Point-Counterpoint: Can Newly Developed, Rapid Immunochromatographic Antigen Detection Tests Be Reliably Used for the Laboratory Diagnosis of Influenza Virus Infections?

Dunn, James J.; Ginocchio, Christine C.

doi:10.1128/jcm.02739-14

Cited by 38 publications

(25 citation statements)

References 39 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…These newer-generation RADTs eliminate the potential subjectivity of an operator visualizing and interpreting test results, which can lead to improved assay performance (106). However, the pooled estimates of the sensitivities of these novel RSV RADTs (76% and 77% compared to RT-PCR) were not substantially different from those of other assays in our review.…”

Section: Discussionmentioning

confidence: 74%

Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis

et al. 2015

View full text Add to dashboard Cite

eRespiratory syncytial virus (RSV) rapid antigen detection tests (RADT) are extensively used in clinical laboratories. We performed a systematic review and meta-analysis to evaluate the accuracy of RADTs for diagnosis of RSV infection and to determine factors associated with accuracy estimates. We searched EMBASE and PubMed for diagnostic-accuracy studies of commercialized RSV RADTs. Studies reporting sensitivity and specificity data compared to a reference standard (reverse transcriptase PCR [RT-PCR], immunofluorescence, or viral culture) were considered. Two reviewers independently extracted data on study characteristics, diagnostic-accuracy estimates, and study quality. Accuracy estimates were pooled using bivariate random-effects regression models. Heterogeneity was investigated with prespecified subgroup analyses. Seventy-one articles met inclusion criteria. Overall, RSV RADT pooled sensitivity and specificity were 80% (95% confidence interval [CI], 76% to 83%) and 97% (95% CI, 96% to 98%), respectively. Positive-and negative-likelihood ratios were 25.5 (95% CI, 18.3 to 35.5) and 0.21 (95% CI, 0.18 to 0.24), respectively. Sensitivity was higher in children (81% [95% CI, 78%, 84%]) than in adults (29% [95% CI, 11% to 48%]). Because of this disparity, further subgroup analyses were restricted to pediatric data (63 studies). Test sensitivity was poorest using RT-PCR as a reference standard and highest using immunofluorescence (74% versus 88%; P < 0.001). Industry-sponsored studies reported significantly higher sensitivity (87% versus 78%; P ‫؍‬ 0.01). Our results suggest that the poor sensitivity of RSV RADTs in adults may preclude their use in this population. Furthermore, industry-sponsored studies and those that did not use RT-PCR as a reference standard likely overestimated test sensitivity.A cute respiratory infection (ARI) due to respiratory syncytial virus (RSV) is a leading cause of emergency department (ED) visits and hospitalizations in infants and children (1-3). RSV also produces substantial morbidity and mortality among the elderly and adults with underlying medical conditions (4, 5).Accurate and prompt diagnosis of RSV ARI can have important benefits for patient care. Because concurrent serious bacterial infection with RSV is uncommon, especially in children (6), a timely diagnosis of RSV ARI should diminish unnecessary antibiotic use (7)(8)(9). It may also minimize ancillary testing (10), decrease hospital stay durations (11), and permit prompt implementation of cohort assignment for the purpose of limiting nosocomial transmission within hospitals and long-term-care facilities (13)(14)(15)(16)57). Laboratory testing of respiratory secretions is required for confirmation of RSV infection because its seasonality and nonspecific clinical manifestations may overlap those of other viral and bacterial causes of ARI (17,18).There are currently four RSV diagnostic modalities in clinical use. Viral culture was long considered the gold standard for RSV diagnosis, but it has a turnaround time of 3 to 7 day...

show abstract

Section: Discussionmentioning

confidence: 74%

Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis

et al. 2015

View full text Add to dashboard Cite

show abstract

“…On average, between 1997 and 2009, Ͼ19,000 deaths were attributable to influenza and Ͼ11,000 were attributable to RSV (1) annually. The low sensitivity of rapid antigen tests and the delayed time to result of viral cultures combined with the improved sensitivity afforded by molecular methods have led to an increase in FDAcleared tests and systems designed to detect these viruses (2,3). The Xpert Flu/RSV XC assay (Cepheid, Sunnyvale, CA) is a newly FDA-cleared rapid, random-access molecular test capable of detecting and differentiating influenza A, influenza B, and RSV viruses from nasal wash fluid samples/aspirates and nasopharyngeal (NP) swabs.…”

mentioning

confidence: 99%

Performance Characteristics of Xpert Flu/RSV XC Assay

Popowitch

Miller

2015

J Clin Microbiol

View full text Add to dashboard Cite

The Xpert Flu/RSV XC assay was compared to laboratory-developed tests (LDTs) (n ‫؍‬ 207) and the Xpert Flu assay (n ‫؍‬ 147) using archived nasopharyngeal swabs. The percentages of positive agreements with LDTs were 97.8% for influenza A, 97.2% for influenza B, and 89.3% for RSV. The sensitivity of influenza detection was improved with the Xpert Flu/RSV XC assay compared to the Xpert Flu assay.

show abstract

“…When positive, these rapid methods correlate well with actual influenza virus infection. 5,6 However, their M A N U S C R I P T…”

Section: Performance Of Rapid Influenza Bedside Testsmentioning

confidence: 98%

“…4 In addition, rapid identification of outbreaks allows timely introduction of measures to block transmission, thereby reducing both the number of secondary cases and disease mortality. 5,6 Not all hospitals have virology or microbiology laboratories. Lack of them can be a problem for the rapid identification of a nosocomial pathogen when the incubation period is long, when asymptomatic carriers can be the source, or when the nosocomial cases are infrequent.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…The probability that a positive result is a false positive is high during low prevalence periods, and any positive RIDT should be confirmed with assays with very high sensitivity and specificity such as polymerase chain reaction (PCR). 5,6 To increase the sensitivity of the RIDTs, three assays that use a reading device have been developed (Sofia, BD Veritor, and Fujifilm). These assays, which can be seen as second generation RIDTs, have higher sensitivity.…”

Section: A C C E P T E D Accepted Manuscriptmentioning

confidence: 99%

See 1 more Smart Citation

Rapid bedside tests for diagnosis, management, and prevention of nosocomial influenza

Bouscambert

Valette

Lina

2015

Journal of Hospital Infection

View full text Add to dashboard Cite

Point-Counterpoint: Can Newly Developed, Rapid Immunochromatographic Antigen Detection Tests Be Reliably Used for the Laboratory Diagnosis of Influenza Virus Infections?

Abstract: POINT

Cited by 38 publications

References 39 publications

Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis

Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis

Performance Characteristics of Xpert Flu/RSV XC Assay

Rapid bedside tests for diagnosis, management, and prevention of nosocomial influenza

Contact Info

Product

Resources

About