Product Manual

Page 17 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.
INTERFERING SUBSTANCES
Several over-the-counter (OTC) products and common chemicals were evaluated
and did not interfere with the QuickVue RSV test at the levels tested. These included
the following: three OTC mouthwashes (25%); three OTC cough drops (25%); three
nasal sprays/gel (10%); Acetamidophenol (10 mg/mL); Acetylsalicylic Acid (20 mg/mL);
Chlorpheniramine (5 mg/mL); Dextromethorphan (10 mg/mL); Diphenhydramine
(5 mg/mL); Mucin (4 mg/mL); Guaiacol (20 mg/mL); Phenylephrine (50 mg/mL);
Rimantadine (50 ug/mL); and Albuterol (20 mg/mL).
PRECISION STUDIES
The total within-run and between-run performance of the QuickVue RSV test was
evaluated for precision. A panel consisting of two positives (3.0 x 10
6
vp/mL and
5.9 x 10
6
vp/mL) of inactivated RSV virus was tested in replicates of 50 on 2 different
days with each of 3 validation lots. One hundred percent (100%) accuracy was
obtained for all specimens tested.
CONSUMER PRECISION STUDY
Lay Users vs. Trained Laboratorians
The QuickVue RSV test was evaluated by seventy-one (71) operators with no professional
laboratory experience (lay users) at three different sites. Each operator at each site tested
four concentration levels of RSV, comprising a coded panel of negative, weak positive,
low positive, and positive samples. In order to demonstrate equivalent performance
among lay users and trained laboratorians, six (6) trained laboratorians at two laboratory
sites ran the panel of blind coded samples containing the same negative, weak positive,
low positive, and positive samples described above.
As indicated by the overlapping 95% confidence intervals in Tables 6 and 7 below, no
significant differences were observed between the performance of the lay users and the
trained laboratorians. These results demonstrate that users with no formal laboratory
training can read the package insert and perform the QuickVue test with the same
precision as trained laboratorians. No significant differences were observed between
the untrained users at the three different lay user sites.