Detected type Not Wild Detected Detected Toxigenic Clostridium difficile Detected Detected type Not Toxigenic & PCR ribotype 027 Clostridium Detected Detected Mutant Detected difficile Detected Not Not Wild Detected Toxigenic Clostridium difficile Detected Detected Detected type Not Wild Detected Detected Toxigenic Clostridium difficile Detected Detected type Not Toxigenic & PCR ribotype 027 Clostridium Detected Detected Mutant Detected difficile Detected Not Not Wild Detected Toxigenic Clostridium difficile Detected Detected Detected type Error calls related to an invalid test are listed in the Table 2 below, together with the appropriate recourse which should be taken by the user. Table : Invalid Calls and Recourse Call Reason Recourse* Ensure protective silver tape has been removed from back of Test Substrate. Ensure Test Substrate is seated properly in the Substrate Holder. Repeat image No Call – NO GRID Reader unable to image Test Substrate analysis by selecting ‘Menu’ and ‘Enter Barcode’ and then scanning the Substrate barcode. If the No-Call persists, repeat CDF from original stool specimen tcdC is not detected but tcdA and/or No Call – IND tcdB is Detected or tcdC is mutant and Binary is not detected INT CTL 1 Not Detected. Probable failure during the target hybridization part of the procedure No Call – INT CTL 1 only. This control does not require extraction or amplification to work properly. INT CTL 2 Not Detected. No Call – INT CTL 2 Repeat CDF Probable failure during extraction or amplification part of the procedures.
Detected type Detected Not Detected Detected Wild type Toxigenic Clostridium difficile Detected Detected Not Detected Detected Mutant Toxigenic & PCR ribotype 027 Clostridium difficile Detected Detected Not Detected Not Detected Wild type Toxigenic Clostridium difficile Detected Not Detected Detected Detected Wild type Toxigenic Clostridium difficile Detected Not Detected Detected Detected Mutant Toxigenic & PCR ribotype 027 Clostridium difficile Detected Not Detected Detected Not Detected Wild type Toxigenic Clostridium difficile Detected Error calls related to an invalid test are listed in the Table 2 below, together with the appropriate recourse which should be taken by the user. Table : Invalid Calls and Recourse Call Reason Recourse* No Call – NO GRID Reader unable to image Test Substrate Ensure protective silver tape has been removed from back of Test Substrate. Ensure Test Substrate is seated properly in the Substrate Holder. Repeat image analysis by selecting ‘Menu’ and ‘Enter Barcode’ and then scanning the Substrate barcode. If the No-Call persists, repeat CDF from original stool specimen No Call – IND tcdC is not detected but tcdA and/or tcdB is Detected or tcdC is mutant and Binary is not detected No Call – INT CTL 1 INT CTL 1 Not Detected. Probable failure during the target hybridization part of the procedure only. This control does not require extraction or amplification to work properly. No Call – INT CTL 2 INT CTL 2 Not Detected. Probable failure during extraction or amplification part of the procedures. Repeat CDF
13-0002-b_nanosphere_verigene_cdf_example_procedure.docx