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
7
Step 5:
• Press the attached tip firmly onto the extraction reagent tube containing the
processed sample (threading or twisting is not required). Mix thoroughly by
swirling or flicking the bottom of the tube.
NOTE: Do not use tubes or tips from any other product, including other products
from BD or other manufacturers.
After processing the swab in the extraction reagent, the sample should be analyzed within 30 minutes.
After step 5, choose from the BD Veritor Plus Analyzer workflow option below before continuing to step 6:
BD Veritor Plus Analyzer in
Analyze Now mode
BD Veritor Plus Analyzer in
Walk Away mode
BD Veritor Plus Analyzer with the
BD Veritor InfoScan module
in Analyze Now
mode
in Walk Away
mode
Instructions in
section:
A
B
C
D
A
Using a BD Veritor Plus Analyzer in “Analyze Now” mode:
Step 6A: 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 7A: Timing test development
•
After adding the sample, allow the test to run for
15 minutes
before inserting
the test device into the BD Veritor Plus Analyzer.
•
During incubation time, turn the
BD Veritor Plus
Analyzer on by pressing the
blue power button once.
•
NOTE:
If running test under laminar flow hood, cover test device to avoid
inconsistent flow.
Step 8A: Using the BD Veritor Plus Analyzer
•
The BD Veritor Plus Analyzer will complete a self-test before it is ready for
use. After the self-test the display window shows INSERT TEST DEVICE OR
DOUBLE-CLICK BUTTON FOR WALK AWAY MODE.
•
INSERT THE TEST DEVICE when the 15-minute assay development time
is complete.
•
The status of the assay analysis process appears in the display window.
Follow the on-screen prompts to complete the procedure. Do not touch the
Instrument or remove the test device until the result appears.
•
When analysis is complete, the test result appears in the display window.
Step 9A: Record the Result before removing the test device
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).
5