The Public Health Laboratory Service (PHLS) is a cluster of laboratory sections that has a function to develop an effective, fit-for-purpose public health laboratory system. It is a specialized laboratory system that offers advanced essential public health laboratory leadership through science and services.
Advancing Public Health through Laboratory Excellence
In line with the mandate of promoting scientific and technological solutions and capacity building, the National Public Health Laboratory (NPHL) is responsible for the implementation of Quality Management Systems, Coordination of Proficiency Testing Schemes, and championing accreditation services across the entire laboratory network. It strengthens the performance of the national public health laboratory network by mapping all laboratories in Malawi, aligning them with One Health requirements.
Mission Statement
“To provide strategic leadership and coordination through multi-disciplinary and multi-sectoral responses to public health emergencies and threats, disease detection and control, and generate information that informs policy and practice to achieve public health security.”
Vision Statement
“To be a centre of excellence in public health that contributes towards the high quality and productive life of all people in Malawi.”
Joseph Bitilinyu-Bangoh
Deputy Director, National Public Health Laboratory Division
Providing strategic leadership and technical coordination for the national laboratory network, ensuring effective disease detection and emergency response across Malawi.
Laboratory Structure and Units
Section Lead
Mrs. Dorothy Donata Kalata
National Microbiology Reference Laboratory
The National Microbiology Reference Laboratory serves as the cornerstone for bacterial disease surveillance and specialized diagnostic support within Malawi’s public health framework. It is fundamentally responsible for the definitive identification of enteric pathogens, meningitis-causing bacteria, and other high-consequence bacterial agents that threaten community health. By employing standardized culture methods alongside modern biochemical testing, the lab ensures that outbreak-related samples are processed with the highest level of precision and clinical accuracy. Furthermore, this unit provides the essential evidence base required for the National Antimicrobial Resistance (AMR) surveillance program by documenting phenotypic resistance profiles across various regions.
Beyond its primary diagnostic functions, the department plays a critical role in capacity building and quality assurance for microbiology services nationwide. It coordinates the distribution of proficiency testing panels to district and central hospital laboratories to ensure uniform testing standards are maintained across the country. The laboratory also maintains an extensive repository of clinical isolates which are invaluable for retrospective research and the longitudinal tracking of pathogen evolution. Through its participation in global surveillance networks, the unit contributes vital data to international health organizations, ensuring Malawi remains aligned with global standards for infectious disease monitoring and response strategies.
Section Lead
Mrs. Chifundo Banda
National HIV Reference Laboratory
As the apex facility for HIV-related diagnostics, the National HIV Reference Laboratory is instrumental in supporting Malawi’s ambitious goals for HIV epidemic control and management. The unit specializes in high-throughput molecular diagnostics, specifically focused on Viral Load (VL) monitoring and Early Infant Diagnosis (EID) for children exposed to the virus. By utilizing advanced automated platforms, the laboratory provides clinicians with the critical data needed to assess treatment efficacy and detect potential therapeutic failures at the earliest possible stage. This centralized expertise ensures that even the most remote health facilities can access world-class virological testing through integrated sample transport systems.
The laboratory also leads the nation in validating new diagnostic technologies and testing algorithms before they are scaled up for general clinical use. It maintains a rigorous oversight role, conducting regular site assessments and coordinating the National HIV Proficiency Testing program to guarantee the reliability of rapid diagnostic testing at the point of care. Additionally, the unit is deeply involved in surveillance activities aimed at monitoring HIV drug resistance patterns, which is vital for informing national antiretroviral therapy (ART) policy. By fostering collaboration between research institutions and public health implementers, the lab ensures that Malawi’s HIV response remains grounded in the latest scientific evidence and diagnostic innovations.
