VIDAS®Anti-HEV IgM & Anti-HEV IgG For actionable patient reporting decisions

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AVAILABLE ON INSTRUMENTS OFTHE VIDAS® FAMILY:VIDAS®, MINI VIDAS®

AND VIDAS® 3

VIDAS®Anti-HEV IgG

REFERENCES1. WHO, Hepatitis E Factsheet, July 2017.2. N. Kamar, et al., Hepatitis E, Lancet 379 (9835) (2012) 2477–2488.

bioMérieux S.A. • 69280 Marcy l’Etoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90www.biomerieux.com • www.biomerieux-diagnostics.com

VIDAS®Anti-HEV IgMVIDAS® HEPATITIS PANEL

HEPATITIS A HAV IgM Anti-HAV Total

HEPATITIS B HBs Ag Ultra HBs Ag Ultra Con� rmation Anti-HBs Total II Anti-HBc Total II HBc IgM II HBe/Anti-HBe

HEPATITIS C Anti-HCV

HEPATITIS E Anti-HEV IgM Anti-HEV IgG

Reference number 418115 418116

Tests / kit 30 30

Time to result 40 minutes 40 minutes

Sample type Serum, Plasma Serum, Plasma

Sample volume 100 µL 100 µL

Calibrators & Controls frequency Every 28 days Every 28 days

BIOMÉRIEUXBIOMÉRIEUX

Did you know?

VIDAS®

Anti-HEV IgM & Anti-HEV IgG O� er even greater value to your clinicians!PERFORM HEPATITIS E TESTS IN YOUR OWN LAB● Control the whole process: your quality, your way● Streamline your work� ow: save time and improve your lab e� ciency

● O� er rapid and actionable results to your clinicians through

same-day complete hepatitis diagnosis (A, B, C, E)

BECAUSE IT MAKES SENSE ON VIDAS®

● AUTOMATED tests

● On-demand testing adapted to small volumes

● Result in only 40 minutes● Cost-e� cient solution: 1 patient = 1 test

EXCELLENT PERFORMANCEClear result for the diagnosis of acute hepatitis E:

Think Hepatitis E!

The most common cause of acute viral hepatitis worldwide (2)

1 virus, 2 di� erent epidemiological patterns: Genotypes 1 & 2 (■)● Transmission via contaminated water● Large outbreaks

Genotypes 3 (■) & 4 (■)● Transmission via ingestion of

undercooked meat ● Sporadic cases

Populations at risk● Pregnant women (20/25% case

fatality rates in 3rd trimester (1))● Immunocompromised patients● Patients with pre-existing liver disease

WHY? ● Clinically undistinguishable from other types of acute

hepatitis ● Self-limiting disease in most cases, but can also be fatal in its

fulminant form, in pregnant women, infants or patients with pre-existing liver disease

● Immunocompromised patients may develop chronic infection

WHEN? ● First-line test for acute hepatitis ● All patients with clinical signs and symptoms of hepatitis● All patients with biological signs

of cytolysis (increase in serum transaminase levels)

DIAGNOSIS ● Due to the short period of HEV viremia, diagnosis of HEV

infection is mainly based on speci� c anti-HEV IgM and IgG detection.

● Complementary detection of IgM and IgG antibodies: - IgM to detect recent infection - IgG to detect recent or past infection

WITH VIDAS®

INTEGRATE HEPATITIS EINTO YOUR ROUTINE

TESTING

97.65%*Positive concordance

for viremic phase

96.67%* Positive concordance

VIDAS® Anti-HEV IgMQUALITATIVE Assay

VIDAS® Anti-HEV IgGQUANTITATIVE Assay

99.34%*Negative concordance

96.42%* Negative concordance

Evaluatedby a National

Reference Centerfor Hepatitis E

20 million infections with hepatitis E virus (HEV)/year (1)

3.3 million acute cases/year (1)

44,000 deaths in 2015 (1)

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14

IgM

IgGALT

15

* Immunocompetent populationSee package insert

HEV RNA in Blood = viremic phase

Number of weeks post infection

Jaundice

HEV RNA in faeces

VIDAS®Anti-HEV IgM & Anti-HEV IgG For actionable patient reporting decisions

01 18

/ 93

1464

3/00

8/G

B/A

/ Do

cum

ent a

nd/o

r pic

ture

s no

t leg

ally

bin

ding

. Mod

i� ca

tions

by

bioM

érie

ux c

an b

e m

ade

with

out p

rior n

otic

e /

BIO

MÉR

IEU

X, th

e bl

ue lo

go a

nd V

IDAS

are

use

d, p

endi

ng a

nd/o

r reg

iste

red

trad

emar

ks

belo

ngin

g to

bio

Mér

ieux

, or o

ne o

f its

sub

sidi

arie

s or

one

of i

ts c

ompa

nies

. Any

oth

er tr

adem

ark

is th

e pr

oper

ty o

f its

resp

ectiv

e ow

ner.

VIDA

S ap

para

tus

is a

use

d, p

endi

ng a

nd/o

r reg

iste

red

desi

gns

belo

ngin

g to

bio

Mér

ieux

or o

ne o

f its

sub

sidi

arie

s or

one

of i

ts c

ompa

nies

/ b

ioM

érie

ux S

.A. R

CS Ly

on 6

73 6

20 3

99 /

Prin

ted

in F

ranc

e / thera/

RCS

Lyon

B 3

98 16

0 24

2

AVAILABLE ON INSTRUMENTS OFTHE VIDAS® FAMILY:VIDAS®, MINI VIDAS®

AND VIDAS® 3

VIDAS®Anti-HEV IgG

REFERENCES1. WHO, Hepatitis E Factsheet, July 2017.2. N. Kamar, et al., Hepatitis E, Lancet 379 (9835) (2012) 2477–2488.

bioMérieux S.A. • 69280 Marcy l’Etoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90www.biomerieux.com • www.biomerieux-diagnostics.com

VIDAS®Anti-HEV IgMVIDAS® HEPATITIS PANEL

HEPATITIS A HAV IgM Anti-HAV Total

HEPATITIS B HBs Ag Ultra HBs Ag Ultra Con� rmation Anti-HBs Total II Anti-HBc Total II HBc IgM II HBe/Anti-HBe

HEPATITIS C Anti-HCV

HEPATITIS E Anti-HEV IgM Anti-HEV IgG

Reference number 418115 418116

Tests / kit 30 30

Time to result 40 minutes 40 minutes

Sample type Serum, Plasma Serum, Plasma

Sample volume 100 µL 100 µL

Calibrators & Controls frequency Every 28 days Every 28 days

BIOMÉRIEUXBIOMÉRIEUX