Product Manual

Page 11 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.

PERFORMANCE CHARACTERISTICS

QuickVue RSV Test Performance

Background on the 2005/2006 Clinical Studies

In the 2005/2006 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 general practice clinics, one hospital emergency department and

one pediatric clinic in the southwestern United States. In this multi-center, point-of-care

(POC) field trial, nasopharyngeal aspirate specimens were collected from two hundred

thirty-seven (237) patients. Two nasopharyngeal swab specimens were collected from

each of two hundred seventy-five (275) patients. All clinical samples were collected from

symptomatic patients eighteen (18) years of age and younger. 55% were male and 45%

were female.

On-site testing of one nasopharyngeal swab specimen, or a portion of nasopharyngeal

aspirate, was performed by physician office personnel with the QuickVue RSV test. All

samples were freshly collected and tested within one hour which demonstrates optimal

performance. No samples were frozen prior to testing. The remaining sample was placed

in viral transport media and stored at 2–8°C for up to 18 hours prior to culture.

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

at a designated reference laboratory.

Results with Fresh Nasopharyngeal Aspirate Specimens

Nasopharyngeal aspirate specimens from two hundred thirty-seven (237) patients were

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

99% (68/69) RSV culture-positive specimens and 92% (155/168) RSV culture-negative

specimens. These results are shown in Table 1.

Table 1

QuickVue RSV Nasopharyngeal Aspirate Results versus Culture

(≤18 years of age)

RSV Culture

Sensitivity = 68/69 = 99% (95% C.I. 91–100%)

Speciﬁcity = 155/168 = 92% (95% C.I. 87–96%)

PPV = 68/81 = 84%

NPV = 155/156 = 99%

QV Pos

QV Neg

–

68 13

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