Section Lead
Mr. Mabvuto Chiwaula
National TB Reference Laboratory
The National Tuberculosis Reference Laboratory (NTRL) operates as the highest authority in the diagnosis and monitoring of tuberculosis and other mycobacterial infections in Malawi. It is uniquely equipped with advanced Biosafety Level 3 (BSL-3) facilities, allowing for the safe handling and cultivation of Mycobacterium tuberculosis from clinical specimens across the nation. The unit employs a sophisticated diagnostic algorithm that integrates GeneXpert technology with specialized liquid culture systems (MGIT) and Line Probe Assays (LPA). These tools enable the rapid detection of both first-line and second-line drug resistance, which is absolutely critical for the effective management of Multi-Drug Resistant TB (MDR-TB) cases within the population.
Beyond its diagnostic mandate, the NTRL serves as the technical backbone of the National TB Control Program by providing rigorous quality assurance and training for the country’s decentralized microscopy and GeneXpert sites. It conducts systematic blinded re-checking of smears and manages a comprehensive external quality assessment (EQA) scheme to ensure diagnostic accuracy at all levels of care. The laboratory also spearheads national TB prevalence surveys and operational research projects aimed at improving case detection and treatment outcomes for vulnerable populations. By maintaining strong links with the World Health Organization’s Supranational Reference Laboratory network, the NTRL ensures that its protocols remain at the global cutting edge of mycobacteriology.
Section Lead
Mr. Shenton Kacheche
National Parasitology & Vector Control Lab
The National Parasitology and Vector Control Laboratory is dedicated to the study and surveillance of parasitic diseases that pose a significant burden to the Malawian populace, with a particular emphasis on malaria, schistosomiasis, and soil-transmitted helminths. The laboratory provides expert microscopy services which serve as the “gold standard” for validating results from peripheral health centers and supporting complex clinical investigations. It is heavily involved in entomological surveillance, tracking the distribution and density of disease-carrying vectors such as Anopheles mosquitoes. This data is essential for the Ministry of Health to determine the appropriate timing and locations for indoor residual spraying and the distribution of insecticide-treated bed nets.
A critical component of this unit’s work is the monitoring of insecticide resistance and drug efficacy through molecular and bioassay techniques. By understanding the genetic mechanisms behind resistance, the laboratory provides early warnings to policy makers regarding the potential failure of current control tools. The unit also supports the national mapping of neglected tropical diseases (NTDs), ensuring that mass drug administration programs are targeted toward the communities in greatest need. Through active field research and laboratory analysis, the parasitology unit works to bridge the gap between bench science and community-level interventions. Their ongoing commitment to specialized training ensures a steady supply of skilled microscopists and entomologists to support the nation’s vector-borne disease elimination goals.
Section Lead
Dr. Merriam Nyenje
National Genomics Lab
The National Genomics Laboratory represents the frontier of modern public health in Malawi, utilizing Next-Generation Sequencing (NGS) and bioinformatics to provide unparalleled insights into pathogen dynamics. This unit was instrumental during the COVID-19 pandemic for variant tracking, enabling health authorities to monitor the introduction and spread of different lineages in real-time. By analyzing the entire genetic blueprint of viruses and bacteria, the lab can identify subtle mutations that might lead to increased transmissibility or resistance to existing vaccines and treatments. This level of molecular intelligence allows for a more proactive and “precision-based” approach to outbreak management, moving beyond traditional diagnostic methods to high-resolution surveillance.
In addition to its role in acute emergency response, the genomics unit is increasingly applied to chronic public health challenges, such as tracking the transmission pathways of drug-resistant tuberculosis and cholera. The laboratory works closely with international research consortia to build local bioinformatics capacity, ensuring that Malawian scientists can interpret complex genomic data within the domestic context. By integrating genomic information with epidemiological data, the unit helps to create “transmission maps” that can pinpoint the exact source of an outbreak. This facility is a key asset for the nation’s biosurveillance strategy, providing a technological safeguard against both known and emerging biological threats. Its presence ensures that Malawi is a contributing partner in the global network of genomic surveillance and health security.
