Mologic partnering wit ith the In Institut Pasteur de Dakar Home - PowerPoint PPT Presentation

Mologic partnering wit ith the In Institut Pasteur de Dakar Home of the Mologic Centre for Advanced Rapid Diagnostics (The CARD)

Coronavirus – getting up-close and personal, warts and all!

Coronavirus – Footprints, fingerprints and other give-away clues found at the scene of the crime – the human body

Catching the felon red-handed – present and in the act of breaking, entering and plundering! RT-PCR Detects and amplifies some of the genes

ANTIGEN TEST: unmistakeable evidence of the felon’s presence at the scene of the crime and caught in the act! RT-PCR Assay configuration Gen 1 Antigen test RDT ELISA Nasopharyngeal swab Saliva?

ANTIBODY TEST: Witness statements! Reliable affidavits from numerous sworn-in parties. RT-PCR Assay configuration Gen 1 Antigen test Antibody test RDT ELISA Blood Secretions? IgA/M

Have I got antibodies in my body against the virus (SARS-CoV-2)? Am I likely to be immune? Did my vaccine work (when it’s ready)?

Have I got antibodies in my body against the virus (SARS-CoV-2)? Am I likely to be immune? Did my vaccine work (when it’s ready) Sample passes through test line where Control gold is captured on the control antibodies are captured by anti-human line, to demonstrate that the test is IgG/IgM antibodies. If the sample is complete and has run correctly. positive gold particles are captured and form a visible line

Paper submitted for publication: “Rapid development of COVID -19 rapid diagnostics for low resource settings: accelerating delivery through transparency, responsiveness, and open collaboration.” ➢ Tropical Disease Biology, Centre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, UK ➢ Institute for Infection & Immunity, St George’s University of London, London, UK ➢ Mologic COVID-19 Diagnostics Development Team ➢ RLBUHT, Royal Liverpool & Broadgreen University Hospitals NHS Trust, Liverpool, UK ➢ Institut Pasteur de Dakar, Dakar, Senegal Corresponding authors: Sanjeev Krishna – s.krishna@sgul.ac.uk Emily Adams – Emily.adams@lstmed.ac.uk A very special consortium with a globally distributed testing network across 4 continents to evaluate novel RDTs in ➢ Malaysia, ➢ Kenya, ➢ Malawi, Collaboration and sharing: ➢ China, A global crisis needs global cooperation ➢ Spain, ➢ North America, ➢ Latin America, ➢ Pakistan

Mologic launches manufacturing facility to boost access to COVID-19 rapid diagnostic tests, April 24 2020 ➢ Construction has begun on a new diagnostic manufacturing site, which will have capacity to produce up to 40 million tests per year ➢ The first products to be manufactured will be rapid COVID-19 diagnostic tests ➢ The new facility is a legally separate social enterprise with a mission to deliver diagnostics at a fair price to the national and international markets ➢ It will also become a training facility for partners in low-income countries and regions currently poorly served by diagnostics provision Builds on Mologic’s existing partnership with the Institut Pasteur de Dakar in Senegal where manufacture of our Dengue test has started in the diaTROPiX unit, a flagship manufacturing facility in Senegal. The COVID19 diagnostics are to start in early May. MANUFACTURING: To ensure widespread access, we need scaled-up manufacture. Re-deployment of staff at Mologic! DiaTROPIX building and team in February. The beginning!

The ANTIBODY TEST. We would like it to be equivalent to the RT-PCR test for diagnosis of infection But the challeng is – Analytical sensitivity.

Issues to tackle: Supply chain: Nb Gates initiative Price point and access Clear use cases and proper use of tests and information Clear point of contact with responsible government officials to provide guidance, feedback and discussion on product evaluation, performance criteria and routes for adoption of new technology.

What about the so-called false negatives? Complete reliance on the antibody test as the sole correlate of immunity neglects an important compartment of the adaptive immune system. Text book immunology. DON’T FORGET THE MUCOSAL IMMUNE SYSTEM! DON’T FORGET THE T -CELL!

Not enough attention paid to:- - route of immune stimulation/infection, - presentation of the virus (superficial or systemic) - Viral dosage/rate of proliferation - Severity of disease.

Mass Testing

What’s our objective? • Objective • Objective • Hold off the virus until a • Reduce harm (health, vaccine is developed economic, social) of Covid-19 • Strategy • Strategy • Suppress the virus using • Mitigate the virus with: lockdown • Test and trace and isolate • AND other measures (therapeutics, masks, shielding etc.)

S.T.I.R. S Screen all people and administer both antibody and antigen tests. Prioritise key workers and those identified through contact tracing based on availability of tests. T Trace anyone who has come into contact with a person positive Covid-19. This will use a combination of tracing technology and offline community tracing. I Isolate anyone who tests positive and initiate contact tracing (antigen). Immunity certificates issued to anyone who has sufficient antibodies (antibody). R Repeat the process on a daily basis for key workers and biweekly for others.

PERSON CHOSEN FOR MASS TESTING Person is NHS worker Person is key worker Person is identified through contact tracing Person has symptoms Person is randomly selected (e.g. 7% of population every 2 weeks) Antibody test administered: Has the patient had COVID-19 and is now immune? Antigen test administered: Does the patient have COVID-19? Contact Self- Isolate No and Negative Positive for 14 Yes and NOT is not is Days Immune Immune infected infected Patient is free to Immunity certificate is continue with [new] Patient enters self- Contacts traced issued, patient free to normal life isolation for 14 days work, travel and excluded from test Dies Recovers Contacts traced

If those going for testing do both tests, we will: Ranked by priority but PERSON CHOSEN FOR MASS TESTING 1. Identify those who have had the keep under review disease but are still carriers Person is NHS worker 2. Those who have had the disease and Person is key worker are now immune It will also make contact tracing more Person is identified through contact tracing This will be the Increased complete and effective majority of people as testing Person has symptoms – their risk of capacity Person is randomly selected (e.g. 7% of infection will be grows. population every 2 weeks) lowered through Objective: contact tracing and everyone self-isolation of as often as carriers. They can possible Antibody test administered: Has the patient had COVID-19 and is now immune? Antigen test administered: Does the patient have COVID-19? continue life outside of lockdown. Contact Antibody tests likely to Self- become more widely Isolate No and available. Their use won’t Negative Positive for 14 Yes and NOT be restricted by antigen is not is Days Immune Immune availability and patients Objective will be to increase infected infected the number of COVID-19 may receive these more often. positive people going into this box through healthcare Patient is free to capacity and therapeutics Immunity certificate is continue with [new] Patient enters self- Contacts traced issued, patient free to normal life isolation for 14 days work, travel and excluded from test Contact tracing of those who have and have had the disease, and subsequent testing/isolation will reduce R0 rate If symptoms come back, patient should re- Dies Recovers Contacts traced enter testing cycle

Scalin ing Testin ing Appoint a Minister for Testing reporting directly into the Prime Minister Scale antigen testing using every means possible Recognise the importance of antibody testing and rapid PCR Don’t let the best be the enemy of good enough Prepare for community testing and tracing now