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
4
are collected and evaluated.
12. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical
specimens. Standard precautions and institutional guidelines should always be followed in handling, storing, and
disposing of all specimens and all items contaminated with blood or other body fluids.
13. The SARS-CoV-2 positive control swabs have been prepared from recombinant viral proteins and do not contain
infectious material.
14. Dispose of used BD Veritor System test devices as biohazardous waste in accordance with federal, state and
local requirements.
15. Reagents contain sodium azide, which is harmful if inhaled, swallowed or exposed to skin. Contact with acids produces
very toxic gas. If there is contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and
copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide
build-up.
16. Test devices used in a laminar flow hood or in areas with high air flow should be covered during test development to
ensure proper sample flow.
17. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please
refer to the Safety Data Sheet (SDS) located at bd.com.
STORAGE
Kits may be stored at 2–30 °C. DO NOT FREEZE. Reagents and devices must be at room temperature (15–30 °C) when
used for testing.
SPECIMEN COLLECTION AND HANDLING
Specimen Collection and Preparation
Acceptable specimens for testing with this kit include nasal swab specimens obtained by the dual nares collection method. It
is essential that correct specimen collection and preparation methods be followed. Specimens obtained early during symptom
onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative
results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling
and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to
the importance of specimen quality for generating accurate test results.
Specimen Transport and Storage
Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen
collection. It is essential that correct specimen collection and preparation methods be followed.
Nasal Swab Specimen Collection
1. The BD Veritor System Kit includes swabs for nasal specimen collection.
2. Insert the swab into one nostril of the patient. The swab tip should be inserted
up to 2.5 cm (1 inch) from the edge of the nostril. Roll the swab 5 times along
the mucosa inside the nostril to ensure that both mucus and cells are collected.
3. Using the same swab, repeat this process for the other nostril to ensure that an
adequate sample is collected from both nasal cavities.