**2. Methodology**

Zimbabwe employed a multisectoral approach through setting up dedicated expert committees to cover specific areas of the response based on the WHO guidelines on COVD-19 response preparedness [20]. In addition, a literature review of the available evidence was also done to understand the role of the laboratory in emergencies particularly of infectious diseases and how other countries have responded to the need to scale up laboratory capacity in order to meet the country needs in emergencies and outside emergencies [14, 26]. An operational plan was developed as well as guidelines and procedures for implementation. Coordination led by the MoHCC involved daily updates at the beginning reducing their frequency as implementation progressed. There were also weekly national coordination meetings for the national taskforce who reported to the inter-ministerial committee, cabinet and ultimately the presidium.

#### **2.1 Expansion of laboratory testing**

One of the Joint External Evaluation (JEE) focus areas in the laboratory technical area is the presence of an effective national diagnostic network [17]. Zimbabwe set out to scale up laboratory capacity to test for SARS-CoV-2 leveraging existing capacity from other programs like influenza, HIV and TB. This expansion was spearheaded by the laboratory pillar in a stepwise manner as explained in the following sections.

#### *2.1.1 The laboratory pillar structure establishment*

The journey in the COVID-19 laboratory response in Zimbabwe began with establishing of the Laboratory Pillar members mandated to support scale up of COVID-19 testing through developing a testing strategy and supporting its implementation. The laboratory pillar was one of the Zimbabwe modified Incident Management System (IMS) guided by WHO Emergency Response Framework (ERF) [27] in which the Laboratory was one of the pillars in addition to surveillance, case management and continuity of essential services, Infection

prevention and control, Risk Communication and Community Engagement, Logistics and Points of Entry. MoHCC and partners conducted a rapid assessment of the available capacity in country, leveraging existing investments in different programs and established a diagnostic network and infrastructure for COVID-19 testing. The Laboratory Pillar was led by the Directorate of Laboratory services (DLS) under the MoHCC and constituted of partners including United States Centers of Disease Control and Prevention (US. CDC), World Health Organization (WHO), Clinton Health Access Initiative (CHAI), African Society of Laboratory Medicine (ASLM), the leadership from the COVID-19 testing laboratories including the National Reference laboratories (NMRL) and institutions providing testing services on behalf of the MoHCC. With the pillar in place, a testing strategy, following the WHO guidance and recommendations for laboratory testing [20] was developed to guide the scale up process. The strategy employed a tier-based approach for expansion which activated higher tier laboratories followed by provincial then district. The pillar members were involved in the planning of this expansion which involved identifying through assessment and listing the laboratories with available capacity for COVID-19 molecular testing, drafting budgets and partner commitment to support in particular areas of the response.

## *2.1.2 The scale-up of testing: the tier-based system*

In March, when the first case was detected, minimal testing was being done by the National Microbiology Reference Laboratory (NMRL) only with a few staff trained to perform testing for COVID-19 virus using RT-PCR. Tier-1 of the expansion involved assessment of the NMRL and training of extra staff who would support to test for COVID-19 virus using RT-PCR and further train other staff during the expansion process. After successful implementation of tier-1, tier-2 was initiated as shown in the scale up plan in **Figure 1**. This involved training of more laboratory cadres and capacitating five more national level laboratories to test for COVID-19 virus using RT-PCR on open PCR platforms to support the tier-1 laboratory. The cadres trained in tier-2 were from the laboratories listed during the initial planning process. The laboratories included tertiary, research and training laboratories namely, National Tuberculosis Reference Laboratory (NTBRL), National Virology Reference Laboratory (NVRL), African institute of Biomedical Research (AiBST), Biomedical Research Training Institute (BRTI) and University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC). The inclusion criterion was based on presence of existing testing capacity based on availability of RT-PCR equipment and resources as well as staff experienced in RT-PCR. This process took a total of 3 months to complete full rollout of tier-2 testing.

