Product Manual

Page 14 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.
Table 5
QuickVue RSV Reproducibility Study Intra-laboratory Agreement
*The concentration of virus particles (vp/mL) was determined by electron microscopic
techniques.
ANALYTICAL SENSITIVITY AND LIMIT OF DETECTION
The analytical sensitivity of the QuickVue RSV test was evaluated with four different
isolates of RSV A and four different isolates of RSV B. Viral lysates from each were
titered in immunoperoxidase plaque assays using established methodology and
tested in the QuickVue RSV test. All eight isolates of RSV were readily detected. The
analytical sensitivity was shown to be somewhat greater for RSV B than for RSV A. The
limit of detection was determined by enumeration of viral plaques after serial two-fold
dilutions of viral lysates on LLC-MK2 cells and comparison of the visually read QuickVue
RSV results to the calculated plaque forming units (pfu) per mL of the diluted lysates.
For RSV A the average limit of detection (taking the mean value obtained with all
four RSV A isolates) was 394 pfu/mL. For the four RSV B isolates, the average limit of
detection observed was 142 pfu/mL. Therefore, the assay has a slightly higher analytical
sensitivity for RSV B than for RSV A.
ANALYTICAL SPECIFICITY  CROSS REACTIVITY
A total of thirty-three (33) bacterial and twenty-four (24) viral isolates were tested in
duplicate in the QuickVue RSV test. None (i.e., 0/66 bacterial and 0/48 viral isolates) of
the microorganisms tested at the levels indicated showed any sign of cross-reactivity in
the assay. Flow of the sample and appearance of the Control Line were also not affected.
These results confirm high immunological specificity of the QuickVue RSV Test
Site
Low Negative
Samples
Low Positive
Samples
High Positive
Samples
Intermediate Positive
Samples
1.5 x 10
4
vp/mL*
1.4 x 10
6
vp/mL
2.2 x 10
6
vp/mL
6.3 x 10
6
vp/mL
1.8 x 10
6
vp/mL
1 59/59 60/60 59/60 60/60 60/60
2 59/60 59/60 60/60 58/59 60/60
3 60/60 58/60 59/59 60/60 60/60
% Overall
Agreement
(95% C.I.)
99.7% (298/299)
(98.2–100%)
99% (296/299)
(97.1–99.8%)
99.3% (297/299)
(97.6–99.9%)