Respiratory Syncytial Virus European Laboratory Network 2022 Survey: Need for Harmonization and Enhanced Molecular Surveillance.

Respiratory syncytial virus (RSV) is a common pathogen causing mostly cold-like symptoms, but in very young infants and elderly individuals it can lead to severe disease and even death. There are currently promising developments both in vaccine development and in therapeutics that are expected to be approved soon. To get an impression within European countries of the laboratory diagnostics and surveillance activities, in anticipation of these developments, we queried the members of the European Respiratory Syncytial Virus Laboratory Network (RSV-LabNet, under the umbrella of the PROMISE project) via an online survey. The answers from the consortium members showed scattered monitoring and the application of a broad array of techniques in the laboratories. A majority of the members expressed strong interest in harmonization and collaboration for setting up surveillance programs and the need for sharing laboratory protocols. The additional value of RSV whole-genome sequencing is broadly appreciated, but implementation requires further development and closer collaboration. The RSV-LabNet can have an important responsibility in establishing contacts and exchange of expertise and providing a platform for communication to advance diagnostics, preparedness, and surveillance.

Impact of randomized blinded rechecking program on the performance of the AFB Microscopy Laboratory Network in Uganda: a decadal retrospective study.

BACKGROUND: Smear microscopy has remained the initial diagnostic test for presumptive tuberculosis (TB) patients in health facilities without the World Health Organization (WHO) recommended rapid diagnostic tools. In the Uganda TB laboratory network, the technique remains the only tool to monitor response to treatment among drug susceptible TB patients, with the country currently having over 1,600 microscopy TB testing units. It has been evidenced that acid-fast bacilli (AFB) microscopy's yield highly depends on the staining technique and reading ability of the laboratory personnel. For the quality of TB testing in the country, the TB control program set up a Randomized Blinded Rechecking (RBRC) program in 2008 to monitor the testing performance of laboratories to continuously improve the reliability and efficiency of results. This is the first study to determine the effectiveness and impact of the RBRC program on the performance of the participating laboratories in Uganda. METHODS: This was a retrospective cross-sectional study based on a record review of the RBRC's annual results compilations between January 2008 and December 2017. RESULTS: Between January 2008 and December 2017, a total of 265,523 smears were re-checked during the RBRC program. The number of enrolled laboratories in the RBRC program rose from 660 to 2008 to 1,406 in 2017. The RBRC program resulted in a statistically significant reduction in microscopy errors, with false positives decreasing from 12.8% to 2008 to 7.6% in 2017, false positive errors decreasing from 10 to 6.3%, false negative errors decreasing from 2.9 to 0.7%, quantification errors decreasing from 6.0 to 1.8%, and the overall sensitivity of smear microscopy compared to the controllers increased with statistical significance from 93 to 97%. CONCLUSION: The study reveals an overall significant error reduction and an improved sensitivity of smear microscopy upon continuous implementation of the RBRC program in an AFB microscopy TB laboratory network. Implementation of a RBRC program is crucial and essential to maintaining a reliable TB laboratory service that can facilitate accurate diagnosis and offset the disadvantages of using smear microscopy.

Enhancing SARS-CoV-2 Surveillance through Regular Genomic Sequencing in Spain: The RELECOV Network.

Millions of SARS-CoV-2 whole genome sequences have been generated to date. However, good quality data and adequate surveillance systems are required to contribute to meaningful surveillance in public health. In this context, the network of Spanish laboratories for coronavirus (RELECOV) was created with the main goal of promoting actions to speed up the detection, analyses, and evaluation of SARS-CoV-2 at a national level, partially structured and financed by an ECDC-HERA-Incubator action (ECDC/GRANT/2021/024). A SARS-CoV-2 sequencing quality control assessment (QCA) was developed to evaluate the network's technical capacity. QCA full panel results showed a lower hit rate for lineage assignment compared to that obtained for variants. Genomic data comprising 48,578 viral genomes were studied and evaluated to monitor SARS-CoV-2. The developed network actions showed a 36% increase in sharing viral sequences. In addition, analysis of lineage/sublineage-defining mutations to track the virus showed characteristic mutation profiles for the Delta and Omicron variants. Further, phylogenetic analyses strongly correlated with different variant clusters, obtaining a robust reference tree. The RELECOV network has made it possible to improve and enhance the genomic surveillance of SARS-CoV-2 in Spain. It has provided and evaluated genomic tools for viral genome monitoring and characterization that make it possible to increase knowledge efficiently and quickly, promoting the genomic surveillance of SARS-CoV-2 in Spain.

