National Standards for the Determination of Luteinizing Hormone Immunoassay

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National standard for immunoassay of luteinizing hormone
Luteinizing Hormone , LH
[Category] in vitro diagnostic reagent standard [batch number] 150531-201804
【Properties】Light yellow lyophilized powder 【Use】 This product is prepared by using human pituitary luteinizing hormone as raw material for LH quantitative labeling immunoassay. It is suitable for enzyme-linked immunosorbent assay, chemiluminescence method and time-resolved immunofluorescence. Evaluation. (Note: Users of other methodological products are required to prove their suitability by themselves).
[Composition and specifications] This product is a lyophilized product. Each ampoule contained LH 1.12 IU and 0.5 ml de-hormone serum after lyophilization.
[Characteristics] Traced to LH international standard (NIBSC 81/535), the collaborative calibrated LH immunoreactivity in each ampoule was 1.12 IU, with an uncertainty of 0.12 IU.
[Usage and requirements] When using, completely reconstitute the contents with 1.0ml of deionized water, and then select the appropriate dilution to prepare the desired concentration. The diluent is recommended to use 0.5% to 1.0% human serum albumin (HSA) or bovine serum albumin (BSA) in 10 mM phosphate buffer (pH = 7.2-7.4) or other protein-containing neutral buffer system. . Dilute the standard with a validated dilution to prepare one or several concentration gradients within the linear range of the kit. The accuracy of the kit should be such that the relative deviation between the measured value and the theoretical value should be within ±10.0%.
[Storage] Long-term storage should be placed below -20 °C to avoid repeated freezing and thawing. After reconstitution, if you need to use it multiple times, you can dispense the vial. Sealed and stored below -20 °C.
【Precautions】
1. This product has potential biological hazard and should not be disposed of at will.
2. Avoid repeated freezing and thawing.
[Validity Period] The national drug reference materials do not have a specific expiration date, and the standard substances stored in accordance with the prescribed conditions are valid before the Central Inspection and Quarantine issues a notice of deactivation.
statement:
1. Please use according to the instructions of this product. If it is used for other purposes, the user must prove the applicability by himself;
2. The user bears the relevant responsibilities for damages or complaints caused by improper use or storage by the user;
3. After receiving this product, the user should check the variety, quantity, packaging, etc. immediately. If there is any discrepancy between quality and quantity, the relevant compensation is limited to the standard substance itself and does not involve any other losses. (Batch batch: 201003: 930mIU / branch; 201804: 1.12mIU / branch)

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