Dataset Information

Universal admission screening for COVID-19 using quantitative antigen testing and questionnaire screening to prevent nosocomial spread.

ABSTRACT:

Background

In this study, we investigated diagnostic accuracy of quantitative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen testing and whether universal screening was effective to prevent a nosocomial outbreak of coronavirus disease 2019 (COVID-19).

Methods

All adult patients admitted to an acute-care hospital in Tokyo, Japan, after receiving LUMIPULSE SARS-CoV-2 Ag using a nasopharyngeal swab and a brief questionnaire to evaluate symptoms and exposures from December 3, 2020 to March 20, 2021 were included.

Results

Of the 5191 patients, 53 were antigen-positive, 19 were inconclusive and 5119 were negative. The sensitivity and specificity (positive or inconclusive results) of the quantitative antigen test for COVID-19 diagnosis at admission was 0.957 (95% confidence interval [CI]: 0.855-0.995) and 0.995 (95% CI: 0.992-0.997), respectively. Six asymptomatic patients were identified on admission. Two patients were antigen-negative and diagnosed with COVID-19 later; however, they had been isolated prior to diagnosis because both had symptoms of COVID-19 and exposure. No nosocomial infections occurred during the period.

Conclusion

Quantitative SARS-CoV-2 antigen testing was found to be valid for the early detection of asymptomatic COVID-19 patients as a universal screening test on admission.

SUBMITTER: Morishima M

PROVIDER: S-EPMC9648767 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Universal admission screening for COVID-19 using quantitative antigen testing and questionnaire screening to prevent nosocomial spread.

Morishima Masayo M Kimura Muneyoshi M Sakoh Takashi T Yamamuro Ryosuke R Ogura Sho S Takahashi Namiko N Baba Masaru M Herai Takashi T Endo Shigeyuki S Taniguchi Shuichi S Araoka Hideki H

PloS one 20221110 11

<h4>Background</h4>In this study, we investigated diagnostic accuracy of quantitative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen testing and whether universal screening was effective to prevent a nosocomial outbreak of coronavirus disease 2019 (COVID-19).<h4>Methods</h4>All adult patients admitted to an acute-care hospital in Tokyo, Japan, after receiving LUMIPULSE SARS-CoV-2 Ag using a nasopharyngeal swab and a brief questionnaire to evaluate symptoms and exposures fro ...[more]

PMID: 36355849

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Project description:The majority of SARS-CoV-2 transmissions originates from either asymptomatic or presymptomatic individuals. To prevent unnoticed introduction of SARS-CoV-2, many hospitals have implemented universal admission screening during the COVID-19 pandemic. The present study aimed to investigate associations between results of an universal SARS-CoV-2 admission screening and public SARS-CoV-2 incidence. Over a study period of 44 weeks, all patients admitted to a large tertiary care hospital were tested for SARS-CoV-2 by polymerase chain reaction. SARS-CoV-2 positive patients were retrospectively categorized as symptomatic or asymptomatic at admission. Cantonal data were used to calculate weekly incidence rates per 100,000 inhabitants. We used regression models for count data to assess the association of the weekly cantonal incidence rate and the proportion of positive SARS-CoV-2 tests in the canton with (a) the proportion of SARS-CoV-2 positive individuals and (b) the proportion of asymptomatic SARS-CoV-2 infected individuals identified in universal admission screening, respectively. In a 44-week period, a total of 21,508 admission screenings were performed. SARS-CoV-2 PCR was positive in 643 (3.0%) individuals. In 97 (15.0%) individuals, the positive PCR reflected residual viral replication after recent COVID-19, 469 (72.9%) individuals had COVID-19 symptoms and 77 (12.0%) SARS-CoV-2 positive individuals were asymptomatic. Cantonal incidence correlated with the proportion of SARS-CoV-2 positive individuals [rate ratio (RR): 2.03 per 100 point increase of weekly incidence rate, 95%CI 1.92-2.14] and the proportion of asymptomatic SARS-CoV-2 positive individuals (RR: 2.40 per 100 point increase of weekly incidence rate, 95%CI 2.03-2.82). The highest correlation between dynamics in cantonal incidence and results of admission screening was observed at a lag time of one week. Similarly, the proportion of positive SARS-CoV-2 tests in the canton of Zurich correlated with the proportion of SARS-CoV-2 positive individuals (RR: 2.86 per log increase in the proportion of positive SARS-CoV-2 tests in the canton, 95%CI 2.56-3.19) and the proportion of asymptomatic SARS-CoV-2 positive individuals (RR: 6.50 per log increase in the proportion of positive SARS-CoV-2 tests in the canton, 95%CI 3.93-10.75) in admission screening. Around 0.36% of admission screenings were positive in asymptomatic patients. Admission screening results paralleled changes in population incidence with a brief lag.