Leveraging existing TB GeneXpert platforms in the different provinces, university Bio-labs and Mobile trucks, tier-3 was implemented through capacitating thirty-three provincial and district laboratories to test for COVID-19 and 5 provincial laboratories to test using the Abbott platforms.

With the country experiencing a high influx of returnees from South Africa, there was increased risk of local transmission. This heightened the need for a robust surveillance strategy to minimize transmission. The country projected to test 33 000 tests in the month of April which target was not reached as planned. This saw the laboratory encouraging support from private laboratories which also joined forces increasing testing capacity. In this line, Lancet and CIMAS laboratories joined in supporting to test for SARS-CoV-2 using RT-PCR to complement government efforts to test for SARS-COV-2.

*Timely Detection of SARS-CoV-2 in Limited Resource Settings: The Role of the Laboratory… DOI: http://dx.doi.org/10.5772/intechopen.96629*

#### **Figure 1.**

*National COVID-19 Laboratory Diagnostic Preparedness Scale Up plan. Tier 1; NMRL initially carried out all the testing, tier 2; expanded laboratory testing to National Virology Reference Laboratory (NVRL), Biomedical Research and Training Institute (BRTI), National Tuberculosis Reference Laboratory (NTBRL), African Institute of Biomedical Science and Technology (AiBST) and UZ Clinical Trials Research Centre, tier 3; capacitation of all provincial laboratories, University Biolabs and mobile trucks to test using GeneXpert.*

#### *2.1.3 Managing human resources*

With the increase in samples being tested a day, it was pertinent to organize the flow of work to meet the workload demand. To do this, a two-shift duty system was introduced at every testing laboratory to increase daily throughput and reduce staff burnout. This extra shift system also involved separation of staff into cohorts such that in case of infection, quarantine and isolation procedures could be implemented without bringing the laboratories to a complete standstill. Additionally, locum staff were also hired in select laboratories to maintain adequate human resource for laboratory operations.

#### *2.1.4 Quality assurance*

Implementation of a new testing method for SARS-CoV-2 and use of a wide range of equipment, reagents, kits and consumables meant that a robust quality management system needed to be in place. The Laboratory services leveraged existing Quality Management Systems (QMS) to ensure key quality system essentials were adapted for the new testing requirements. Given that at least 7 laboratories had ISO 15189 accreditation, this process moved smoothly. Safety trainings were implemented together with waste management activities related to Guanidine thiocyanate (GITC) waste produced during RT-PCR testing using Abbott and GeneXpert machines. In addition, thirty-two laboratories were enrolled for external quality assurance Proficiency Testing (PT) program with Thistle, a South African PT provider as an external means to objectively check and ensure reliable results are being produced.

#### *2.1.5 Data management*

A robust data management system is key in the response to enable timely identification of at-risk populations, timely contact tracing and resource mobilization and response optimization [28]. With the increasing testing, there was a growing need for streamlining data management and flow to efficiently manage and report data. To achieve this, we leveraged on the HIV CDC-PEPFAR supported Laboratory Information Management System (LIMS) by introducing the COVID-19 module and training laboratory data staff for data entry. Fifteen testing laboratories were added on the LIMS allowing timely relay of results to requesting sites. To further reduce the data linked TAT, instant messaging system was added to the LIMS for automatic patient notification as soon as the results were released and published by the testing laboratory.

#### *2.1.6 Resource mobilization*

The beginning of the response was mostly supported through donations of testing kits and supplies from China Embassy, Jack Ma foundation, Africa CDC, World Health Organization (WHO), Clinton Health Access Initiative (CHAI), USAID and many other well-wishers. The laboratory pillar members also developed a budget projection that specified the test expansion requirements and partners in the pillar committed to specific items on the budget, making the process easier. Procurement requests were made through the WHO global procurement platform [22] which was established as a hub for laboratory to support the LMIC countries in procuring these resources with assured equitable distribution.