Building a network of TP53 and IGHV testing reference centers across Spain: the Red53 initiative.

Among the different biomarkers predicting response in chronic lymphocytic leukemia (CLL), the most influential parameters are the mutational status of the IGHV genes and the presence of TP53 gene disruptions. Nevertheless, these important assessments are not readily available in most centers dealing with CLL patients. To provide this molecular testing across the country, the Spanish Cooperative Group on CLL (GELLC) established a network of four analytical reference centers. A total of 2153 samples from 256 centers were analyzed over a period of 30 months. In 9% of the patients, we found pathological mutations in the TP53 gene, whereas 48.96% were classified as IGHV unmutated. Results of the satisfaction survey of the program showed a Net Promoter Score of 85.15. Building a national network for molecular testing in CLL allowed the CLL population a broad access to complex biomarkers analysis that should translate into a more accurate and informed therapeutic decision-making.

Performance of HIV detection in Zhejiang province in China: The Pareto principle at work.

BACKGROUND: Timely detection of HIV infection is critical for curbing the AIDS epidemic, and building an extensive and effective HIV laboratory network is of great importance. Therefore, improving quality management of the laboratory network and optimizing detection strategies are desirable research issues. METHODS: We assessed the applicability of the Pareto principle to HIV detection performance. We conducted a retrospective review of basic information and numbers of screening tests among an HIV laboratory network (1,452 laboratories) in Zhejiang province in 2014 and statistically analyzed HIV testing data for different population categories. RESULTS: Approximately, 80% of the cumulative HIV screening tests and positive screening tests originated from 17.3% (251/1,452) and 11.7% (170/1,452) of the laboratories in the whole province, respectively, and similar patterns were observed at the prefectural level. We found that the top five population screening categories (25%, 5/20) had the highest contribution (approximately 80%) to not only the number of screening tests (77.2%) but also the numbers of positive (76.4%) and confirmed positive tests (81.5%). CONCLUSIONS: The Pareto principle provides a method for identifying noteworthy laboratories to deliver prior quality supervision and developing highly efficient screening strategies that best suit local needs.

Managing COVID-19 outbreak in Nigeria: matters arising.

Severe Acute Respiratory Syndrome - novel Coronavirus 2 (SARS-nCoV-2), was first reported in Wuhan, China, in December, 2019. Since the outbreak, the virus has infected more than 9,866,685 individuals, 4,983,029 treated and discharged and 495,692 deaths globally. The first Coronavirus Disease 2019 (COVID-19) in Nigeria was imported in February, 2020 and since then community transmission has been prevalent. As at the time of writing this report, Nigeria has reported about 23,298 cases of COVID-19, 8,253 treated and discharged and 554 deaths, giving a case mortality ratio of 2.4%. While responsible government agencies and international partners have been working hard to curtail the spread of the disease, we present in this report, some matters arising from managing COVID-19 pandemic in Nigeria; and proffered suggestions which could help not only in managing the current COVID-19 pandemic, but also for winning future outbreaks of public health significance with a view to curtailing global health security.

Identifying hotspots of viral haemorrhagic fevers in the Eastern Mediterranean Region: perspectives for the Emerging and Dangerous Pathogens Laboratory Network.

