Calls for Invalid Test - Error Calls and Recourse Error calls related to an invalid test are listed in the table below, together with the appropriate recourse which should be taken by the user. Error Call Reason Recourse No Call – INT CTL 1 IC1 Not Detected. Repeat BC-GP from original blood Processing and/or culture specimen. lysis/extraction Issues. No Call – INT CTL 2 IC2 Not Detected. Repeat BC-GP from original blood Inhibition during the target culture specimen. hybridization procedure. No Call – INT CTL IC1 and IC2 Not Detected. Repeat BC-GP from original blood Processing and/or culture specimen. lysis/extraction Issues and Inhibition during target hybridization. No Call – NO GRID Reader unable to image Test Ensure protective silver tape has Substrate. 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 BC-GP from original blood culture specimen No Call – VARIATION Inability to obtain the test result Repeat BC-GP from original blood because of high variability in the culture specimen. No Call – BKGD target-specific signals. No Call – NEG CTL Processing Error Pre-analytical error. Power cycle Processor SP and Internal checks within the repeat BC-GP from original blood Processor SP detected an culture specimen. unexpected event. QUALITY CONTROL: Quality control, as a component of an overall quality assurance program, consists of tests and procedures for monitoring and evaluating the analytical performance of a measurement system to ensure the reliability of patient test results.
Calls for Invalid Test - Error Calls and Recourse Error calls related to an invalid test are listed in the table below, together with the appropriate recourse which should be taken by the user. Error Call Reason Recourse No Call – INT CTL 1 IC1 Not Detected. Processing and/or lysis/extraction Issues. Repeat BC-GP from original blood culture specimen. No Call – INT CTL 2 IC2 Not Detected. Inhibition during the target hybridization procedure. Repeat BC-GP from original blood culture specimen. No Call – INT CTL IC1 and IC2 Not Detected. Processing and/or lysis/extraction Issues and Inhibition during target hybridization. Repeat BC-GP from original blood culture specimen. 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 BC-GP from original blood culture specimen No Call – VARIATION Inability to obtain the test result because of high variability in the target-specific signals. Repeat BC-GP from original blood culture specimen. No Call – BKGD No Call – NEG CTL Processing Error Pre-analytical error. Internal checks within the Processor SP detected an unexpected event. Power cycle Processor SP and repeat BC-GP from original blood culture specimen. QUALITY CONTROL: Quality control, as a component of an overall quality assurance program, consists of tests and procedures for monitoring and evaluating the analytical performance of a measurement system to ensure the reliability of patient test results.
12-0019-f_nanosphere_verigene_bc-gp_example_procedure.docx