Diagnostic performances of the Xpert® Flu PCR test and the OSOM® immunochromatographic rapid test for influenza A and B virus among adult patients in the Emergency Department

Stephanie Antoniol; Nadhira Fidouh; Aiham Ghazali; Houria Ichou; Donia Bouzid; Philippe Kenway; Christophe Choquet; Benoit Visseaux; Enrique Casalino; Emergency Department study group on respiratory viruses

doi:10.1016/j.jcv.2017.12.005

Diagnostic performances of the Xpert^® Flu PCR test and the OSOM^® immunochromatographic rapid test for influenza A and B virus among adult patients in the Emergency Department

J Clin Virol. 2018 Feb-Mar:99-100:5-9. doi: 10.1016/j.jcv.2017.12.005. Epub 2017 Dec 13.

Authors

Stephanie Antoniol¹, Nadhira Fidouh², Aiham Ghazali¹, Houria Ichou², Donia Bouzid¹, Philippe Kenway³, Christophe Choquet³, Benoit Visseaux², Enrique Casalino⁴; Emergency Department study group on respiratory viruses

Affiliations

¹ Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Universitaire Paris Nord Val de Seine, Emergency Department, Paris, France; Université Paris Diderot, Sorbonne Paris Cité, EA 7334, Recherche clinique coordonnée ville-hôpital, Méthodologies et Société (REMES), Paris, France; Study Group for Efficiency and Quality of Emergency Departments and Non-Scheduled Activities Departments, Paris, France.
² IAME (Infection, Antimicrobials, Modelling, Evolution), Université Paris Diderot, Sorbonne Paris Cité, UMR 1137, INSERM, Paris, France; Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Universitaire Paris Nord Val de Seine, Laboratoire de Virologie, Hôpital Bichat, AP-HP, Paris, France.
³ Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Universitaire Paris Nord Val de Seine, Emergency Department, Paris, France; Study Group for Efficiency and Quality of Emergency Departments and Non-Scheduled Activities Departments, Paris, France.
⁴ Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Universitaire Paris Nord Val de Seine, Emergency Department, Paris, France; Université Paris Diderot, Sorbonne Paris Cité, EA 7334, Recherche clinique coordonnée ville-hôpital, Méthodologies et Société (REMES), Paris, France; Study Group for Efficiency and Quality of Emergency Departments and Non-Scheduled Activities Departments, Paris, France. Electronic address: enrique.casalino@aphp.fr.

PMID: 29257982
DOI: 10.1016/j.jcv.2017.12.005

Abstract

Background: New rapid influenza diagnostic tests (RIDT) are available but their clinical utility in adults has not been validated.

Objectives: To evaluate the diagnostic performances of OSOM^® Ultra Flu A&B a RIDT on viral strains of influenza A/B from the last epidemic season, and its feasibility by Emergency Department (ED) physicians and nurses.

Study design: Of the 1099 patients admitted to the ED with suspected influenza, all having a nasopharyngeal swab tested by the Xpert^® Flu PCR and then stored at -20 °C; 500 were selected at random and their samples were tested using the RIDT. Two experts reviewed ED and hospital medical records and all virological data to define influenza cases. Intra- and inter-observer variability were calculated.

Results: Of the 500 patients included 45% were ≥75 years, 122 (24.4%) presented with influenza based on clinical and virological criteria. PCR test performances (%) were Se 98.4 (95% CI 93.6-99.7), Spe 99.7 (98.3-100), PPV 99.2 (94.8-100) and NPV 99.5 (97.9-100); and RIDT performances were Se 95.1 (89.2-97.9), Spe 98.4 (96.4-99.4), PPV 95.1 (87.2-99.9) and NPV 98.4 (96.4-98). There was no difference in test performance between influenza A and B virus nor between the influenza A subtypes. Intra- and inter-observer variability of RIDT were 0.94 (0.89-0.99) and 0.96 (0.92-1).

Conclusion: Our results show that the Xpert^® Flu PCR and the OSOM^® Ultra Flu A&B Test perform very well in diagnosing strains of circulating virus in adults and elderly. Our results also confirm the feasibility of this RIDT at point-of-care by ED staff.

Keywords: Adults; Diagnostic performance; Elderly; Emergency department; PCR influenza; Rapid influenza diagnostic test.

Publication types

Evaluation Study

MeSH terms

Adult
Aged
Diagnostic Tests, Routine
Emergency Service, Hospital
France / epidemiology
Humans
Immunoassay / standards*
Influenza A virus / isolation & purification*
Influenza B virus / isolation & purification*
Influenza, Human / diagnosis*
Influenza, Human / epidemiology
Middle Aged
Molecular Diagnostic Techniques / methods*
Molecular Diagnostic Techniques / standards
Nasopharynx / virology
Point-of-Care Systems
Polymerase Chain Reaction / methods*
Reproducibility of Results
Sensitivity and Specificity