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
6
DOs and DON’Ts of Sample Collection
• Do collect sample as soon as possible after onset of symptoms.
• Do test sample immediately.
• Use only swabs provided with the kit.
• Refer to: Interim Guidelines for Collecting, Handling and Testing Clinical Specimens from persons for COVID-19 at
https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html
TEST PROCEDURE
Reagents, specimens and devices must be at room temperature (15–30 °C) for testing.
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” tube. This kit IS NOT INTENDED for testing liquid samples such as wash or aspirate samples
or swabs in transport media as results can be compromised by over dilution.
Getting ready to test
The following steps assume that the BD Veritor Plus Analyzer is ready to use. To choose or change any
BD Veritor Plus Analyzer settings, see the BD Veritor Plus Analyzer Instructions for Use, section 4.7. A printer is
not necessary to display results. However, if your facility has chosen to connect the BD Veritor Plus Analyzer to a
printer, check that the BD Veritor Plus Analyzer is plugged into a power source, paper supply is adequate and any
necessary network connections are enabled before testing.
Freshly collected specimens should be processed within 1 hour.
Procedure for Nasal Swabs or control swabs:
Step 1:
• Remove one extraction reagent tube/tip and one BD Veritor System test device
from its foil pouch immediately before testing.
• Label one test device and one extraction reagent tube for each specimen or
control to be tested.
• Place the labeled extraction reagent tube(s) in a rack in the designated area of
the workspace.
Process the Specimen or Control Swab
1
Step 2:
• Remove and discard the cap from the extraction reagent tube.
2
Step 3:
• Insert the swab into the tube and plunge the swab up and down in the fluid for a
minimum of 15 seconds, taking care not to splash contents out of the tube.
Step 4:
• Remove the swab while squeezing the sides of the tube to extract the liquid
from the swab.
15 seconds
3
4