Mobile Lab-Diagnostik

Transcription

1 Mobile Lab-Diagnostik Jenaer Technologietag 2013 Alere Technologies GmbH, Jena; , Torsten Schulz ALERE TECHNOLOGIES

2 Alere Technologies GmbH former CLONDIAG GmbH 1998/1999 Foundation; 2001 first OEM business with own products (ArrayTube) (2002 Building OEM Manufacturing for IVD Products) 2006 Joining Inverness Medical Innovations (Alere Inc.) starting PIMA Project & HIV-NAT-POC Project 2009 Launching PIMA CD Instruments are in the field, production capacity 5 Mill / a 320 employees ~ 170 R&D; ~ 110 Operational business 2013 Launche of Alere q (IUO) HIV-NAT-POC One of the main locations for Alere

3 About Alere Inc. Waltham Massachusetts World market leader in POC diagnostics Revenue B $ Profit 1.25 B $ Employees worldwide over >12.000; 1000 sales and marketing; 500 R&D Fields of activities: Consumer diagnostic Professional diagnostic cardiology, womens health, infectious disease, oncology and toxicology Health care management:disease management program, patient self-testing services, womens and childrens health, oncology programs Selling points and manufacturing sites all over the world

4 Mobile Lab Diagnostik am Beispiel NAAT POC Alere q Platform: HIV NAAT POC Diagonstik: Alere q Vollblut & Plasma TB NAAT POC Diagnostik TB-Resistenz NAAT POC Diagnositk HIER STEHT DER DISCLAIMER 4

5 Challenges of HIV Diagnosis and Treatment

6 Challenges of TB Diagnosis and Treatment Estimated 8,8 million new cases (2010) and 1,5 million associated deaths 7

7 Microscopy Center Conditions Ziehl-Neelsen 8

8 Field Experience from CD4 Testing Alere Pima CD4 9

9 Alere Q Platform 10

10 Alere Q HIV-1/2 Sample Collection 11

11 Alere Q HIV 1/2 VL Test Intended Test Use Test for Diagnosis of HIV Infection and Monitoring of Viral Load in HIV+ patients Goal of Test Detection of HIV-1 AND/OR HIV-2 RNA in whole blood OR EDTA plasma; fully quantitative viral load measurement of HIV-1 M, N HIV-1 O and HIV-2 LOD 100cp / test Anaylyzer Instrument Portable device; app 5kg weight; no maintenance or calibration required Quantitation Quantitative; HIV-1 and HIV-2 separately reported Precision 0.3 log Sample Specimen 25 µl of finger prick blood (25µL) or EDTA plasma # steps required to run the test Test does not require any sample handling or pre-treatment by user 12

12 Introduction to Alere q lyse whole blood in the presence of capture molecules with anchor groups Complex of HIV nucleic acids and capture probes with anchor groups is formed (hybridization) Capture complex onto solid matrix (via anchor groups) Remove all unbound material (nucleic acids, proteins, low molecular weight contaminants etc. amplify captured nucleic acids and quantitatively detect the formation of amplified nucleic acids by quantitative real time reporter hybridization PCR 13

13 The cartridge HIER STEHT DER DISCLAIMER 14

14 cap The cartridge design Capillary containing EDTA Septum Venting Washing buffer chamber NAAT Reactor chamber with detection chip and capture beads Lysis & IPC & capture oligos PR-TRT Pellet chamber Wash Buffer Reservoir Alere Technologies Jena valve chanels Page 15

15 Sputum Sample Collection 17

16 TB cartridge NEAR-NAAT HIER STEHT DER DISCLAIMER 18

17 Alere Q Modifications for Large Volume Cartridges 19

18 Sputum Sample Cup and Cap 21

19 Sputum Sample Cup and Cap Threaded screw cap 22

20 Sputum Sample Cup and Cap Red line disappears when fully closed 23

21 Sputum Collection Cup and Cartridge Slide sample cup onto cartridge until it click-locks in place 25

22 Inserting Complete Cartridge into Q instrument 26

23 Fully-Automated Workflow for TB Diagnosis 27

24 Fully-Automated Workflow for TB Diagnosis 1. Sputum liquefaction, homogenization an filtration 28

25 Fully-Automated Workflow for TB Diagnosis 2. Nucleic acid purification and mycobacterial DNA enrichment 29

26 Fully-Automated Workflow for TB Diagnosis 3. Reagent reformulation and NEAR reaction setup - Filtration -washing - Lyse -buffer setup 30

27 Fully-Automated Workflow for TB Diagnosis 4. NEAR isothermal amplification 31

28 Fully-Automated Workflow for TB Diagnosis 5. Real-time fluorescence signal detection 32

29 Results and Connectivity Options Touchscreen Printer USB ports Ethernet port GPRS Modem 34

30 TB Drug Resistance Testing Strategy Separate reflex cartridges matched to the clinical utility of the drug resistance information and location of therapy TB diagnosis on TB suspects First-line drug resistance testing on TB patients Second-line drug resistance testing on MDR-TB patients Uses same cartridge with fully automated sample prep Works with sputum or cell culture PCR amplification and CMA (competitor monitor amplification) detection ideal for multiplex SNP s Developing model system that can be adapted to different SNP s depending on TB drug therapy clinical trial outcomes 36

31 TB Drug Resistance Test Cartridge Multiplex amplification with CMA (competitor monitor amplification) detection integrated into cartridge Hybridization pattern converted into quantitative output Resistance information derived by applying test-specific algorithms Integrated controls for high specificity and failure mode analysis Total analysis time approx min 37

32 Kontakt Vielen Dank! Dr. Torsten Schulz Alere Technolgies GmbH Löbstedter Str D Jena 38