Prospective population-level validation of the Abbott ID NOW severe acute respiratory syndrome coronavirus 2 device implemented in multiple settings for testing asymptomatic and symptomatic individuals.

OBJECTIVE: Diagnostic evaluation of the ID NOW coronavirus disease 2019 (COVID-19) assay in various real-world settings among symptomatic and asymptomatic individuals. METHODS: Depending on the setting, the ID NOW testing was performed using oropharyngeal swabs (OPSs) taken from patients with symptoms suggestive of COVID-19, asymptomatic close contacts, or asymptomatic individuals as part of outbreak point prevalence screening. From January to April 2021, a select number of sites switched from using OPS to combined oropharyngeal and nasal swab (O + NS) for ID NOW testing. For every individual tested, two swabs were collected by a health care worker: one swab (OPS or O + NS) for ID NOW testing and a separate swab (OPS or nasopharyngeal swab) for RT-PCR. RESULTS: A total of 129 112 paired samples were analysed (16 061 RT-PCR positive). Of these, 81 697 samples were from 42 COVID-19 community collection sites, 16 924 samples were from 69 rural hospitals, 1927 samples were from nine emergency shelters and addiction treatment facilities, 23 802 samples were from six mobile units that responded to 356 community outbreaks, and 4762 O + NS swabs were collected from three community collection sites and one emergency shelter. The ID NOW assay sensitivity was the highest among symptomatic individuals presenting to community collection sites (92.5%; 95% CI, 92.0-93.0%) and the lowest for asymptomatic individuals associated with community outbreaks (73.9%; 95% CI, 69.8-77.7%). Specificity was >99% in all populations tested. DISCUSSION: The sensitivity of ID NOW severe acute respiratory syndrome coronavirus 2 testing is the highest when used in symptomatic community populations not seeking medical care. Sensitivity and positive predictive value drop by approximately 10% when tested on asymptomatic populations. Using combined oropharyngeal and nasal swabs did not improve the performance of ID NOW assay.

Face Masks Impact Auditory and Audiovisual Consonant Recognition in Children With and Without Hearing Loss.

Teachers and students are wearing face masks in many classrooms to limit the spread of the coronavirus. Face masks disrupt speech understanding by concealing lip-reading cues and reducing transmission of high-frequency acoustic speech content. Transparent masks provide greater access to visual speech cues than opaque masks but tend to cause greater acoustic attenuation. This study examined the effects of four types of face masks on auditory-only and audiovisual speech recognition in 18 children with bilateral hearing loss, 16 children with normal hearing, and 38 adults with normal hearing tested in their homes, as well as 15 adults with normal hearing tested in the laboratory. Stimuli simulated the acoustic attenuation and visual obstruction caused by four different face masks: hospital, fabric, and two transparent masks. Participants tested in their homes completed auditory-only and audiovisual consonant recognition tests with speech-spectrum noise at 0 dB SNR. Adults tested in the lab completed the same tests at 0 and/or -10 dB SNR. A subset of participants from each group completed a visual-only consonant recognition test with no mask. Consonant recognition accuracy and transmission of three phonetic features (place of articulation, manner of articulation, and voicing) were analyzed using linear mixed-effects models. Children with hearing loss identified consonants less accurately than children with normal hearing and adults with normal hearing tested at 0 dB SNR. However, all the groups were similarly impacted by face masks. Under auditory-only conditions, results were consistent with the pattern of high-frequency acoustic attenuation; hospital masks had the least impact on performance. Under audiovisual conditions, transparent masks had less impact on performance than opaque masks. High-frequency attenuation and visual obstruction had the greatest impact on place perception. The latter finding was consistent with the visual-only feature transmission data. These results suggest that the combination of noise and face masks negatively impacts speech understanding in children. The best mask for promoting speech understanding in noisy environments depend on whether visual cues will be accessible: hospital masks are best under auditory-only conditions, but well-fit transparent masks are best when listeners have a clear, consistent view of the talker's face.

Influence of Protective Face Coverings on the Speech Recognition of Cochlear Implant Patients.

OBJECTIVES: The objectives were to characterize the effects of wearing face coverings on: 1) acoustic speech cues, and 2) speech recognition of patients with hearing loss who listen with a cochlear implant. METHODS: A prospective cohort study was performed in a tertiary referral center between July and September 2020. A female talker recorded sentences in three conditions: no face covering, N95 mask, and N95 mask plus a face shield. Spectral differences were analyzed between speech produced in each condition. The speech recognition in each condition for twenty-three adult patients with at least 6 months of cochlear implant use was assessed. RESULTS: Spectral analysis demonstrated preferential attenuation of high-frequency speech information with the N95 mask plus face shield condition compared to the other conditions. Speech recognition did not differ significantly between the uncovered (median 90% [IQR 89%-94%]) and N95 mask conditions (91% [IQR 86%-94%]; P = .253); however, speech recognition was significantly worse in the N95 mask plus face shield condition (64% [IQR 48%-75%]) compared to the uncovered (P < .001) or N95 mask (P < .001) conditions. CONCLUSIONS: The type and combination of protective face coverings used have differential effects on attenuation of speech information, influencing speech recognition of patients with hearing loss. In the face of the COVID-19 pandemic, there is a need to protect patients and clinicians from spread of disease while maximizing patient speech recognition. The disruptive effect of wearing a face shield in conjunction with a mask may prompt clinicians to consider alternative eye protection, such as goggles, in appropriate clinical situations. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:E2038-E2043, 2021.

Evaluation of Six Commercial Mid- to High-Volume Antibody and Six Point-of-Care Lateral Flow Assays for Detection of SARS-CoV-2 Antibodies.

Coronavirus disease (COVID) serological tests are essential to determine the overall seroprevalence of a population and to facilitate exposure estimates within that population. We performed a head-to-head assessment of enzyme immunoassays (EIAs) and point-of-care lateral flow assays (POCTs) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies. Demographics, symptoms, comorbidities, treatment, and mortality of patients whose sera were used were also reviewed. Six EIAs (Abbott, Affinity, Bio-Rad, DiaSorin, Euroimmun, and Roche) and six POCTs (BTNX, Biolidics, Deep Blue, Genrui, Getein BioTech, and Innovita) were evaluated for the detection of SARS-CoV-2 antibodies in known COVID-19-infected individuals. Sensitivity of EIAs ranged from 50 to 100%, with only four assays having overall sensitivities of >95% after 21 days after symptom onset. Notably, cross-reactivity with other respiratory viruses (parainfluenza virus [PIV-4] [n = 5], human metapneumovirus [hMPV] [n = 3], rhinovirus/enterovirus [n = 1], CoV-229E [n = 2], CoV-NL63 [n = 2], and CoV-OC43 [n = 2]) was observed; however, overall specificity of EIAs was good (92 to 100%; all but one assay had specificity above 95%). POCTs were 0 to 100% sensitive >21 days after onset, with specificity ranging from 96 to 100%. However, many POCTs had faint banding and were often difficult to interpret. Serology assays can detect SARS-CoV-2 antibodies as early as 10 days after symptom onset. Serology assays vary in their sensitivity based on the marker (IgA/IgM versus IgG versus total) and by manufacturer; however, overall only 4 EIAs and 4 POCTs had sensitivities of >95% >21 days after symptom onset. Cross-reactivity with other seasonal coronaviruses is of concern. Serology assays should not be used for the diagnosis of acute infection but rather in carefully designed serosurveys to facilitate understanding of seroprevalence in a population and to identify previous exposure to SARS-CoV-2.