BD Veritor System Respiratory Syncytial Virus Rapid Antigen Detection Test: Point-of-Care Results in Primary Care Pediatric Offices Compared With Reverse Transcriptase Polymerase Chain Reaction and Viral Culture Methods

During respiratory syncytial virus season, many children present to pediatric offices and urgent care medical facilities with cough, tachypnea, intercostal retraction, wheezing, as well as disturbed appetite and sleep. Identification of the responsible viral pathogen is quite difficult because sever...

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Vydáno v:Pediatric emergency care Ročník 31; číslo 12; s. 830 - 834
Hlavní autoři: Schwartz, Richard H, Selvarangan, Rangaraj, Zissman, Edward N
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 01.12.2015
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ISSN:1535-1815
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Abstract During respiratory syncytial virus season, many children present to pediatric offices and urgent care medical facilities with cough, tachypnea, intercostal retraction, wheezing, as well as disturbed appetite and sleep. Identification of the responsible viral pathogen is quite difficult because several pathogens can produce similar signs and symptoms. Nasopharyngeal specimens were collected from symptomatic sick children younger than 6 years, in 8 geographically representative primary care pediatric practices during a 4-month RSV season. Institutional review board approval and signed parental consent were obtained. The primary objective of the study was the estimation of the sensitivity and specificity of the Becton Dickinson (BD) Veritor RSV point-of-care (POC) assay as compared with reverse transcriptase-polymerase chain reaction (RT-PCR). Of 523 specimens, 58.3% (n = 305) were from patients younger than 2 years. The BD Veritor RSV POC assay sensitivity and specificity are 81.6% (146/179) and 99.1% (341/344), respectively. When compared with RT-PCR, the BD Veritor RSV POC assay false positive was 0.9% (3/344, with a 95% confidence interval of 0.3%-2.5%) and the false negative was 18.4% (33/179, with a 95% confidence interval of 13.4%-24.5%). The BD Veritor RSV POC assay identified more true positive specimens (n = 146) than viral cell culture (n = 134 positive specimens). In 8 participating primary care pediatric offices with 523 evaluable subjects, POC BD Veritor RSV tests performed better than viral cell culture results when RT-PCR was the reference standard.
AbstractList During respiratory syncytial virus season, many children present to pediatric offices and urgent care medical facilities with cough, tachypnea, intercostal retraction, wheezing, as well as disturbed appetite and sleep. Identification of the responsible viral pathogen is quite difficult because several pathogens can produce similar signs and symptoms. Nasopharyngeal specimens were collected from symptomatic sick children younger than 6 years, in 8 geographically representative primary care pediatric practices during a 4-month RSV season. Institutional review board approval and signed parental consent were obtained. The primary objective of the study was the estimation of the sensitivity and specificity of the Becton Dickinson (BD) Veritor RSV point-of-care (POC) assay as compared with reverse transcriptase-polymerase chain reaction (RT-PCR). Of 523 specimens, 58.3% (n = 305) were from patients younger than 2 years. The BD Veritor RSV POC assay sensitivity and specificity are 81.6% (146/179) and 99.1% (341/344), respectively. When compared with RT-PCR, the BD Veritor RSV POC assay false positive was 0.9% (3/344, with a 95% confidence interval of 0.3%-2.5%) and the false negative was 18.4% (33/179, with a 95% confidence interval of 13.4%-24.5%). The BD Veritor RSV POC assay identified more true positive specimens (n = 146) than viral cell culture (n = 134 positive specimens). In 8 participating primary care pediatric offices with 523 evaluable subjects, POC BD Veritor RSV tests performed better than viral cell culture results when RT-PCR was the reference standard.
BACKGROUNDDuring respiratory syncytial virus season, many children present to pediatric offices and urgent care medical facilities with cough, tachypnea, intercostal retraction, wheezing, as well as disturbed appetite and sleep. Identification of the responsible viral pathogen is quite difficult because several pathogens can produce similar signs and symptoms.METHODSNasopharyngeal specimens were collected from symptomatic sick children younger than 6 years, in 8 geographically representative primary care pediatric practices during a 4-month RSV season. Institutional review board approval and signed parental consent were obtained. The primary objective of the study was the estimation of the sensitivity and specificity of the Becton Dickinson (BD) Veritor RSV point-of-care (POC) assay as compared with reverse transcriptase-polymerase chain reaction (RT-PCR).RESULTSOf 523 specimens, 58.3% (n = 305) were from patients younger than 2 years. The BD Veritor RSV POC assay sensitivity and specificity are 81.6% (146/179) and 99.1% (341/344), respectively. When compared with RT-PCR, the BD Veritor RSV POC assay false positive was 0.9% (3/344, with a 95% confidence interval of 0.3%-2.5%) and the false negative was 18.4% (33/179, with a 95% confidence interval of 13.4%-24.5%). The BD Veritor RSV POC assay identified more true positive specimens (n = 146) than viral cell culture (n = 134 positive specimens).CONCLUSIONSIn 8 participating primary care pediatric offices with 523 evaluable subjects, POC BD Veritor RSV tests performed better than viral cell culture results when RT-PCR was the reference standard.
Author Schwartz, Richard H
Selvarangan, Rangaraj
Zissman, Edward N
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  organization: From the Department of Pediatrics, Inova Children's Hospital, Falls Church, VA; †Laboratory Medicine Section, Children's Mercy Hospitals and Clinics; ‡School of Medicine, University of Missouri-Kansas City, Kansas City, MO; and §Altamonte Pediatric Associates, Altamonte Springs, FL
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  surname: Zissman
  fullname: Zissman, Edward N
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Snippet During respiratory syncytial virus season, many children present to pediatric offices and urgent care medical facilities with cough, tachypnea, intercostal...
BACKGROUNDDuring respiratory syncytial virus season, many children present to pediatric offices and urgent care medical facilities with cough, tachypnea,...
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SubjectTerms Antigens, Viral - immunology
Child
Child, Preschool
Female
Humans
Infant
Male
Nasopharynx - virology
Point-of-Care Systems
Predictive Value of Tests
Primary Health Care
Respiratory Syncytial Virus Infections - diagnosis
Respiratory Syncytial Virus Infections - virology
Respiratory Syncytial Viruses - isolation & purification
Reverse Transcriptase Polymerase Chain Reaction - methods
Sensitivity and Specificity
Virus Cultivation - methods
Title BD Veritor System Respiratory Syncytial Virus Rapid Antigen Detection Test: Point-of-Care Results in Primary Care Pediatric Offices Compared With Reverse Transcriptase Polymerase Chain Reaction and Viral Culture Methods
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