Product Manual
Table Of Contents
- For In Vitro Diagnostic Use
- For In Vitro Diagnostic Use
- INTENDED USE
- INTENDED USE
- SUMMARY AND EXPLANATION OF THE TEST
- SUMMARY AND EXPLANATION OF THE TEST
- PRINCIPLES OF THE PROCEDURE
- PRINCIPLES OF THE PROCEDURE
- REAGENTS
- REAGENTS
- Materials Provided:
- Materials Provided:
- Optional Equipment:
- Optional Equipment:
- WARNINGS AND PRECAUTIONS
- WARNINGS AND PRECAUTIONS
- STORAGE
- STORAGE
- SPECIMEN COLLECTION AND HANDLING
- SPECIMEN COLLECTION AND HANDLING
- Specimen Transport and Storage
- Specimen Transport and Storage
- Nasal Swab Specimen Collection
- Nasal Swab Specimen Collection
- DOs and DON’Ts of Sample Collection
- DOs and DON’Ts of Sample Collection
- TEST PROCEDURE
- TEST PROCEDURE
- This BD Veritor System assay kit is only intended for nasal swab specimens that are collected and tested directly (i.e., swabs that have NOT been placed in transport media). The kit includes a pre-diluted processing reagent in a ready to use “unitized...
- This BD Veritor System assay kit is only intended for nasal swab specimens that are collected and tested directly (i.e., swabs that have NOT been placed in transport media). The kit includes a pre-diluted processing reagent in a ready to use “unitized...
- Step 4:
- Step 4:
- Step 5:
- Step 5:
- NOTE: Do not use tubes or tips from any other product, including other products from BD or other manufacturers.
- NOTE: Do not use tubes or tips from any other product, including other products from BD or other manufacturers.
- NOTE: Squeezing the tube too close to the tip may cause leakage.
- NOTE: Squeezing the tube too close to the tip may cause leakage.
- If a printer is not connected, record the result before removing the assay device.
- If a printer is not connected, record the result before removing the assay device.
- INTERPRETATION OF RESULTS
- INTERPRETATION OF RESULTS
- REPORTING OF RESULTS
- REPORTING OF RESULTS
- QUALITY CONTROL
- QUALITY CONTROL
- EXTERNAL POSITIVE AND NEGATIVE CONTROLS
- EXTERNAL POSITIVE AND NEGATIVE CONTROLS
- If the kit controls do not perform as expected, do not report patient results. Contact BD Technical Services at 1.800.638.8663.
- If the kit controls do not perform as expected, do not report patient results. Contact BD Technical Services at 1.800.638.8663.
- CONDITIONS OF AUTHORIZATION FOR THE LABORATORY
- CONDITIONS OF AUTHORIZATION FOR THE LABORATORY
- CLINICAL PERFORMANCE
- CLINICAL PERFORMANCE
- ANALYTICAL PERFORMANCE
- ANALYTICAL PERFORMANCE
- CROSS REACTIVITY (ANALYTICAL SPECIFICITY)
- CROSS REACTIVITY (ANALYTICAL SPECIFICITY)
- HIGH DOSE HOOK EFFECT
- HIGH DOSE HOOK EFFECT
- TECHNICAL SUPPORT
- TECHNICAL SUPPORT
- REFERENCES
- REFERENCES
13
Potential Cross-Reacting Organism Concentration Tested Results
Influenza B
2.9 x 10
5
TCID
50
/mL
No
Enterovirus
4.0 x 10
5
TCID
50
/mL
No
Respiratory syncytial virus
4.0 x 10
5
TCID
50
/mL
No
Rhinovirus
1.1 x 10
5
PFU/mL No
SARS-coronavirus
4.5 x 10
5
PFU/mL No
MERS-coronavirus
1.5 x 10
5
TCID
50
/mL
No
Haemophilus influenza
1.4 x 10
6
CFU/mL No
Streptococcus pneumoniae
1.0 x 10
6
CFU/mL No
Streptococcus pyogenes
1.6 x 10
6
CFU/mL No
Candida albicans
1.8 x 10
6
CFU/mL No
Pooled human nasal wash
100% No
Bordetella pertussis
1.4 x 10
6
CFU/mL No
Mycoplasma pneumoniae
1.0 x 10
6
CFU/mL No
Chlamydia pneumoniae
1.0 x 10
6
IFU/mL No
Legionella pneumophila
1.0 x 10
6
CFU/mL No
To estimate the likelihood of cross-reactivity with SARS-CoV-2 of organisms that were not available for wet testing,
In silico analysis using the Basic Local Alignment Search Tool (BLAST) managed by the National Center for Biotechnology
Information (NCBI) was used to assess the degree of protein sequence homology.
• For P. jirovecii one area of sequence similarity shows 45.4% homology across 9% of the sequence, making
cross-reactivity in the BD Veritor sandwich immunoassay highly unlikely.
• No protein sequence homology was found between SARS-CoV-2 and M. tuberculosis, and thus homology-based
cross-reactivity can be ruled out.
• The comparison between SARS-CoV-2 nucleocapsid protein and human coronavirus HKU1 revealed that the only
potential for homology is with the HKU1 nucleocapsid phosphoprotein. Homology is relatively low, at 36.7% across
82% of sequences, but cross-reactivity cannot be ruled out.
HIGH DOSE HOOK EFFECT
No high dose hook effect was observed up to 2.8 x 10
5
TCID
50
/mL of gamma-inactivated SARS-CoV-2 with the BD Veritor
System for Rapid Detection of SARS-CoV-2 test.
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).
REFERENCES
1. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed
March 30, 2020.
2. bioRxiv. (https://www.biorxiv.org/content/10.1101/2020.02.07.937862v1). Accessed March 30, 2020.
3. Lauer, Stephen A et al. “The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported
Confirmed Cases: Estimation and Application.” Annals of internal medicine vol. 172,9 (2020): 577-582.
doi:10.7326/M20-0504
Technical Information: In the United States contact BD Technical Service and Support at 1.800.638.8663 or bd.com.