[142504285]
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.
Patient Sequence No: 1, Text Type: D, B5