BD Veritor Respiratory Syncytial Virus Test Kit

Features of BD Veritor Respiratory Syncytial Virus Test Kit

• Rapid results: The test provides results in just 15 minutes, allowing healthcare providers to quickly diagnose RSV infections and initiate appropriate treatment.
• Easy to use: The test kit is designed to be easy to use, with clear instructions for sample collection, preparation, and testing. The test device is intuitive and does not require any specialized equipment or training to use.
• Accurate: The BD Veritor RSV Test Kit uses lateral flow immunochromatography technology to detect RSV antigens in patient samples. This technology is highly sensitive and specific, providing accurate results even in cases of low viral load.
• Nasal or nasopharyngeal swab: The test kit can be used with either a nasal or nasopharyngeal swab sample, allowing healthcare providers to choose the most appropriate sample collection method for their patients.
• Room temperature storage: The test kit can be stored at room temperature, eliminating the need for refrigeration and making it easier to store and transport.
• CLIA waived: The BD Veritor RSV Test Kit has been waived under the Clinical Laboratory Improvement Amendments (CLIA), meaning that it can be used in a variety of healthcare settings without requiring complex laboratory infrastructure or expertise.
• FDA-approved: The BD Veritor RSV Test Kit is approved by the U.S. Food and Drug Administration (FDA) for use in healthcare settings, providing assurance of its safety, efficacy, and quality.

Frequently Bought Together

• Latex-Free Vinyl Exam Gloves
• TriDerma Moisturizing Hand Sanitizer
• LYSOL Disinfectant Spray

How to use BD Veritor System for Rapid Detection of RSV CLIA-waived Kit?

Specimen Collection and Preparation:

• The acceptable specimen for testing with the BD Veritor System for Rapid Detection of RSV is a nasopharyngeal (NP) swab. It is essential that correct specimen collection and preparation methods be followed.
• Specimens obtained early in the course of the illness will contain the highest viral titers.
• Inadequate specimen collection or improper specimen handling and/or transport may yield a false 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 and tested within one hour. It is essential that correct specimen collection and preparation methods be followed.

1. The BD Veritor System RSV Kit includes swabs with a flocked tip for nasopharyngeal specimen collection.

 

2. Insert the swab into one nostril of the patient, reaching the surface of the posterior nasopharynx.

 

3. Rotate the swab over the surface of the posterior nasopharynx.

 

4. Withdraw the swab from the nasal cavity. The sample is now ready for processing using the BD Veritor System Kit.

 

Prepare for testing

The following steps assume that users of a BD Veritor Plus Analyzer have chosen and set all configuration options, and that the Analyzer is ready to use. To choose or change these 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 Analyzer is plugged into a power source, paper supply is adequate and any necessary network connections are enabled before testing.

Step 1: For each patient specimen:

• Remove one RV Reagent D tube/tip and one BD Veritor System RSV device from its foil pouch immediately before testing.
• Label with patient’s name or ID number
• Place the labeled RV Reagent D tube(s) in the designated area of the tube rack.

 

Prepare the Sample

Step 2: Remove and discard the cap from the RV Reagent D tube corresponding to the sample to be tested.
Step 3: Insert the patient sample swab all the way into the RV Reagent D tube and swirl it against the inside wall three (3) times.
Step 4: Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Properly dispose of the swab.
Step 5:

• Press the attached tip firmly onto the RV Reagent D tube containing the processed sample (threading/twisting not required).
• Vortex or mix thoroughly by swirling or flicking the bottom of the tube.
• Do not use tips from any other product, including other products from BD or other manufacturers.

 

Dos and Don’ts of Sample Collection

• Do collect samples as soon as possible after the onset of symptoms
• Do test sample immediately
• BD recommends flocked swabs which are provided in the BD Veritor System RSV Kit
• Do not use cotton tips and wood shafts
• Do not use calcium alginate swabs

Step 6A: Adding the specimen

• Invert the RV Reagent D tube and hold the tube vertically (approximately one inch above the labeled BD Veritor System RSV device sample well).
• Gently squeeze the ridged body of the tube, dispensing three (3) drops of the processed specimen into the sample well of a labeled BD Veritor System RSV device.
  Note: Squeezing the tube too close to the tip may cause leakage.

Step 7A: Timing development

• After adding the sample, allow the test to run for 10 minutes before inserting into the BD Veritor Instrument.
• Note: If running test under laminar flow hood or in an area with heavy ventilation, cover test device to avoid inconsistent flow.

Step 8A: Using the BD Veritor Instrument

• During incubation time, turn the BD Veritor Instrument on by pressing the power button once.
• Insert assay device when the 10 minute assay development time is complete. Follow the on-screen prompts to complete the procedure.
• The status of the assay analysis process appears in the display window.

Step 9A: Record the Result

• When analysis is complete, the test result appears in the display window.

 

Step 6B: Starting Walk Away mode

• Turn the 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.

