Evaluation of a Digitally Guided Self-Rehabilitation Device Coupled With Telerehabilitation Monitoring in Patients With Parkinson Disease (TELEP@RK): Open, Prospective Observational Study.

BACKGROUND: Parkinson disease is a neurodegenerative disease causing a progressive loss of autonomy. This requires long-term rehabilitation care. Currently, new technologies are being developed for use in daily life, and there is a progressive implementation of telerehabilitation. OBJECTIVE: The aim of this study (the TELEP@RK study) is to evaluate the uses of a digital self-rehabilitation device in patients with Parkinson disease and their independent physiotherapists on the scale of a health territory. METHODS: A total of 10 independent physiotherapists and 31 patients with Parkinson disease were followed for 1 year to evaluate the use of a telerehabilitation tool (digital tablet and inertial sensor) via questionnaires of the Unified Theory of Acceptance and Use of Technology (UTAUT). The questionnaires were submitted to participants at 0, 2, and 12 months from the start of follow-up. The averages of the scores of the different determinants and constructs of the UTAUT questionnaires were compared at the different follow-up times. RESULTS: Among professionals, the averages of the various determinants were generally high at the beginning of the study with an average (out of 5) performance expectancy of 4.19, effort expectancy of 3.88, social influence of 3.95, facilitating conditions of 4, and intention to use of 3.97. These averages decreased over time. CONCLUSIONS: Acceptability, acceptance, and appropriation of the tool were very high among the physiotherapists as well as the patients, despite the tool's lack of evolution during the study. In the current health care context, these results allow us to envision a new organization of the care pathway for patients with chronic diseases, with the increased use of new technologies associated with telecare.

Exploratory Study on Application of MALDI-TOF-MS to Detect SARS-CoV-2 Infection in Human Saliva (preprint)

SARS-CoV-2 caused a large outbreak since its emergence in December 2019. The COVID-19 diagnosis became a priority to isolate and treat infected individuals in order to break the contamination chain. Currently, the reference test for COVID-19 diagnosis is the molecular detection (RT-qPCR) of the virus from nasopharyngeal swab (NPS) samples. Although this sensitive and specific test remains the gold standard, it has several limitations, such as the invasive collection method, the relative high cost and the duration of the test. Moreover, the material shortage to perform tests due to the discrepancy between the high demand for tests and the production capacities puts additional constraints on RT-qPCR. Here, we propose a PCR-free method for diagnosing SARS-CoV-2 based on Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) profiling and machine learning (ML) models from salivary samples. Kinetic saliva samples were collected at enrollment and ten and thirty days later (D0, D10 and D30), to assess the classification performance of the ML models compared to the molecular tests performed on NPS specimens. Spectra were generated using an optimized protocol of saliva collection and successive quality control steps were developed to ensure the reliability of spectra. A total of 360 averaged spectra were included in the study. At D0, the comparison of MS spectra from SARS-CoV-2 positive patients (n=105) with healthy healthcare controls (n=51) revealed nine peaks that significantly distinguished the two groups. Among the five ML models tested, Support Vector Machine with Linear Kernel (SVM-LK) provided the best performance on the training dataset (accuracy = 85.2 %, sensitivity = 85.1 %, specificity = 85.3 %, F1-Score = 85.1 %). The application of the SVM-LK model on independent datasets confirmed it performances with 88.9% and 80.8% of correct classification for samples collected at D0 and D30, respectively. Conversely, at D10, the proportion of correct classification fallen to 64.3%. The analysis of saliva samples by MALDI-TOF MS and ML appears as an interesting supplementary tool for COVID-19 diagnosis, despite the mitigated results obtained for convalescent patients (D10).

Mouth Washing Impaired SARS-CoV-2 Detection in Saliva (preprint)

Background. A previous study demonstrated the performance of the Salivette® (SARSTEDT, Numbrecht, Germany) as a homogeneous saliva collection system to diagnose COVID-19 by RT-qPCR, notably for symptomatic and asymptomatic patients. However, for convalescent patients, the corroboration of molecular detection of SARS-CoV-2 in paired nasopharyngeal swabs (NPS) and saliva samples was unsatisfactory. Objectives. The aim of the present work was to assess the concordance level of SARS-CoV-2 detection between paired sampling of NPSs and saliva collected with Salivette® at two time points, with ten days of interval. Results. A total of 319 paired samples from 145 outpatients (OP) and 51 healthcare workers (HW) were collected. Due to significant waiting rate at hospital, most of the patients ate and/or drank in waiting their turn. Consequently, a mouth washing was systematically proposed prior saliva collection. None of the HW were diagnosed SARS-CoV-2 positive using NPS or saliva specimens at both time points (n=95) by RT-qPCR. The virus was detected in 56.3% (n=126/224) of the NPS samples from OP, but solely 26.8% (n=60/224) of the paired saliva specimens. The detection of the internal cellular control, the human RNase P, in more than 98% of the saliva samples, underlined that the low sensitivity of saliva specimens (45.2%) for SARS-CoV-2 detection was not attributed to an improper saliva sample storing or RNA extraction. Conclusions. Then, the mouth washing decreased viral load of buccal cavity conducting to impairment of SARS-CoV-2 detection. Viral loads in saliva neo-produced appeared insufficient for molecular detection of SARS-CoV-2. At the time that saliva tests could be a rapid, simple and noninvasive strategy to assess on large scale schooled children in France, the determination of the performance of saliva collection become imperative to standardize procedures.

Saliva, a relevant alternative sample for SARS-CoV2 detection (preprint)

Background: Currently, COVID-19 diagnosis relies on quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) from nasopharyngeal swab (NPS) specimens, but NPSs present several limitations. The simplicity, low invasive and possibility of self-collection of saliva imposed this specimen as a relevant alternative for SARS-CoV-2 detection. However, the discrepancy of saliva test results compared to NPSs made of its use controversial. Here, we proposed to assess Salivettes, as a standardized saliva collection device, and to compare SARS-CoV-2 positivity on paired NPS and saliva specimens. Methods: A total of 303 individuals randomly selected among those investigated for SARS-CoV-2 were enrolled, including 30 (9.9%) patients previously positively tested using NPS (follow-up group), 90 (29.7%) mildly symptomatic and 183 (60.4%) asymptomatic. Results: The RT-qPCR revealed a positive rate of 11.6% (n=35) and 17.2% (n=52) for NPSs and saliva samples, respectively. The sensitivity and specificity of saliva samples were 82.9% and 91.4%, respectively, using NPS as reference. The highest proportion of discordant results concerned the follow-up group (33.3%). Although in the symptomatic and asymptomatic groups the agreement exceeded 90.0%, 17 individuals were detected positive only in saliva samples, with consistent medical arguments. Conclusion: Saliva collected with Salivette demonstrated more sensitive for detecting symptomatic and pre-symptomatic infections.