Cepheid GeneXpert® Test Overview
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i ' GeneXpert® System : Clinical CE-IVD Test Overview Minimum Hands- Test Run Targeted Software Kit On Time Time Gene Sample Version Test Name Intended Use Configuration (Min) (Min) EAT Sequences Sample Storage Condition Required Healthcare-Associated Infections Xpert® MRSA NxG MRSA surveillance testing 10 / 120 <1 3 Rayon swab, ESwab Xpert® SA Nasal Complete Pre-surgical testing of S. aureus and MRSA 10 / 120 <1 Detection of MRSA and S. aureus in positive blood cultures 50 pL positive blood culture Immediately when culture positive; 4 hours at bottle 2-8°C Xpert® MRSA/SA SSTI Detection of MRSA and S. aureus skin and soft tissue infections Detection of Clostridium difficile infection and differentiate 027 strain Swab from unformed stool Xpert® vanA/vanB Detection of Clostridium difficile infection with an independent call-out of binary toxin and differentiation of the 027 strain Rapid VRE screening for active outbreak prevention and control Swab from unformed stool Rectal or peri-anal swab Xpert® Carba-R Detection and differentiation of KPC, NDM, VIM, IMP-1, and OXA-48 (now covering OXA-181 and OXA-232) Rectal or perirectal swab or Swab: 15-28°C up to 5 days; Fresh isolates: bacterial isolate 2-28°C < 7 days Xpert® Norovirus Identification and differentiation of Norovirus GI and GII Swab from unformed stool Women’s & Sexual Health Xpert® CT/NG Detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections Urine or vaginal/endocervical swab Xpert® CT Detection of Chlamydia trachomatis infections 10 <1' 90' Urine: 2-15°C < 45 days (F/M); RT < 3 days (F); RT < 30 days (M) Swab: 2-30°C < 60 days On-demand male and female Trichomonas vaginalis results 10 <1’ 65’ 40’* Urine or vaginal/endocervical swab Urine: 2-8°C < 4 days (F/M); 15-30°C < 4 hours (F/M) Preserved Urine: 2-8°C < 28 days (F/M); 15-30°C < 14 days (F/M) Swabs: 2-30°C < 60 days Reliable detection of high-risk HPV DNA with genotyping of HPV 16 and 18/45 Cervical specimens collected 5 with PreservCyt solution Intrapartum or antepartum Group B Streptococcus testing 10 <1' 55’ 35’* 1 Vaginal/rectal swab Not all tests may be available in all countries. Other notes: Store all kits at room temperature except Xpert Norovirus (store at 2-8°C). * EAT (Early Assay Termination), for Positive Results.

i ' GeneXpert® System : Clinical CE-IVD Test Overview (continued) Minimum Hands- Test Run Targeted Software Kit On Time Time Gene Sample Version Test Name Intended Use Configuration (Min) (Min) EAT Sequences Sample Storage Condition Required Detection of Streptococcus pyogenes from patients with symptoms of pharyngitis 1 Throat swab, Eswab Xpert® Flu Detection of Flu A and Flu B with 2009 H1N1 call-out Nasals apirates or 3 nasopharyngeal swab in 2-8°C < 72 hours Xpert® Flu/RSV XC Detection and differentiation of Flu A, Flu B, and RSV Nasal aspirates/washes 5 and nasopharyngeal swab Xpert®...

Kit On Time Time Gene Sample Version Test Name Intended Use Configuration (Min) (Min) EAT Sequences Sample Storage Condition Required Fast, sensitive on-demand HCV diagnosis1 and quantitative monitoring for effective treatment Xpert® HIV-1 Qual Same day detection of HIV-1 infection to support early infant diagnosis and identification of acute infection Xpert® HIV-1 Viral Load Fast, on-demand testing of HIV-1 viral load monitoring 10 <1' 90' Whole blood: 15-35°C for 6 hours, 15-25 °C for 24 hours; 2-8°C up to 72 hours; Plasma and serum: 15-35°C for 24 hours; 2-8 °C for 72 hours; -70 to -18°C...