LIFECODES HLA-A ERES TYPING KITS

Description of Event or Problem

ON 18 FEBRUARY 2019 MM. COSTUMER CONTACTED TC WITH CONCERNS REGARDING UNEXPECTED FALSE POSITIVE REACTIONS ON PROBE 348 WHILE USING LIFECODES HLA-A ERES TYPING LOT 3006499. THEY INDICATED THE POSITIVE REACTION OF PROBE 348 IN SOME SAMPLES WERE WAY ABOVE 100% WHEN COMPARED TO THE CUT-OFF. COSTUMER PROVIDED THE CSV FILE (B)(4) OF A RUN PERFORMED ON 14 FEBRUARY 2019 WHICH CONTAINED SAMPLES 0994719000332V AND 0994719000339H AS EXAMPLES AND ALSO A SCREENSHOT OF THE HISTORIC GRAPH OF PROBE 348. THEY CONFIRMED THE DNA QUALITY OF THE SAMPLES WAS GOOD AND IT WAS RUN USING A HALF VOLUME PROTOCOL FOR BOTH THE PCR AND THE HYBRIDIZATION WITH NO PROBE HEATING ON THE RECOMMENDED 9700 THERMOCYCLER. THE RUN WAS REVIEWED AND ACCEPTED AS TECHNICALLY VALID WITH THE EXPECTED PROBES COUNTS AND CONSENSUS PROBES MFIS. THE MATCH TYPE OF SAMPLE 0994719000332V WAS "EXACT" WITH RARE A*03:274, A*29:73 ASSIGNMENT WITH PROBE 348 POSITIVE AND WITHIN 162% FROM THE CUT-OFF. THE SAME WAS PREVIOUSLY TYPED A*03:02, A*29:02 WHICH CAN ONLY OBTAINED BY EDITING PROBE 347 WHICH WAS WITH 10% OF THE CUT-OFF AND PROBE 348. THE MATCH TYPE OF SAMPLE 0994719000339H WAS "REVIEW PROBES" WITH RARE A*03:103, A*31:01 ASSIGNMENT WITH SUGGESTION TO CHANGE PROBE 348 TO NEGATIVE DESPITE IT WAS CLEAR POSITIVE AND BOUT 259 % OF THE CUT-OFF. THE SAME WAS PREVIOUSLY TYPED A*03:01, A*31:02 WHICH CAN ONLY BE OBTAINED BY EDITING PROBE 348 AND PROBE 321. THE SCREENSHOT OF PROBE 348 SHOWED SIGNIFICANT NUMBER OF EDITS BY THE COSTUMER. COSTUMER WAS ADVISED TO RE RUN THE SAMPLES USING THE IFU STANDARD PROTOCOL WITH PROBE HEATING. COSTUMER ALSO ASKED TO CONFIRM IF THE WHAT IS THE METHOD USED TO PREVIOUSLY TYPED SAMPLES 0994719000332V AND 0994719000339H. COSTUMER CONFIRMED THEY REPORTED SAMPLES TYPED BY LIFECODES HLA-A ERES TYPING LOT 3006499 WITH PROBE 348 EDITING. 04 MARCH 2019 MM. COSTUMER CONFIRMED THEY STILL DID NOT RETEST THE TWO SAMPLES USING THE STANDARD IFU PROTOCOL. THEY INDICATED THE TWO SAMPLES WERE PREVIOUSLY TYPED AND REPORTED BY LIFECODES HLA-A ERES KIT USING THEIR HALF VOLUME PROTOCOL. THEY ALSO HIGHLIGHTED THAT THERE WERE NO NEED TO EDIT PROBE 348 IN THE TWO SAMPLES WHEN TESTED FOR THE FIRST TIME (THEY ASKED TO PROVIDE THE CSV FILE FOR REVIEW). COSTUMER SPECIFIED THAT THEY HAVE NO CONCERN ABOUT WRONG TYPES REPORTED FOR SAMPLES 0994719000332V AND 0994719000339H USING LIFECODES HLA-A ERES TYPING LOT 3006499 AS THEY WAS NO DISCREPANCY BETWEEN THE TWO LOW RESOLUTION ASSIGNMENTS OBTAINED USING LIFECODES HLA-A ERES TYPING KITS. ON 11 MARCH 2019 MM. COSTUMER CONTACTED TC TODAY CONFIRMING THEY ARE GOING TO RETEST SAMPLES 0994719000332V AND 0994719000339H USING LIFECODES HLA-A ERES TYPING KIT LOT 3006499 TODAY AS PREVIOUSLY AGREED ON 15 MARCH 2019 MM. COSTUMER CONTACTED TC CONFIRMING SAMPLES 0994719000332V AND 0994719000339H WERE RE TESTED BY LIFECODES HLA-A ERES TYPING KIT LOT 3006499 ON THE 11 MARCH 2019 USING THEIR OWN HALF VOLUME PROTOCOL FOR BOTH THE PCR AND THE HYBRIDIZATION WITH NO PROBE HEATING ON THE RECOMMENDED 9700 THERMOCYCLER AND THEY PROVIDED THE CSV FILE OF THE RUN FOR REVIEW. DESPITE THE RUN WAS PERFORMED USING AN OFF LABEL PROTOCOL IT WAS TECHNICALLY VALID WITH THE EXPECTED PROBES COUNT AND CONSENSUS PROBES MFIS. THE MATCH TYPE OF SAMPLE 0994719000332V WAS "EXACT" WITH THE EXPECTED A*03:02, A*29:02 ASSIGNMENT WITH NEGATIVE PROBE 348. THE MATCH TYPE OF SAMPLE 0994719000339H WAS "EXACT" WITH THE EXPECTED A*03:01, A*31:01 ASSIGNMENT WITH NEGATIVE PROBE 348 TO NEGATIVE. IT WAS CLEAR AFTER THE RETEST, THE RAW MFI OF CONSENSUS PROBE 300 WHICH IS USED TO CALCULATE THE CUT OFF RATIO FOR PROBE 348 HAS IMPROVED BY ABOUT 30% FOR BOTH SAMPLES ((SEE CONSENSUS PROBE 300 MFI FOR SAMPLES (B)(6)) INDICATING TECHNICAL ISSUE DURING THE SETUP OF THE RUN PERFORMED ON 14 FEBRUARY 2019 RATHER THAN ANY DEFICIENCY WITH THE KIT. THE DNA QUALITY OF THE SAMPLES WAS GOOD AND IT WAS RUN USING A HALF VOLUME PROTOCOL FOR BOTH THE PCR AND THE HYBRIDIZATION WITH NO PROBE HEATING ON THE RECOMMENDED 9700 THERMOCYCLER. FAILURE TO PERFORM ASSAY PER IFU.

