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
If the BD Veritor Plus Analyzer is connected to an LIS, a steady ENVELOPE symbol will appear to indicate that results
are awaiting transmission. If a network connection is not detected while the ENVELOPE symbol is still displayed, the
BD Veritor Plus Analyzer will queue all untransmitted results and attempt to transmit them when reconnected. If it is
powered off during this time, it will attempt to transmit as soon as power is restored, and connection is re-established.
A flashing envelope indicates that data are in the process of being transmitted.
8
C
Using the BD Veritor Plus Analyzer In “
Analyze Now
” mode
with the BD Veritor InfoScan module installed
Step 6C:
Adding the specimen to the test device
•
Invert the extraction reagent tube and hold it vertically (approximately one inch above the
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.
Step 7C: Timing development
•
Allow the test to develop for
15 minutes.
CAUTION: incorrect results may occur if development time is less than 15 minutes.
Some
lines may appear on the device sooner. Do not read device visually.
•
If running the test in a laminar flow hood or in an area with heavy ventilation, cover test
device to avoid inconsistent flow.
Step 8C: Using the BD Veritor Plus Analyzer
During the incubation time, turn on the BD Veritor Plus Analyzer by pressing the blue button once.
The display window briefly shows “SCAN CONFIG BARCODE.” This is an opportunity to change the
configuration of the BD Veritor Plus Analyzer. Ignore this message and postpone this process when
an assay is awaiting analysis. Please refer to the BD Veritor Plus Analyzer Instructions for Use for
configuration steps.
•
When assay development time is complete and the BD Veritor Plus Analyzer display
window reads “INSERT TEST DEVICE OR DOUBLE-CLICK FOR WALK AWAY MODE”,
insert the BD Veritor System SARS-CoV-2 device into the slot on the right side of
the BD Veritor Plus Analyzer.
Step 9C: Using the barcode scanner
•
Follow the prompts on the display screen to complete any required barcode scans of:
–
OPERATOR ID
–
SPECIMEN ID and/or
–
KIT LOT NUMBER
After required scans are completed, the BD Veritor Plus Analyzer displays a countdown timer and test analysis begins.
•
Do not touch the BD Veritor Plus Analyzer or remove the test device during this process. Doing so will abort
the assay analysis.
•
When analysis is complete a result appears in the display window. If configured to display, the specimen ID
barcode value also appears. If a printer is connected, specimen ID and result are automatically printed.
If a printer is not connected, record the result before removing the assay device.
Step 10C: Remove the test device
• Remove and then discard the test device appropriately. The display will show “INSERT TEST DEVICE OR DOUBLE-CLICK
BUTTON FOR WALK AWAY MODE” to indicate the BD Veritor Plus Analyzer is ready to perform another test.
•
Prompts for each scanning step appear in the display window for only 30 seconds. Failure to complete scans during
that time will cause the BD Veritor Plus Analyzer to default to the beginning of step 8C. To restart this step, remove
and reinsert the test device to initiate a new reading sequence.
•
Move barcodes slowly toward the window until a confirmation tone sounds. The scanned barcode value appears in
the next display window.
•
The BD Veritor Plus Analyzer can record the Kit Lot Number and expiration date in the test record but does not restrict
the use of expired or inappropriate reagents. Management of expired materials is the responsibility of the user.
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).
15 min