GeneXpert System : Clinical CE-IVD Test Overview

Minimum
Hands- Targeted Software Modules Launch
On Time Test Run Gene Kit Storage Version Version date/ Cartridge
Test Name Intended Use (Min) Time (Min) ROBAL Sequences Condition Sample Sample Storage Condition Required Required CE mark Type
HEALTHCARE ASSOCIATED INFECTIONS
15-30°C < 24 hours;
Xpert® MRSA Screening for MRSA <1' 69' YES 1 RT Nasal swab 1.6 4 color Oct. 2006 A
5 days at 2-8°C
Xpert SA Nasal
®
Pre-surgical screening for S. aureus 15-28°C < 24 hours;
<1' 71' YES 3 RT Nasal swab 2.1 4 color Mar. 2009 A
Complete and MRSA 5 days at 2-8°C
Xpert® MRSA/SA Diagnose S. aureus infections from 50 μL positive blood Immediately when culture
<1' 66' YES 3 RT 1.6 4 color Dec. 2007 A
BC positive blood cultures culture bottle positive; 4 hours at 2-8°C
Xpert® MRSA/SA Diagnose S. aureus infections 15-30°C < 24 hours;
<1' 66' YES 3 RT Skin/wound swab 1.6 4 color Dec. 2007 A
SSTI directly from wounds and ulcers 5 days at 2-8°C
Diagnose C. difficile infection and Swab from 15-30°C < 24 hours;
Xpert® C. difficile <1' 47' YES 3 RT 2.1 4 color Nov. 2008 A
differentiate 027 strain unformed stool 5 days at 2-8°C
Rapid VRE screening for active Rectal or peri-anal
Xpert® vanA/vanB <1’ 47’ YES 2 RT 5 days at 2-8°C 1.6 4 color Oct. 2008 A
outbreak prevention and control swab
58’ for
Rapid identification and positive
Swab from
Xpert Norovirus
®
differentiation of Norovirus GI <1’ results*; 90’ YES 2 2-8°C 2-8°C < 2 days 4.3 6 color Apr. 2014 C
unformed stool
and GII for negative
results
Rapid identification and
15-28°C < 6 hours;
Xpert® Carba-R differentiation of KPC, NDM, VIM, <1' 48' YES 5 RT Rectal swab 4.3 6 color Jun. 2014 A
2-28°C < 7 days
OXA-48 and IMP-1
SEXUAL HEALTH/WOMEN'S HEALTH
36’ for positive
Rapid intrapartum GBS testing for 15-30°C < 24 hours;
Xpert® GBS <1' results*; 52’ for YES 1 RT Vaginal/rectal swab 1.6 4 color Mar. 2006 A
effective prevention of EOD 6 days at 2 to 8°C
negative results
4.3+ New
Real-time diagnosis of Chlamydia Urine or vaginal/ Urine:
Xpert® CT <1' 95' YES 1 RT motherboard 6 color Jun. 2012 C
trachomatis (CT) infections endocervical swab 2-15°C < 45 days (F/M);
modules
2-30°C < 3 days (F);
Real-time diagnosis of Chlamydia 2-30°C < 30 days (M) 4.3+ New
Urine or vaginal/
Xpert® CT/NG trachomatis (CT) and Neisseria <1' 95' YES 3 RT motherboard 6 color Jun. 2012 C
endocervical swab Swab: 2°C-30°C < 60 days
gonorrhoeae (NG) infections modules
Screening and differentiation of high- Cervical Specimens
Xpert® HPV risk HPV types for active control of <1’ 60’ YES 5 RT collected with 2-30°C < 6 months 4.3 6 color Apr. 2014 A
cervical cancer PreservCyt Solution
Urine: 2-8°C < 3 days (F/M);
15-30°C < 2 hours (F/M)
Revealing underdiagnosed Urine or vaginal/ Preserved Urine:
Xpert® TV <1’ 60’ YES 1 RT 4.3 6 color Sep. 2014 C
Trichomonas vaginalis infections endocervical swab 2-8°C < 28 days (F/M);
15-30°C < 14 days (F/M)
Swabs: 2-30°C < 60 days