BACKGROUND: The emergence and re-emergence of viral haemorrhagic fevers (VHFs) is a growing concern worldwide. They are associated with major epidemics with an estimated 51-101 million cases each year, of which around 67 000 are fatal. In 2007, 13 countries in the Eastern Mediterranean Region reported VHF cases. AIMS: The main purpose of the study was to review the epidemiological situation in the Region vis-à-vis VHFs to obtain baseline epidemiological information for the establishment of the Emerging Dangerous Pathogen Laboratory Network (EDPLN). METHODS: A literature search was performed using PubMed, ProMED-Mail and GIDEON databases. Reported data included disease burden (reported cases and deaths), human prevalence (general population, high-risk groups), vectors and reservoirs. A scoring method was employed to divide countries into 4 groups (very highly, highly, medium and low affected countries). RESULTS: Very highly affected countries were Afghanistan, Egypt, Islamic Republic of Iran, Saudi Arabia and Sudan. Highly affected countries were Djibouti, Morocco, Oman, Pakistan, Tunisia and Yemen. Medium affected countries were Iraq, Somalia and United Arab Emirates. Low affected countries were Bahrain, Jordan, Lebanon, Libya, Palestine, Qatar and Syrian Arab Republic. CONCLUSIONS: This study contributes in prioritizing countries to be part of EDPLN and in addressing specific needs related to outbreak investigations, surveillance and research.

Expansion of Surveillance for Vaccine-preventable Diseases: Building on the Global Polio Laboratory Network and the Global Measles and Rubella Laboratory Network Platforms.

Laboratory networks were established to provide accurate and timely laboratory confirmation of infections, an essential component of disease surveillance systems. The World Health Organization (WHO) coordinates global laboratory surveillance of vaccine-preventable diseases (VPDs), including polio, measles and rubella, yellow fever, Japanese encephalitis, rotavirus, and invasive bacterial diseases. In addition to providing high-quality laboratory surveillance data to help guide disease control, elimination, and eradication programs, these global networks provide capacity-building and an infrastructure for public health laboratories. There are major challenges with sustaining and expanding the global laboratory surveillance capacity: limited resources and the need for expansion to meet programmatic goals. Here, we describe the WHO-coordinated laboratory networks supporting VPD surveillance and present a plan for the further development of these networks.

Risk of Zika virus transmission in the Euro-Mediterranean area and the added value of building preparedness to arboviral threats from a One Health perspective.

In the alarming context of risk of Zika virus (ZIKV) transmission in the Euro-Mediterranean area, there is a need to examine whether capacities to detect, diagnose and notify ZIKV infections in the region are in place and whether ongoing capacity-building initiatives are filling existing gaps.The MediLabSecure network, created in 2014, comprises 55 laboratories of virology and medical entomology and 19 public health institutions in 19 countries in the Balkans, North-Africa, the Middle-East and the Black Sea regions. It aims to set up awareness, risk assessment, monitoring and control of emerging and re-emerging vector-borne viruses. We here examine the actions and strategies that MediLabSecure has been implementing and how they will contribute to the prevention and control of the ZIKV threat in the Euro-Mediterranean area.Capacity-building for arbovirus diagnostics is a major objective of the project and follows a methodological rather than disease-driven approach. This enables the implementation of laboratory trainings on techniques that are common to several arboviruses, including ZIKV, and putting into action appropriate diagnostic tools in the target region.Moreover, by its One Health approach and the interaction of its four sub-networks in human virology, animal virology, medical entomology and public health, MediLabSecure is fostering intersectoral collaboration, expertise and sharing of information. The resulting exchanges (methodological, communication and operational) across disciplines and across countries, dedicated research on intersectoral collaboration and increasing diagnostic capacities are providing new paths and tools to public health professionals to face emerging viral threats such as a ZIKV epidemic in the Euro-Mediterranean region.

A Generalizable Decision-Making Framework for Selecting Onsite versus Send-out Clinical Laboratory Testing.

