Product Manual

Page 1 of 124QuickVue RSV Test
FOR INFORMATIONAL USE ONLY

FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
INTENDED USE
The QuickVue RSV test is a dipstick immunoassay, which allows for the rapid, qualitative
detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly
from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash
specimens for symptomatic pediatric patients (eighteen years of age and younger).
The test is intended for use as an aid in the diagnosis of acute respiratory syncytial viral
infections. It is recommended that negative test results be confirmed by cell culture.
Negative results do not preclude RSV infection and it is recommended that they not
be used as the sole basis for treatment or other management decisions. The test is
intended for professional and laboratory use.
SUMMARY AND EXPLANATION
Respiratory syncytial virus is a single-stranded (negative strand) RNA virus of the
Paramyxoviridae family.
1
It is the causative agent of a highly contagious, acute, viral
infection of the respiratory tract. Nearly half of all children become infected by their
first year of life. It is also the major viral cause of nosocomial illness in children already
hospitalized for other reasons.
2
In the United States, RSV is estimated to be responsible
for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia alone
among children younger than 1 year.
3
In children hospitalized with RSV infection, it is
believed to be the most common viral cause of death in children younger than 5 years,
particularly in children younger than one year.
4
Among children hospitalized with RSV
infection, the mortality rate is estimated to be as low as 0.3% to 1.0%.
3,5,6,7
and in the
range of 2.5% to 4.0% for children with underlying cardiac or pulmonary disease.
3,5,8
CLIA Complexity: WAIVED