mPharma designed a plan to use pharmacies as hubs for decentralizing Covid PCR testing.

2. 1
Project Title Implementation of mLabs in the Democratic Republic of the
Congo
Project Organization mPharma
Organization
Contact
Gregory Rockson
CEO and Founder
gregory@mpharma.com
Project Partner Programme National d’Approvisionement en Médicaments Essentiels
Total Budget $500,000 Total Duration 4 months
Start Date September, 2020 End Date December, 2020
CONFIDENTIAL

3. 2
Table of Content
Part A: Executive Summary 3
Part B: Project Background and Introduction 4
Introduction of mPharma 5
Part C: Project Strategy 5
Pilot Overview 5
Scope of Pilot 6
Part D: Implementation Details 7
Responsibilities of mPharma 7
Responsibilities of PNAM 7
Requirements for Participating Pharmacies/Health Facilities 8
Space Requirements 8
Space Setup 8
Sample Collection and Testing 8
Reporting Test Results 8
Waste Management 9
Human Capital Requirements 9
Testing Workflow 9
Project Implementation Timelines 12
Expected Project Results 12
Part E: Project Monitoring and Evaluation Plan 12
Part F: Budget 13
Part G: Appendices 13
CONFIDENTIAL

4. 3
Part A: Executive Summary
The spread of COVID-19 across Africa has exposed the important need to expand the continent’s
molecular diagnostics capabilities. At the height of the global pandemic, mPharma, a healthcare
technology company with a network of over 400 pharmacies, established mLab to set up Polymerase
chain reaction (PCR) equipment across Africa. For us, this fight extends beyond the novel
coronavirus to include the many viral infections that continue to plague the continent. mLab is a
molecular diagnostics service offered through our robust network of retail pharmacies and private
and public sector laboratory partners. Our goal is to make advanced molecular diagnostics
affordable and accessible to the public by advancing a point of care testing (POCT) system across
our key markets. Ghana and Nigeria currently host the first three iterations of mLab, with the
capacity to test for COVID-19 in a timely and efficient manner.
This project seeks to take the mLab model to the Democratic Republic of the Congo (DRC). With a
population of over 80 million, the DRC has considerable experience dealing with viral infections.
The government’s resilience and proactivity in recent years have helped wade off the scourge of
infectious diseases like ebola. mPharma hopes to build on these successes and ongoing efforts to
fight COVID-19 by establishing 4 mLab point of care testing (POCT) facilities in Kinshasa.
Expanding testing for Kinshasa’s 11 million residents will prove central to the fight against the
coronavirus in the DRC. In partnership with PNAM (Programme National d’Approvisionement en
Médicaments Essentiels), mPharma will establish these community-centred testing facilities to
rapidly rump up testing at local levels in order to radically reduce turnaround time and backlogs at
national laboratories. To achieve the desired outcomes of mLab in the DRC, the following activities
will take place:
1. Select 4 facilities (2 pharmacies and 2 clinics/hospitals with basic laboratory facilities) to
serve as mLabs;
2. Place 2 iPonatics in each facility;
3. Train existing staff on the use of our fully automated molecular diagnostic workstation, the
iPonatic;
4. Match each of these mLab facilities with 10 clinics/hospitals based on proximity; 40
clinics/hospitals in total for the pilot;
5. Provide 250 swabs and viral transport mediums (VTM) to each of the 40 selected
clinics/hospitals to be used for sample collection and transportation to their designated
mLab;
6. Test samples in mLab and send results to the clinic/hospital for immediate action.
Collectively, mLabs will test about 480 samples weekly.
CONFIDENTIAL