BACKGROUND: Laboratory networks provide services through onsite testing or through specimen transport to higher-tier laboratories. This decision is based on the interplay of testing characteristics, treatment characteristics, and epidemiological characteristics. OBJECTIVES: Our objective was to develop a generalizable model using the threshold approach to medical decision making to inform test placement decisions. METHODS: We developed a decision model to compare the incremental utility of onsite versus send-out testing for clinical purposes. We then performed Monte Carlo simulations to identify the settings under which each strategy would be preferred. Tuberculosis was modeled as an exemplar. RESULTS: The most important determinants of the decision to test onsite versus send-out were the clinical utility lost due to send-out testing delays and the accuracy decrement with onsite testing. When the sensitivity decrements of onsite testing were minimal, onsite testing tended to be preferred when send-out delays reduced clinical utility by >20%. By contrast, when onsite testing incurred large reductions in sensitivity, onsite testing tended to be preferred when utility lost due to delays was >50%. The relative cost of onsite versus send-out testing affected these thresholds, particularly when testing costs were >10% of treatment costs. CONCLUSIONS: Decision makers can select onsite versus send-out testing in an evidence-based fashion using estimates of the percentage of clinical utility lost due to send-out delays and the relative accuracy of onsite versus send-out testing. This model is designed to be generalizable to a wide variety of use cases. HIGHLIGHTS: The design of laboratory networks, including the decision to place diagnostic instruments at the point-of-care or at higher tiers as accessed through specimen transport, can be informed using the threshold approach to medical decision making.The most important determinants of the decision to test onsite versus send-out were the clinical utility lost due to send-out testing delays and the accuracy decrement with onsite testing.The threshold approach to medical decision making can be used to compare point-of-care testing accuracy decrements with the lost utility of treatment due to send-out testing delays.The relative cost of onsite versus send-out testing affected these thresholds, particularly when testing costs were >10% of treatment costs.

Prevalence of familial hypercholesterolemia in a country-wide laboratory network in Pakistan: 10-year data from 988, 306 patients.

INTRODUCTION: Familial hypercholesterolemia (FH) is a modifiable risk factor for premature coronary heart disease but is poorly diagnosed and treated. We leveraged a large laboratory network in Pakistan to study the prevalence, gender and geographic distribution of FH. METHODOLOGY: Data were curated from the Aga Khan University Hospital clinical laboratories, which comprises of 289 laboratories and collection points spread over 94 districts. Clinically ordered lipid profiles from 1st January 2009 to 30th June 2018 were included and data on 1,542,281 LDL-C values was extracted. We used the Make Early Diagnosis to Prevent Early Death (MEDPED) criteria to classify patients as FH and reported data on patients with low-density liporotein -cholesterol (LDL-C) ≥ 190 mg/dL. FH cases were also examined by their spatial distribution. RESULTS: After applying exclusions, the final sample included 988,306 unique individuals, of which 24,273 individuals (1:40) had LDL-C values of ≥190 mg/dL. Based on the MEDPED criteria, 2416 individuals (1:409) had FH. FH prevalence was highest in individuals 10-19 years (1:40) and decreased as the patient age increased. Among individuals ≥40 years, the prevalence of FH was higher for females compared with males (1:755 vs 1:1037, p < 0.001). Median LDL-C for the overall population was 112 mg/dL (IQR = 88-136 mg/dL). The highest prevalence after removing outliers was observed in Rajan Pur district (1.23% [0.70-2.10%]) in Punjab province, followed by Mardan (1.18% [0.80-1.70%]) in Khyber Pakhtunkhwa province, and Okara (0.99% [0.50-1.80%]) in Punjab province. CONCLUSION: There is high prevalence of actionable LDL-C values in lipid samples across a large network of laboratories in Pakistan. Variable FH prevalence across geographic locations in Pakistan may need to be explored at the population level for intervention and management of contributory factors. Efforts at early diagnosis and treatment of FH are urgently needed.

The importance of verifying manufacturer's claim on specimen stability: An example in serum angiotensin converting enzyme testing.

