Evaluation of Respiratory Syncytial Virus Detection by Rapid Antigen Tests in Childhood

Abstract

Background: Rapid and reliable diagnosis is crucial for clinical management of respiratory syncytial virus infection in childhood. We assessed the performance characteristics of respiratory syncytial virus antigen immunoassays in children hospitalized for respiratory infection.

Method: A total of 1600 children up to three years of age hospitalized for diseases potentially caused by RSV were included in the study. Nasopharyngeal secretions were obtained in a standardized manner in the first 24 hours after hospital admission and tested in parallel by PCR and rapid antigen tests for RSV. The following parameters were recorded: recruitment center, gender, age, presence of fever, rhinitis, stridor, barking cough, cough, wheezing, vomiting, disturbed eating or sleep, tachypnea, tachycardia, increased body temperature, decreased oxygen saturation, C-reactive protein, erythrocyte sedimentation rate and chest X-ray results.

Results: Considering PCR testing as gold standard, rapid antigen testing had a specificity of 89.9% and a sensitivity of 66.2% for all samples tested. Logistic regression analysis revealed age and recruitment center as the only parameters influencing sensitivity whereas no such influence on specificity was found. Positive likelihood ratios ranged from 4,9 to 6.9 in different age groups. Negative likelihood ratio was 0.24 (95% CI: 0.18-0.42) in children aged up to 3 months but 0.67 (95% CI: 0.53-0.84) for children older than 2 years.

Conclusion: Rapid detection of RSV antigen in this study was useful in detection of RSV mediated disease in younger infants but shows decreasing sensitivity in children older than three months.

Zusammenfassung

Hintergrund: Die rasche und zuverlässige Diagnosestellung einer RSV-Infektion ist für das weitere klinische Management von wesentlicher Bedeutung. Ziel dieser Studie ist die Evaluation von RSV-Antigen-Schnelltests bei Kindern mit Atemwegsinfektionen im Alter bis zu drei Jahren.

Patienten: Im Rahmen der multizent-ischen PRI.DE-Studie untersuchten wir an drei Studienorten insgesamt 1600 stationäre Patienten mit klinischen Zeichen einer tiefen Atemwegsinfektion. Klinische Symptome, Laborparameter, Sauerstoffsättigung und Röntgenthoraxbefunde wurden dokumentiert. Nasopharyngealsekret wurde innerhalb von 24 h nach stationärer Aufnahme standardisiert gewonnen und mittels Antigen-Schnelltest und Polymerasekettenreaktion untersucht.

Ergebnisse: Verwendet man die PCR-Befunde als Referenzwert, zeigte der RSV-Antigen-Schnelltest eine Spezifität von 89,9% und eine Sensitivität von 66,2% aller getesteten Proben. Die logistische Regressionsanalyse identifizierte Patientenalter und Studienzentrum als die einzigen Parameter mit Einfluss auf die Sensitivität, jedoch ohne Effekt auf, die Spezifität. Die „positive likelihood ratio” betrug zwischen 4,9 und 6,9 in den verschiedenen Altersgruppen. Die „negative likelihood ratio” betrug 0,24 (95% CI: 0,18-0,42) bei Säuglingen unter 3 Monaten, aber 0,67 (95% CI: 0,53-0,84) bei Patienten älter als 2 Jahre.

Schlussfolgerungen: RSV-Antigen-Schnelltests zeigten in allen Alterklassen eine befriedigende Spezifität, bei Säuglingen in den ersten drei Lebensmonaten besteht zudem eine hohe Sensitivität. Die Ausagekraft wird bei älteren Patienten durch abnehmende Sensitivität stark eingeschränkt.

Key words

Respiratory syncytial virus - reverse transcriptase polymerase chain reaction - enzyme-linked immunosorbent assay - antigen test

Schlüsselwörter

Respiratory-syncytial-Virus - reverse Transkriptase-Polymerase-Kettenreaktion - Enzyme-linked-Immunosorbent-Assay - Antigen-Schnelltest

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