5. 4
mPharma will provide all the equipment required for establishing an mLab in the DRC, including
remote video training for lab technicians and routine maintenance of equipment. The iPonatic, a
portable molecular diagnostic workstation, will be deployed in each mLab to test for samples. The
fully automated nature of the iPonatic device allows for quickly upskilling existing pharmacy and
clinic laboratorians. PNAM will play a pivotal role by selecting facilities to include in the pilot and
coordinating all activities on the ground.
Through this initiative, we hope to partner with the Government of DRC and the World Bank to
decentralise coronavirus testing through expanding the country’s capacity to conduct point of care
testing (POCT). POCT will allow us to reduce the turnaround time by localizing testing and cutting
unnecessary human interference in the testing process. Beyond COVID-19, mLabs will have the
capacity to provide testing for other viral infections and position the DRC as a leader in molecular
diagnostics in the region.
Part B: Project Background and Introduction
The global spread of COVID-19 has led to a scramble for medical equipment around the world.
Demand for nose masks, personal protective equipment, test kits and testing devices have expanded
rapidly. In the midst of this global surge, rich countries have pushed poorer countries to the side by
paying more for the same products or advancing coercive diplomacy. As rich countries outbid each
other for these supplies, African countries especially have been on the losing end. With a historically
underfunded healthcare sector, COVID-19, coupled with the inability of manufacturers to meet
equipment orders from African countries, threatens to cripple already weak institutions. Countries
like the Democratic Republic of the Congo (DRC) often bear the brunt of an unfair testing regime
which often alienates small and less economically developed countries.
While many African countries, including the DRC, have so far avoided an explosion in positive
cases, scientists fear this is the result of weak and inadequate testing capacity. In many of the
continent’s countries, the rate of testing has been low and limited only to people showing symptoms.
Furthermore, testing is highly centralized and mostly conducted by government-financed research
labs located in major cities. The World Health Organisation has often remarked that “test test test”
is Africa’s surest way to avoid an escalation of the existing COVID-19 crisis.
As the DRC deals with an uptick in the number of positive cases, there is a dire need for innovative
testing approaches to fight the novel coronavirus; this need birthed our interest in leveraging Point
of Care Testing (POCT) in DRC. Across the continent, centralization of COVID-19 testing has
compounded existing pressure on existing public laboratories. This has given rise to delayed results
and logistical challenges in transporting samples from rural areas to the urban areas where national
COVID-19 labs are often located. POCT allows for the decentralization of testing and allows
CONFIDENTIAL

6. 5
medical staff to receive accurate results within a shorter time. For DRC to rapidly increase testing
and improve coronavirus management, these processes must be decentralized and taken to patients.
This initiative is focused on developing a public-private partnership model led by mPharma which
will allow communities to have easy access to coronavirus testing.
Introduction of mPharma
mPharma is a technology-driven company with a bold mission to develop an Africa in good health.
The company operates a network of more than 400 pharmacies in Ghana, Nigeria, Zambia, Kenya
and Zimbabwe. These pharmacies collectively serve over 1 million customers annually. mPharma
operates a molecular diagnostics service across its retail pharmacy network known as mLab; the goal
of mLab is to make advanced molecular diagnostics affordable to the public and to help doctors find
the most effective treatments for their patients.
mPharma recently developed and rolled out a testing strategy to increase the availability of Covid-19
PCR testing in Africa in collaboration with Sansure Biotech. Through this partnership, more than
120 PCR equipment and 700,000 test kits have been deployed to several Sub-Saharan African
governments, private hospitals and NGOs across Benin, Gabon, Ghana, Nigeria, Kenya, Congo
Brazzaville and Zimbabwe to name a few.
These efforts have led to partnerships with private sector players to establish Ghana’s first private
COVID-19 testing laboratory in May 2020. This laboratory, repurposed for coronavirus, has the
capacity to test up to 1,500 samples daily. The company has since moved on to establish two private
coronavirus testing facilities in Nigeria. mPharma has developed the capacity to work with both the
public and private sectors to quickly ramp up molecular testing. It is this experience that is leading us
to take on impending challenges with COVID-19 testing in the DRC.
mPharma’s core business ensures that essential medication reaches patients who need it the most.
Pharmacies play a pivotal role in serving as the first point of care in low and middle-income
countries. In establishing and managing hundreds of pharmacies, mPharma has developed an affinity
for working to address pressing community-centred challenges. The existing COVID-19 testing
regime has exposed the need for community testing. Our vast experience in this field makes us well
poised to take on this challenge.
CONFIDENTIAL

