Background As SARS-CoV-2 testing expands, particularly to widespread asymptomatic testing, high sensitivity point-of-care PCR platforms may optimise potential benefits from pooling multiple patients’ samples. Method We tested patients and asymptomatic citizens for SARS-CoV-2, exploring the efficiency and utility of CovidNudge (i) for detection in individuals’ sputum (compared to nasopharyngeal swabs), (ii) for detection in pooled sputum samples, and (iii) by modelling roll out scenarios for pooled sputum testing. Results Across 295 paired samples, we find no difference ( p = 0.1236) in signal strength for sputum (mean amplified replicates (MAR) 25.2, standard deviation (SD) 14.2, range 0–60) compared to nasopharyngeal swabs (MAR 27.8, SD 12.4, range 6–56). At 10-sample pool size we find some drop in absolute strength of signal (individual sputum MAR 42.1, SD 11.8, range 13–60 vs. pooled sputum MAR 25.3, SD 14.6, range 1–54; p < 0.0001), but only marginal drop in sensitivity (51/53,96%). We determine a limit of detection of 250 copies/ml for an individual test, rising only four-fold to 1000copies/ml for a 10-sample pool. We find optimal pooled testing efficiency to be a 12–3-1-sample model, yet as prevalence increases, pool size should decrease; at 5% prevalence to maintain a 75% probability of negative first test, 5-sample pools are optimal. Conclusion We describe for the first time the use of sequentially dipped sputum samples for rapid pooled point of care SARS-CoV-2 PCR testing. The potential to screen asymptomatic cohorts rapidly, at the point-of-care, with PCR, offers the potential to quickly identify and isolate positive individuals within a population “bubble”. Supplementary Information The online version contains supplementary material available at 10.1186/s12879-021-06316-z.
【저자키워드】 COVID-19, coronavirus, molecular diagnostics, PCR, 【초록키워드】 SARS-CoV-2, point of care, sputum, Prevalence, Probability, Nasopharyngeal swab, point-of-care, sensitivity, PCR testing, Cohort, Asymptomatic, SARS-CoV-2 testing, nasopharyngeal swabs, Patient, limit of detection, utility, platform, Efficiency, SARS-CoV-2 PCR testing, Sputum sample, Standard deviation, supplementary material, Increases, no difference, signal, potential benefits, first test, sputum samples, positive individuals, offer, widespread, Result, tested, amplified, identify, replicate, determine, potential benefit, maintain, rising, MAR, positive individual, 【제목키워드】 point-of-care, molecular, utility, Efficiency,