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Results of a pilot study using self-collected mid-turbinate nasal swabs for detection of influenza virus infection among pregnant women.

ABSTRACT: We evaluated the feasibility of asking pregnant women to self-collect and ship respiratory specimens.In a preliminary laboratory study, we compared the RT-PCR cycle threshold (CT) values of influenza A and B viruses incubated at 4 storage temperatures (from 4 to 35°C) for 6 time periods (8, 24, 48, 72, and 168 hours and 30 days), resulting in 24 conditions that were compared to an aliquot tested after standard freezing (-20°C) (baseline condition). In a subsequent pilot study, during January-February, 2014, we delivered respiratory specimen collection kits to 53 pregnant women with a medically attended acute respiratory illness using three delivery methods.CT values were stable after storage at temperatures <27°C for up to 72 hours for influenza A viruses and 48 hours for influenza B viruses. Of 53 women who received kits during the pilot, 89% collected and shipped nasal swabs as requested. However, 30% (14/47) of the women took over 2 days to collect and ship their specimen. The human control gene, ribonuclease P (RNase P), was detected in 100% of nasal swab specimens. However, the mean CT values for RNase P (26.5, 95% confidence interval [CI] = 26.0-27.1) and for the 8 influenza A virus positives in our pilot (32.2, 95% CI = 28.9-35.5) were significantly higher than the CTs observed in our 2010-2012 study using staff-collected nasal pharyngeal swabs (P-values < 0.01).Self-collection of respiratory specimens is a promising research method, but further research is needed to quantify the sensitivity and specificity of the approach.

SUBMITTER: Thompson MG

PROVIDER: S-EPMC4415700 | biostudies-other | 2015 May

REPOSITORIES: biostudies-other

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Results of a pilot study using self-collected mid-turbinate nasal swabs for detection of influenza virus infection among pregnant women.

Thompson Mark G MG Ferber Jeannette R JR Odouli Roxana R David Donna D Shifflett Pat P Meece Jennifer K JK Naleway Allison L AL Bozeman Sam S Spencer Sarah M SM Fry Alicia M AM Li De-Kun DK

Influenza and other respiratory viruses 20150501 3

<h4>Background</h4>We evaluated the feasibility of asking pregnant women to self-collect and ship respiratory specimens.<h4>Methods</h4>In a preliminary laboratory study, we compared the RT-PCR cycle threshold (CT) values of influenza A and B viruses incubated at 4 storage temperatures (from 4 to 35°C) for 6 time periods (8, 24, 48, 72, and 168 hours and 30 days), resulting in 24 conditions that were compared to an aliquot tested after standard freezing (-20°C) (baseline condition). In a subsequ ...[more]

PMID: 25711978

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Project description:OBJECTIVES: Swab-based nasal screening is commonly used to identify asymptomatic carriage of Staphylococcus aureus in patients. Bacterial detection depends on the uptake and release capacities of the swabs and on the swabbing technique itself. This study investigates the performance of different swab-types in nasal MRSA-screening by utilizing a unique artificial nose model to provide realistic and standardized screening conditions. METHODS: An anatomically correct artificial nose model was inoculated with a numerically defined mixture of MRSA and Staphylococcus epidermidis bacteria at quantities of 4×10(2) and 8×10(2) colony forming units (CFU), respectively. Five swab-types were tested following a strict protocol. Bacterial recovery was measured for direct plating and after elution into Amies medium by standard viable count techniques. RESULTS: Mean recovered bacteria quantities varied between 209 and 0 CFU for MRSA, and 365 and 0 CFU for S. epidermidis, resulting swab-type-dependent MRSA-screening-sensitivities ranged between 0 and 100%. Swabs with nylon flocked tips or cellular foam tips performed significantly better compared to conventional rayon swabs referring to the recovered bacterial yield (p<0.001). Best results were obtained by using a flocked swab in combination with Amies preservation medium. Within the range of the utilized bacterial concentrations, recovery ratios for the particular swab-types were independent of the bacterial species. CONCLUSIONS: This study combines a realistic model of a human nose with standardized laboratory conditions to analyze swab-performance in MRSA-screening situations. Therefore, influences by inter-individual anatomical differences as well as diverse colonization densities in patients could be excluded. Recovery rates vary significantly between different swab-types. The choice of the swab has a great impact on the laboratory result. In fact, the swab-type contributes significantly to true positive or false negative detection of nasal MRSA carriage. These findings should be considered when screening a patient.

Project description:IntroductionMost SARS-CoV-2 antigen-detecting rapid diagnostic tests require nasopharyngeal sampling, which is frequently perceived as uncomfortable and requires healthcare professionals, thus limiting scale-up. Nasal sampling could enable self-sampling and increase acceptability. The term nasal sampling is often not used uniformly and sampling protocols differ.MethodsThis manufacturer-independent, prospective diagnostic accuracy study, compared professional anterior nasal and nasal mid-turbinate sampling for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test. The second group of participants collected a nasal mid-turbinate sample themselves and underwent a professional nasopharyngeal swab for comparison. The reference standard was real-time polymerase chain reaction (RT-PCR) using combined oro-/nasopharyngeal sampling. Individuals with high suspicion of SARS-CoV-2 infection were tested. Sensitivity, specificity, and percent agreement were calculated. Self-sampling was observed without intervention. Feasibility was evaluated by observer and participant questionnaires.ResultsAmong 132 symptomatic adults, both professional anterior nasal and nasal mid-turbinate sampling yielded a sensitivity of 86.1% (31/36 RT-PCR positives detected; 95%CI: 71.3-93.9) and a specificity of 100.0% (95%CI: 95.7-100). The positive percent agreement was 100% (95%CI: 89.0-100). Among 96 additional adults, self nasal mid-turbinate and professional nasopharyngeal sampling yielded an identical sensitivity of 91.2% (31/34; 95%CI 77.0-97.0). Specificity was 98.4% (95%CI: 91.4-99.9) with nasal mid-turbinate and 100.0% (95%CI: 94.2-100) with nasopharyngeal sampling. The positive percent agreement was 96.8% (95%CI: 83.8-99.8). Most participants (85.3%) considered self-sampling as easy to perform.ConclusionProfessional anterior nasal and nasal mid-turbinate sampling are of equivalent accuracy for an antigen-detecting rapid diagnostic test in ambulatory symptomatic adults. Participants were able to reliably perform nasal mid-turbinate sampling themselves, following written and illustrated instructions. Nasal self-sampling will facilitate scaling of SARS-CoV-2 antigen testing.

Dataset Information

Results of a pilot study using self-collected mid-turbinate nasal swabs for detection of influenza virus infection among pregnant women.

Publications

Results of a pilot study using self-collected mid-turbinate nasal swabs for detection of influenza virus infection among pregnant women.

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