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

RT-PCR Detects and amplifies some of the genes

Catching the felon red-handed – present and in the act

• f breaking, entering and plundering!

Assay configuration Gen 1

Antigen test RDT ELISA RT-PCR

ANTIGEN TEST: unmistakeable evidence of the felon’s presence at the scene of the crime and caught in the act!

Nasopharyngeal swab Saliva?

Assay configuration Gen 1

Antibody test RDT ELISA Antigen test RT-PCR

ANTIBODY TEST: Witness statements! Reliable affidavits from numerous sworn-in parties.

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 antibodies are captured by anti-human IgG/IgM antibodies. If the sample is positive gold particles are captured and form a visible line Control gold is captured on the control line, to demonstrate that the test is complete and has run correctly.

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, ➢ China, ➢ Spain, ➢ North America, ➢ Latin America, ➢ Pakistan

Collaboration and sharing: A global crisis needs global cooperation

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
• Hold off the virus until a

vaccine is developed

• Strategy
• Suppress the virus using

lockdown

• Objective
• Reduce harm (health,

economic, social) of Covid-19

• Strategy
• Mitigate the virus with:
• 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

• f 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.

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

Antigen test administered: Does the patient have COVID-19? Positive is infected Patient enters self- isolation for 14 days Antibody test administered: Has the patient had COVID-19 and is now immune? Yes and Immune No and NOT Immune Immunity certificate is issued, patient free to work, travel and excluded from test Contacts traced Recovers Dies Negative is not infected Patient is free to continue with [new] normal life Person has symptoms Person is NHS worker Person is key worker Person is randomly selected (e.g. 7% of population every 2 weeks) Person is identified through contact tracing PERSON CHOSEN FOR MASS TESTING Contacts traced Contact Self- Isolate for 14 Days Contact tracing of those who have and have had the disease, and subsequent testing/isolation will reduce R0 rate This will be the majority of people – their risk of infection will be lowered through contact tracing and self-isolation of

• carriers. They can

continue life

• utside of

lockdown. If those going for testing do both tests, we will:

• 1. Identify those who have had the

disease but are still carriers

• 2. Those who have had the disease and

are now immune It will also make contact tracing more complete and effective Objective will be to increase the number of COVID-19 positive people going into this box through healthcare capacity and therapeutics Increased as testing capacity grows. Objective: everyone as often as possible If symptoms come back, patient should re- enter testing cycle Ranked by priority but keep under review Antibody tests likely to become more widely

• available. Their use won’t

be restricted by antigen availability and patients may receive these more

• ften.

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