- •Deployment of molecular testing in resource-limited settings needs to be approached in the broader context of laboratory strengthening.
- •Scale-up of molecular testing was built on existing pathogen control programs for human immunodeficiency virus and tuberculosis.
- •National reference laboratories have an essential role to play in successful roll out of molecular testing.
- •Pooled testing and direct-to-polymerase chain reaction methods have great potential for cost saving and increasing access to molecular testing.
- Chan J.F.-W.
- Yip C.C.-Y.
- To K.K.-W.
- et al.
- Yu D.
- Souteyrand Y.
- Banda M.A.
- et al.
Role of the national reference laboratory
|Thematic Area||Activities||Partners||Main Outcomes/Highlights|
|Equipment||Inventory of available platforms||MoH||Updated inventory available at central level|
Identification of 22 high-throughput platforms across the country for molecular testing facilitated planning, procurement, and distribution of supplies
|Servicing and calibration of equipment||MoH|
CDC Malawi through UMB
|Auxiliary equipment with valid calibration certificates. Securing of service contracts|
Ensuring availability of calibrators through implementing partners
|Biosafety cabinets||CDC Malawi through UMB||Functional and fully serviced biosafety cabinets in every testing site|
|Procurement of Abbott m2000 platform|
Quant Studio 5
|Scaled up capacity for molecular testing|
|Infrastructure||Demarcation/partitioning of laboratories for molecular testing||MoH, CDC Malawi through UMB||All sites partitioned to accommodate separate molecular testing.|
|personnel||Recruitment of additional laboratory||MoH|
CDC Malawi through UMB
|Additional 150 laboratory personnel recruited.|
Repurposing of UMB staff to support COVID testing.
Uninterrupted service for other molecular assays due to adequate personnel
|Procurement of reagents and consumables||Determining needs||MoH|
CDC Malawi through UMB and I-TECH
|Constant supply of reagents|
Sufficient supply of reagents
|Coordination with development partners||MoH||Ensured collaborative effort and maximum resource allocation|
Monitoring of reagents and distribution to various testing sites
|Supply chain and logistics||UNICEF/WFP|
Central Medical Stores Trust
|Ensured delivery of reagents, supplies, and PPE amid global supply chain constraints|
|Training||Training in sample collection and processing||MoH|
CDC Malawi through I-TECH
WHO, World Bank
|Training of laboratory officers in SARS-CoV-2 testing to scale-up testing capacity|
Supported initial TOT for PCR testing
25,000 health workers trained in sample collection
|Sample transportation||Development of a transportation system||UMB/Riders for Health||Successful transportation of 231,850 samples to molecular laboratories.|
Transportation from ports of entry and hard to reach areas.
|Data management||Production of case-based surveillance form||MoH||Standardization of data|
|Development of a national dashboard||I-TECH||Stakeholders are able to access data through the dashboard|
|connectivity||EGPAF||Majority (85%) of testing sites are connected to the dash board|
|Quality management||Approval of laboratories to perform SARS-CoV-2 PCR testing||MoH-HTSS||15 molecular laboratories and 320 antigen testing sites have been approved|
|Validation of different platforms||PHL||Validated 3 molecular platforms and 4 antigen test kits|
All molecular assays in use validated in county against available platforms
|EQA||PHIM supported by UMB||Ensured accurate result generation using annual EQA with score of 94%|
Polymerase chain reaction platforms
- Africa C.D.C.
- Brown S.
- Leavy J.E.
- Jancey J.
Impact on tuberculosis and human immunodeficiency virus control programs
Transition to antigen tests and use cases for molecular tests
- Muthamia E.
- Mungai S.
- Mungai M.
- et al.
- American Society for Microbiology
- American Society for Microbiology
- Limb M.
- Kumar M.
- Joshi M.
- Kumar A.
- et al.
- Kumar M.
- Joshi M.
- Kumar A.
- et al.
Approaches to cost reduction
- Garcia-Venzor A.
- Rueda-Zarazua B.
- Marquez-Garcia E.
- et al.
- Mutesa L.
- Ndishimye P.
- Butera Y.
- et al.
Simplified Extraction and Straight to Polymerase Chain Reaction Methods
Concluding remarks and future directions
SAHPRA approves affordable, locally developed Coronavirus COVID-19 antigen test.
Global agencies sign tech transfer deals to boost COVID testing in Africa, Latam.
Clinics care points
- •Molecular testing for SARS-CoV-2 in many settings is dependent on GeneXpert and Abbott platforms.
- •Scale up of testing has pargely been well handled to minimise the impact on HIV and TB control programs.
- •Introduction of rapid antibody testing has enabled increases in testing capacity and reach and it has simutlaneously releived pressure on infrastructure, equipment and personnel.
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