Valid and Reliable Assessment of Upper Respiratory Tract Specimen Collection Skills during the COVID-19 Pandemic

Todsen, Tobias; Bohr, Anne; Hovgaard, Lisette Hvid; Eið, Rebekka Consuelo; Benfield, Thomas; Svendsen, Morten Bo Søndergaard; Kirkby, Nikolai; Konge, Lars; Buchwald, Christian von; Melchiors, Jacob; Tolsgaard, Martin G.

doi:10.3390/diagnostics11111987

Cited by 6 publications

(5 citation statements)

References 27 publications

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“…6 However, the investigators performed throat swabs only in a small subgroup of 115 of 731 participants included in the study, and a suboptimal sample technique may explain the low sensitivity. 20,21 Our results also demonstrate that the throat sample technique is more challenging than obtaining a nasal sample, as we found a lower sensitivity and a higher number of inconclusive rapid antigen test results for selfcollected throat specimens compared with HCW-collected throat specimens. In contrast, no difference was found between HCW-collected and self-collected nasal specimens.…”

Section: Jama Network Open | Infectious Diseasessupporting

confidence: 52%

“…Our results contrast with a prior study finding that throat specimens had a lower sensitivity of 36.8% (compared with 69.4% in our study) for rapid antigen testing . However, the investigators performed throat swabs only in a small subgroup of 115 of 731 participants included in the study, and a suboptimal sample technique may explain the low sensitivity . Our results also demonstrate that the throat sample technique is more challenging than obtaining a nasal sample, as we found a lower sensitivity and a higher number of inconclusive rapid antigen test results for self-collected throat specimens compared with HCW-collected throat specimens.…”

Section: Discussionmentioning

confidence: 57%

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COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker–Collected Nasal and Throat Swab Specimens

Todsen,

Jakobsen,

Grønlund

et al. 2023

JAMA Netw Open

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ImportanceSelf- or health care worker (HCW)–collected nasal swab specimens are the preferred sampling method to perform rapid antigen testing for COVID-19, but it is debated whether throat specimens can improve test sensitivity.ObjectiveTo compare the diagnostic accuracy of self- and HCW-collected nasal vs throat swab specimens for COVID-19 rapid antigen testing.Design, Setting, and ParticipantsThis per-protocol multicenter randomized clinical trial was conducted from February 15 through March 25, 2022. The participants, individuals aged 16 years or older requesting a COVID-19 test for diagnostic or screening purposes, had 4 specimens collected for individual testing at 1 of 2 urban COVID-19 outpatient test centers in Copenhagen, Denmark.InterventionsParticipants were randomized 1:1 to self-collected or HCW-collected nasal and throat swab specimens for rapid antigen testing. Additional HCW-collected nasal and throat swab specimens for reverse transcriptase–polymerase chain reaction (RT-PCR) were used as the reference standard.Main Outcomes and MeasuresThe primary outcome was sensitivity to diagnose COVID-19 of a self- vs HCW-collected nasal and throat specimen for rapid antigen testing compared with RT-PCR.ResultsOf 2941 participants enrolled, 2674 (90.9%) had complete test results and were included in the final analysis (1535 [57.4%] women; median age, 40 years [IQR, 28-55 years]); 1074 (40.2%) had COVID-19 symptoms, and 827 (30.9%) were positive for SARS-CoV-2 by RT-PCR. Health care worker–collected throat specimens had higher mean sensitivity than HCW-collected nasal specimens for rapid antigen testing (69.4% [95% CI, 65.1%-73.6%] vs 60.0% [95% CI, 55.4%-64.5%]). However, a subgroup analysis of symptomatic participants found that self-collected nasal specimens were more sensitive than self-collected throat specimens for rapid antigen testing (mean sensitivity, 71.5% [95% CI, 65.3%-77.6%] vs 58.0% [95% CI, 51.2%-64.7%]; P &lt; .001). Combining nasal and throat specimens increased sensitivity for HCW- and self-collected specimens by 21.4 and 15.5 percentage points, respectively, compared with a single nasal specimen (both P &lt; .001).Conclusions and RelevanceThis randomized clinical trial found that a single HCW-collected throat specimen had higher sensitivity for rapid antigen testing for SARS-CoV-2 than a nasal specimen. In contrast, the self-collected nasal specimens had higher sensitivity than throat specimens for symptomatic participants. Adding a throat specimen to the standard practice of collecting a single nasal specimen could improve sensitivity for rapid antigen testing in health care and home-based settings.Trial RegistrationClinicalTrials.gov Identifier: NCT05209178

