A CLIA test kit for the quantitative determination of LH in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
LH Test Kit (CLIA),quantitative Determination Of LH, Chemiluminescence Immunoassay Test |
| Principle: |
Two-step Chemiluminescence Immunoassay |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-LH |
| Specimen: |
S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
1-200 MIU/mL |
【INTENDED USE】
The LH Test Kit (CLIA) is intended for quantitative determination of LH in human serum and plasma, as an aid in evaluation of pituitary endocrine function.
For professional in vitro diagnostic use only.
【SUMMARY】
LH is a member of the gonadotropin family. LH and FSH synergistically promote the growth and development of the gonads (ovaries and testes). LH is composed of two different non-covalent glycoprotein subunits, represented by α and β. On the α subunit, it contains two N-linked carbohydrate chains; on the β subunit, it contains an asparagine link. The alpha subunit is similar to the glycoproteins LH, HCG, FSH and TSH in structure. The difference in glycoprotein β subunits causes their immunological and physiological specificity.
LH in the female body stimulates the final maturation of the follicle, the division of the follicle, and ovulation. 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; the level of LH in menopausal women will increase, while the ovarian estrogen and progesterone will decrease, and the pituitary gland The negative feedback mechanism of the glands is eliminated, and as a result, the ovulation and menstrual cycle are reduced until the final stop. LH in men usually refers to interstitial cell stimulating hormone, which can affect the production of testosterone through the Leydig cells of the testis. The combined detection of luteinizing hormone and follicle stimulating hormone can indicate the occurrence of polycystic ovary, congenital diseases such as chromosomal aberrations, and can also clarify diseases such as irregular menstruation, menopausal syndrome, and suspected testicular stromal cell dysfunction.
【PRINCIPLE】
The LH CLIA Test Kit use two-step chemiluminescence immunoassay. In the first step, the sample and the magnetic particles coated with the LH 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 LH in the sample.
Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of LH in the sample.
【REAGENTS】
The reagent strip includes LH antibody coated with magnetic particles, alkaline phosphatase labeled LH 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 LH 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 when stored at 2-8 °C.
Opened:
Stable for 1 week at 2-8 °C
