIA), Ovarian Diseases,Double Antibody Sandwich Method,0.50-200 MIU/mL
Principle:	Double Antibody Sandwich Method
Pack:	40T
Format:	Strip
Storage Temperature:	2-8℃
Cat No.:	CI-FSH
Specimen:	S/P
Shelf Life:	2 Years
Certificate:	CE
Cut-Off:	0.50-200 MIU/mL

A CLIA test kit for the quantitative determination of FSH in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.

【INTENDED USE】

The FSH Test Kit (CLIA) is intended for quantitative determination of FSH in human serum and plasma, as an aid in diagnosis of ovarian diseases. For professional in vitro diagnostic use only.

【SUMMARY】

Follicle stimulating hormone(FSH)is a hormone secreted by the basophils of the anterior pituitary gland. The component is glycoprotein. Its main function is to promote the maturation of follicles. After ovulation, FSH and LH are responsible for turning the divided follicles into the corpus luteum, then act on the corpus luteum cells to secrete progesterone.1 For women with a normal menstrual cycle, the difference in the length of the follicular period can be used to observe the difference in the length of their menstrual cycle. Follicle stimulating hormone reaches its peak in the middle of menstruation. During menopause, due to ovarian atrophy, the secretion of is significantly reduced, which stimulates the pituitary gland to secrete a large amount of follicle stimulating hormone.

FSH levels in menopausal women will increase, while ovarian and progesterone will decrease. FSH in the male body stimulates spermatogenesis through receptors on sertoli cells in the testicular vas deferens. Generally, menstrual cycle, fertility and adolescent developmental abnormalities such as early-onset ovarian failure, menopause, ovulation disorders and pituitary failure are checked by measuring the levels of human LH and FSH.3 Low levels of luteinizing hormone and follicular may indicate pituitary failure, while elevated levels of luteinizing hormone and follicular and decreased levels of gonadal steroids may indicate gonadal failure (menopause, oophorectomy, early-onset ovarian syndrome, Turner syndrome).

【PRINCIPLE】

This product uses the double antibody sandwich method. In the first step, the sample, the FSH antibody labeled with alkaline phosphatase, and the magnetic particles coated with the FSH antibody are mixed. After incubation, the FSH in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed 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 FSH in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of FSH in the sample.

【REAGENTS】

The reagent strip includes FSH antibody coated with magnetic particles, alkaline phosphatase labeled FSH 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.The FSH Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.

【STORAGE AND STABILITY】

1. Unopened test kits should be stored at 2-8 °C. When stored and handled as required, all unopened reagents are stable through the expiration date printed on the label.

2. Do not freeze. Do not turn the reagent strips over.

3. Store the test kit upright. Do not expose reagents to strong light during storage. Care should be taken to protect the components of the test from contamination.

4. Remaining reagents in the kit should be stored at 2-8°C immediately.

5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment,

containers or reagents may lead to false results.

6. Calibrator and Control Materials:Unopened:

Stable until the expiration date

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products details

FSH Test Kit CLIA Ovarian Diseases Double Antibody Sandwich Method 0.50-200 MIU/ML

FSH Test Kit CLIA Ovarian Diseases Double Antibody Sandwich Method 0.50-200 MIU/ML

Chemiluminescence Immunoassay FSH Test Kit

CLIA FSH Test Kit

200 MIU/ML FSH Test Kit