Product Manual

3
REAGENTS
The following components are included in the BD Veritor System for Rapid Detection of SARS-CoV-2 kit.
Materials Provided:
Kit Component Quantity Description
BD Veritor System
Test Devices
30 single use test devices Foil pouched test device containing one reactive strip.
Each strip has one line of murine anti-SARS coronavirus
monoclonal antibody on the test line, and one of biotin
coupled to bovine protein on the positive control line.
Murine and Leporine anti-SARS coronavirus and
anti-biotin monoclonal antibodies conjugated to detector
reagents are bound in the sample delivery area.
Extraction
Reagent
30 single use reaction tubes, each with
325 µL extraction reagent and having an
integral dispensing tip
Detergent solution with less than 0.1% sodium azide
(preservative).
Specimen
sampling swabs
30 sterile, single use specimen sampling
swabs
For sample collection and transfer.
SARS-CoV-2 (+)
Control Swab
1 each – individually wrapped for single
use
Non-infectious, recombinant viral protein antigen with
less than 0.1% sodium azide.
SARS-CoV-2 (–)
Control Swab
1 each – individually wrapped for single
use
Buffer with less than 0.1% sodium azide.
Assay
documentation
1 each - Instructions for use
1 each - Quick reference instruction card
1 each - Nasal sampling instructions
Materials Required but not provided:
• BD Veritor™ Plus Analyzer (Cat. No. 256066)
• timer
• tube rack for specimens
• any necessary personal protective equipment
Optional Equipment:
• BD Veritor InfoScan Module (Cat. No. 256068)
• USB Printer cable for BD Veritor Plus Analyzer (Cat. No. 443907)
• Epson Printer model TM-T20 II
• BD Veritor Plus Connect (contact BD Technical Services for details).
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use.
2. In the USA, this test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by
authorized laboratories;
use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform to
perform moderate, high or waived complexity tests and at the Point of Care (POC), i.e., in patient care settings operating
under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
3. This test has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens;
and,
in the USA, this test is only authorized for the duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19
under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
.
4. Do not use this kit beyond the expiration date printed on the outside carton.
5. Do not use the kit to evaluate patient specimens if either the positive control swab or negative control swab fail to give
expected results.
6. Test results are not meant to be visually determined. All test results must be determined using the
BD Veritor Plus Analyzer.
7. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section.
8. Do not reuse any BD Veritor System test device or kit components.
9. When collecting a nasal swab sample, use the nasal swab supplied in the kit. Use of alternative swabs may result in false
negative results.
10. Proper specimen collection, storage and transport are critical to the performance of this test.
11. Specific training or guidance is recommended if operators are not experienced with specimen collection and handling
procedures. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens