OFFICIAL SENSITIVE COMMERCIAL INTRODUCTION TO LATERAL FLOW TESTING

OFFICIAL – SENSITIVE – COMMERCIAL INTRODUCTION TO LATERAL FLOW TESTING Overview of approach : DPH Led Community Testing (Early Years Providers) 9 February 2021 Paul Robinson, Assistant Director, Organisational Change and Cumbria Lateral Flow Test Programme Director Dan Barton, Assistant Director, Education and Skills Emma Robinson, Lateral Flow Testing Project Lead DRAFT

OFFICIAL – SENSITIVE – COMMERCIAL DRAFT Lateral Flow Testing – an overview • Provides asymptomatic testing of employees • Aims to identify and isolate positive cases to break chains of transmission • Results within 30 minutes • 76. 8% sensitivity • Two delivery channels 2

OFFICIAL – SENSITIVE – COMMERCIAL DRAFT Lateral Flow Testing – an overview Institutional Testing Delivery Channel – led by central government Institutional Testing already undertakes asymptomatic lateral flow testing for a range of sectors including NHS, adult social care and education settings such as schools, universities and maintained nurseries. Going forward, large institutions in both the public and private sector with over 250 staff should access asymptomatic testing through the institutional testing delivery channel. Medium sized institutions in both the public and private sector with between 50 and 250 staff can also access asymptomatic testing through institutional testing and should do so wherever possible. However, where organisations of this size and type can access asymptomatic testing more effectively through community testing these should be considered for testing through this channel by local authorities. Small institutions in both the public and private sector with less than 50 staff, sole traders and self-employed citizens are expected to be access asymptomatic testing through community testing delivered by local authorities. Two delivery methods – workplace testing and at home testing 3

OFFICIAL – SENSITIVE – COMMERCIAL DRAFT Lateral Flow Testing – an overview Community Testing Delivery Channel – in Cumbria this is led by Cumbria County Council Community Testing is led by local authorities who will prioritise their community testing plans according to local needs, primarily for citizens that need to leave home to work and unable to access testing provided through the institutional testing channel. In Cumbria our priorities are: • Education and healthcare settings not covered by institutional testing, including PVI nurseries and childminders • First Responders including Police, Fire, Mountain Rescue • Other high risk Frontline workers e. g. District Council waste management workers • Key service businesses where people cannot work from home (under 50 employees) • Rapid Response offer delivered by Cumbria Fire and Rescue where outbreaks occur Two delivery methods – workplace testing and community site-based testing LFT is not licenced for home testing under the Community Testing Delivery Channel. 4

DRAFT OFFICIAL – SENSITIVE – COMMERCIAL Your employees will be tested using validated Lateral Flow Antigen tests The LFD brand currently available in this scheme is: ü Fast result (20 -30 minutes) ü Outside of a formal laboratory setting ü Well-suited for frequent testing of large numbers of asymptomatic people Innova has an overall sensitivity of 76. 8% for all PCR-positive individuals but detects over 95% of individuals with high viral loads, and minimal difference between the ability of the test to pick up viral antigens in symptomatic and asymptomatic individuals 1 Register & Swab 2 Process Key Facts Lateral Flow Antigen testing involves the processing of nasal and throat samples with a Lateral Flow device, highlighting a coloured strip on the device to show a positive result Test kit composition Innova’s SARS-Co. V-2 Antigen Rapid Qualitative Test 3 4 3 1 1 Swab 2 Extraction vial 3 Extraction solution 4 Lateral flow device 2 Manufacturer Innova Tried & Tested Product Test Type Name Innova SARSSwab Cov-2 Antigen test Analyse Sensitivity est. Specificity est. Sample-toanalysis est. 76. 8% 99. 68% 20 – 30 mins 4 Log result Negative result: Log result against test ID by scanning the barcode (individual does not have to self isolate) Complete a self-administered throat & nasal swab test Prepare and load (‘dropping’) the sample onto the cartridge, conduct proper extraction and wait 20 -30 minutes Analyse result against manufacturer IFU and interpret result as Negative, Positive or Invalid Positive result: self-isolate according to national guidelines if positive Invalid result: retest 5