Appropriate specimen handling is integral to quality and minimizing medical errors. Clinical laboratories often rely on manufacturer's claims for handling specimens, such as sample stability conditions. Serum angiotensin converting enzyme (ACE) is an example in which manufacturer claims and stability in the literature is limited. The purpose of this study was to demonstrate the importance to verify manufacturer's stability using serum ACE as an example. Serum was collected from 39 healthy volunteers and ACE activity levels measured at baseline, after 4 h, 1, 3, 7 days at room temperature, after 3, 7, and 14 days refrigerated at 4 °C, after 1, 2, 4 and 8 weeks frozen at -20 °C, and after three freeze/thaw cycles. An additional 42 discarded patient serum specimens were re-analyzed after 1 or 2 weeks frozen at -20 °C. To evaluate stability performance, percent difference was compared to the clinical acceptance criteria, which was defined as a ½ total allowable error of ±10.9 %. This study found serum ACE to be stable 4 h at room temperature, 14 days refrigerated at 4 °C, up to 1 week frozen at -20 °C, and up to three freeze/thaw cycles. The preferred storage condition for serum ACE is refrigerated at 4 °C as there was minimal change in percent bias over the 14 day period. The false increase observed in samples stored frozen longer than 1 week could impact clinical decision making. The stability findings differed from manufacturer claims, highlighting the importance of verifying stability, especially for esoteric testing such as serum ACE where specimens travel long distances in varying climates to reach centralized testing locations.

Evaluation of Direct Detection Protocols for Poliovirus from Stool Samples of Acute Flaccid Paralysis Patients.

Polio surveillance in the Global Polio Eradication Initiative has been conducted with virus isolation from stool samples of acute flaccid paralysis (AFP) cases. Under the current biorisk management/regulations, challenges arise in the timelines of the report, sensitivity of the test and containment of poliovirus (PV) isolates. In the present study, we evaluated protocols of previously reported direct detection (DD) methods targeting the VP1 or VP4-VP2 regions of the PV genome in terms of sensitivity and sequencability. An optimized protocol targeting the entire-capsid region for the VP1 sequencing showed a high sensitivity (limit of detection = 82 copies of PV genome) with a simpler and faster reaction than reported ones (i.e., with the addition of all the primers at the start of the reaction, the RT-PCR reaction finishes within 2.5 h). The DD methods targeting the VP1 region detected PV in 60 to 80% of PV-positive stool samples from AFP cases; however, minor populations of PV strains in the samples with virus mixtures were missed by the methods. Sequencability of the DD methods was primarily determined by the efficiency of the PCRs for both Sanger and nanopore sequencing. The DD method targeting the VP4-VP2 region showed higher sensitivity than that targeting the VP1 region (limit of detection = 25 copies of PV genome) and successfully detected PV from all the stool samples examined. These results suggest that DD methods are effective for the detection of PV and that further improvement of the sensitivity is essential to serve as an alternative to the current polio surveillance algorithm.

Role of Laboratory in Emerging Infectious Disease Control in Iran, Pasteur Institute of Iran, and national laboratory network.

Strengthening surveillance systems is a key aspect of outbreak response and was particularly important during the COVID-19 pandemic. Respiratory pathogens spread rapidly, and laboratory capacity is key to monitoring the spread. Prior to the pandemic, Iran had established a rapid response team and laboratory network to provide identification, monitoring, and detection of emerging infectious diseases, but did not have the laboratory capacity to respond to COVID-19. Following the announcement of the COVID-19 pandemic, the rapid response team diverted all attention to supporting COVID-19 surveillance. Iran built on the existing national laboratory infrastructure to incorporate SARS-CoV-2 surveillance into the response network. Based on existing international protocols, in-house molecular diagnosis capacity was operationalized, and commercial controls and assays were acquired and validated to national standards. The first COVID-19 laboratory was operational by January 25, less than 4 weeks before the initial detection of SARS-CoV-2 was announced. Assays and support were expanded and rolled out to form the COVID-19 National Laboratory Network, which consists of 560 multi-sectoral laboratories covering all provinces of Iran. The national laboratory network supports a wide range of operational capacities, including assay validation and protocol development, quality assurance, respiratory pathogen diagnosis and surveillance, and variant identification and assessment using multiple sequencing platforms. This network has supported the testing of over 55 million samples over the past 36 months using RT-qPCR and has sequenced approximately 2200 samples across the country, contributing the data to international databases, including GISAID.