7. 6
Part C: Project Strategy
Pilot Overview
Point of Care testing (POCT) is a critical tool that facilitates the ability for physicians to efficiently
diagnose diseases and offer timely treatments to patients, accordingly. The driving notion behind
POCT is to bring the test conveniently and immediately to the patient. This increases the likelihood
that the patient, physician, and care team will receive the results quicker, and make immediate clinical
management decisions.
The iPonatic, a POCT molecular diagnostic workstation, is central to mPharma’s decentralised
COVID-19 testing strategy. Produced and serviced by Sansure Biotech Inc, the device hosts a
4-channel fluorescent dye detection system that allows real-time collection of PCR data in the
presence or absence of a pathogen’s gene (RNA or DNA) target. Evaluated for competitive
sensitivity and specificity among others, Sansure’s reagent kit for COVID-19 diagnosis has received
the US FDA approval and is currently applied on diverse PCR machines, including the POCT
iPonatic device.
The iPonatic device fully automates the processes involved in testing any respiratory specimen (nasal
swabs, nasal aspirates, sputum, etc.), requiring minimal manipulations thereby cutting down on
outcomes subject to human manipulations. The device combines nucleic acid extraction and PCR
detection of SARs-CoV-2 ORF1ab and N gene, and this is controlled by human-specific internal
control that validates the experiment. More so, the device provides feedback on a sample tested in
less than an hour, aiding physicians and other care-givers to take the necessary action in patient
management in hospitals or pharmacies.
mPharma is working with its partners to advance POCT, using the iPonatic device, to improve
healthcare delivery across our key markets. Expanding the use of POCT devices like the iPonatic will
facilitate rapid healthcare management in the continuous fight against COVID-19 and future global
pandemics.
Scope of Pilot
This document is a technical proposal focused on decentralizing COVID-19 testing in DRC which
serves the following purposes:
I. It provides detailed strategies for:
a. setup or refurbishment of 4 molecular labs situated in pharmacies and/or healthcare
centres in Kinshasa; 2 community pharmacies and 2 clinics with basic laboratory
infrastructure.
CONFIDENTIAL

8. 7
b. deploying the POCT iPonatic PCR device to augment DRC’s pre-existing
COVID-19 testing facilities.
c. implementation through sample collection, sample transportation, sample testing,
test results reporting and waste management.
d. determining the timelines for deploying the iPonatic devices into the national testing
regime.
II. It describes the responsibilities of each collaborating partner
III. It also lays out the human capital needs for effective implementation of the plans detailed in
this proposal
Part D: Implementation Details
Responsibilities of mPharma
mPharma will:
1. provide the equipment, reagents and consumables required, namely:
a. iPonatic - Portable PCR workstation (2 devices each for the 4 selected facilities)
b. Class 2 Biosafety Cabinet
c. Dry Bath Incubator
d. Vortex Mixer
e. Covid-19 Nucleic Acid Diagnostic Kits and Sample release reagent
f. Throat Swab and Storage Reagent
g. Protective Body Suits
h. Facemasks, Goggles and Gloves
2. provide remote video training to the selected facilities in the pilot.
3. ensure that laboratories selected for the use of the iPonatic have full support in terms of
designing a laboratory space and ensuring a full setup for the device to be operational.
4. serve as the nearest point of call to troubleshoot the device or to seek for the best possible
protocols and other services like the replenishment of reagents and consumables to ensure
the smooth running of the device.
5. be responsible for the arrangement of Sansure-certified Maintenance Officers to perform
routine maintenance of all the devices.
6. pay each mLab testing facility $5 for each sample tested during the pilot.
Responsibilities of PNAM
1. Select the 4 health facilities to participate in the mLab pilot based on the requirements
provided by mPharma.
CONFIDENTIAL

