ABSTRACT
The ongoing COVID-19 pandemic has clearly established how vital rapid, widely accessible diagnostic tests are in controlling infectious diseases and how difficult and slow it is to scale existing technologies. Here, we demonstrate the use of the rapid affinity pair identification via directed selection (RAPIDS) method to discover multiple affinity pairs for SARS-CoV-2 nucleocapsid protein (N-protein), a biomarker of COVID-19, from in vitro libraries in 10 weeks. The pair with the highest biomarker sensitivity was then integrated into a 10-minute, vertical-flow cellulose paper test. Notably, the as-identified affinity proteins were compatible with a roll-to-roll printing process for large-scale manufacturing of tests. The test achieved 40 pM and 80 pM limits of detection in 1×PBS (mock swab) and saliva matrices spiked with cell-culture generated SARS-CoV-2 viruses and is also capable of detection of N-protein from characterized clinical swab samples. Hence, this work paves the way towards the mass production of cellulose paper-based assays which can address the shortages faced due to dependence on nitrocellulose and current manufacturing techniques. Further, the results reported herein indicate the promise of RAPIDS and engineered binder proteins for the timely and flexible development of clinically relevant diagnostic tests in response to emerging infectious diseases.
ABSTRACT
Full night polysomnography (PSG) remains the gold standard diagnostic test for the evaluation of sleep and the detection of sleep disorders. The computer-assisted scoring methods have been developed to accelerate the scoring. It is said that there was a concordance up to 80% between these scoring softwares and manual scoring. According to our experiences, it is not matched with this belief. In this study, we intend to examine whether the results of automatic analysis match with manual (visual) evaluation. The PSG records of 30 cases with a diagnosis of obstructive sleep apnea syndrome (OSAS) are chosen randomly. We compare the results of automatic analysis with the results of two scorers who have a concordance of 80-95% and at least 1000 PSG scoring experiences. We evaluated 21.060 epochs of 18 men with 48.83 + or - 13.51 ages, and 12 women with 44.56 + or - 14.28 ages. In automatic analysis; total sleep time (p= 0.003) and sleep efficiency (p= 0.004) were low. AHI (p= 0.802) and ODI (p= 0.193) values were high. The epochs scored differently were 8819 epochs (41.88%). The stage I (88.43%) scored mostly different, was allocated to be awake (572 epochs). Stage II and stage IV were scored as stage III in 2276 and 983 epochs respectively. REM epochs were allocated to stage II (574 epochs). The differences in recording times and sleep architecture of PSG tests which examed by automatic analysis will affect all other parameters. Thus, we believe that it will make mistakes in the diagnosis and treatment of sleep disorders.