Step 7B: Adding the specimen:

• When the display window reads “Add Specimen To Test Device And Insert Immediately”:
  • Invert the tube, holding it vertically (approximately one inch above the BD Veritor System RSV device sample well).
  • Gently squeeze the ridged portion of the tube, allowing three (3) drops of the processed specimen to dispense into the sample well of a labeled BD Veritor System RSV device.
    Note: Squeezing the tube close to the tip may cause leakage.

Step 8B: Start the development and reading sequence

• Immediately insert the test device into the slot on the right side of the 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.
• A countdown timer in the display window shows the remaining analysis time.
  Note: Do not touch the 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.

 

Step 6C: Adding the specimen

• Invert the tube, holding it vertically (approximately one inch above the BD Veritor System RSV device sample well).
• Gently squeeze the ridged body of the tube, dispensing three (3) drops of the processed specimen into the sample well of a labeled BD Veritor System RSV device. Note: Squeezing the tube close to the tip may cause leakage.

Step 7C: Timing development

• Allow the test to develop for 10 minutes.
• 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 Analyzer During the incubation time, turn the BD Veritor Plus Analyzer on by pressing the blue button once.
The display window briefly shows “Scan Config Barcode.” This is an opportunity to change the configuration of the Analyzer. Please refer to the Analyzer Instructions for Use for configuration instructions. Ignore this message and postpone this process when an assay is awaiting analysis.

• When assay development time is complete and the Analyzer display window reads: “Insert Test Device Or Double Click For Walk Away Mode”:
  • Insert the BD Veritor System RSV device into the BD Veritor Plus Analyzer.

Step 9C: Using the Bar Code scanner

• Follow the prompts on the display window to complete any required barcode scans of:
  • Operator ID
  • Specimen ID and/or
  • Kit Lot Number
• According to site requirements and Analyzer settings.

Step 10C: Remove the test device

• Pull the device out. The display will show insert test device or double-click button for walk away mode to indicate the Analyzer is ready to perform another test.
  If an InfoSync module is installed the envelope symbol will appear to indicate that results are transmitting.
• In the event that the BD Veritor Plus Analyzer does not detect adequate cellular network strength while the envelope symbol is still displayed, it will queue all results to be transmitted and continuously attempt to transmit them. If it is powered off during this time, it will attempt to transmit as soon as power is restored.

 

To use Walk Away mode - Connect the AC power adapter to the Analyzer and a power source

Step 6D: Starting Walk Away mode

• Turn the Analyzer on by pressing the blue power button once. The display window will briefly show “Scan Config Barcode.” This is an opportunity to change the configuration of the Analyzer. Please refer to the Analyzer Instructions for Use for configuration instructions. Ignore this message and postpone this process when an assay is awaiting analysis.
• When the display window reads: “Insert Test Device Or Double-click For Walk Away Mode”
  • Double-click the blue power button.

Step 7D: Using the Bar Code scanner

• Follow the prompts on the display window to complete any required barcode scans of:
  • Operator ID
  • Specimen ID and/or
  • Kit Lot Number
• According to site requirements and Analyzer settings.

Step 8D: Add the specimen to the test device:

• When the display window reads: “Add Specimen To Test Device And Insert Immediately”:
  • Invert the tube, holding it vertically (approximately one inch above the BD Veritor System RSV device sample well).
  • Gently squeeze the ridged portion of the tube away from the tip, allowing three (3) drops of the processed specimen to dispense into the sample well of a labeled BD Veritor System RSV device. Note: Squeezing the tube close to the tip may cause leakage.

Step 9D: Start the development and reading sequence

• Immediately insert the test device into the slot on the right side of the 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.
• A countdown timer in the display window shows the remaining analysis time.

Do not touch the 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 10D: Remove the test device

• Pull the device out. The display will show “Insert Test Device Or Double-click Button For Walk Away Mode” to indicate the Analyzer is ready to perform another test. Note that the Analyzer returns to Analyze Now mode at the conclusion of each read sequence.
  If an InfoSync module is installed the envelope symbol will appear to indicate that results are transmitting.
• In the event that the BD Veritor Plus Analyzer does not detect adequate cellular network strength while the envelope symbol is still displayed, it will queue all results to be transmitted and continuously attempt to transmit them. If it is powered off during this time, it will attempt to transmit as soon as power is restored.

 

 

Frequently Asked Questions

How does the BD Veritor RSV Test Kit work?

The BD Veritor RSV Test Kit uses lateral flow chromatographic immunoassay technology. The test kit contains a test device, a reagent strip, and a sample collection swab. The sample is collected using the swab and then inserted into the reagent strip, which is then placed into the test device. The test device then detects RSV antigens in the sample and produces a visual result.

What is the sensitivity and specificity of the BD Veritor RSV Test Kit?

According to the manufacturer's package insert, the BD Veritor RSV Test Kit has a sensitivity of 98.1% and a specificity of 99.4%.

What types of respiratory specimens can be used with the BD Veritor Respiratory Syncytial Virus Test Kit?

The BD Veritor RSV Test Kit can be used with nasal swabs, nasopharyngeal swabs, and nasal aspirates.