Group A Strep
BD Veritor™ Plus System
Group A Streptococcus rapid antigen testing
Effective pathogen detection for confidence in choosing treatment plans
Rapid diagnosis and early antibiotic therapy for Group A Streptococcal infection are the best means of preventing medical complications and reducing the spread of the disease¹.
BD Veritor™ Plus System for Group A Strep
The BD Veritor™ Plus System for Rapid Detection of Group A Strep is a digital immunoassay that quickly, efficiently and reliably detects the presence of Group A Strep antigen from throat swabs of patients suspected of having Group A Strep by their healthcare provider.
The system offers one-button functionality and workflow flexibility, allowing health care providers to confidently use the Analyzer.
Simple sample collection with throat swabs
Fast, reliable results in as few as 6 minutes²
Two analysis options to optimize workflow
Rapid Group A Strep test accuracy + clinical performance data
Testing can be complicated. We aim to make it simple, effective and reliable.
Comparison of BD Veritor™ System for Rapid Detection of Group A Strep Test to Culture
Group A Strep is a bacterial infection common in school-age children (with limited cases in infants and older adults) that is generally experienced in the United States during winter and spring¹. The ability to provide rapid testing for patients at point-of-care sites is critical to preventing complications by supplying the information necessary to develop treatment plans.
The BD VeritorTM System for Rapid Detection of Group A Strep was employed in four point-of-care sites, to compare diagnostic results to bacterial culture testing conducted at a clinical lab. In the chart below, BD data shows a high Sensitivity rate (sensitivity measures the ability of the test to appropriately make a positive identification) and fewer false negatives2. In addition, data shows a high Specificity rate (specificity measures the ability of the test to properly identify the absence of the test target) and fewer false positives².
Clinical Performance Data – All Sites²
96.6%
Sensitivity
(95% C.I 92.4-98.6.0%)
95.5%
Specificity
(95% C.I 93.6-96.9%)
CLIA Waiver Clinical Performance Data
CULTURE
BD Veritor TM
| P | N | Total | |
|---|---|---|---|
| P | 144 | 29 | 173 |
| N | 5 | 618 | 623 |
| Total | 149 | 647 | 796 |
Reference method: Culture
Sensitivity:96.6% (95% C.I 92.4-98.6%)
Specificity: 95.5% (95% C.I 93.6-96.9%)
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 above.
Explanation of Terms:
Sensitivity: Ability of the test to properly identify the test target when it is present, compared to an accepted standard method.
Specificity: Ability of the test to properly identify when the test target is not present, compared to an accepted standard method.
P: Positive
N: Negative
C.I.: Confidence Interval
CLINICAL PERFORMANCE STUDY
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.
CLIA WAIVER STUDY²
Comparison of BD Veritor™ System for Rapid Detection of Group A Strep
The clinical performance of the BD Veritor System™ for Rapid Detection of Group A Strep test was evaluated at four non-laboratory point-of-care sites. A total of 14 operators, representative of CLIA-waived users, participated in the study. No training on the use of the test was provided.
In the chart below, data shows that, when compared to an accepted standard method, the BD Veritor™ System has a high Sensitivity rate (sensitivity measures the ability of the test to appropriately make a positive identification) and fewer false negatives². In addition, data shows a high Specificity rate (specificity measures the ability of the test to properly identify the absence of the test target) and fewer false positives².
BD Group A Strep²
95.4%
Sensitivity
(95% C.I 90.3-97.9.0%)
95.7%
Specificity
(95% C.I 93.7-97.1%)
CLIA Waiver Clinical Performance Data
CULTURE
BD Veritor TM
| P | N | Total | |
|---|---|---|---|
| P | 124 | 24 | 148 |
| N | 6 | 538 | 544 |
| Total | 130 | 562 | 692 |
Reference method: Culture
Sensitivity:95.4% (95% C.I 90.3-97.9%)
Specificity: 95.7% (95% C.I 93.7-97.1%)
The results above represent the performance of untrained operators at the point-of-care sites of the BD Veritor™ Group A Strep test compared to culture.
Explanation of Terms:
Sensitivity: Ability of the test to properly identify the test target when it is present, compared to an accepted standard method (bacterial culture).
Specificity: Ability of the test to properly identify when the test target is not present, compared to an accepted standard method (bacterial culture).
P: Positive
N: Negative
C.I.: Confidence Interval
BD Veritor™ Plus System ordering and reimbursement
As your facility continues to provide valuable rapid diagnostic testing, you may need to reorder. Please click here for more information.
REFERENCES
- https://www.cdc.gov/groupastrep/diseases-hcp/strep-throat.html Accessed January 24, 2021
- BD Veritor System for Rapid Detection of Group A Strep, CLIA-waived kit [package insert], 8087675. Franklin Lakes, NJ: Becton, Dickinson and Company.
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