Description of Event or Problem

ON 18 FEBRUARY 2019 MM; COSTUMER CONTACTED TC WITH CONCERNS REGARDING UNEXPECTED FALSE POSITIVE REACTIONS ON PROBE 348 WHILE USING LIFECODES HLA-A ERES TYPING LOT 3006499. THEY INDICATED THE POSITIVE REACTION OF PROBE 348 IN SOME SAMPLES WERE WAY ABOVE 100% WHEN COMPARED TO THE CUT-OFF. COSTUMER PROVIDED THE CSV FILE ((B)(4)) OF A RUN PERFORMED ON (B)(6) 2019 WHICH CONTAINED SAMPLES (B)(6) AS EXAMPLES AND ALSO A SCREENSHOT OF THE HISTORIC GRAPH OF PROBE 348. THEY CONFIRMED THE DNA QUALITY OF THE SAMPLES WAS GOOD AND IT WAS RUN USING A HALF VOLUME PROTOCOL FOR BOTH THE PCR AND THE HYBRIDIZATION WITH NO PROBE HEATING ON THE RECOMMENDED 9700 THERMOCYCLER. THE RUN WAS REVIEWED AND ACCEPTED AS TECHNICALLY VALID WITH THE EXPECTED PROBES COUNTS AND CONSENSUS PROBES MFIS. THE MATCH TYPE OF SAMPLE (B)(6) WAS "EXACT" WITH RARE A*03:274, A*29:73 ASSIGNMENT WITH PROBE 348 POSITIVE AND WITHIN 162% FROM THE CUT-OFF. THE SAME WAS PREVIOUSLY TYPED A*03:02, A*29:02 WHICH CAN ONLY OBTAINED BY EDITING PROBE 347 WHICH WAS WITH 10% OF THE CUT-OFF AND PROBE 348. THE MATCH TYPE OF SAMPLE (B)(6) WAS "REVIEW PROBES" WITH RARE A*03:103, A*31:01 ASSIGNMENT WITH SUGGESTION TO CHANGE PROBE 348 TO NEGATIVE DESPITE IT WAS CLEAR POSITIVE AND BOUT 259 % OF THE CUT-OFF. THE SAME WAS PREVIOUSLY TYPED A*03:01, A*31:02 WHICH CAN ONLY BE OBTAINED BY EDITING PROBE 348 AND PROBE 321. THE SCREENSHOT OF PROBE 348 SHOWED SIGNIFICANT NUMBER OF EDITS BY THE COSTUMER. COSTUMER WAS ADVISED TO RE RUN THE SAMPLES USING THE IFU STANDARD PROTOCOL WITH PROBE HEATING. COSTUMER ALSO ASKED TO CONFIRM IF THE WHAT IS THE METHOD USED TO PREVIOUSLY TYPED SAMPLES (B)(6). COSTUMER CONFIRMED THEY REPORTED SAMPLES TYPED BY LIFECODES HLA-A ERES TYPING LOT 3006499 WITH PROBE 348 EDITING. ON 04 MARCH 2019 MM; COSTUMER CONFIRMED THEY STILL DID NOT RETEST THE TWO SAMPLES USING THE STANDARD IFU PROTOCOL THEY INDICATED THE TWO SAMPLES WERE PREVIOUSLY TYPED AND REPORTED BY LIFECODES HLA-A ERES KIT USING THEIR HALF VOLUME PROTOCOL. THEY ALSO HIGHLIGHTED THAT THERE WERE NO NEED TO EDIT PROBE 348 IN THE TWO SAMPLES WHEN TESTED FOR THE FIRST TIME (THEY ASKED TO PROVIDE THE CSV FILE FOR REVIEW). COSTUMER SPECIFIED THAT THEY HAVE NO CONCERN ABOUT WRONG TYPES REPORTED FOR SAMPLES (B)(6) USING LIFECODES HLA-A ERES TYPING LOT 3006499 AS THEY WAS NO DISCREPANCY BETWEEN THE TWO LOW RESOLUTION ASSIGNMENTS OBTAINED USING LIFECODES HLA-A ERES TYPING KITS. ON 11 MARCH 2019 MM; COSTUMER CONTACTED TC TODAY CONFIRMING THEY ARE GOING TO RETEST SAMPLES (B)(6) USING LIFECODES HLA-A ERES TYPING KIT LOT 3006499 TODAY AS PREVIOUSLY AGREED.