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Updated: May 13, 2026

An Improved and High Throughput Respiratory Syncytial Virus (RSV) Micro-neutralization Assay
Published on: January 26, 2019
Validity of laboratory-based surveillance for detection of respiratory syncytial virus seasons
Christian Hampp1, Nabih Asal, Earlene Lipowski
1Division of Epidemiology I, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services, Silver Spring, MD 20993, USA. christian.hampp@fda.hhs.gov
Abstract:
In this study, we validated the Centers for Disease Control and Prevention's use of a 10% threshold of median proportion of positive laboratory tests (median proportion positive (MPP)) to identify respiratory syncytial virus (RSV) seasons against a standard based on hospitalization claims. Medicaid fee-for-service recipients under 2 years of age from California, Florida, Illinois, and Texas (1999-2004), continuously eligible since birth, were categorized for each week as high-risk or low-risk with regard to RSV-related hospitalization based on medical and pharmacy claims data and birth certificates. Weeks were categorized as on-season if the RSV hospitalization incidence rate in high-risk children exceeded the seasonal peak of the incidence rate in low-risk children. Receiver operating characteristic (ROC) curves were used to measure the ability of MPP to discriminate between on-season and off-season weeks as determined from hospitalization data. Areas under the ROC curve ranged from 0.88 (95% confidence interval: 0.83, 0.92) in Illinois to 0.96 (95% confidence interval: 0.94, 0.98) in California. Requiring at least 5 positive tests in addition to the 10% MPP threshold optimized accuracy, as indicated by minimized root mean square errors. The 10% MPP with the added requirement of at least 5 positive tests is a valid method for identifying clinically significant RSV seasons across geographically diverse states.

