Product Manual

Page 10 of 124QuickVue RSV Test
FOR INFORMATIONAL USE ONLY
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FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
LIMITATIONS
n This test is suitable for the pediatric population (eighteen years of age and younger)
only and should not be used in an adult population.
n The contents of this kit are to be used for the qualitative detection of RSV fusion
protein antigen from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/
nasopharyngeal wash specimens.
n Analytical testing has demonstrated the test is slightly more sensitive for RSV B than
for RSV A (refer to the Analytical Sensitivity and Limit of Detection section of this
Package Insert).
n A negative test result may occur if the level of antigen in a sample is below the
detection limit of the test, or if the sample was collected improperly.
n Failure to follow the Test Procedure and Interpretation of Results may adversely affect
test performance and/or invalidate the Test Result.
n Test Results must be evaluated in conjunction with other clinical data available to the
physician.
n Negative test results are not intended to rule in other non-RSV viral or bacterial
infections.
n Positive test results do not rule out co-infections with other pathogens.
n Positive and negative predictive values are highly dependent on prevalence. False
negative test results are more likely during peak activity when prevalence of disease is
high. False positive test results are more likely during periods of low RSV activity when
prevalence is moderate to low.
EXPECTED RESULTS
The rate of positivity observed in RSV testing will vary depending on the method of
specimen collection, handling/transport system employed, detection method utilized,
time of year, age of the patient, and most importantly, disease prevalence. The prevalence
observed with culture during the clinical study (December 2005 – February 2006) was
18.6% (95/512). The prevalence observed with culture during the clinical study
(December 2006 – February 2007) was 41.9% (121/289).