256082 500048916(01) 2020-07 English Veritor™ System For Rapid Detection of SARS-CoV-2 Kit configured for testing nasal swab samples freshly collected, processed and dispensed directly onto assay test device. For use under an Emergency Use Authorization only.
Veritor™ System For Rapid Detection of SARS-CoV-2 For In Vitro Diagnostic Use For use with the BD Veritor™ Plus Analyzer running firmware version 5.4 or later For use under an Emergency Use Authorization only Please read these instructions completely before beginning testing of specimens.
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.
are collected and evaluated. 12. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. Standard precautions and institutional guidelines should always be followed in handling, storing, and disposing of all specimens and all items contaminated with blood or other body fluids. 13. The SARS-CoV-2 positive control swabs have been prepared from recombinant viral proteins and do not contain infectious material. 14.
4. Withdraw the swab from the nasal cavity. The sample is now ready for processing using the BD Veritor System SARS-CoV-2 kit.
DOs and DON’Ts of Sample Collection • Do collect sample as soon as possible after onset of symptoms. • Do test sample immediately. • Use only swabs provided with the kit. • Refer to: Interim Guidelines for Collecting, Handling and Testing Clinical Specimens from persons for COVID-19 at https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html TEST PROCEDURE Reagents, specimens and devices must be at room temperature (15–30 °C) for testing.
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. 5 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.
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.
Using the BD Veritor Plus Analyzer In “Analyze Now” mode with the BD Veritor InfoScan module installed C 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.
Using the BD Veritor Plus Analyzer In “Walk Away” mode with the BD Veritor InfoScan module installed D To use Walk Away mode - connect the AC power adapter to the BD Veritor Plus Analyzer and a power source Step 6D: Starting Walk Away mode • Turn on the BD Veritor Plus Analyzer 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 BD Veritor Plus Analyzer.
INTERPRETATION OF RESULTS The BD Veritor Plus Analyzer (provided separately) must be used for interpretation of all test results. Operators should not attempt to interpret assay results directly from the test strip contained within the BD Veritor assay device. Display Interpretation CoV2: + Positive Test for SARS-CoV-2 (antigen present) CoV2: - Presumptive Negative Test for SARS-CoV-2 (no antigen detected) CONTROL INVALID Test Invalid.* Repeat the test.
• The BD Veritor System for Rapid Detection of SARS-Cov-2 can detect both viable and non-viable SARS-CoV-2 material. The BD Veritor System for Rapid Detection of SARS-CoV-2 performance depends on antigen load and may not correlate with other diagnostic methods performed on the same specimen. • Negative test results are not intended to rule in other non-SARS-CoV-2 viral or bacterial infections. • Positive and negative predictive values are highly dependent on prevalence rates.
CLINICAL PERFORMANCE The performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 was established with 226 direct nasal swabs prospectively collected and enrolled from individual symptomatic patients (within 5 days of onset) who were suspected of COVID-19. As with all antigen tests, performance may decrease as days since symptom onset increases. Samples were collected by qualified personnel in 21 geographically diverse areas across the United States.
Potential Cross-Reacting Organism Influenza B Concentration Tested Results 2.9 x 105 TCID50/mL No 5 Enterovirus 4.0 x 10 TCID50/mL Respiratory syncytial virus 4.0 x 105 TCID50/mL No 1.1 x 105 PFU/mL No SARS-coronavirus 4.5 x 105 PFU/mL No MERS-coronavirus 1.5 x 105 TCID50/mL No 1.4 x 106 CFU/mL No Streptococcus pneumoniae 1.0 x 106 CFU/mL No Streptococcus pyogenes 1.6 x 106 CFU/mL No Candida albicans 1.8 x 106 CFU/mL No 100% No 1.
Change History Revision Date 01 2020-06 Change Summary Initial release. US Customers only: For symbol glossary, refer to bd.com/symbols-glossary.
Consult Instructions for Use / Направете справка в инструкциите за употреба / Prostudujte pokyny k použití / Se brugsanvisningen / Gebrauchsanweisung beachten / Συμβουλευτείτε τις οδηγίες χρήσης / Consultar las instrucciones de uso / Lugeda kasutusjuhendit / Consulter la notice d’emploi / Koristi upute za upotrebu / Olvassa el a használati utasítást / Consultare le istruzioni per l’uso / Пайдалану нұсқаулығымен танысып алыңыз / 사용 지침 참조 / Skaitykite naudojimo instrukcijas / Skatīt lietošanas pamācību / Raad
Collection time / Време на събиране / Čas odběru / Opsamlingstidspunkt / Entnahmeuhrzeit / Ώρα συλλογής / Hora de recogida / Kogumisaeg / Heure de prélèvement / Sati prikupljanja / Mintavétel időpontja / Ora di raccolta / Жинау уақыты / 수집 시간 / Paėmimo laikas / Savākšanas laiks / Verzameltijd / Tid prøvetaking / Godzina pobrania / Hora de colheita / Ora colectării / Время сбора / Doba odberu / Vreme prikupljanja / Uppsamlingstid / Toplama zamanı / Час забору / 采集时间 Peel / Обелете / Otevřete zde / Åbn / Abzi
