System Overview. cobas Liat

Transcription

1 System Overview cobas Liat

2 cobas Liat System A complete POC PCR solution from sample in to result out ANALYZER 19.0 cm ASSAY SOFTWARE 11.4 cm

3 cobas Liat System A complete solution from sample in to result out ANALYZER 19.0 cm cm

4 cobas Liat Analyzer Intuitive touchscreen display Assay tube entry door Laser barcode scanner Touchscreen soft keys Function buttons Navigation buttons Power on/off

5 cobas Liat System A complete solution from sample in to result out 19.0 cm SOFTWARE 11.4 cm

6 Software Assay reagent lot checks & internal control processed with every sample QUALITY CONTROL Secured login & keyed user roles for operation and report review USER SECURITY Sample process monitoring and insufficient sample volume warnings VOLUME SENSING Comprehensive self-monitoring and continuous self-calibration REAL-TIME MONITORING Auto analysis, interpretation & reporting; no user interpretation required AUTOMATED DATA INTERPRETATION

7 Connectivity 1 Test results transmitted The cobas Liat Analyzer supports HL-7 and the POCT1-A Standard Driver plug-in HL7 Available driver: cobas IT1000 cobas infinity cobas IT middleware cobas IT 3000/5000 Laboratory Information System (LIS) POCT-1A Test & QC results transmitted cobas Liat Analyzer Remote management of users, lots and devices Middleware (DML supported)

8 cobas Liat System A complete solution from sample in to result out 19.0 cm ASSAY cm

9 Assay Menu, Sample Types & Collection Media Sample Type Collection Media Time to result cobas Influenza A/B Nasopharyngeal swab UTM Media ~20 min cobas Strep A Throat swab Liquid Amies (Eswab) ~15 min cobas Influenza A/B & RSV Nasopharyngeal swab UTM Media (3ml) ~20 min cobas Cdiff Unformed stool cobas PCR Media ~20 min In development cobas STI TBC TBC TBC cobas HIV-1/2 Qual Whole blood capillary/edta ~30 min* Transfer from primary vial to assay tube estimated to be less than 1 minute**. Roche Diagnostics Global looking into the option of a Global Supply Agreement for collection media * Design goal **Source: Nolte S. et.al J. Clin. Microbiol. doi: /jcm

10 Assay tube Pre-packed reagents in a single assay tube Sample segment Automated sample preparation & silica bead-based nucleic acid extraction in tube Completely closed system Dilution buffer Internal process control Proteinase K Magnetic beads Lysis buffer Wash buffer Elution buffer PCR reagents *Some assay tubes include dilution buffer and/or Uracyl N Glycosylase enzyme. Contents varies by assay and coloring is for illustrative purposes only. *Contents varies by assay and coloring is for illustrative purposes only.

11 Secure and Simple Workflow Results in about 20 MINUTES or less* Sample Add patient sample to the cobas Liat assay tube with provided transfer pipette Scan Scan assay tube using built-in barcode scanner Start Insert assay tube into the cobas Liat Analyzer * Turnaround times vary by assay

12 Secure and Simple Workflow Results in about 20 MINUTES or less* Intuitive touchscreen user interface Step-by-step guided instructions No operator intervention or interpretation No laptops or additional equipment required * Varies by assay

13 cobas Liat System Designed for a failsafe experience SAMPLE & QC SYSTEM SELF CHECK SAMPLE TRACKING ERROR DIAGNOSTIC SYSTEM OPERATOR CONTROLS

14 cobas Liat System In Summary DESIGN QUALITY SPEED EASE OPERATION Innovative modular architecture and fluid processing capabilities fully automates nucleic acid chemistries from sample in to result out A high standard for quality is maintained throughout the process with built-in internal control and fail-safe software measures Innovative processing & proprietary algorithms enable rapid time to results (15-20 min depending on assay), without comprising performance Sample in to results out in 3 simple steps, with automated results interpretation Completely closed system with all reagent pre-packed, requiring no user intervention The simplicity of the cobas Liat System enables use by healthcare professionals at all skill levels, and in non-laboratory environments, such as physician offices

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16 NZ Evaluation Overview 1) ManaKidz Counties Manukau 2) Canterbury Health Laboratories

17 ManaKidz how the program works 61 schools (decile1-3) 25k children 1,034 classroom visits RN/WSW health team based at school Rheumatic fever prevention Skin infection management Child health and wellbeing Standing orders Free treatment Onwards referrals every day

18 ManaKidz Service provider structure Union Health Otara 9 PHO s managing approx. 7 schools each Overseen by the NHC ( also a PHO)

19 Global Distribution of Acute Rheumatic Fever Mean incidence of ARF Indigenous NZ/ Australia China Eastern Europe Middle East / North Africa Latin America Asia Other South Central Asia Africa ARF cases per 100,000 Carapetis et al. Lancet Infect Dis 2005;5:

20 ARF in New Zealand Rates of ARF for 5-14 year old children are 20 or 40 fold higher respectively for those self-identified as Māori or Pacific than non-māori/non-pacific Admission rates differ across age groups, with the highest prevalence being among children of schoolgoing age

21 ARF in New Zealand North-South Gradient ARF Admissions 2006/ Year Olds Rate per 100,000 Rheumatic fever is unevenly distributed in New Zealand, with most cases recorded in the North Island. Counties Manakau, Gisborne and Northland having the highest admission rates in the country >25

22 Rheumatic Heart Disease in NZ

23 ManaKidz Counties Manakau Salient Points A study to screen children for Strep A using the cobas Liat System for the prevention of Rheumatic Fever (RF) Assay: Strep A Start date: 29 January 2019 Primary endpoint: feasibility of using the cobas Liat strep A assay to screen children for Strep throat in order to improve result TAT and therefore improve time to treatment Secondary endpoints: 1. reduce inappropriate use of antibiotics 2. improved patient experience/treatment outcomes 3. sensitivity and specificity equivalence/improved vs laboratory method 350 tests Liat vs lab culture (TAT 2-3 days)

24 cobas strep A - workflow efficiency an example of a Strep A patient impact workflow

25 Canterbury Health Laboratories Salient Points Trial Objective: Could a rapid molecular test offered 24/7 for influenza viruses be of value to the emergency department at the CDHB during the winter season? Possible benefits: Improvement of patient management due to cohorting Reduction of stress on virology staff during winter month Reduction of the unnecessary use of isolation beds Reduction of nosocomial cross-transmission of influenza Earlier appropriate treatment and infection control measures Reduction of patient stay in the ED department Reduction of overall stay in hospital Start date: August-October 2018 ED & Acute medical Assessment Unit (AMAU) Liat vs Fast Track respiratory panel Connected to LIS ( Éclair)

26 cobas Influenza A/B & RSV workflow efficiency one test, three results, simplified testing

27 Doing now what patients need next