virotrack portfolio & roadmap 2020 · virotrack portfolio & roadmap what is virotrack®?...

VIROTRACK PORTFOLIO & ROADMAP2020

DIAGNOSTICS OF TRUE VALUE

ViroTrack portfolio & Roadmap

At risk of life-threatening diseases

About BluSense

Every single day, thousands of physicians postpone the prescription of

medical treatment for their patients because they lack immediate access

to accurate blood test results at the point-of-care.

To date, mosquito-borne diseases have been diagnosed by taking a

blood sample from a patient and sending it to be tested at a central

laboratory, resulting in a lengthy delay for treatment. While the patient is

waiting for the results, just one mosquito could transmit the disease to

several other members of the community.

Data gathered by the World Health Organization shows that mosquitos

cause more than 700,000 deaths annually, making them “the world’s

deadliest animals”. In light of this, there is a pronounced need for medical

diagnostics devices that could provide accurate results in a matter of

minutes.

Enabled by their ground-breaking Immuno Magnetic Assay (IMA), Taiwan-

and Denmark-based BluSense place future technology in the hands of

healthcare professionals today.

By combining state-of-the-art Scandinavian bio-engineering and

medical device design with first-rate Taiwanese hardware, software

and manufacturing engineering, BluSense has created a breakthrough

diagnostic system for detecting infectious diseases.

2020

Since its incorporation in 2014, BluSense has rapidly grown from three

founders to a large team of qualified scientists and engineers around

the globe. A core of experienced and dedicated professionals with a

solid scientific background, all driven by one goal - to improve the life of

patients through accurate and fast diagnostics.

Investors from Taiwan and Europe, as well as a strong global network of

partners, empower BluSense to expand their portfolio of ViroTrack tests

and diagnose even more infectious diseases over the coming years.

Quality stamp

BluSense has developed powerful technology and at the same time a

commitment to provide healthcare professionals with the highest quality

performance devices.

By building quality into all steps: from design to manufacture, release

to delivery of products, BluSense offers in vitro diagnostics devices that

meet international standards for safety, accuracy and superior clinical

performance.

In 2017, BluSense achieved certification according to the requirements

of ISO 13485:2016, the standard for quality management systems in the

medical device industry.

The company’s quality management system provides the tools to meet

and even exceed the expectations of customers. BluSense devices are

CE marked in compliance with the European IVD Directive (98/79/EC).


What is ViroTrack®?

ViroTrack® is a line of hand-fitting, single-use cartridges containing

nanoparticles and microfluidic structures - the two building blocks of

BluSense patented IMA technology. To receive the results of the test,

you need only a single drop of blood.

ViroTrack® and BluBox® can be handled by one health care professional

and requires only 20 seconds of hands-on time. This allows healthcare

professionals to provide patients with fast and accurate diagnostic test

results.

. High reproducibility (low CV%)

. Low Limit of Detection (LoD)

. Minimal lot-to-lot variation

. The same level of accuracy for venous whole blood (EDTA, heparin),

serum, plasma and capillary blood

. Quantitative numerical results

ViroTrack® cartridges are suited for single assay tests (acute,

serology) and as combo tests. The ViroTrack® line has been designed,

developed, tested, and manufactured in one of the world’s leading

life-science clusters - Medicon Valley - in Copenhagen, Denmark.

Blood inlet assures

smooth loading

of the sample

Area for

hand-written patient ID

Gripping area guarantees

secure holding

of the cartridge

Nanoparticles assure

accurate test results

QR code contains all test

and assay information

2020

Proven diagnostics from a single drop of blood

There are many companies that have attempted to diagnose infectious

diseases from a single drop of blood. Unlike many of them, BluSense

technology is evidence-based and peer-reviewed in more than 20

scientific publications. Capillary blood dengue infection identification

has been validated in a 500-patient study conducted in Malaysia, which

demonstrates ViroTrack®’s excellent correlation across serum, venous

blood and capillary blood.

Integrated microfluidics allow ViroTrack® + BluBox® to perform fully

automated plasma separation and requires only one drop of blood to

provide accurate results in a matter of minutes. The unique aspect of

ViroTrack® is that the integrated sample micro-centrifugation gives over

97% agreement between results from whole blood (WB) and serum.

