Diagnostic accuracy of rapid antigen tests for COVID-19 compared to the viral genetic test in adults: a systematic review protocol.

OBJECTIVE: The objective of this diagnostic accuracy review is to evaluate the effectiveness of rapid antigen tests versus viral genetic PCR-based tests on COVID-19 diagnostic accuracy in adults 18 years and over. INTRODUCTION: Due to the rapidly changing nature of the COVID-19 pandemic, it is imperative that clinicians have access to the most relevant and effective tools and information required to combat this disease. Testing strategies are being developed continuously and need to be evaluated to ensure their appropriate implementation into clinical practice. INCLUSION CRITERIA: This systematic review will include publications that are in the English language (originally or translated) and any gray literature pertaining to the tests of interest. All races, ages over 18, and geographic locations will be considered. METHODS: MEDLINE (PubMed), Embase (Elsevier), Scopus (Elsevier), Qinsight (Quertle), and WHO COVID-19 database (World Health Organization) will be searched. Scopus, Qinsight, and WHO COVID-19 include gray literature. Studies in English published from November 2019 to the present will be considered. Animal studies and studies including pregnant women will be excluded. Retrieval of full-text studies, data extraction, and assessment of methodological quality will be performed independently by two reviewers. A custom data extraction table will be used. Findings will be graphically represented with two forest plots, one for sensitivity and the other for specificity. The strategy for meta-analysis includes producing a summary receiver operating characteristic curve and estimating the summary sensitivity/specificity for each threshold provided in the articles. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020224250.

Quantitative fluorescence in situ hybridization and its ability to predict bladder cancer recurrence and progression to muscle-invasive bladder cancer.

Fluorescence in situ hybridization (FISH) testing is used to detect bladder cancer in urine specimens. The purpose of this study was to determine whether there are associations between the percentage of chromosomally abnormal cells by FISH and time to bladder cancer recurrence and progression to metastasis. Clinical records were searched to identify patients with urine FISH results, history of non-invasive bladder cancer, and at least one follow-up pathological diagnosis. Covariates analyzed included age, gender, smoking status, treatment after FISH, cystoscopy result, and prior stage of bladder cancer. The percentage of abnormal cells (hazard ratio [HR] 1.03, 95% CI 1.02-1.03; P < 0.001), age (HR 1.02, 95% CI 1.00-1.03; P = 0.033), male gender (HR 0.60, 95% CI 0.41-0.87; P < 0.001), treatment (HR 0.37, 95% CI 0.25-0.55; P < 0.001), and history of TIS/T1-stage tumors (HR 1.66, 95% CI 1.23-2.24; P = 0.001) were significantly associated with time to cancer recurrence. Time to invasive cancer was significantly associated with the percentage of abnormal cells (HR 1.02, 95% CI 1.01, 1.03; P < 0.001), history of TIS/T1 tumor (HR 3.73, 95% CI 1.88, 7.38; P = 0.001), and treatment (HR 0.33, 95% CI 0.13, 0.83; P = 0.019), suggesting that the percentage of abnormal cells independently predicts cancer recurrence and progression to invasive disease in patients with a history of non-invasive bladder cancer.