Patient-collected tongue, nasal, and mid-turbinate swabs compared to health care worker-collected nasopharyngeal swabs for COVID-19 testing

Patient-Collected Swabs for SARS-CoV-2 Testing Tongue, nasal, and mid-turbinate swabs to detect SARS-CoV-2 were collected by 530 outpatients before a health care worker collected nasopharyngeal swa...

Participants self-collected of all three anatomic sites: tongue, nasal and MT and health care worker-collection from the NP.Inclusion criteria included evidence of symptoms suggestive of an upper respiratory illness (subjective and objective fevers, cough, sore throat, fevers, myalgia, or rhinorrhea) indicating higher risk of COVID-19 in this community and the ability to consent and agree to participate in the study.People who were not able to demonstrate understanding of the study, not willing to commit to having all four samples collected, had a history of nosebleed in the past 24 hours, nasal surgery in the past two weeks, chemotherapy treatment with documented low platelet and low white blood cell counts, or acute facial trauma were excluded from the study.
Health care workers used a spoken script to explain the study and give eligible patients the opportunity to decline.Any patient who had all four samples collected is considered as having willingly participated in the study as they allowed the sample collection and the use of the data produced from the sample.This study protocol was deemed to be an operational project by the Office of Human Research Affairs at UnitedHealth Group.
Participants were provided instructions and asked to self-collect tongue, nasal, and MT samples, in that order (see Supplement).Tongue samples were collected with a nylon flocked swab (Copan FLOQSwab 502CS01) via the following steps: 1) Extending the tongue, and 2) firmly but gently brushing the swab along the length of the anterior 2/3 of dorsum of the tongue for 10 seconds.Nasal samples were collected with a foam swab (Puritan 25-1506 1PF100) via the following steps: 1) gently inserting the swab in the vertical position into one nasal passage until there is gentle resistance, 2) leaving the swab in place for 10-15 seconds, rotating the swab, and 3) repeating the procedure on the other side with the same swab.MT samples were collected with a nylon flocked swab (MDL NasoSwab A362CS02.MDL, 56380CS01 for adults and 56780CS01 for pediatrics) via the following steps: 1) inserting the swab in the horizontal position until gentile resistance was met, 2) leaving the swab in for 10-15 seconds on each side, rotating the swab, 3) repeating in the other nostril with the same swab.After patient sampling was completed, NP samples were collected by a health care worker using a polyester tipped swab on a skinny wire (Puritan 25-800-2PDBG) via the following steps: 1) pass the swab along the floor of the nose until meeting gentle resistance as the swab touches the posterior pharynx, in the nostril corresponding to the patient's dominant hand, and 2) rotate the swab several times and withdraw the swab.
All samples were stored in viral transport media and refrigerated at 4°C before shipping on ice packs to a reference laboratory for rRT-PCR testing (Quest Diagnostics, San Juan Capistrano, CA).Patient results were transmitted back to the clinical practice via the standard lab information system and electronic health record protocol.Additionally, cycle threshold (Ct) values for all samples that tested positive for SARS-CoV-2 were reported back to the clinical sites.A higher Ct value corresponds to a lower viral load.
Three separate analyses were performed: one comparing tongue samples to NP samples, a second comparing nasal samples to NP samples, and a third comparing MT samples to NP samples; all used health care worker-collected NP samples are the comparator.Samples included in the final analysis had RT-PCR results returned for both samples in question (i.e.NP and one patient-collected sample) at the time of data freeze.All statistical analysis was performed using R version 3.6.1.≥ 60 14/94 (14.9%) 13/91 (14.3%) 13/93 (14.0%)Mean (SD) Mean (SD) Mean (SD) Among Pos.

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Neg. Temperature

Table 2 :
A 2x2 table of the test results for all patients who had an NP and a

Table 3 :
A 2x2 table of the test results for all patients who had an NP and a Nasal

Table 4 :
A 2x2 table of the test results for all patients who had an NP and a MT sample tested.