#### **2.2 Data analysis**

The outcomes of this response were measured through the increase in number of testing laboratories which was linked to the number of samples tested per day. The changes in sample testing per day was analyzed using R 3.62 software.

### **3. Results**

Through this response, Zimbabwe had an opportunity to strengthen systems regarding partner coordination, staff capacitation, resource mobilization, data management and laboratory testing output during this critical time. This response created and encouraged lasting coordination among the different partners on the laboratory pillar enabling a quick and successful scale up of testing. This coordinated approach enabled capacitation of staff to test for SARS-CoV-2 while observing the necessary biosafety measures and quality assurance. Besides the increased knowledge in using a wide range of testing platforms, a number of scientists gained the skills which can be used in other instances where testing is required. Data management platforms have been put in place and these have strengthened the data handling and dissemination system. Resource mobilization was enhanced through the response and timely stock replenishment measures put in place. Stock projections were developed and monitored strictly to avoid stock-outs using a stock availability tracing tool. In addition, the WHO global platform [24] was established to support procurement of COVID-19 commodities in an equitable way. This greatly reduced the delays in procurement and ensured timely and equitable supply of the required resources through a hub. In this line, over a period of 5 months, more than thirty-three laboratories could perform molecular testing for COVID-19 using available PCR platforms, capacity that can be used in case of any other emergency that requires extensive molecular testing. With this expansion, testing increased from five samples a day to more than 1000 samples a day over six months. As a result of this collaborative effort, the target of testing 1000 samples per day was surpassed

*Timely Detection of SARS-CoV-2 in Limited Resource Settings: The Role of the Laboratory… DOI: http://dx.doi.org/10.5772/intechopen.96629*

**Figure 2.**

*Trends of samples tested and positives detected. Testing started in early March with one laboratory performing PCR testing. There was a marked increase in testing from April owing to the capacitation of five other labs to support the main reference laboratory to test using PCR. There were fluctuations owing to stock depletion due to the global challenge of timely delivery of reagents. Provincial laboratories were further capacitated to test using GeneXpert which further boosted the testing hence increasing the number of samples tested per day by early August.*

in August and this exceeded the monthly projected target of 33,000 tests to 35,816 tests that month. The number of positive samples detected also increased with increase in testing as shown in **Figure 2**. There were notable fluctuations in testing as seen in **Figure 2** and these were due to intermittent stock outs which were due to the strain on the global supply that led to late delivery of commodities.

#### **4. Discussion**

The escalated and smooth scaling up of testing was made possible by leveraging existing capacity from other programs like Influenza Surveillance, HIV and TB work [29, 30]. The role of network optimsation exercises that had been done prior to the pandemic better placed the country to respond. The knowledge of locations and existing capacities and sample transport networks that had been mapped supported decision making in terms of activating new testing sites. However, like other countries, repurposing of testing laboratory facilities and consumables in Zimbabwe affected the HIV and TB programmes both in terms of human resources and consumables being repossessed for COVID-19 testing [31]. In addition, it was initially difficult to maintain quality management system for COVID-19 testing since everything operated as an emergency. At that time, there had not been proper planning and projecting of resources whether human resource or consumables which interfered with the processes. Partner coordination ensured the development of inter laboratory comparison panels and support sourcing of external quality assessment panels. Another challenge arose from the dependence on imports through external suppliers of all consumables which affected testing as supply chain portals were overloaded with orders and could not meet the demand. Furthermore, competing with high income countries on these platforms to access *in vitro* diagnostics limited the projected rate of testing expansion. As a result like many other African countries [32], Zimbabwe faced a shortage in essential supply for use like GeneXpert supplies, PPE, molecular testing consumables and sample collecting kits which highly affected the testing capacity for over two months. Staff remuneration and motivation was also a setback throughout the participating pillars. In addition, some laboratory staff got infected in the course of the response which affected the work output and duty roster.