Section Lead
Mr. Henry Limula
Influenza, Biochemistry & Nutrition Lab
This multi-disciplinary unit serves as a vital bridge between infectious disease monitoring and the management of non-communicable diseases (NCDs) and nutritional health. The biochemistry section provides specialized clinical chemistry testing that supports the monitoring of organ function in patients undergoing long-term treatment for HIV and TB. It utilizes automated analyzers to ensure high-precision results for glucose, lipids, and liver/renal function tests, which are essential for holistic patient care. Parallel to this, the nutrition laboratory performs micronutrient assays and monitors population-level nutritional indicators, providing the evidence needed to design effective food fortification and supplementation programs throughout Malawi.
The unit also functions as the National Influenza Centre, maintaining year-round surveillance for respiratory viruses, including seasonal flu and Avian Influenza. Through a network of sentinel sites, the laboratory collects and analyzes samples to identify circulating strains, contributing valuable data to the WHO Global Influenza Surveillance and Response System (GISRS). This surveillance is crucial for identifying viruses with pandemic potential and for informing the composition of annual flu vaccines. By housing these diverse functions under one roof, the unit provides a unique integrated perspective on the dual burden of disease in Malawi—addressing both the nutritional deficiencies and the viral threats that impact public health. Their work is essential for maintaining national health resilience and informing comprehensive public health policies.
Laboratory Quality Management Unit (LQMU)
The Laboratory Quality Management Unit (LQMU) is the institutional custodian of diagnostic excellence, mandated to implement and sustain international quality standards across Malawi’s tiered laboratory network. Its primary mission is to ensure that every clinical result generated is accurate, reliable, and timely, thereby directly impacting patient management and public health outcomes. The unit spearheads the national drive toward ISO 15189 accreditation, providing technical mentorship to laboratories at central and district levels to bridge the gap between current practices and international benchmarks. Through the systematic implementation of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA), the LQMU facilitates a culture of continuous improvement and rigorous self-assessment.
It oversees the National External Quality Assurance (EQA) program, managing the distribution of proficiency testing panels for diverse diagnostic disciplines and analyzing performance data to identify systemic weaknesses. Additionally, the unit coordinates the validation and verification of new diagnostic equipment and reagents to ensure they meet stringent performance specifications before national deployment. Internal audits are conducted regularly by the LQMU to identify non-conformities, followed by the development of corrective and preventive action plans that address root causes. The unit also maintains a comprehensive national database for laboratory quality indicators, allowing health leaders to monitor progress and allocate resources strategically. Capacity building is a core pillar of the LQMU, as it regularly organizes training workshops for laboratory personnel on documentation, equipment maintenance, and clinical governance. By fostering collaboration with regulatory bodies and international partners, the unit ensures that Malawi’s laboratory services remain globally competitive and ethically sound. Ultimately, the LQMU serves as a safeguard for the health of the nation, ensuring that diagnostic science is conducted with the highest possible level of professional integrity and technical competence.
Biosafety & Biosecurity Unit
The Biosafety and Biosecurity Unit is the national authority responsible for establishing and enforcing the safety protocols required to handle infectious biological agents and hazardous laboratory materials. It plays a critical role in protecting laboratory professionals, the general public, and the environment from accidental exposure or intentional misuse of dangerous pathogens. The unit develops comprehensive national guidelines that categorize biological risks and specify the required containment levels, ranging from basic facilities to specialized Biosafety Level 3 (BSL-3) suites. It is responsible for the periodic certification of biological safety cabinets and the validation of sterilization equipment, ensuring that all physical barriers against infection are fully operational.