9. 8
a. The ideal mix for the participating health facilities will be 2 community pharmacies
and 2 clinics with a basic laboratory.
2. Select the 40 clinics/hospitals to be assigned to the mLabs. Each mLab will be responsible
for testing samples from 10 clinics/hospitals. PNAM will supply 250 swabs provided by
mPharma to each of the 40 clinics/hospitals.
3. Clear the equipment and test kits supplied by mPharma through customs when they arrive in
the DRC.
4. Provide a key person to serve as a focal point to coordinate all the engagements on the
ground with the selected mLab and other government agencies. This person will also
monitor the performance of each mLab.
5. Provide in country storage for all equipment, consumables, and test kits. PNAM will store
the test kits and supply them to the mLabs upon their request.
Requirements for Participating Pharmacies/Health Facilities
Space Requirements
The device requires only a minimal space of about 10x10ft. The lab should be in a separate room at
the pharmacy. The clinics can use their existing laboratory for the pilot.
Space Setup
Find below a list of equipment/facilities required to set up a fully operational iPonatic device for
COVID-19 testing:
1. Within the space, a fine lab bench is necessary to host the device and its accessories
(microfuge, pipette tips and cartridge), as well as to accommodate the initial sample
preparation steps.
2. mPharma recommends the use of an uninterrupted power supply (capacity of about 2.5 to 3
kVA) to protect specifically the iPonatic device from any form of breakdown due to erratic
power supply.
3. A vortex mixer will also share the same table space to enable homogenization of specimens
collected into sample storage buffers.
4. A heated block (or dry bath incubator) is required for initial inactivation of specimens
collected.
5. A fridge-freezer is required to keep reagents at desirable temperature conditions.
6. An infectious bin to collect all used pipette tips, paper towels, PCR tubes and consumables.
Sample Collection and Testing
1. mLabs do not accept walk-ins as all test patients must be referred by a physician
2. Each mLab will be linked with 10 clinics/hospitals which are in close proximity
CONFIDENTIAL

10. 9
a. These selected facilities will be responsible for sample collection and transportation
to their assigned mLab.
3. Each clinic/hospital will be provided with 250 Swabs and Viral Transport Mediums (VTM)
to use solely for COVID-19 sample collection.
a. Collected samples should be transported on a cold chain to the designated mLab
b. To ensure a streamlined process, clinics/hospitals can only send samples to their
assigned mLab, which will by design, be the closest to the facility.
Refer to appendix I for the COVID-19 testing protocol on the iPonatic device.
Reporting Test Results
The mLab will use existing test data sharing protocols in the DRC Covid-19 plan to communicate
results to the necessary stakeholders.
Waste Management
Benchtops must be disinfected regularly with 10% bleach (hypochlorite) and a follow-on thorough
cleaning with 70% ethanol to remove all traces of the harsh bleach. Application of chemicals must
be performed whilst wearing PPEs and chemicals should be cleaned using paper towels. Only apply
paper towel dampened with 70% ethanol to clean the iPonatic device and the accessories. All used
paper towels must be discarded into a designated infectious bin. Refer to appendix II for a detailed
protocol on laboratory decontamination.
Laboratory waste requires a rigorous process of decontamination and/or sterilization. The use of
discard jars containing 10% hypochlorite-containing bleach is efficient enough to disinfect pipette
tips employed in the aspiration and dispensation of samples and reagents. Subsequently, an autoclave
is required to sterilize all infectious waste generated, after which incineration is performed. Due to
sophistication of this process, arrangements should be made with the country’s central reference
lab—or another third party with lab waste management capacity—to routinely collect and manage
waste in accordance with approved pre-existing waste management protocols.
Human Capital Requirements
The iPonatic does not require prior PCR experience to operate. This eliminates costs associated with
hiring new staff. mLabs are specifically designed to leverage existing laboratory and pharmacy
technicians in the testing process. mPharma will offer training to one pharmacist or laboratory
technician in each of the selected mLab facilities on the use and management of the iPonatic.
Diagnostic laboratories require the full implementation of good laboratory practices, including
appropriate donning and doffing of PPEs during sample collection and sample processing.
CONFIDENTIAL

