Patent ID: 7981606

Claim:
A method for detecting the presence or the absence of a target biomolecule in a sample suspected to comprise the target biomolecule, comprising: a) adding an internal control biomolecule to the sample suspected to comprise the target biomolecule, and a negative control sample not comprising the target biomolecule, and a positive control sample comprising the target biomolecule, and a second positive control sample comprising the target biomolecule, b) purifying the biomolecules from the samples of step a) except the second positive control sample, to obtain samples comprising the purified biomolecules, c) determining in each sample obtained in step a) or b) the presence or the absence of a signal of the internal control biomolecule and of the target biomolecule, d) verifying the presence or absence of the signal of the target biomolecule in the sample suspected to comprise the target biomolecule by: checking the sample suspected to comprise the target biomolecule for the presence of a signal for the target biomolecule independently from the presence of a signal of the internal control biomolecule or checking for the presence of a signal of the internal control biomolecule in the case of an absence of a signal for the target biomolecule, checking the negative control sample for the presence of a signal of the internal control biomolecule and for the absence of a signal of the target biomolecule, checking the positive control sample for the presence of a signal of the target biomolecule and for the presence of a signal of the internal control biomolecule, and checking the second positive control sample for the presence of a signal for the target biomolecule in step d) of the method or checking the second positive control sample for the presence of a signal for the target biomolecule and optionally for the internal control biomolecule e) detecting the presence or the absence of the target biomolecule whereby the presence or absence of the signals for the target biomolecule and the internal control biomolecule determined in step c) and verified in step d) indicate the presence or the absence of the target biomolecule in the test sample.