Through rigorous site inspections, the unit monitors compliance with national biosafety laws and provides the necessary oversight for the transportation of infectious substances across the country. Biosecurity is a major focus, with the unit implementing strict access controls and inventory management systems to prevent the unauthorized acquisition of high-consequence pathogens. The unit also coordinates the National Biosafety Committee, bringing together multi-sectoral experts to review research protocols involving genetically modified organisms and emerging viral threats. Training is a continuous activity, as the unit educates staff on the correct use of Personal Protective Equipment (PPE), spill response procedures, and occupational health monitoring. In the event of a laboratory-acquired infection or a breach in containment, the unit leads the investigation to determine the cause and implement immediate mitigation strategies. It also advocates for the “One Health” approach, recognizing that biosecurity in human laboratories is deeply connected to veterinary and environmental health safety. By maintaining active participation in global health security agendas, the unit ensures that Malawi adheres to the Biological Weapons Convention and other international safety treaties.
Core Functions Overview
Diagnostic Leadership
The National Public Health Laboratory Division provides top-tier confirmatory diagnostics for pathogens that require specialized expertise and advanced high-containment infrastructure. This pillar ensures that complex clinical cases, which exceed the capabilities of district and central hospitals, receive definitive identification through state-of-the-art molecular and phenotypic methods. By maintaining a centralized pool of highly skilled scientists, the laboratory acts as the final arbiter in diagnostic dilemmas and rare disease investigations. It is specifically equipped to characterize drug-resistant strains and novel pathogens, ensuring that the clinical response is tailored to the exact biological threat.
Beyond individual patient care, this diagnostic leadership extends to the validation and standardization of laboratory protocols used throughout Malawi. The division routinely evaluates new diagnostic technologies to ensure they are suitable for national deployment and meet the specific needs of the local population. By setting the clinical benchmark for testing accuracy, the laboratory fosters a culture of excellence that permeates every level of the health system. It also serves as a critical training ground for specialized laboratory techniques, ensuring a sustainable pipeline of expertise for the nation. Ultimately, this pillar provides the scientific certainty required to manage both routine health challenges and unprecedented biological emergencies.
Intelligence & Surveillance
This function focuses on the seamless integration of laboratory diagnostic data with epidemiological surveillance to provide real-time situational awareness for health authorities. By monitoring pathogen activity across the country, the division can detect unusual trends or localized outbreaks before they escalate into national crises. The laboratory utilizes modern digital health platforms to ensure that results are communicated rapidly to emergency response teams and policy makers. This “molecular intelligence” allows the Ministry of Health to move from reactive crisis management to a more proactive, data-driven approach.
Furthermore, the surveillance pillar is instrumental in tracking the evolution of infectious agents, such as mutations in viruses or changing resistance patterns in bacteria. This longitudinal data is vital for assessing the continued effectiveness of vaccines, antibiotics, and diagnostic assays within the Malawian context. Through deep-dive genomic analysis and bioinformatics, the laboratory can pinpoint the geographical origins and transmission pathways of various diseases. This intelligence supports targeted public health interventions, ensuring that limited resources are directed toward the most impacted areas. By serving as the nation’s early warning system, this pillar is fundamental to achieving and maintaining national public health security.
Network Coordination
The division acts as the central coordinating body for the entire tiered laboratory system in Malawi, ensuring that services are harmonized and aligned with international standards. It provides essential technical guidance to regional, district, and community-level laboratories to maintain a uniform standard of care nationwide. Through the management of integrated sample transportation systems, the laboratory ensures that specimens from remote areas reach reference facilities without compromising biological integrity. This coordination is essential for creating a “seamless” diagnostic network where geographical location does not dictate the quality of health services.
In addition to logistical oversight, this pillar focuses on human resource development and the strategic allocation of laboratory reagents and equipment. The division coordinates national procurement needs, ensuring that all facilities are adequately stocked to respond to both daily patient loads and sudden surges in disease. It fosters multi-sectoral partnerships under the “One Health” framework, linking human, animal, and environmental health laboratories for a unified defense against zoonotic threats. By facilitating regular communication and knowledge sharing among laboratory managers, the division builds a resilient community of practice. This systemic approach guarantees that the national laboratory infrastructure remains robust, adaptable, and capable of meeting future health challenges.