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Section: Jama Network Open | Infectious Diseasessupporting

confidence: 52%

Section: Discussionmentioning

confidence: 57%

COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker–Collected Nasal and Throat Swab Specimens

Todsen,

Jakobsen,

Grønlund

et al. 2023

JAMA Netw Open

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“…Only healthcare workers who completed a validated competency-based training programme were allowed to collect respiratory specimens for the SAMPLE trial to ensure standardised and high-quality specimen collection. 15 Denmark had one of the highest RT-PCR testing rates for SARS-CoV-2 per capita in the world and the SAMPLE participants were representative of the general urban population tested. 1 20 As 23 102 participants were enrolled during mass testing, the SAMPLE trial provides unique insight into the pattern of viral shedding during the initial infection stage of asymptomatic individuals not previously investigated.…”

Section: Discussionmentioning

confidence: 99%

“…The gag reflex makes OPS a challenging procedure, and there is a risk that the tongue and gums may be swabbed instead of the oropharyngeal cavity (palatine tonsils and the posterior oropharyngeal wall). As all healthcare workers in the SAMPLE trial completed an additional competency-based training programme, 15 we ensured a standardised collection of high-quality respiratory specimens from the different anatomical sites. Another difference compared with previous studies is the enrolment of many asymptomatic participants from mass testing.…”

Section: Discussionmentioning

confidence: 99%

“…To ensure standardised collection methods, respiratory specimens were only obtained by healthcare workers who had received additional competency-based training (see online supplemental appendix A for detailed training material). 15 16 All specimens were placed into separate sterile tubes with 2 mL of inactivation transport medium (Wuxi NEST Biotechnology).…”

Section: Methodsmentioning

confidence: 99%

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Higher SARS-CoV-2 detection of oropharyngeal compared with nasopharyngeal or saliva specimen for molecular testing: a multicentre randomised comparative accuracy study

Todsen

Tolsgaard

Benfield

et al. 2023

Thorax

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BackgroundTesting is critical for detecting SARS-CoV-2 infection, but the best sampling method remains unclear.ObjectivesTo determine whether nasopharyngeal swab (NPS), oropharyngeal swab (OPS) or saliva specimen collection has the highest detection rate for SARS-CoV-2 molecular testing.MethodsWe conducted a randomised clinical trial at two COVID-19 outpatient test centres where NPS, OPS and saliva specimens were collected by healthcare workers in different orders for reverse transcriptase PCR testing. The SARS-CoV-2 detection rate was calculated as the number positive by a specific sampling method divided by the number in which any of the three sampling methods was positive. As secondary outcomes, test-related discomfort was measured with an 11-point numeric scale and cost-effectiveness was calculated.ResultsAmong 23 102 adults completing the trial, 381 (1.65%) were SARS-CoV-2 positive. The SARS-CoV-2 detection rate was higher for OPSs, 78.7% (95% CI 74.3 to 82.7), compared with NPSs, 72.7% (95% CI 67.9 to 77.1) (p=0.049) and compared with saliva sampling, 61.9% (95% CI 56.9 to 66.8) (p<0.001). The discomfort score was highest for NPSs, at 5.76 (SD, 2.52), followed by OPSs, at 3.16 (SD 3.16) and saliva samples, at 1.03 (SD 18.8), p<0.001 between all measurements. Saliva specimens were associated with the lowest cost, and the incremental costs per detected SARS-CoV-2 infection for NPSs and OPSs were US$3258 and US$1832, respectively.ConclusionsOPSs were associated with higher SARS-CoV-2 detection and lower test-related discomfort than NPSs for SARS-CoV-2 testing. Saliva sampling had the lowest SARS-CoV-2 detection but was the least costly strategy for mass testing.Trial registration numberNCT04715607.