ROBAL (Reagents on board all line); RT: Room Temperature

* With EAT (Early Assay Termination), for Positive Results.
 GeneXpert System : Clinical CE-IVD Test Overview (continued)
®

Minimum
Hands- Targeted Software Modules Launch
On Time Test Run Gene Kit Storage Version Version date/ Cartridge
Test Name Intended Use (Min) Time (Min) ROBAL Sequences Condition Sample Sample Storage Condition Required Required CE mark Type
CRITICAL INFECTIOUS DISEASE
Diagnose M. tuberculosis and detect
Fresh sputum or RT< 72 hours;
Xpert® MTB/RIF Rifampicin-resistant strains in less <1' 110' YES 5 RT 4.0 6 color Apr. 2009 A
induced sputum 2-8°C 4 to 10 days
than 2 hours
2-8°C < 72 hours
Xpert® EV Diagnose Enteroviral meningitis 5' 151' NO 1 RT Cerebrospinal Fluid 1.6 4 color Jun. 2006 C
-20°C > 72 hours
Nasals apirates or
Determination of Flu A and B nasopharyngeal
Xpert Flu ®
<1' 77' YES 3 RT 2-8°C < 72 hours 2.1 6 color Dec. 2010 C
infection, identification of 2009 H1N1 swab in
3 ml UTM
Nasal aspirates/ 2-8°C < 24 hours
40’ for positive
Detection and differentiation of Flu A, washes and In sample collection transport
Xpert® Flu/RSV XC <1' results*; 63’ for YES 5 RT 4.3 6 color Aug. 2014 RCC
Flu B, and RSV infection nasopharyngeal media: 2-28°C < 24 hours
negative results
swab specimens 2-8°C < 7 days
VIROLOGY
Whole blood: 2-8°C up to
72 hours; 15-35°C up to 6
Xpert® HIV-1 Viral
Rapid HIV-1 Viral Load monitoring <1' 90' YES 5’LTR RT 1 ml of Plasma hours; Plasma: 15-35°C up 4.6a 6 color Dec. 2014 RCC
Load
to 8 hours; 2-8°C up to 4
days; -20°C at least 6 weeks
Whole blood: 2-8° up to
72 hours; 15-30°C up to
Rapid detection of HIV-1 directly 100 µl Whole Blood 24 hours; 31-35°C up to 8
Xpert® HIV-1 Qual <1’ 92' YES 5’LTR RT 4.6a 6 color Apr. 2015 RCC
from whole blood / 1 DBS hours; DBS: 2-25°C or -15°C
(or colder) up to 12 weeks;
31-25°C up to 8 weeks
Plasma or serum: 15-35°C up
Xpert® HCV Viral 1ml of Plasma /
Rapid HCV Viral Load monitoring <1' 105' YES 5’UTR RT to 24 hours; 2-8°C up to 72 4.6a 6 color Apr. 2015 RCC
Load Serum
hours; -20°C up to 6 weeks
ONCOLOGY/GENETICS
200 μL whole blood
Xpert® BCR-ABL Rapid testing for improved CML (EDTA, sodium
15' 92' NO 2 RT 2-8°C < 48 hours 4.0 4 color Jun. 2006 C
Monitor patient management citrate or PAXgeneR
RNA tubes)
Diagnose factor II and factor V 50 μL whole blood 22-28°C < 24 hours;
Xpert® FII & FV Leiden genetic variations associated <1' 32' YES 4 RT (EDTA or sodium 2-8°C < 15 days; 4.0 4 color Mar. 2012 A
with thrombophilia citrate) frozen up to 3 months

CORPORATE HEADQUARTERS EUROPEAN HEADQUARTERS www.Cepheidinternational.com ROBAL (Reagents on board all line); RT: Room Temperature
904 Caribbean Drive Vira Solelh * With EAT (Early Assay Termination), for Positive Results.
Sunnyvale, CA 94089 USA 81470 Maurens-Scopont, France
TOLL FREE +1.888.336.2743 PHONE +33.563.82.53.00
PHONE +1.408.541.4191 FAX +33.563.82.53.01
FAX +1.408.541.4192 EMAIL cepheid@cepheideurope.fr 3000-04