11. 10
Furthermore, laboratorians familiar with molecular diagnosis are most appropriate due to expertise
in both handling reagents and samples, especially during aliquoting of tiny volumes of reagents or
samples - deviations from which could drastically affect the precision or the repeatability of the
process. Even though the iPonatic device is fully automated, it still requires professional handling of
reagents and samples, which are deemed necessary to avert in-lab transmission and, more
importantly, produce high-quality results.
Testing Workflow
Participating pharmacies/health facilities will only test people with a valid referral from their clinic/hospital.
1. A Patient visits a participating clinic/hospital showing symptoms of Covid-19.
2. A laboratory technician at the facility takes a sample from the patient using the swab and
VTM provided to them by mLab.
3. Sample is transported to the mLab that has been assigned to the clinic/hospital.
4. The sample is tested, and results sent back to the clinic/hospital by the mLab.
Below are algorithms describing testing workflows:
CONFIDENTIAL

12. 11
Figure 1 : Flux de travail des tests COVID-19 en mLab
Figure 2
: Modèle
de
transport
des
échantillons depuis les hôpitaux pour les tests aux mLabs proximaux
CONFIDENTIAL

13. 12
Project Implementation Timelines
The project is expected to kick off from September to December 2020 with proposed stages shown
below.
STAGES
JUN JUL AUG SEPT OCT NOV DEC
1 2 3 4 1 2 3 41 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 34
1 Project Conception
Submission of Terms of Reference
Approval of Terms of Reference
2 Project Initiation
Delivery of equipment and reagents
Training of Staff on COVID-19
diagnosis
Laboratories up and running
3 Project Performance / Monitoring
Device performance monitoring
Expected Project Results
According to the stated timelines, we expect to:
1. Initiate decentralization of COVID-19 testing in DRC by September 2020.
2. Test about 480 people each week across the 4 selected mLabs
3. Forge a long-term collaboration with both the World Bank and the DRC Health Ministry.
4. Build capacity in molecular diagnostics.
5. Set up the molecular diagnostics infrastructure which will allow the DRC to test for other
viral pathogens, such as hepatitis B (HBV), hepatitis C (HCV), human papillomavirus
(HPV), beyond COVID-19 diagnostics.
Part E: Project Monitoring and Evaluation Plan
CONFIDENTIAL

14. 13
The project processes/input; sample collection, testing and reporting of results - will be monitored
daily to ensure timely delivery. Monitoring data would be used to continually improve the structure
of the processes in order to achieve the stated targets.
The project will also be evaluated on its impact on national morbidity and mortality data associated
with the COVID-19 pandemic. It is expected that with timely testing and activation of treatment
protocols, the burden of disease will steadily decrease.
Refer to appendix III for details of the Monitoring& Evaluation plan
Part F: Budget
The proposed budget for the project is expected to cover the key costs associated with the set up
and running of the 4 labs. mPharma will be responsible for procuring and shipping the required
items to the DRC; customs clearance will be the responsibility of the recipient duty.
Included in the budget is what we have termed “incentive budget”—this is an incentive for each test
administered by the labs who will participate in the program. We have found this to be a necessary
factor in the successful implementation of the mLab.
Item Qty Unit Price ($) Total Budget
Iponatic 8 $18,200 $145,600
Test Kits 10,000 $16 $156,000
Testing Incentive 10,000 $5 $50,000
Throat swab and sample storage reagent 10,000 $3 $26,000
Dry Bath Incubator 4 $1,000 $4,000
Vortex Mixer 4 $1,000 $4,000
Biosafety Cabinet 4 $18,000 $72,000
Protective Suits 150 $35 $5,265
Goggles 150 $9 $1,365
Face Masks 5,000 $1 $2,500
Gloves 22,000 $0.4 $8,270
Logistics 1 $25,000.0 $25,000
Total $500,000
CONFIDENTIAL

15. 14
Part G: Appendices
Appendix I: Protocol Working aid iPonatic real time PCR device
Appendix II: Laboratory Decontamination SOP for mLabs
Appendix III: Monitoring and Evaluation
CONFIDENTIAL