Product Manual

Page 12 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.

Results with Fresh Nasopharyngeal Swab Specimens

Nasopharyngeal swab (Copan Diagnostics, item #501CS01.US) specimens from two

hundred seventy-five (275) patients were tested in QuickVue RSV and in cell culture. The

QuickVue RSV test correctly identified 92% (24/26) RSV culture-positive specimens and

92% (230/249) RSV culture-negative specimens. These results are shown in Table 2.

Table 2

QuickVue RSV Nasopharyngeal Swab Results versus Culture

(≤18 years of age)

Background on the 2006/2007 Clinical Studies

In the 2006/2007 clinical studies, the performance of the QuickVue RSV test was

compared to viral cell culture methods and DFA in a multi-center clinical study during

the RSV season in the United States. This study was performed by professional health

care personnel at two pediatric clinics and two hospital emergency departments in

various geographical regions within the United States. In this multi-center, point-of-

care (POC) field trial, nasal/nasopharyngeal wash specimens were collected from two

hundred eighty-nine (289) patients. All clinical samples were collected from symptomatic

patients less than six years of age. 60% were male and 40% were female.

On-site testing of a portion of nasal/nasopharyngeal wash was performed by physician

office personnel with the QuickVue RSV test. All samples were freshly collected and

tested within one hour. No samples were frozen prior to testing. The remaining sample

was placed in viral transport media and transported to a reference laboratory for culture,

where cells were inoculated with the specimen, incubated at 36°C for 48 hours, and then

removed from culture and tested for RSV by direct fluorescent antibody (DFA) staining.

Results with Fresh Nasal/Nasopharyngeal Wash Specimens

Nasal/nasopharyngeal wash specimens from two hundred eighty-nine (289) patients

were tested in QuickVue RSV and in cell culture. The QuickVue RSV test correctly

identified 83% (100/121) RSV culture-positive specimens and 90% (152/168) RSV culture-

negative specimens. These results are shown in Table 3.

Sensitivity = 24/26 = 92% (95% C.I. 75–99%)

Speciﬁcity = 230/249 = 92% (95% C.I. 88–95%)

PPV = 24/43 = 56%

NPV = 230/232 = 99%

RSV Culture

QV Pos

QV Neg

–

24 19

2230