Discrepant covid-19 ag test; location effected camp (b)(6) testing timeline on (b)(6), this camp sent samples to be tested using the vault covid-19 pcr test to conduct universal screening of campers and staff.All samples tested were negative.On (b)(6), this camp sent samples to be tested using the vault covid-19 pcr test to conduct selective screening of campers and staff.All samples tested were negative.On (b)(6), this camp used the quidel sofia 2 antigen to conduct universal screening of campers and staff.Three separate samples were taken and analyzed.The first sample of each patient was positive.Subsequent samples tested either negative or positive.On (b)(6), this camp sent samples to the (b)(6) public health lab to conduct universal screening of campers and staff.All samples tested were negative using the opti-sars-cov-2 fda eua real time rt pcr assay.Additional notes (b)(6) cdc has a line list of patients and results: temperature of room where samples were collected for saliva pcr? a.69 degrees (roughly) ¿ specimens stored inside but collected outside; temperature of room where samples were collected for the quidel sofia 2 antigen test a, 69 degrees (roughly) - specimens stored inside but collected outside; was the quidel sofia 2 test be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a clia certificate of waiver, certificate of compliance, or certificate of accreditation? a.Yes, maybe.Unknown?; what type media and swab used for the quidel sofia 2 antigen test a.The ones that came in the package (sterile foam tipped applicator); collection media for other tests specifically a.Saliva pcr = vault test kit b.Hetl tests = np swab c.Antigen test = sofia kit (reagent solution) ¿ whatever came in the kit; samples for hetl test? what type? a.Only np; all staff arrived with a pre-arrival negative pcr swab (obtained independently within 5 d prior to arrival).Onsite rapid ag testing with quidel sofia2 fia test.On (b)(6), 2 medical staff rn arrived quidel training provided by watching instructional video.On (b)(6), 2 medical staff rn arrived quidel training provided by watching instructional video.Calibration conducted with cassette per instructions.On (b)(6), qc conducted lot # 141867, 4 medical staff tested; 1 tested ag pos, repeated x2 (separate sample) ag neg lot#141702, serial # (b)(4).Vault saliva pcr obtained resulted ag neg on this staff member.On (b)(6) a few staff ag tested upon arrival; (b)(6) all staff tested 68 ag tested neg lot number.Staff self-quarantine x14days.Staff retested at 7days on (b)(6) 2020 and (b)(6) 2020 68 all ag neg; 15 west coast campers + 1 camp med staff + family member arrived on (b)(6) 2020 all with confirmed independent neg pcr testing obtained within prior 5 days.On (b)(6) all campers arrived with confirmed independent neg pcr testing obtained within prior 5 days.On (b)(6) testing performed on-site with quidel sofia2 ag by garnet transport medicine with their on team and equipment all remaining 101 campers--all neg.On (b)(6) 4 campers arrived late and had sofia 2 ag test performed with camp equipment all neg.On (b)(6) 4 campers (3 in one bunk) plus 1 in another bunk but same age group had nausea or an episode of vomiting--isolated and ag tested onsite all neg; (b)(6) random sample of 40 campers across all age groups/bunks and geographic regions obtained vault saliva pcr testing-resulted (b)(6) all neg.On (b)(6) qc lot# 141867; (b)(6) conducted camp wide testing starting with oldest camper cohort (age (b)(6)) 17 tested with onsite sofia 2 ag with, 5 resulting pos (you have remaining sequence of testing results).3 of 5 pos on retest with new nasal sample lot# 141702, serial # (b)(4), same lot, serial # (b)(4), same lot, serial # (b)(4), same lot, serial# (b)(4).Same lot, serial # (b)(4).Total of 24 (16 campers/8 staff) had at least one pos ag test, all 24 samples tested positive by the quidel sofia 2 antigen test for covid-19.Subsequent tests using either he quidel sofia 2 antigen test or rt real-time pcr tests were negative.Fda safety report id# (b)(4).
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