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
8
B
Using the BD Veritor Plus Analyzer in “Walk Away” mode:
with no barcode scanning module installed
To use Walk Away mode - connect the AC power adapter to the Analyzer and a power source
Step 6B: Starting Walk Away Mode
•
Turn the
BD Veritor Plus
Analyzer on by pressing the blue power button
once
•
When the display window reads: “INSERT TEST DEVICE OR
DOUBLE-CLICK FOR WALK AWAY MODE, Double-click the
blue power button.
•
The display window reads “ADD SPECIMEN TO TEST DEVICE AND
INSERT IMMEDIATELY”
Step 7B: Adding the specimen to the test device
•
Invert the tube, holding it vertically (approximately one inch above the
BD Veritor System test device sample well).
•
Gently squeeze the ridged body of the tube, dispensing three (3) drops of the
processed specimen into the sample well.
•
Excess volume remains for retesting if necessary.
NOTE: Squeezing the tube too close to the tip may cause leakage.
CAUTION: A countdown timer displays the time remaining for test insertion.
Walk Away mode must be activated again when this timer expires. Confirm
timer is visible and Walk Away mode is activated before inserting
test device.
Step 8B: Starting the development and reading sequence
•
Insert the test device into the slot on the right side of the
BD Veritor
Plus
Analyzer.
The test device must remain horizontal to prevent spilling the specimen out of
the sample well
•
“DO NOT DISTURB TEST IN PROGRESS” appears in the display window.
Automatic timing of the assay development, image processing and result
analysis begins.
•
The display window shows the remaining analysis time.
Do not touch the BD Veritor Plus Analyzer or remove the test device during this
process. Doing so will abort the assay analysis.
Step 9B: Record the Result
•
When analysis is complete, the test result appears in the display window. Record the result and discard the test
device appropriately.
ATTENTION: TEST Results are NOT maintained in the display window when the device is removed or if the
BD Veritor Plus Analyzer is left unattended for more than 15 minutes (60 minutes if AC power adapter is connected).