Product Manual

12
CLINICAL PERFORMANCE
The performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 was established with 226 direct nasal swabs
prospectively collected and enrolled from individual symptomatic patients (within 5 days of onset) who were suspected of
COVID-19. As with all antigen tests, performance may decrease as days since symptom onset increases. Samples were
collected by qualified personnel in 21 geographically diverse areas across the United States.
Nasal swabs were collected following the dual nares method and handled as described in the package insert of the collection
device. Specimens were frozen within 30 minutes of collection and stored until tested. All specimens within a prespecified
date range were selected and then sequentially tested in a blinded fashion. The performance of the BD Veritor System Assay
was compared to results of a nasopharyngeal or oropharyngeal swab stored in 3 mL viral transport media tested with an
Emergency Use Authorized molecular (RT-PCR) test for detection of SARS-CoV-2.
BD Veritor Results
Reference PCR Results
POS
NEG
Total
POS
26
0
26
NEG
5
195
200
Total
31
195
226
PPA: 84% (C.I. 67%–93%)
NPA: 100% (C.I. 98%–100%)
OPA: 98% (C.I. 95%–99%)
EXPLANATION OF TERMS:
PPA: Positive Percent Agreement = True Positives / True Positives + False Negatives
NPA: Negative Percent Agreement = True Negatives / True Negatives + False Positives.
OPA: Overall Percent Agreement = True Positives + True Negatives / Total Samples
C.I.: Confidence Interval
ANALYTICAL PERFORMANCE
LIMIT OF DETECTION (ANALYTICAL SENSITIVITY)
The LOD for the BD Veritor System for Rapid Detection of SARS-CoV-2 was established using limiting dilutions of a viral
sample inactivated by gamma irradiation. The material was supplied at a concentration of 2.8 x 10
5
TCID
50
/mL. In this study,
designed to estimate the LOD of the assay when using a direct nasal swab, the starting material was spiked into a volume
of pooled human nasal matrix obtained from healthy donors and confirmed negative for SARS-CoV-2. An initial range finding
study was performed testing devices in triplicate using a 10-fold dilution series. At each dilution, 50 µL samples were added
to swabs and then tested in the BD Veritor assay using the procedure appropriate for patient nasal swab specimens. A
concentration was chosen between the last dilution to give 3 positive results and the first to give 3 negative results. Using this
concentration, the LOD was further refined with a 2-fold dilution series. The last dilution demonstrating 100% positivity was
then tested in an additional 20 replicates tested in the same way.
Starting Material Concentration Estimated LOD No. Positive/Total % Positive
2.8 x 10
5
TCID
50
/mL 1.4 x 10
2
TCID
50
/mL 19/20 95%
CROSS REACTIVITY (ANALYTICAL SPECIFICITY)
Cross-reactivity of the BD Veritor System for Rapid Detection of SARS-CoV-2 was evaluated by testing a panel of high
prevalence respiratory pathogens that could potentially cross-react with the BD Veritor System for Rapid Detection of
SARS-CoV-2. Each organism and virus was tested in triplicate. The final concentration of each organism is documented in
the following table.
Potential Cross-Reactant Concentration Tested Cross-Reactivity (Yes/No)
Human coronavirus 229E (heat inactivated)
1.0 x 10
5
U/mL No
Human coronavirus OC43
1.0 x 10
5
TCID
50
/mL No
Human coronavirus NL63
1.0 x 10
5
TCID
50
/mL No
Adenovirus
1.0 x 10
5
TCID
50
/mL No
Human Metapneumovirus
1.0 x 10
5
TCID
50
/mL
No
Parainfluenza virus 1
1.0 x 10
5
TCID
50
/mL No
Parainfluenza virus 2
1.0 x 10
5
TCID
50
/mL No
Parainfluenza virus 3
5.2 x 10
5
TCID
50
/mL No
Parainfluenza virus 4
1.6 x 10
4
TCID
50
/mL No
Influenza A
2.5 x 10
5
TCID
50
/mL No