Advantages of capillary blood over venous blood:

. Easy to collect (venipuncture can be difficult, especially in infants)

. Taking the sample is minimally invasive and causes less pain

. ViroTrack® tests can be run after less than 15 minutes of training

. Results can be obtained in as little as 10 minutes


ViroTrack Acute Dengue NS1 Ag V1 is available without sample collection pipettes

Sample Collection

Pipettes (30μL)

ViroTrack Acute Dengue NS1 Ag V2

2020

Catalog number - 01VTA02-25

Sample type - S/P, WB, Capillary WB

Sample volume - 30 μL

Shelf-life - 15 months

Storage temperature - 2-30 °C

Sample-to-answer time - 10 min

Numerical results in IMA units

ELISAIgG 96.7% 97.1%

ELISAIgM 96.8% 96.8%

ELISACapillary blood 100% 97.1%

Sample Reference Specificity Sensitivity

Test Performance

Dengue NS1 Ag

0 23.0 27.0 100

POSITIVE

82.3

1 Published in Scientific Reports, 2015, Antunes et al.

ViroTrack Acute Dengue NS1 Ag is an Immuno Magnetic Assay (IMA)1

cartridge for the semi-quantitative detection of dengue virus NS1

antigen in human serum, plasma or whole blood. The test is used as

an aid for diagnosing an early acute dengue infection.

ViroTrack Acute Dengue NS1 Ag V1 available - V2 coming soon

PP

P


Loading Pipettes (50 μL)

ViroTrack Sero Dengue IgG/lgM Ab Kit

Sample Dilution Buffer Vials

Sample Collection Pipettes (10 μL)

2020

Catalog number - 01VTS01-25







ViroTrack Sero Dengue IgG/IgM Ab is an in vitro IMA kit for the semi-

quantitative testing of human anti-dengue virus IgG and IgM antibodies

in venous whole blood, serum or plasma.

ViroTrack Sero Dengue IgG/IgM Ab Kit Available for research-use only

0

0

100

100

85.8

31.5

pos

Dengue IgG

Dengue IgM

posELISADengue IgG 95%

ELISADengue IgM 82%

Reference Specificity Sensitivity

Test PerformanceP

ViroTrack

>90%*

>90%*

*External studies ongoing






ViroTrack Combo Dengue Ns1 lgG/IgM Ag+Ab Kit

2020

Catalog number - 01VTC01-25




Storage temperature - 2-30°C



ELISASerum

ELISAVenous blood

ELISACapillary blood

Sample Reference Specificity Sensitivity

Test Performance

*Estimates based on internal verification studies.

External studies ongoing

ViroTrack Combo Dengue IgG/IgM Ag+Ab is an in vitro IMA kit for the

semi-quantitative testing of human dengue virus NS1 antigen and anti-

dengue virus IgG and IgM antibodies in venous whole blood, serum or

plasma.

ViroTrack Combo Dengue NS1/IgG/IgM Ag+Ab Kit Coming soon

0

0

0

100

100

100

50.1

45.2

41.3

pos

pos

Dengue NS1

Dengue IgG

Dengue IgM

pos>95%*

>95%*

>95%*

>95%*

>95%*

>95%*




ViroTrack Sero Zika lgG/IgM Ab Kit


2020








ViroTrack Sero Zika IgG/IgM is an IMA kit for the semi-quantitative

detection of human IgG and IgM antibodies directed against Zika virus

in human whole blood, serum or plasma. The kit is used as an aid for

diagnosing Zika virus infection.

ViroTrack Sero Zika IgG/IgM Ab Kit Available for research-use only

ELISAZika IgG

ELISAZika IgM

ViroTrack Reference Specificity Sensitivity

Test Performance

0

0

100

100

45.2

50.1

pos

Zika IgG

Zika IgM

pos62%*

96%*

86%*

96%*

2 Published in MDPI, 2020, Liao et al.

*External clinical evaluation study was performed with 122 samples




ViroTrack Sero COVID-19 IgA+IgM/IgG Ab


2020








ViroTrack Sero COVID-19 IgA+IgM/IgG Ab is an IMA kit for the semi-

quantitative detection of human IgG and IgA+IgM antibodies directed

against chikungunya virus in human whole blood, serum or plasma. The

kit can be used as an aid to the diagnosis of SARS-CoV-2 virus infection.


Days from symptoms

onset to blood col-

lection

PCR

results

9-14

>14 days

POS

POS

TOTAL


IgA+IgM (+) IgG (+) IgA+IgM/IgG (+)

N/A

10/11 (90.9%)

18/21 (85.7%)

28/32 (87.5%)

9/11 (81.8%) 10/11 (90.9%)

18/21 (85.7%)

27/32 (84.4%)

19/21 (90.5%)

29/32 (90.6%)

BluSense is a Denmark and Taiwan based company, continuously striving to improve

patient care through accurate and fast diagnosis of life-threatening infectious diseases.

Find your local distributor at www.blusense-diagnostics.com

DRIVEN BY VISIONARIES, POWERED BY SCIENTISTS

T: +45 39 17 97 14

E: [email protected]

Fruebjergvej 3

DK-2100 Copenhagen, Denmark

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