Diagnostic tests for influenza and other respiratory viruses: determining performance specifications based on clinical setting

Takahashi, Hiroshi; Otsuka, Yoshihito; Patterson, Bruce K.

doi:10.1007/s10156-010-0035-y

Cited by 32 publications

(27 citation statements)

References 33 publications

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“…Influenza virus infection is confirmed by virus isolation, viral nucleic acid detection (eg, by RT-PCR) or detecting a rising serum antibody titre in the acute and convalescent period 19 23 25 26. However, these tests are time consuming and costly, so they are rarely used clinically in Japan 24.…”

Section: Discussionmentioning

confidence: 99%

Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study

et al. 2014

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ObjectiveTo evaluate the diagnostic accuracy of the rapid influenza antigen detection test (RIADT) and determine which symptoms are relevant to results.DesignSingle-centre, cross-sectional study.SettingPrimary care centre, Tokyo, Japan.Participants82 consecutive outpatients presenting with upper respiratory symptoms and fever ≥37°C at any time from symptom onset, between December 2010 and April 2011.Main outcome measuresResults of history and physical examination including age, sex, temperature, time of test from symptom onset, vaccination record and current symptoms (sore throat, arthralgia and/or myalgia, headache, chills, cough and/or throat phlegm, nasal discharge) were recorded. The RIADT and a fully automated respiratory virus nucleic acid test (Verigene Respiratory Virus Plus; VRV), the latter being the gold standard, were performed. Patients were divided into four groups: false negative (FN), RIADT− and VRV+; true positive (TP), RIADT+ and VRV+; true negative (TN), RIADT− and VRV−; and false positive, RIADT+ and VRV−. Groups were compared regarding age, sex, temperature, time of test from symptom onset, vaccination record and symptoms.ResultsRIADT sensitivity, specificity, positive predictive value and negative predictive value were 72.9% (95% CI 61.5% to 84.2%), 91.3% (79.7% to 102.8%), 95.6% (89.5% to 101.6%) and 56.8% (40.8% to 72.7%), respectively. Time from symptom onset to test was shorter for the FN group than the TP group (p=0.009). No significant differences were detected for the other factors assessed. Results revealed higher temperatures for FN than TN patients (p=0.043), and more FN than TN patients had chills (p=0.058).ConclusionsThe RIADT sensitivity was low, due to early administration of the test. In the epidemic season, the RIADT should not be used for suspected influenza until 12 h after symptom onset. A positive RIADT firmly supports the influenza diagnosis; a negative result does not confirm its absence. High fever and chills might indicate influenza, but additional tests are sometimes necessary.

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Section: Discussionmentioning

confidence: 99%

Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study

et al. 2014

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“…First, a rapid immunoassay (Quick Chaser Flu A, B; Mizuho Medy, Japan) for detecting pdmV [10] was performed by the pediatricians using the swab samples. In addition, separate samples from nasopharyngeal swabs were sent to the Laboratory of Molecular Epidemiology for Infectious Agents at the Graduate School of Infection Control Sciences of Kitasato University for microbiologic identification.…”

Section: Microbiologic Identificationmentioning

confidence: 99%

Characteristic findings of pediatric inpatients with pandemic (H1N1) 2009 virus infection among severe and nonsevere illnesses

Okada

Morozumi

Matsubara

et al. 2011

Journal of Infection and Chemotherapy

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“…During the pandemic, rapid influenza tests on the market were widely used and found to be dramatically lacking in sensitivity [8], [9], [10], [11] such that the Centers for Disease Control and Prevention (CDC, Atlanta, GA) recommended that a negative test result be ignored for clinical decision-making [12]. Although the DFA test worked well during the 2009 H1N1 pandemic [13], [14], the labor-intensive nature of the test and potentially subjective aspects of results interpretation somewhat reduced its utility [7].…”

Section: Introductionmentioning

confidence: 99%

Microfluidic Chip for Molecular Amplification of Influenza A RNA in Human Respiratory Specimens

et al. 2012

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A rapid, low cost, accurate point-of-care (POC) device to detect influenza virus is needed for effective treatment and control of both seasonal and pandemic strains. We developed a single-use microfluidic chip that integrates solid phase extraction (SPE) and molecular amplification via a reverse transcription polymerase chain reaction (RT-PCR) to amplify influenza virus type A RNA. We demonstrated the ability of the chip to amplify influenza A RNA in human nasopharyngeal aspirate (NPA) and nasopharyngeal swab (NPS) specimens collected at two clinical sites from 2008–2010. The microfluidic test was dramatically more sensitive than two currently used rapid immunoassays and had high specificity that was essentially equivalent to the rapid assays and direct fluorescent antigen (DFA) testing. We report 96% (CI 89%,99%) sensitivity and 100% (CI 95%,100%) specificity compared to conventional (bench top) RT-PCR based on the testing of n = 146 specimens (positive predictive value = 100% (CI 94%,100%) and negative predictive value = 96% (CI 88%,98%) ). These results compare well with DFA performed on samples taken during the same time period (98% (CI 91%,100%) sensitivity and 96% (CI 86%,99%) specificity compared to our gold standard testing). Rapid immunoassay tests on samples taken during the enrollment period were less reliable (49% (CI 38%,61%) sensitivity and 98% (CI 98%,100%) specificity). The microfluidic test extracted and amplified influenza A RNA directly from clinical specimens with viral loads down to 10 3 copies/ml in 3 h or less. The new test represents a major improvement over viral culture in terms of turn around time, over rapid immunoassay tests in terms of sensitivity, and over bench top RT-PCR and DFA in terms of ease of use and portability.

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Diagnostic tests for influenza and other respiratory viruses: determining performance specifications based on clinical setting

Cited by 32 publications

References 33 publications

Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study

Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study

Characteristic findings of pediatric inpatients with pandemic (H1N1) 2009 virus infection among severe and nonsevere illnesses

Microfluidic Chip for Molecular Amplification of Influenza A RNA in Human Respiratory Specimens

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