Low sensitivity of BinaxNOW® RSV in infants.

Roy P Zuurbier, Louis J Bont, Annefleur C Langedijk, Mirjam Hamer, Koos Korsten, Simon B Drysdale, Matthew D Snape, Hannah Robinson, Andrew J Pollard, Federico Martinón-Torres, Carmen Rodríguez-Tenreiro Sánchez, Alberto Gómez-Carballa, Ana Isabel Dacosta-Urbieta, Terho Heikkinen, Steve Cunningham, Marlies A van Houten, Joanne G Wildenbeest, for the RESCEU Investigators.


Abstract

Background
Respiratory syncytial virus (RSV) is a major cause of hospitalization in infants. Early detection of RSV can optimize clinical management and minimize use of antibiotics. BinaxNOW RSV (BN) is a rapid antigen detection test that is widely used. We aimed to validate the sensitivity of BN in hospitalized and nonhospitalized infants against the gold standard of molecular diagnosis.

Methods
We evaluated the performance of BN in infants with acute respiratory tract infections with different degrees of disease severity. Diagnostic accuracy of BN test results were compared with molecular diagnosis as reference standard.

Results
One hundred sixty-two respiratory samples from 148 children from October 2017 to February 2019 were studied. Sixty-six (40.7%) samples tested positive for RSV (30 hospitalizations, 31 medically attended episodes not requiring hospitalization, and 5 nonmedically attended episodes). Five of these samples tested positive with BN, leading to an overall sensitivity of BN of 7.6% (95% confidence interval [CI], 3.3%–16.5%) and a specificity of 100% (95% CI, 96.2%–100%). Sensitivity was low in all subgroups.

Conclusions
We found a low sensitivity of BN for point-of-care detection of RSV infection. BinaxNOW RSV should be used and interpreted with caution.

Full article here.