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Molecular detection of SARS-CoV-2 from throat swabs performed with or without specimen collection from the palatine tonsils: Proposal for a multicenter randomized controlled trial (Preprint)

Hartvigsen,

Jakobsen,

Benfield

et al. 2023

JMIR Research Protocols

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Background Testing for SARS-CoV-2 is essential to provide early COVID-19 treatment for people at high risk of severe illness and to limit the spread of infection in society. Proper upper respiratory specimen collection is the most critical step in the diagnosis of the SARS-CoV-2 virus in public settings, and throat swabs were the preferred specimens used for mass testing in many countries during the COVID-19 pandemic. However, there is still a discussion about whether throat swabs have a high enough sensitivity for SARS-CoV-2 diagnostic testing, as previous studies have reported a large variability in the sensitivity from 52% to 100%. Many previous studies exploring the diagnostic accuracy of throat swabs lack a detailed description of the sampling technique, which makes it difficult to compare the different diagnostic accuracy results. Some studies perform a throat swab by only collecting specimens from the posterior oropharyngeal wall, while others also include a swab of the palatine tonsils for SARS-CoV-2 testing. However, studies suggest that the palatine tonsils could have a tissue tropism for SARS-CoV-2 that may improve the SARS-CoV-2 detection during sampling. This may explain the variation of sensitivity reported, but no clinical studies have yet explored the differences in sensitivity and patient discomfort whether the palatine tonsils are included during the throat swab or not. Objective The objective of this study is to examine the sensitivity and patient discomfort of a throat swab including the palatine tonsils compared to only swabbing the posterior oropharyngeal wall in molecular testing for SARS-CoV-2. Methods We will conduct a randomized controlled study to compare the molecular detection rate of SARS-CoV-2 by a throat swab performed from the posterior oropharyngeal wall and the palatine tonsils (intervention group) or the posterior oropharyngeal wall only (control group). Participants will be randomized in a 1:1 ratio. All participants fill out a baseline questionnaire upon enrollment in the trial, examining their reason for being tested, symptoms, and previous tonsillectomy. A follow-up questionnaire will be sent to participants to explore the development of symptoms after testing. Results A total of 2315 participants were enrolled in this study between November 10, 2022, and December 22, 2022. The results from the follow-up questionnaire are expected to be completed at the beginning of 2024. Conclusions This randomized clinical trial will provide us with information about whether throat swabs including specimens from the palatine tonsils will improve the diagnostic sensitivity for SARS-CoV-2 molecular detection. These results can, therefore, be used to improve future testing recommendations and provide additional information about tissue tropism for SARS-CoV-2. Trial Registration ClinicalTrials.gov NCT05611203; https://clinicaltrials.g...

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Valid and Reliable Assessment of Upper Respiratory Tract Specimen Collection Skills during the COVID-19 Pandemic

Cited by 6 publications

References 27 publications

COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker–Collected Nasal and Throat Swab Specimens

COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker–Collected Nasal and Throat Swab Specimens

Higher SARS-CoV-2 detection of oropharyngeal compared with nasopharyngeal or saliva specimen for molecular testing: a multicentre randomised comparative accuracy study

Molecular detection of SARS-CoV-2 from throat swabs performed with or without specimen collection from the palatine tonsils: Proposal for a multicenter randomized controlled trial (Preprint)

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