An assessment of the laboratory network in Ghana: A national-level ATLAS survey (2019-2020).

Background: Integrated health systems with strong laboratory networks are critical in improving public health. The current study assessed the laboratory network in Ghana and its functionality using the Assessment Tool for Laboratory Services (ATLAS). Intervention: A national-level laboratory network survey was conducted among stakeholders of the Ghanaian laboratory network in Accra. Face-to-face interviews were conducted from December 2019 to January 2020, with follow-up phone interviews between June and July 2020. Also, we reviewed supporting documents provided by stakeholders for supplementary information and transcribed these to identify themes. Where possible, we completed the Laboratory Network scorecard using data obtained from the ATLAS. Lessons learnt: The Laboratory Network (LABNET) scorecard assessment was a valuable addition to the ATLAS survey as it quantified the functionality of the laboratory network and its overall advancement toward achieving International Health Regulations (2005) and Global Health Security Agenda targets. Two significant challenges indicated by respondents were laboratory financing and delayed implementation of the Ghana National Health Laboratory Policy. Recommendations: Stakeholders recommended a review of the country's funding landscape, such as funding laboratory services from the country's internally generated funds. Also, they recommended laboratory policy implementation to ensure adequate laboratory workforce and standards.

Integration and evaluation of cutaneous leishmaniasis laboratory diagnosis in the primary health care laboratory network.

Background: The lack of an integrated national system prevents the Islamic Republic of Iran from registering and reporting all cases of cutaneous leishmaniasis. Aim: To establish a laboratory network for the improvement of diagnosis and surveillance of cutaneous leishmaniasis in endemic areas of the Islamic Republic of Iran using parasitological and molecular methods. Methods: This descriptive, cross-sectional, pilot study examined 49 laboratories in the 2 endemic areas for cutaneous leishmaniasis in the Islamic Republic of Iran. Samples were taken for identification of the dominant Leishmania species from individuals with cutaneous leishmaniasis referred to the laboratories and had not travelled to other endemic regions. Statistical analysis was conducted using SPSS version 25.0. Using the primary healthcare laboratory network, we established a 3-level surveillance system. We compared misdiagnosis, new cases, clinical relapses, treatment resistance, and treatment failure before and after establishment of the network. Results: Network implementation reduced relapse of cutaneous leishmaniasis. After the laboratory training, the average misdiagnosis rate decreased from 49.3% to 4.2% for positive microscopic slides and from 31.6% to 12% for negative slides. Correct diagnosis was significantly higher in the study areas after the intervention. Conclusion: Implementation of a cutaneous leishmaniasis laboratory network can enhance diagnosis, unify diagnostic methods and improve patient care.

Providing specimen transport through an online marketplace in the Northern region of Ghana.

Background: Integrated diagnostic networks, which are themselves dependent on robust specimen transport solutions, are fundamental to effective healthcare systems. Objective: This study aimed to pilot an online marketplace for the transport of specimens throughout a laboratory network in Ghana. Methods: Independent drivers were matched with health facilities that required specimen transport using a suite of mobile applications and web portals developed for this study. This marketplace was piloted with seven drivers, two laboratories, and five health facilities in Ghana's Northern region from March 2019 to October 2019. Results: During the pilot, 182 deliveries were completed for 691 patients, including 4118 laboratory tests for antenatal care, disease surveillance, and clinical testing. Testing included 34 tests for communicable and non-communicable diseases. All but two specimens (laboratory cancellations) were successfully delivered and tested. The median time from request to encrypted emailing of results was 19.7 h, while that for a drop-off request was 0.9 h. In the midwife registry, the median time from patient visit to result recording was 1 day, compared to 4 days in the same months in 2018, and the number of mothers without documented testing decreased from 41 to 3. Similarly, the proportion of tuberculosis specimen deliveries from Buipe Polyclinic to Tamale Zonal Laboratory taking over 1 day fell from 62% at baseline to 3% during the pilot. Conclusion: An online marketplace successfully orchestrated the delivery of laboratory specimens under a variety of clinical circumstances, reducing overall turn-around time without diminution of the overall specimen delivery process. What this study adds: This study established the efficacy of an online marketplace to orchestrate timely and high-quality delivery of specimens within a laboratory network.

