In 2016 we amended the protocol to improve the pace of patient recruitment. The first change allows for the use of nasopharyngeal (NP) wash as an alternative to NP swab to collect upper airway specimens. NP wash may be better tolerated than NP swab and is routinely used during patient care at the NIH Clinical Center. The second change allows for use of NP wash specimens collected up to 24 hours preceding a clinically indicated bronchoscopy. This change eliminates the need for repeat upper airway sampling in a subset of patients. Up to 100 male or female subjects age 12 and above who are already undergoing bronchoscopy for the collection of a BAL specimen and who will have respiratory virus PCR ordered on the BAL specimen as part of their ongoing care at the NIH Clinical Center will be eligible for inclusion in this study. NP swab and wash specimens have been validated for testing using the FilmArray assay. Both the NP swab/wash and the BAL specimens will have the respiratory virus PCR (FilmArray) assay ordered in CRIS and the specimens will be processed and tested by the medical technologists in the Microbiology Service of the Department of Laboratory Medicine. Results from both specimens will be reported in CRIS. Instructions from the Centers for Disease Control on the proper technique for collecting NP swab specimens are presented in Appendix A. To resolve discrepant results, NP (swab or wash) and BAL specimens with conflicting results will be tested by a second multiplex PCR (Luminex Fast RVP) in the Laboratory of Infectious Diseases, Viral Pathogenesis and Evolution Branch, NIAID. These results will only be used for research purposes. Demographic and clinical data (including but not limited to laboratory results, microbiologic data, and radiology results) on study participants will be abstracted from CRIS and correlated with results from the FilmArray assay. Excess NP swab/wash or BAL samples will be stored for potential future use by study investigators. To date we have enrolled 35 subjects. The results thus far: 21 had negative results for respiratory virus PCR 14 had positive results for respiratory virus PCR Of the 14 positive results: 11 had matching viral results from BAL and NP swab 1 showed positive results from BAL and NP swab identifying different pathogens 2 showed positive respiratory virus PCR on BAL only. In April 2017, we changed the status of this protocol to Open for Data Analysis Only. In May 2018 we closed the study due to slow/Insufficient accrual and all samples were transferred to ZIA CL009005-11 CCMD.
