A Cost, Time, and Demographic Analysis of Participant Recruitment and Urine Sample Collection Through Social Media Optimization.

INTRODUCTION: Clinical research can be expensive and time consuming due to high associated costs and/or duration of the study. We hypothesized that urine sample collection using online recruitment and engagement of research participants via social medial has the potential to reach a large population in a small timeframe, at a reasonable cost. METHODS: We performed a retrospective cost analysis of a cohort study comparing cost per sample and time per sample for both online and clinically recruited participants for urine sample collection. During this time, cost data were collected based on study associated costs from invoices and budget spreadsheets. The data were subsequently analyzed using descriptive statistics. RESULTS: Each sample collection kit contained 3 urine cups, 1 for the disease sample and 2 for control samples. Out of the 3,576 (1,192 disease + 2,384 control) total sample cups mailed, 1,254 (695 control) samples were returned. Comparatively, the 2 clinical sites collected 305 samples. Although the initial startup cost of online recruitment was higher, cost per sample for online recruited was found to be $81.45 compared to $398.14 for clinic sample. CONCLUSIONS: We conducted a nationwide, contactless, urine sample collection through online recruitment in the midst of the COVID-19 pandemic. Results were compared with the samples collected in the clinical setting. Online recruitment can be utilized to collect urine samples rapidly, efficiently, and at a cost per sample that was 20% of an in-person clinic, and without risk of COVID-19 exposure.

Using social media to crowdsource collection of urine samples during a national pandemic.

The COVID-19 pandemic and subsequent lockdown had a substantial impact on normal research operations. Researchers needed to adapt their methods to engage at-home participants. One method is crowdsourcing, in which researchers use social media to recruit participants, gather data, and collect samples. We utilized this method to develop a diagnostic test for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Participants were recruited via posts on popular social-media platforms, and enrolled via a website. Participants received and returned a mail kit containing bladder symptom surveys and a urine sample cup containing room-temperature preservative. Using this method, we collected 1254 IC/BPS and control samples in 3 months from all 50 United States. Our data demonstrate that crowdsourcing is a viable alternative to traditional research, with the ability to reach a broad patient population rapidly. Crowdsourcing is a powerful tool for at-home participation in research, particularly during the lockdown caused by the COVID-19 pandemic.

Urine Cytokines as biomarkers in COVID-19 Patients

Introduction COVID-19 pandemic has been one of the main global health concerns in 2020, and many aspects of the disease remain enigmatic. While some patients infected with the disease-causing virus SARS-CoV2 have no or mild symptoms, others experience severe symptoms requiring hospitalization. Of these more severe patients, some remain stable while others experience cytokine storm syndrome or an exaggerated immune response that has been correlated with disease severity and progression of acute respiratory deterioration. It is currently unknown why some patients with COVID-19 demonstrate this response and others do not. In light of the apparent prominent role of the inflammatory mediators (i.e. cytokines) in COVID-19 pathogenesis, the ability to identify screening tools not only for the SARS-CoV2 virus but also for cytokines is important. The present investigation was designed to identify the urinary cytokine signature in COVID-19 patients. Methods The study enrolled 17 COVID-19 patients and 10 control subjects (SARS-CoV-2 negative) 18 years or older with glomerular filtration rate of > 60mL/min. Urine samples were collected and cytokines quantitated using the Luminex multiplex assay. The cytokines analyzed were growth-regulated oncogene (GRO), interleukin-8 (IL-8), and interleukin-6 (IL-6). Results The levels of GRO and IL-6 were significantly elevated in urine samples obtained from COVID-19 patients compared to controls (mean 16.8 pg/ml vs. 9.2 pg/ml ± 2.39, p < 0.0171 and mean 16.8 pg/ml vs 9.2 pg/ml ± 2.42, p < 0.0157, respectively). Conversely, IL-8 level was similar between COVID-19 patients and controls (15.6 pg/ml vs 11.3 pg/ml ± 1.3, p<0.1833). Conclusion The present investigation found that the levels of urinary cytokines GRO and IL-6 were significantly elevated in COVID-19 patients compared to controls and may serve as urinary biomarkers of disease progression. Furthermore, IL-8 although elevated in COVID-19 patients, did not reach statistical significance in our population sample. The findings of this proof of concept study underscore that the urinary cytokines may serve as prognostic and diagnostic accessible biomarkers in COVID-19.

Rapid detection of novel coronavirus/Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by reverse transcription-loop-mediated isothermal amplification.

Novel Corona virus/Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or 2019-nCoV), and the subsequent disease caused by the virus (coronavirus disease 2019 or COVID-19), is an emerging global health concern that requires a rapid diagnostic test. Quantitative reverse transcription PCR (qRT-PCR) is currently the standard for SARS-CoV-2 detection; however, Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) may allow for faster and cheaper field based testing at point-of-risk. The objective of this study was to develop a rapid screening diagnostic test that could be completed in 30-45 minutes. Simulated patient samples were generated by spiking serum, urine, saliva, oropharyngeal swabs, and nasopharyngeal swabs with a portion of the SARS-CoV-2 nucleic sequence. RNA isolated from nasopharyngeal swabs collected from actual COVID-19 patients was also tested. The samples were tested using RT-LAMP as well as by conventional qRT-PCR. Specificity of the RT-LAMP was evaluated by also testing against other related coronaviruses. RT-LAMP specifically detected SARS-CoV-2 in both simulated patient samples and clinical specimens. This test was performed in 30-45 minutes. This approach could be used for monitoring of exposed individuals or potentially aid with screening efforts in the field and potential ports of entry.