Performance Characteristics - BD Veritor System Bedienungsanleitung

7. As recommended by the American Academy of Pediatrics, patients with symptoms and an antigen negative test should
have a follow-up culture.
8. The use of antibiotics or over-the-counter medications may suppress the growth of Group A Streptococcus in culture
despite the presence of organisms detectable by rapid antigen tests.
EXPECTED VALUES
Approximately 15% of pharyngitis in children ages 3 months to 5 years is caused by group A beta-hemolytic Streptococcus.
In school-aged children and adults, the incidence of Strep throat infection is about 40%.
winter and early spring in temperate climates.

PERFORMANCE CHARACTERISTICS

Explanation of Terms:
P: Positive
N: Negative
C.I.: Confidence Interval
CLINICAL PERFORMANCE
Performance characteristics for the BD Veritor System for Rapid Detection of Group A Strep were established in a multi-
center clinical trial conducted at one clinical laboratory site and four POC sites during the 2011-2012 respiratory season. A
total of 796 prospectively collected specimens were evaluated using the BD Veritor System for Rapid Detection of Group
A Strep and bacterial culture. Throat swabs from symptomatic patient were obtained, 51.8% from females and 48.2% were
from males. Specimens from patients five years old or younger comprised 39.1% of the total, with 59.3% from patients 6 to
21 years of age and 1.6% from patients 22 years of age or older.
The performance of the BD Veritor System for Rapid Detection of Group A Strep was determined by comparison to bacterial
culture and is presented in the table below.
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3
Clinical Performance Data – All Sites
BD Veritor
P
N
Total
Sensitivity: 96.6% (95% CI: 92.4%, 98.6%)
Specificity: 95.5% (95% CI: 93.6%, 96.9%)
Clinical Performance Data – By Site
Site Code BD Veritor
Clinical Site P
N
Total
Sensitivity: 100% (95% CI: 83.9%, 100%)
Specificity: 97.6% (95% CI: 91.7%, 99.3%)
P
POC 1
N
Total
Sensitivity: 91.5% (95% CI: 81.6%, 96.3%)
Specificity: 98.4% (95% CI: 95.5%, 99.5%)
P
POC 2
N
Total
Culture
P N
144 29
5 618
149 647
Reference Method: Culture
Culture
P
20
0
20
Reference Method: Culture
54
5
59
Reference Method: Culture
21
0
21
11
12 This disease usually occurs in the
Total
173
623
796
Total
N
2 22
82 82
84 104
3
57
188 193
191 250
9
30
111 111
120 141
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