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Diagnosis of Influenza in the Community
Relationship of Clinical Diagnosis to Confirmed Virological, Serologic, or Molecular Detection of Influenza
Maria Zambon, PhD;
John Hays, PhD;
Alison Webster, MD;
Robert Newman, MSc;
Oliver Keene, MA, MSc
Arch Intern Med. 2001;161:2116-2122.
Background Successful treatment of influenza depends on an accurate diagnosis of
the illness and prompt intervention. However, there is a lack of data comparing
clinical diagnosis vs laboratory diagnostic techniques.
Objective To compare the clinical diagnosis of community cases of influenza with
various laboratory diagnostic techniques including multiplex, reverse transcription
polymerase chain reaction.
Methods Clinical diagnosis, viral isolation, hemagglutinin inhibition serology,
and multiplex, reverse transcription polymerase chain reaction were used to
diagnose influenza in patients enrolled in international phase 3 studies designed
to investigate the efficacy and safety of an anti-influenza drug (inhaled
zanamivir). Patients clinically diagnosed with influenza were enrolled at
centers across North America and Europe.
Results A total of 791 (77%) of 1033 patients with laboratory results from all
3 methods were confirmed positive for influenza by 1 or more test results.
For 692 patients (67%), the results of all 3 tests agreed. Total symptom scores
at baseline showed a significant association toward greater severity of symptoms
with an increasing number of positive test results (P<.001).
An increasing number of positive test results also showed a significant correlation
with a longer time to alleviation of symptoms of influenza in the placebo
group (P = .001).
Conclusions During a time when influenza was known to be circulating and clinical
diagnostic criteria were applied, diagnosis of influenza in these trials was
accurate in approximately 77% of adults on clinical grounds alone. This highlights
the need for primary care physicians to be alerted to circulating influenza
and to be aware that presentation with cough and fever provide the most predictive
symptoms.
From the Influenza Unit, Enteric and Respiratory Virus Laboratory,
Central Public Health Laboratory, London (Drs Zambon and Hays); Glaxo Wellcome
Research and Development, Greenford (Dr Webster and Mr Keene); and the National
Institute for Biological Standards and Control, South Mimms (Dr Newman), England.
Dr Zambon was a consultant to Glaxo Wellcome Inc between 1997 and 1999. Dr
Webster and Mr Keene are employees with benefits (ie, pension, equity, and
stock options) with GlaxoSmithKline.
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