Expected Normal Values; Quality Control - DRG EIA-2395 Instrucciones De Uso

7

EXPECTED NORMAL VALUES

It is strongly recommended that each laboratory should determine its own normal and abnormal values.
In a study conducted with apparently healthy adults, using the DRG Leptin Sandwich ELISA the following data were
observed:
Population ng/mL
Males 3.84 ± 1.79
Females 7.36 ± 3.73
The results alone should not be the only reason for any therapeutic consequences. The results should be correlated to
other clinical observations and diagnostic tests.
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QUALITY CONTROL

Good laboratory practice requires that controls be run with each calibration curve. A statistically significant number of
controls should be assayed to establish mean values and acceptable ranges to assure proper performance.
It is recommended to use control samples according to state and federal regulations. The use of control samples is
advised to assure the day to day validity of results. Use controls at both normal and pathological levels.
The controls and the corresponding results of the QC-Laboratory are stated in the QC certificate added to the kit. The
values and ranges stated on the QC sheet always refer to the current kit lot and should be used for direct comparison of
the results.
It is also recommended to make use of national or international Quality Assessment programs in order to ensure the
accuracy of the results.
Employ appropriate statistical methods for analysing control values and trends. If the results of the assay do not fit to the
established acceptable ranges of control materials patient results should be considered invalid.
In this case, please check the following technical areas: Pipetting and timing devices; photometer, expiration dates of
reagents, storage and incubation conditions, aspiration and washing methods.
After checking the above mentioned items without finding any error contact your distributor or DRG directly.
Version 10.0 2017/05 - vk
Leptin Sandwich ELISA EIA-2395
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