BD Veritor System Handbuch Seite 92

Another study was designed to assess the capability of untrained users to test weakly reactive samples and deliver results
with accuracy. This study was conducted at three CLIA waived intended use sites using simulated swab samples. The
samples were spiked with RSV virus targeting three concentrations (high negative =~5% positivity, low positive =~95%
positivity and moderate positive =~100% positivity). The swabs were provided to the operators in panels that were masked
and randomized prior to shipment to the sites. The samples were also tested by trained laboratorians at one clinical site.
Each site had two operators who each tested the panel on each of ten days. Each swab was processed and tested in a
single device according to the test procedure.
The table below shows the rate of RSV detection for weakly reactive samples when the test was used by untrained intended
users. The rate of RSV detection for weakly reactive samples when the test was used by trained laboratorians at one clinical
laboratory site is also provided.
Sample
% Pos
High
5.0%
negative
(1/20)
RSV
Low positive 75.0%
RSV (15/20)
Moderate
100%
positive
(20/20)
RSV
Using risk analysis as a guide, analytical flex studies were conducted. The studies demonstrated that the test is insensitive to
stresses due to environmental conditions or from potential user errors.
Technical Support
For questions, or to report a problem please call Technical Support at 1.800.638.8663. Test system problems may
also be reported to the FDA using the MedWatch reporting system (phone: 1.800.FDA.1088; fax: 1.800.FDA.1078;
or http://www.fda.gov/medwatch).
AVAILABILITY
Cat. No. Description
256038 BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV), CLIA waived kit, 30 tests
256042 BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) Laboratory kit, 30 tests
256045 BD Veritor™ System for Rapid Detection of Flu A+B, CLIA Waived kit, 30 tests
256041 BD Veritor™ System for Rapid Detection of Flu A+B, Laboratory kit, 30 tests
256061 BD Veritor™ System RSV Control Swab Set, 10 pairs of swabs
220252 COPAN Flexible Minitip Flocked Swab, 100 swabs
256066 BD Veritor™ Plus Analyzer
256068 BD Veritor™ InfoScan Module
443907 USB Printer Cable for BD Veritor™ Analyzer
To network a BD Veritor Plus Analyzer to an LIS, contact BD Technical Services for details.
Untrained Users
POC 1
95% CI % Pos
0.0%
0.9%, 23.6%
(0/20)
75.0%
53.1%, 88.8%
(15/20)
100%
83.9%, 100%
(20/20)
POC 2
95% CI % Pos
5.0%
0.0%, 16.1%
(1/20)
70.0%
53.1%, 88.8%
(14/20)
100%
83.9%, 100%
(20/20)
14
Trained Users
POC 3
95% CI % Pos
15.0%
0.9%, 23.6%
(3/20)
75.0%
48.1%, 85.5%
(15/20)
100%
83.9%, 100%
(20/20)
Clinical Site
95% CI
5.2%, 36.0%
53.1%, 88.8%
83.9%, 100%