[2888996]
Summary beginning (b)(6) 2012, (b)(6) was asked to begin culturing all cepheid xpert (b)(6) neonatal patients from a 75-bed nicu, using the additional swab obtained during collection for pcr. This was requested by infection control at this hospital facility (b)(6). This request was made for the purpose of pfge (pulse-field gel electrophoresis) testing to further investigate an increased number of xpert (b)(6), if warranted in the future. These samples were plated on chromeid plates specific for (b)(6). Following plating of 12 of these samples, (b)(6) was found on chromeid for only 2 patients ((b)(4)) xpert (b)(6) results were reviewed, and many were found to have (b)(6) results, suggesting low levels of organism which potentially would not yield growth. During this time, a journal article was discovered, describing an infrequent genetic change near the (b)(6) target that would report as (b)(6), but was not (b)(6). This is referred to as an "empty cassette," or "fimec drop out. " this would look like (b)(6), but would behave like (b)(6). To further investigate the empty cassette possibility, microbiology began culturing nicu xpert (b)(6) on both chromeid and cna. The subsequent 4 nicu xpert (b)(6) samples tested in this manner grew only on cna. The subsequent 4 nicu xpert (b)(6) samples tested int his manner grew only on cna, and were determined to be (b)(6) by (b)(6) testing. At this time all xpert (b)(6) in the general population from all locations were sent to microbiology for plating on both chromeid and cna. Specialists employed by cepheid were then consulted to officially assist in our investigation on (b)(6) 2012. The 4 nicu samples above were tested using xpert (b)(6), and were not found to contain the empty cassette. What was suspected in these 4 cases is that high levels of (b)(6) (indicated on the xpert (b)(6) assay) may cause non-specific binding using the xpert (b)(6), therefore reporting a (b)(6) result for the xpert (b)(6) screen at low (b)(6). For the general population, findings were significantly different. It was apparent from these data that the neonatal population is unique with regard to (b)(6) screening using xpert (b)(6), due to the propensity for high levels of (b)(6) in these patients. On (b)(6) 2012, (b)(6) days after the official investigation with cepheid was initiated, it was noted by (b)(6) that the clinical study for xpert (b)(6) did not include patients under the age of 2 years, and the case was officially closed. This limitation of the xpert (b)(6) assay is not clearly defined in the package insert for this test.
Patient Sequence No: 1, Text Type: D, B5