Assays

Embrace flexibility with
open systems and partner assays

The CerTest VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit* for BD MAX™ System is designed for the specific identification and differentiation of SARS-CoV-2 in respiratory samples from individuals suspected of Coronavirus disease 2019 (COVID-19) by their healthcare professional1

  • Detects SARS-CoV-2 by amplification of 2 fragments of the N gene of the virus1
  • New! Combines with CerTest VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit* for BD MAX™ System as a snap-in option to identify and differentiate the 3 variants of concern: B.1.1.7 (Alpha), B.1.351 (Beta), and P.1 (Gamma).2 This new assay can also be used as a reflex test on BD MAX™ System for any SARS-CoV-2 positive results

Both VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit* for BD MAX™ System and VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit* for BD MAX™ System offer rapid and flexible testing1,2

  • Validated on nasopharyngeal and oropharyngeal swabs as well as saliva samples. Saliva offers patients ease and comfort with a non-invasive way to be tested for COVID-19
  • RNA is extracted, amplified using real time RT-PCR and detected using fluorescent reporter dye probes specific to SARS-CoV-21,2
  • Contain all the components necessary for real time RT-PCR assay, as well as an endogenous internal control to monitor PCR inhibition
  • The lyophilized test comes in a tube that snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip
  • Fully integrated on the BD MAX™ System

VIASURE SARS-CoV-2 (N1+N2)
Real Time PCR Detection Kit for BD MAX™*
  • SARS-CoV-2 (N1)
  • SARS-CoV-2 (N2)
VIASURE SARS-CoV-2 Variant
Real Time PCR Detection Kit for BD MAX™*
  • B.1.1.7 (Alpha) variant (69/70 deletion)
  • B.1.351 (Beta) variant (K417N mutation)
  • P.1 (Gamma) variant (K417T mutation)

The CerTest VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit* for BD MAX™ System is designed for the specific identification and differentiation of Flu A and/or B and/or Respiratory Syncytial Virus (RSV) in respiratory samples from patients with signs and symptoms of respiratory infection

Flu A
Flu B
RSV
  • Seasonal influenza can co-circulate as a mix of types A and B each year – in 2019 71% of cases were type A potentially resulting in high mortality in elderly patients3
  • RSV is highly contagious and accounts for 42–45% of hospital admissions for lower respiratory tract infections in children under 2 years of age in Europe4
  • Validated for use with throat swabs and BD MAX™ ExK™ TNA-3 Extraction Kit*
  • Fully integrated on the BD MAX™ System for open system TNA extraction and PCR

With the CerTest VIASURE SARS-CoV-2, Flu (A+B) & RSV Real Time PCR Detection Kit* for BD MAX™ System, you can detect all three important respiratory viruses at the same time, increasing your flexibility

  • Manage pandemic testing during the influenza season according to ECDC guidelines5
  • Benefit from flexible testing options with the ability to select targets reported
  • Get up to three results from one extraction
  • Help inform isolation decisions
  • Provide support for containment measures
  • Fully integrated on the BD MAX™ System

VanR-resistant enterococci (VRE) have become one of the most problematic multi-resistant hospital associated pathogens in Europe6,7

  • Infections that are resistant to VanR are challenging to treat and can result in prolonged hospital stays and further complications for already very ill patients, often appearing as part of long-lasting outbreaks in health care institutions7
  • The EU/EEA population-weighted mean percentage for VanR resistance in E. faecium increased significantly from 10.4% in 2014 to 14.9% in 2017, with the trend increasing and similar rates across different parts of Europe7

The CerTest VIASURE VanR Resistance Real Time PCR Detection Kit* for BD MAX™ System can help in the detection of VRE to support efforts to identify and control transmission

  • Detects and differentiates vanA and vanB genes that can be associated with VRE colonisation
  • Validated for use with perianal and/or rectal swab/ESwab and colonies and BD MAX™ ExK™ TNA-2 Extraction Kit*
  • Fully integrated on the BD MAX™ System for open-system DNA extraction and PCR

The BD MAX™ Open-System Reagents provide versatility to meet emerging diagnostic demands and address regional healthcare needs

Sample Type(s) BD Extraction Kit BD Amplification Reagents
Blood Plasma or Serum and Urine ExK™ DNA-1 DNA MMK
DNA MMK SPC
Dry Swab and CSF ExK™ DNA-2
Dry Swab and CSF ExK™TNA-2 TNA MMK
TNA MMK SPC
Swabs in UTM ExK™ TNA-3
CSF, cerebrospinal fluid; MMK, Master Mix Kit; SPC, Sample Process Control; TNA, Total Nucleic Acid; UTM, Universal Transport Media
  • Fully integrated on the BD MAX™ System for open-system DNA extraction and PCR

The BD MAX™ System is a single platform providing you
with the versatility of running BD and partner developed assays,
as well as 3rd party and laboratory developed tests.

*Products are currently under registration, not available for sale yet. 

COVID-19, coronavirus disease 2019; DNA, deoxyribonucleic acid; ECDC, European Centre for Disease Prevention and Control; EEA, European Economic Area; EU, European Union; PCR, polymerase chain reaction; RSV, Respiratory Syncytial Virus; RT-PCR, real time polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TNA, total nucleic acid; VanR, Vancomycin resistance; VRE, Vancomycin-resistant enterococci.

1. VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX™ System IFU. 2. VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX™ System IFU. 3. European Centre for Disease Prevention and Control. Regional situation assessment – Seasonal influenza. 18 December 2019. Available at: https://www.ecdc.europa.eu/sites/default/files/documents/influenza-situation-assessment-18-December-2019.pdf. 4. ReSiVNET. Respiratory syncytial virus. 2019. Available at: http://www.resvinet.org/about-rsv.html. Accessed March 2020. 5. European Centre for Disease Prevention and Control. COVID-19 testing strategies and objectives. 15 September 2020. Available at: https://www.ecdc.europa.eu/sites/default/files/documents/TestingStrategy_Objective-Sept-2020.pdf?utm_source=POLITICO.EU&utm_campaign=7266515f97-EMAIL_CAMPAIGN_2020_09_18_10_55&utm_medium=email&utm_term=0_10959edeb5-7266515f97-189786733. 6. Rangberg A et al. Sci Rep. 2019;9:11917. 7. European Centre for Disease Prevention and Control. Surveillance of antimicrobial resistance in Europe – Annual report of the European Antimicrobial Resistance Surveillance Network (EARS-Net) 2017. November 2018. Available at: https://www.ecdc.europa.eu/sites/default/files/documents/AMR%202017_Cover%2BInner-web_v3.pdf.