Coordination of chemical analyses under the European Human Biomonitoring Initiative (HBM4EU): Concepts, procedures and lessons learnt.

The European Human Biomonitoring Initiative (HBM4EU) ran from 2017 to 2022 with the aim of advancing and harmonizing human biomonitoring in Europe. More than 40,000 analyses were performed on human samples in different human biomonitoring studies in HBM4EU, addressing the chemical exposure of the general population, temporal developments, occupational exposure and a public health intervention on mercury in populations with high fish consumption. The analyses covered 15 priority groups of organic chemicals and metals and were carried out by a network of laboratories meeting the requirements of a comprehensive quality assurance and control system. The coordination of the chemical analyses included establishing contacts between sample owners and qualified laboratories and monitoring the progress of the chemical analyses during the analytical phase, also addressing status and consequences of Covid-19 measures. Other challenges were related to the novelty and complexity of HBM4EU, including administrative and financial matters and implementation of standardized procedures. Many individual contacts were necessary in the initial phase of HBM4EU. However, there is a potential to develop more streamlined and standardized communication and coordination in the analytical phase of a consolidated European HBM programme.

The National Laboratory Response to the COVID-19 Pandemic in Taiwan.

From April 23 to November 2021, a wave of COVID-19 infections caused by a new Alpha variant swept across Taiwan, resulting in 14,458 positive cases and 830 deaths among over 3.8 million people tested. To cope with the sudden increase in sample volume, as of December 14, 2021, a network of 249 laboratories with a total diagnostic capacity of 158,492 real-time reverse transcription polymerase chain reaction tests per day was established in 22 administrative regions. As of April 2022, over 9.5 million specimens were tested. Fully automated high-throughput and point-of-care nucleic acid testing, and rapid antigen testing, were simultaneously implemented to expand the country's daily diagnostic capacity. Saliva testing and sample pooling were also introduced to increase screening efficiency in certain situations. Antibody testing and genomic sequencing were also adopted for more precise epidemic investigation. Other challenges encountered and overcome include a lack of resources and interfacing of laboratory information management systems for case reporting, limited specimen allocation and delivery, and limited staff for diagnostic processing.

A Feasibility Study on Using the Facilities of Health Centers for Developing a Laboratory Network on Vectors and Reservoir Hosts of Cutaneous Leishmaniasis in Iran.

Background: Cutaneous leishmaniasis is an ancient endemic disease in Iran and continues to be a growing health threat to community development and the environment. This paper explains how to use the facilities of health centers for developing a laboratory network on vectors and reservoir hosts of cutaneous leishmaniasis in Iran. Methods: A literature search was performed of the relevant multiple databases to include studies on vectors and reservoirs of cutaneous leishmaniasis in Iran. A team of experienced experts was performed. After holding several meetings, field visits and organizing workshops, the activities of laboratories were determined at three levels. Results: Entomological studies showed that 5 species of the genus Phlebotomus and 10 species of the genus Sergentomyia are active in the south, 4 species of the genus Phlebotomus and one species of the genus Sergentomyia in the central part and 5 species of the genus Phlebotomus and 2 species of the genus Sergentomyia in the north east. Reservoir hosts were identified in the study areas. The tasks of laboratories were regulated at different levels. Conclusion: The Iranian Ministry of Health and Medical Education should prioritize the employment of capable persons in the field of Medical Entomology and Vector Control. The survival of this laboratory network depends on hiring and employing interested and persistent people. The universities of Medical Sciences that have the facilities to set up this network will be a very effective partner in the control of the disease in high risk areas. The results can be used in neighboring countries.