Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: A cross-sectional study
| Autor: | Moritz Grunwald, Platon Braun, Antonia Zapf, Susanne Pfefferle, Martin Aepfelbacher, Marc Lütgehetmann, Martin Christner, Flaminia Olearo, Anna Both, Kimani Gatzemeyer, Johannes K.-M. Knobloch, Armin Hoffman, Dominik Nörz, Cristina Belmar Campos, Gabriele Andersen |
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| Rok vydání: | 2021 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty Cross-sectional study Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Sensitivity and Specificity Asymptomatic Article Specimen Handling Workflow COVID-19 Testing Nasopharynx Internal medicine medicine Gargling Humans Saliva SARS Coronavirus 2 RT-PCR Testing Mass screening Retrospective Studies business.industry SARS-CoV-2 Clinical performance pooling gargle solution Healthcare worker COVID-19 Retrospective cohort study Infectious Diseases Cross-Sectional Studies mass Screening RNA Viral medicine.symptom business Delivery of Health Care |
| Zdroj: | The Journal of Infection |
| ISSN: | 1532-2742 |
| Popis: | Summary Introduction The large number of asymptomatic SARS-CoV-2 infections necessitates general screening of employees. We evaluate the performance of a SARS-CoV-2 screening program in asymptomatic healthcare-workers (HCW), utilizing self-sampled gargling-solution and sample pooling for RT-qPCR. Methods We conducted a cross-sectional retrospective study to collect real-life data on the performance of a screening-workflow based on automated-pooling and high-throughput qPCR testing over a 3-month-period at the University Hospital Hamburg. Results Matrix validation reveals that lower limit of detection for SARS-CoV-2 RNA in gargling-solution was 180 copies/mL (5-sample-pool). A total of 55,122 self-collected gargle samples (= 7513 HCWs) was analyzed. The median time to result was 8.5 hours (IQR 7.2–10.8). Of 11,192 pools analyzed, 11,041 (98.7%) were negative, 69 (0.6%) were positive and 82 (0.7%) were invalid. Individual testing of pool participants revealed 57 SARS-CoV-2 previously unrecognized infections. All 57 HCWs were either pre-symptomatic or asymptomatic (prevalence 0.76%,CI95%0.58–0.98%). Accuracy based on HCWs with gargle-solution and NP-swab available within 3-day-interval (N = 521) was 99.5% (CI95%98.3–99.9%), sensitivity 88.9% (CI95%65.3–98.6%) while specificity 99.8% (CI95%98.9–99.9). Conclusion This workflow was highly effective in identifying SARS-CoV-2 positive HCWs, thereby lowering the potential of inter-HCW and HCW-patient transmissions. Automated-sample-pooling helped to conserve qPCR reagents and represents a promising alternative strategy to antigen testing in mass-screening programs. |
| Databáze: | OpenAIRE |
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