Project description:BackgroundQuantitative RT-PCR (RT-qPCR) of nasopharyngeal swab (NPS) samples for SARS-CoV-2 detection requires medical personnel and is time consuming, and thus is poorly suited to mass screening. In June, 2020, a chemiluminescent enzyme immunoassay (CLEIA; Lumipulse G SARS-CoV-2 Ag kit, Fujirebio, Tokyo, Japan) was developed that can detect SARS-CoV-2 nucleoproteins in NPS or saliva samples within 35 min. In this study, we assessed the utility of CLEIA in mass SARS-CoV-2 screening.MethodsWe did a diagnostic accuracy study to develop a mass-screening strategy for salivary detection of SARS-CoV-2 by CLEIA, enrolling hospitalised patients with clinically confirmed COVID-19, close contacts identified at community health centres, and asymptomatic international arrivals at two airports, all based in Japan. All test participants were enrolled consecutively. We assessed the diagnostic accuracy of CLEIA compared with RT-qPCR, estimated according to concordance (Kendall's coefficient of concordance, W), and sensitivity (probability of CLEIA positivity given RT-qPCR positivity) and specificity (probability of CLEIA negativity given RT-qPCR negativity) for different antigen concentration cutoffs (0·19 pg/mL, 0·67 pg/mL, and 4·00 pg/mL; with samples considered positive if the antigen concentration was equal to or more than the cutoff and negative if it was less than the cutoff). We also assessed a two-step testing strategy post hoc with CLEIA as an initial test, using separate antigen cutoff values for test negativity and positivity from the predefined cutoff values. The proportion of intermediate results requiring secondary RT-qPCR was then quantified assuming prevalence values of RT-qPCR positivity in the overall tested population of 10%, 30%, and 50%.FindingsSelf-collected saliva was obtained from 2056 participants between June 12 and Aug 6, 2020. Results of CLEIA and RT-qPCR were concordant in 2020 (98·2%) samples (Kendall's W=0·99). Test sensitivity was 85·4% (76 of 89 positive samples; 90% credible interval [CrI] 78·0-90·3) at the cutoff of 0·19 pg/mL; 76·4% (68 of 89; 68·2-82·8) at the cutoff of 0·67 pg/mL; and 52·8% (47 of 89; 44·1-61·3) at the cutoff of 4·0 pg/mL. Test specificity was 91·3% (1796 of 1967 negative samples; 90% CrI 90·2-92·3) at the cutoff of 0·19 pg/mL, 99·2% (1952 of 1967; 98·8-99·5) at the cutoff of 0·67 pg/mL, and 100·0% (1967 of 1967; 99·8-100·0) at the cutoff of 4·00 pg/mL. Using a two-step testing strategy with a CLEIA negativity cutoff of 0·19 pg/mL (to maximise sensitivity) and a CLEIA positivity cutoff of 4·00 pg/mL (to maximise specificity), the proportions of indeterminate results (ie, samples requiring secondary RT-qPCR) would be approximately 11% assuming a prevalence of RT-qPCR positivity of 10%, 16% assuming a prevalence of RT-qPCR positivity of 30%, and 21% assuming a prevalence of RT-qPCR positivity of 50%.InterpretationCLEIA testing of self-collected saliva is simple and provides results quickly, and is thus suitable for mass testing. To improve accuracy, we propose a two-step screening strategy with an initial CLEIA test followed by confirmatory RT-qPCR for intermediate concentrations, varying positive and negative thresholds depending on local prevalence. Implementation of this strategy has expedited sample processing at Japanese airports since July, 2020, and might apply to other large-scale mass screening initiatives.FundingMinistry of Health, Labour and Welfare, Japan.

Dataset Information

Universal admission screening for COVID-19 using quantitative antigen testing and questionnaire screening to prevent nosocomial spread.

Background

Methods

Results

Conclusion

Publications

Universal admission screening for COVID-19 using quantitative antigen testing and questionnaire screening to prevent nosocomial spread.

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