Legal Aspects - DRG EIA-2395 Instrucciones De Uso

Leptin Sandwich ELISA EIA-2395
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LEGAL ASPECTS

11.1 Reliability of Results
The test must be performed exactly as per the manufacturer's instructions for use. Moreover the user must strictly adhere
to the rules of GLP (Good Laboratory Practice) or other applicable national standards and/or laws. This is especially
relevant for the use of control reagents. It is important to always include, within the test procedure, a sufficient number of
controls for validating the accuracy and precision of the test.
The test results are valid only if all controls are within the specified ranges and if all other test parameters are also within
the given assay specifications. In case of any doubt or concern please contact DRG.
11.2 Therapeutic Consequences
Therapeutic consequences should never be based on laboratory results alone even if all test results are in agreement
with the items as stated under point 11.1. Any laboratory result is only a part of the total clinical picture of a patient.
Only in cases where the laboratory results are in acceptable agreement with the overall clinical picture of the patient
should therapeutic consequences be derived.
The test result itself should never be the sole determinant for deriving any therapeutic consequences.
11.3 Liability
Any modification of the test kit and/or exchange or mixture of any components of different lots from one test kit to another
could negatively affect the intended results and validity of the overall test. Such modification and/or exchanges invalidate
any claim for replacement.
Claims submitted due to customer misinterpretation of laboratory results subject to point 11.2 are also invalid.
Regardless, in the event of any claim, the manufacturer's liability is not to exceed the value of the test kit. Any damage
caused to the test kit during transportation is not subject to the liability of the manufacturer.
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