hPL ELISA kit is an enzyme immunoassay (microtiter strips) for the quantitative determination of human plazental lactogen in human serum. The hPL ELISA kit is for in-vitro diagnostic use only. The minimal detectable concentration of hPL by this hPL ELISA kit assay is estimated to be 0.3 mg/l. Two patient samples were serially diluted with Zero Standard in a linearity study. The average recovery using this hPL ELISA kit was 99.7 %. Various patient serum samples of know hPL levels were mixed and assayed in duplicate. The average recovery using this hPL ELISA kit was 101.17 %. In this hPL ELISA kit assay, no hook effect is observed up to 700 mg/l of hPL.
The hPL ELISA kit is a solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. The microtiter wells of this hPL ELISA kit are coated with a monoclonal antibody directed towards a unique antigenic site on a hPL molecule. An aliquot of patient sample containing endogenous hPL is incubated in the coated well with enzyme conjugate, which is an antihPL antibody conjugated with horseradish peroxidase. After incubation the unbound conjugate is washed off with water. The amount of bound peroxidase using this hPL ELISA kit is proportional to the concentration of hPL in the sample. Having added the substrate solution, the intensity of colour developed is proportional to the concentration of hPL in the serum.
When stored at 2 - 8°C unopened reagents will retain reactivity until expiration date of this hPL ELISA kit. Do not use reagents beyond this date. Enzyme Conjugate, Substrate Solution, Standards and Zero Standard must be stored at 2 - 8°C. Microtiter wells of this hPL ELISA kit must be stored at 2 - 8°C. Once the foilbag has been open care should be taken to close it tightly again. The immuno-reactivity of the coated microtiter wells is stable for approx. 6 weeks in the broken, but tightly closed bag containig the dessicant.
The human placental laktogen (hPL) has first been described by Josimovich and Mac Laren in 1962, for which they definitively showed the placental origin. It is a polypeptide with a molecular weight of 21500 Dalton and consists of 191 amino-acids, 160 of which are common with the structure of human growth hormone (hGH). For this reason hPL is also denominated human Chorionic Somatotropin (hCS), having biological and immunological correlations with hGH. It is produced by synsytiotrophoblast cells of placenta and its concentration progressively increases during the pregnancy reaching a maximum value around the 38th week of gestation.
The test results for this hPL ELISA kit are only valid if the test has been performed following the instructions. Moreover the user must strictly adhere to the rules of GLP (Good Laboratory Practice) or other applicable standards/laws. All standards and kit controls used with this hPL ELISA kit must be found within the acceptable ranges as stated on the QC Certificate. If the criteria are not met, the run is not valid and should be repeated. Each laboratory should use known samples as further controls. In case of any deviation the following technical issues should be proven: Expiration dates of (prepared) reagents, storage conditions, pipettes, devices, incubation conditions and washing methods. It is recommended to participate at appropriate quality assessment trials.
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