Evaluation of BioStar® FLU OIA® assay for rapid detection of influenza A and B viruses in respiratory specimens

doi:10.1016/S1386-6532(00)00081-0

Journal of Clinical Virology

Volume 17, Issue 2, August 2000, Pages 119-126

https://doi.org/10.1016/S1386-6532(00)00081-0 Get rights and content

Abstract

Background: Demand for the rapid diagnosis of influenza infections has increased with the advent of the availability of neuraminidase antiviral therapy for influenza A and B. Several rapid assays that detect both influenza A and B are now available. Objectives: In this study we compared the performance of the BioStar® FLU OIA® assay to Bartels Viral Respiratory Screening and Identification Kit (Bartels Inc., Issaquah, WA), and cell culture. Study design: A total of 145 patient specimens for influenza virus detection submitted in either viral transport medium or in sterile containers were evaluated by the three methods. Specimen types included nasal washings, nasal swabs, sputum, throat swabs, and bronchial alveolar lavage (BAL) fluids. Results: Fifty six positive specimens were identified based on culture and/or DFA. Of these, 30 specimens were positive by the OIA assay for an overall sensitivity of 54%. The OIA assay detected 48% (n=21) of the 44 culture positive specimens and 81% (n=29) of the 36 DFA positive specimens. Eighty six of the 89 culture/DFA negative samples were negative by the OIA assay (97% specificity). Analysis of the OIA assay sensitivity from samples submitted in M4 transport medium or in sterile containers revealed that M4 transport medium does not reduce the sensitivity of the OIA assay. Fifteen of the 27 positive samples submitted in M4 transport medium were positive by the OIA assay (56% sensitivity) compared to 15 of 29 positive samples transported in sterile containers (52% sensitivity). Twelve specimens were either culture and/or DFA positive for viruses other than influenza, but negative by the OIA assay, suggesting that there was no cross reactivity of the OIA assay with the other virus types recovered in this study. Conclusions: The overall excellent specificity of the BioStar® FLU OIA® allows for treatment of positive patients for influenza, however, a negative result should be confirmed by DFA and culture.

Introduction

Influenza viruses A and B are members of the Orthomyxoviridae family. The viral particles of this family are characterized by the presence of an envelope that contains a segmented negative-strand RNA genome (Rott et al., 1995). Influenza is responsible for winter epidemics of respiratory illness among all age groups (Lui and Kendal, 1987). Rates of infection are highest among children; however, the morbidity and mortality are highest among individuals aged ≥65 years and immunocompromised patients (CDC, 1999). In the US, influenza infections have great economic impact with 10 000–40 000 annual deaths, and an estimated yearly cost of $3–12 billion (Glezen, 1996). Thus, it is of great importance to make a rapid virologic diagnosis in order to initiate antiviral therapies, reduce patient hospital stay, and to discontinue the use of unnecessary antibiotics.

Current antiviral drugs, amantadine and rimantadine, are effective in reducing influenza virus A, but not B, viral replication if given early in the course of illness (Douglas, 1990, Predra, 1995, Wintermeyer and Nahata, 1995). However, rapid development of drug resistance does occur (Calfee and Hayden, 1998). The new neuraminidase inhibitors Zanamivir and Oseltamivir are FDA approved. These agents are efficacious against both influenza A and B viruses and they have been well tolerated by individuals participating in clinical trials (Hayden et al., 1996, Calfee and Hayden, 1998, Mendel et al., 1998, Hayden et al., 1999).

In this study, we investigated the performance of a new 20-min optical immunoassay antigen detection test (BioStar® FLU OIA® assay) on respiratory samples. We compared the performance of the OIA assay to cell culture and direct immunofluorescence detection on respiratory samples submitted for influenza virus detection.

Section snippets

Clinical specimens

One hundred and forty five specimens submitted to ARUP laboratories during the 1998–1999 respiratory virus season were used to evaluate the BioStar® FLU OIA® assay. Specimens evaluated were submitted for either influenza virus culture or for respiratory virus culture. Specimen types included 15 sputum (10.3%), 79 nasal washes or nasopharyngeal swabs (54.5%), 30 throat swabs (20.7%), and five BAL (3.5%), 16 respiratory samples received without source information (11%)). Approximately half of the

Overall performance of BioStar® FLU OIA® assay compared to cell culture, and Bartels DFA

A total of 56 of the 145 specimens were positive for influenza virus by either DFA or culture. Thus, the positivity rate of the specimens evaluated by the three methods was 39% (Table 1). Of the 56 positive samples, 47 were identified as influenza A (84%) and nine as influenza virus B (16%). Forty four specimens were culture positive and 36 specimens were positive by DFA. Thirty specimens were positive by the BioStar® FLU OIA® assay for an overall sensitivity of 54% (Table 2). Three samples

Discussion

The recent development of several new neuraminidase inhibitors has awakened an interest in the rapid detection of influenza A and B viruses. These new antivirals are most effective when given within 48 h of symptoms (Hayden et al., 1996). Current methods of influenza diagnosis may require up to 14 days in the case of culture or require costly and labor-intensive immunofluorescence procedures.

Several factors need to be considered when implementing a new, non-traditional method. These include

Acknowledgements

We thank BioStar Inc. for contributing the FLU OIA^® kits. In addition, the authors would like to thank Jim Kucera for critical review of the paper and Tracy Adams for her administrative assistance.

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Evaluation of BioStar® FLU OIA® assay for rapid detection of influenza A and B viruses in respiratory specimens

Abstract

Introduction

Section snippets

Clinical specimens

Overall performance of BioStar® FLU OIA® assay compared to cell culture, and Bartels DFA

Discussion

Acknowledgements

New approaches to influenza chemotherapy neuraminidase inhibitors

Drugs

Update: influenza activity — United States, 1998–99 season

MMWR

Comparison of four clinical specimens types for detection of influenza A and B viruses by optical immunoassay (FLU OIA test) and cell culture methods

J. Clin. Microbiol.

Drug therapy. Prophylaxis and treatment of influenza

New Engl. J. Med.

Effect of centrifuging shell vials at 3500×g on detection of viruses in clinical specimens

J. Clin. Microbiol.

Clinical evaluation of the BioStar AB FLU OIA test for direct detection of influenza types A and B in respiratory secretions

Emerging infections: pandemic influenza

Epidemiol. Rev.