Poor Positive Accuracy of QuickVue Rapid Antigen Tests during the Influenza A (H1N1) 2009 Pandemic

Stevenson, Heather L.; Loeffelholz, Michael J.

doi:10.1128/jcm.01562-10

Cited by 16 publications

(9 citation statements)

References 8 publications

(13 reference statements)

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“…RIDTs are valuable for their unique and singular capability of providing rapid point-of-care detection among all the diagnostic tools currently available for influenza. It should be noted, however, that although they have widely been shown to have high specificities and positive predictive values during peak influenza virus prevalence, three recent studies evaluating rapid antigen tests during the recent pandemic reported an unexpectedly high false-positive rate of 37.8% (116) or low specificities, of 48.1% (112) and 50.7% (88). The first study noted the limitations of being retrospective in nature and including some specimens (throat swabs) that were not approved by the kit manufacturer.…”

Section: Rapid Antigen Testsmentioning

confidence: 99%

Update on Influenza Diagnostics: Lessons from the Novel H1N1 Influenza A Pandemic

2012

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SUMMARY The menu of diagnostic tools that can be utilized to establish a diagnosis of influenza is extensive and includes classic virology techniques as well as new and emerging methods. This review of how the various existing diagnostic methods have been utilized, first in the context of a rapidly evolving outbreak of novel influenza virus and then during the different subsequent phases and waves of the pandemic, demonstrates the unique roles, advantages, and limitations of each of these methods. Rapid antigen tests were used extensively throughout the pandemic. Recognition of the low negative predictive values of these tests is important. Private laboratories with preexisting expertise, infrastructure, and resources for rapid development, validation, and implementation of laboratory-developed assays played an unprecedented role in helping to meet the diagnostic demands during the pandemic. FDA-cleared assays remain an important element of the diagnostic armamentarium during a pandemic, and a process must be developed with the FDA to allow manufacturers to modify these assays for detection of novel strains in a timely fashion. The need and role for subtyping of influenza viruses and antiviral susceptibility testing will likely depend on qualitative (circulating subtypes and their resistance patterns) and quantitative (relative prevalence) characterization of influenza viruses circulating during future epidemics and pandemics.

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Section: Rapid Antigen Testsmentioning

confidence: 99%

Update on Influenza Diagnostics: Lessons from the Novel H1N1 Influenza A Pandemic

2012

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“…Also, RADTs for influenza viruses are normally more sensitive for IV A then they are for IV B (138), although poorer performance has been noted in the detection of novel and variant strains of IV A (139)(140)(141)(142)(143)(144). Although the specificity of RADTs is considered to be good, false positives can also occur (145)(146)(147)(148)(149). Assay performance may vary depending on the age of the patient, the specimen type and adequacy, the appropriate handling and storage of the specimens, the amount of virus present in the specimens, the virus type and subtype, the emergence of new strains, and the particular assay that is selected for testing.…”

Section: Solid-phase Immunoassaysmentioning

confidence: 99%

Respiratory RNA Viruses

Hodinka

2016

Microbiol Spectr

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Acute upper and lower respiratory infections are a major public health problem and a leading cause of morbidity and mortality worldwide. At greatest risk are young children, the elderly, the chronically ill, and those with suppressed or compromised immune systems. Viruses are the predominant cause of respiratory tract illnesses and include RNA viruses such as respiratory syncytial virus, influenza virus, parainfluenza virus, metapneumovirus, rhinovirus, and coronavirus. Laboratory testing is required for a reliable diagnosis of viral respiratory infections, as a clinical diagnosis can be difficult since signs and symptoms are often overlapping and not specific for any one virus. Recent advances in technology have resulted in the development of newer diagnostic assays that offer great promise for rapid and accurate detection of respiratory viral infections. This chapter emphasizes the fundamental characteristics and clinical importance of the various RNA viruses that cause upper and lower respiratory tract diseases in the immunocompromised host. It highlights the laboratory methods that can be used to make a rapid and definitive diagnosis for the greatest impact on the care and management of ill patients, and the prevention and control of hospital-acquired infections and community outbreaks.

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“…Such visual detection, intended to improve the usability in near-patient diagnosis, might result in diminished test sensitivity if the dipstick signal for a positive sample is not easily distinguishable from that for negative cases by the operator. Stevenson and Loeffelholz reported weak dipstick signal intensity in nearly 43% of the positive pandemic A(H1N1)pdm09 samples tested using the QuickVue Influenza AϩB test (38). The large proportion of weak positive results could adversely affect the overall test performance due to operator-dependent error in identifying the weak signal as positive.…”

Section: Discussionmentioning

confidence: 99%

Duplex Molecular Assay Intended for Point-of-Care Diagnosis of Influenza A/B Virus Infection

Thomas

Curran

et al. 2013

J Clin Microbiol

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Early diagnosis and management of influenza virus infection directly correlates with the effectiveness in disease control. Current molecular influenza virus tests were designed for use in diagnostic testing facilities, where sophisticated equipment and highly trained technicians are available. A longer turnaround time for the centralized testing than when testing near the sample source could delay the initiation of medical intervention, thereby reducing the efficacy of antiviral treatment. The new assay, the SAMBA (simple amplification-based assay) Flu duplex test, is a dipstick-based molecular assay developed to provide a simple, accurate, and cost-effective solution for the diagnosis of influenza A/B viruses intended for near-patient testing. The test presents an alternative format of influenza virus molecular testing that utilizes isothermal amplification and visual detection of nucleic acid on a test strip. The entire test procedure (extraction, amplification, and detection) is integrated into an enclosed semiautomated system. Analytically, the SAMBA Flu duplex test detects 95 and 85 copies of viral genomes for influenza A and B viruses, respectively, with no cross-reactivity observed against other common respiratory pathogens. The clinical performance was established by blind testing of 328 nasal/throat and nasopharyngeal swab specimens from the United Kingdom and Belgium and comparing the results with the quantitative reverse transcription-PCR method routinely used in two public health laboratories. The SAMBA Flu duplex test showed a clinical sensitivity and specificity of 100% and 97.9% for influenza virus A and 100% and 100% for influenza virus B. The test provides a new technology that could facilitate simple and timely identification of influenza virus infection, potentially resulting in more efficient control measures.

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Poor Positive Accuracy of QuickVue Rapid Antigen Tests during the Influenza A (H1N1) 2009 Pandemic

Cited by 16 publications

References 8 publications

Update on Influenza Diagnostics: Lessons from the Novel H1N1 Influenza A Pandemic

Update on Influenza Diagnostics: Lessons from the Novel H1N1 Influenza A Pandemic

Respiratory RNA Viruses

Duplex Molecular Assay Intended for Point-of-Care Diagnosis of Influenza A/B Virus Infection

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