DRAFT OFFICIAL – SENSITIVE – COMMERCIAL Workplace Testing - Setting up a test service for your employees : six steps ENGAGE EMPLOYEES SET UP TEST SITE & TRAIN STAFF Inform your Employees of your LFT offer test site and its purpose, share related materials with them, explain the testing process and ask them to provide consent to participate in testing ORDER TEST KITS & PREPARE FOR TESTING • Advise of weekly numbers to test and CCC will organise test kit and PPE delivery in advance • Sign the Schedule to agree to the Terms • Communicate booking slots to your employees • Engage with CCC LFT Team to order services and materials described in the pack of supporting documentation • Identify the space for your test site(s) and set up according to the Toolkit and SOP • Mobilise staff to perform Test Operative roles, and organise your employees for testing • Set up Site location(s), and setup Test Operatives on the national Digital Results Logging Website TEST SAMPLE ANALYSIS CONDUCT TESTING RESULT NOTIFICATION & FOLLOW UP Collected samples are processed analysed on site in the allocated area, results will be determined on the day within 30 mins Begin testing employees Feedback any issues and lessons to CCC LFT Team who can support Your consenting employees will receive their results to the contact details they provide when they register. System in place for employees to share results with employer if they consent. 6

1 2 m 2. 4 m 3 4 1. 2 m 2 m 0. 4 m SINGLE OR MULTI Single 0. 6 m 1 m 3 2 m 4 2 m 2 m 2 m OPEN PLAN LAYOUT 3 Use this layout to set up an open plan testing area with one or more testing “PODS”. 6 4 2 m Approx 21 m 2 3 AREAS 1 Entrance 2 One-way walkway 3 Sample colection area 4 Sample processing desk 5 Results analysis and upload area 4 KEY Table (1 x 1 m) 2 m Chair 3 6 4 Floor tape Protective clear screen or tape to mark barrier 2 m Flow of people 6 Accessible sample collection area 7 Exit Time and throughput model 2. 4 m 7 Total Tests (One pod for 1 days) 1 Day Operation L 32 4 (15 mins) M 56 7 (9 mins) H 80 10 (6 mins) 2 m Multiple 8 Approx 10 m SCALE 1 m “POD = Point of Delivery”

OFFICIAL – SENSITIVE – COMMERCIAL DRAFT Workplace testing - Each organisation agrees to accept DHSC’s Terms and Conditions which are underpinned by the following core assumptions Policy Commercial & Legal 1. Testing will not remove requirements to follow all national government guidance on COVID-safe workplaces, such as social distancing 6. 2. Those who test positive will need to self isolate as per government guidelines. Close contacts will need to self isolate. The organisation will construct and set up testing environments in accordance with SOP guidelines (including storage areas for tests) for sample collection, analysis, disposal and reporting 7. NHS Test and Trace will fund and supply the tests via the CCC DPH Community Testing Programme, subject to contractual agreement, for a limited period. Operations Outcomes 3. Tests must be supervised by employer staff who will be given suitable training and support 8. Test results will be shared with national NHS Digital system which may include anonymised onward distribution to Public Health England 4. Employees will be tested under a schedule to be defined by the employer. Testing will be voluntary and must not be compulsory 9. 5. Sample materials need to be treated as healthcare waste. Disposal will take place at the place of test, per SOP & Guidebook requirements Under current legislation, employers do not receive results directly from the national system however a summary spreadsheet is available for Providers to consider for business continuity purposes if national system has problems. 10. A weekly test summary return must be submitted to CCC LFT Team by 1000 hrs each Monday to feed national reporting requirements Note: subject to change, Terms and Conditions apply and must be accepted prior to receiving test kits 8

OFFICIAL – SENSITIVE – COMMERCIAL DRAFT Community Site Testing Cumbria County Council are currently mobilising a number of community test sites for lateral flow testing. These will be for priority cohorts only – including PVI nurseries and childminders. Sites for priority mobilisation – aiming to achieve access across all districts, but focussing on sites where we can mobilise quickly: Carlisle Barrow Dalton-in-Furness Kendal Kirkby Lonsdale Milnthorpe Sedbergh Penrith Whitehaven Millom Workington Silloth Longer term ambition is also to have sites in: Alston Ambleside Appleby Aspatria Brampton Egremont Grange Over Sands Keswick Kirkby Stephen Maryport Shap Ulverston Wigton 9

OFFICIAL – SENSITIVE – COMMERCIAL DRAFT To get started, please see the following next steps 1 Workplace Testing – Larger nurseries please contact Emma Robinson on 07775115501 or emma. robinson 2@cumbria. gov. uk. 2 Community Site Testing – we will be in touch through your Early Years Advisor with a brief survey to gather information on the number of staff you would like to be tested and in which locations. Please look out for this. 10

DRAFT OFFICIAL – SENSITIVE – COMMERCIAL Key Contacts and Support • LFT Programme Engagement Lead : • General enquiries: emma. robinson 2@cumbria. gov. uk 07775 115 501 Ask. LFT@cumbria. gov. uk • Or please contact your Early Years Advisor 11