BD Veritor System Handbuch Seite 91

Interfering Substances
Various substances were evaluated with the BD Veritor System for Rapid Detection of RSV test. These substances included
whole blood (2%) and various medications. No interference was noted with this assay for any of the substances at the
concentrations tested.
Substance
Ayr Saline Nasal Gel
4-Acetamidophenol
Acetylsalicylic acid
Albuterol
Amantadine Hydrochloride
Beclomethasone
Budesonide
Chlorpheniramine maleate
Dexamethasone
Dextromethorphan
Diphenhydramine HCl
Fexofenadine
FluMist™
Flunisolide
Fluticasone
Guaiacol Glyceryl Ether
Homeopathic Allergy Medicine
Ibuprofen
Loratidine
CLIA WAIVER STUDY
The accuracy of the BD Veritor System for Rapid Detection of RSV test was evaluated at eight non-laboratory intended use
Point of Care (POC) sites. A total of 22 operators representative of CLIA waived site personnel (intended users) participated
in the study. No training on the use of the test was provided. The BD Veritor RSV test results obtained by the intended users
were compared with results obtained by a commercially available PCR method. There were 523 prospectively collected
specimens evaluated in this study. Among those there were 179 specimens that tested positive and 344 that tested negative
by the PCR method. The positive percent agreement (PPA) of the BD Veritor RSV assay for specimens that tested positive
by the comparator PCR method was 81.6% (146/179) with the 95% confidence interval (CI) of 75.2–86.6%, and the negative
percent agreement (NPA) was 99.1% (341/344) with the 95% CI of 97.5–99.7%.
The results of the BD Veritor RSV test obtained on the same specimens by the intended users were also compared with the
results obtained by viral cell culture. Among the 523 specimens tested, there were 134 specimens that tested positive and
389 that tested negative by the viral culture method. The sensitivity of the BD Veritor RSV assay for specimens that tested
positive by the comparator viral cell culture was 91.8% (123/134) with the 95% CI of 85.9–95.4%, and the specificity was
93.3% (363/389) with the 95% CI of 90.4–95.4%. Of the 26 BD Veritor RSV positive, viral cell culture negative specimens
there were 23 specimens that tested positive by the PCR comparator method.
The summary of the results is presented below.
BD Veritor RSV Compared to PCR
BD Veritor RSV
P
N
Total
PPA: 81.6% (95% CI: 75.2%, 86.6%)
NPA: 99.1% (95% CI: 97.5%, 99.7%)
*Of the 26 BD Veritor RSV positive, viral cell culture negative specimens, there were 23 specimens that tested positive by the PCR
comparator method.
The overall invalid rate for the BD Veritor System for RSV based on the 523 specimens tested in the study was 0.2% (1/523)
with the 95% CI of 0.0–1.1%.
Concentration
10 mg/mL
10 mg/mL
20 mg/mL
0.083 mg/mL
500 ng/mL
500 ng/mL
500 ng/mL
5 mg/mL
10 mg/mL
10 mg/mL
5 mg/mL
500 ng/mL
1%
500 ng/mL
500 ng/mL
20 mg/mL
10 mg/mL
10 mg/mL
100 ng/mL
PCR
P N
146 3
33 341
179 344
Substance
Menthol Throat Lozenges
Mometasone
Mupirocin
Oseltamivir
Oxymetazoline
Phenylephrine
Pseudoephedrine HCl
Purified Mucin Protein
Ribavirin
Rimantadine
Synagis
Tobramycin
Triamcinolone
Zanamivir
Four OTC nasal sprays
Four OTC throat drops
Two OTC mouthwashes
Whole Blood
BD Veritor RSV Compared to Viral Culture
Total P
149 123
374 11
523
134
Sensitivity: 91.8% (95% CI: 85.9%, 95.4%)
Specificity: 93.3% (95% CI: 90.4%, 94.4%)
13
Concentration
10 mg/mL
500 ng/mL
500 ng/mL
500 ng/mL
0.05 mg/mL
1 mg/mL
20 mg/mL
1 mg/mL
500 ng/mL
500 ng/mL
500 ng/mL
500 ng/mL
1 mg/mL
Viral Culture
N
26*
363
389
4 µg/mL
10%
12.5%
5%
2%
Total
149
374
523