BD Veritor System Bedienungsanleitung Seite 14

Reproducibility
The reproducibility of the BD Veritor System for Rapid Detection of Group A Strep was evaluated at one clinical and
two POC sites. The panel was composed of 4 simulated Group A Strep samples. These included high negative samples
(i.e. samples containing a very low concentration of Group A Strep), a low positive sample (near the limit of detection), a
moderate positive sample and a negative sample. The panel was tested by two operators at each site over five days. The
results are summarized below.
BD Veritor Group A Strep Reproducibility
Sample
% Pos
High 3.3%
negative (1/30)
Low 96.7%
positive (29/30)
Moderate 100%
positive (30/30)
0%
Negative
(0/30)
CLIA WAIVER STUDY
As part of the larger prospective study, as described in the Performance Characteristics section above, the accuracy of the
BD Veritor System for Rapid Detection of Group A Strep test was evaluated at four non-laboratory intended use Point of
Care (POC) sites. A total of 14 operators representative of CLIA waived site personnel (intended users) participated in the
study. No training on the use of the test was provided. A total of 692 prospectively collected specimens were tested.
Results below represent the performance of untrained operators at the POC sites of the BD Veritor Group A Strep test
compared to culture. The results of the BD Veritor GAS test were compared with the results obtained from bacterial culture.
Results are shown in the table below.
Another study was designed to assess the capability of untrained users to test weakly reactive samples and deliver results
with accuracy. The study was conducted at three non-laboratory intended use POC sites and one clinical laboratory site
using panels of simulated samples. The panels were composed of swabs that were masked and randomized prior to
shipment to the sites.
The positive samples were formulated at three levels (high negative =~5% positivity, low positive =~95% positivity and
moderate positive =~100%).
Reproducibility Panel
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 performance of the test with samples near the cutoff of the assay for Group A Strep in the hands of
untrained intended users across the POC sites and in the hands of laboratory personnel at one clinical laboratory site.
Site 1
95% CI % Pos
0%
0.6%,16.7%
(0/30)
83.3%
83.3%, 99.4%
(25/30)
96.7%
88.6%, 100%
(29/30)
0%
0%, 11.3%
(0/30)
CLIA Waiver Clinical Performance Data
BD Veritor
P
N
Total
Sensitivity: 95.4% (95% CI: 90.3%, 97.9%)
Specificity: 95.7% (95% CI: 93.7%, 97.1%)
Number of Samples
1
1
1
Site 2
95% CI % Pos
0%, 11.3%
66.4%, 92.7%
(28/30)
83.3%, 99.4%
(30/30)
0%, 11.3%
Culture
N
P
124 24
6 538
130 562
Reference Method: Culture
Group A Strep
High negative
Low positive
Moderate positive
14
Site 3
95% CI
0%
0%, 11.3%
(0/30)
93.3%
78.7%, 98.2%
100%
88.6%, 100%
0%
0%, 11.3%
(0/30)
Total
148
544
692
Total
95% CI
% Pos
1.1%
0.2%, 6.0%
(1/90)
91.1%
83.4%, 95.4%
(82/90)
98.9%
94.0%, 99.8%
(89/90)
0%
0%, 4.1%
(0/90)