Abstract
The COVID-19 pandemic caused by the newly emerged coronavirus was first detected in China in December 2019 and rapidly spread worldwide. The rapid spread of the disease urged all countries involved, in accordance with their capacities, take the necessary measures to diagnose and manage the disease. The first patient was diagnosed with COVID-19 in Iran in February 2020. Considering the significant role of the laboratory services in detection and management of the disease, planning and programming to provide access to these services was considered as a top priority for healthcare system in Iran. Adopting all existing laboratory capacities and providing necessary infrastructures for expanding COVID-19 laboratory diagnostics, resulted in the establishment of a nationwide network of COVID-19 molecular diagnostic laboratories within the shortest possible time. In addition to expanding the capacity of laboratory services, improving the laboratory network’s performance have been taken into serious consideration. Despite the strict sanctions, the COVID-19 molecular diagnostic laboratories scaled up to more than 430 laboratories currently (September 2021), mostly are operating in the private sector. With considerable efforts, COVID-19 molecular laboratory network was established to provide nationwide diagnostic services. Considering the capacity for the SARS-CoV-2 Rapid Antigen test, we can now perform more than 100,000 COVID-19 diagnostic tests per day. However, due to the ongoing pandemic and in accordance with the requirements of the health system, it is necessary to plan and carry out more COVID-19 diagnostic tests. This study aimed to introduce the process of establishing the COVID-19 laboratory diagnostic network to manage the COVID-19 pandemic in Iran.
Extended Abstract
Background
The newly emerged coronavirus was first detected in China in December 2019. The first patient was diagnosed with COVID-19 in Iran in February 2020. Considering the significant role of laboratory services in detecting infected individuals, providing nationwide access to laboratory services was a top priority for the healthcare system despite the limitations caused by strict sanctions imposed on Iran. Technical experts, specialized equipment, and other necessary resources were mobilized from different sectors nationwide to establish a SARS-CoV-2 molecular diagnostic laboratory network. This article represents the establishment of a laboratory diagnostic network to manage the COVID-19 pandemic in Iran.
Measures to establish and manage a laboratory diagnostic network during the COVID-19 pandemic in Iran:
For integrated management of laboratory services during the COVID-19 pandemic, a national laboratory committee was established at the Ministry of Health and Medical Education of Iran (MOHME) in February 2020. The national COVID-19 laboratory committee was assigned to develop strategies to improve nationwide access to quality, timely and affordable laboratory services by establishing and promoting a molecular diagnostic laboratory network. The main strategic plans developed and implemented in the country are as follows:
Enhancing COVID-19 diagnosis laboratories:
At the beginning of the pandemic in Iran, in February 2020,only two laboratories in Pasteur institute and National Influenza Laboratory, could perform SARS-CoV2 molecular diagnostic tests. The number of laboratories expanded gradually over time. In the first step, fifteen public health laboratories were set up for SARS-CoV2 molecular test. Consequently, some academic and research molecular laboratories joined the SARS CoV2 laboratory network. In a further step, private laboratories that met specific professional requirements were licensed to provide COVID-19 molecular tests. Implementing the “Iran COVID-19 emergency response project” (ICERP), supported by the World Bank and WHO, has also played an essential part in promoting COVID-19 laboratory testing capacity. SARS CoV2 antigen rapid diagnostic test (Ag-RDT) has dramatically enhanced laboratory diagnosis in the COVID-19 pandemic. Focusing on the indications, interpretations, and limitations of the COVID-19 diagnostic tests also led to rational test ordering and efficient use of available resources.
Ensuring quality of COVID-19 diagnostic laboratory services:
Firstly, improving the technical staff’s knowledge and skills was considered to improve the quality of laboratory services during the COVID-19 pandemic. Reference Health Laboratory spent considerable time and effort to improve staff capabilities. One of the most effective measures was launching virtual training programs to allow all laboratory staff, even in remote provinces, to use the training materials. Because the validity of in vitro diagnostics (IVDs) directly affects the laboratory results, supply chain management and centralized procurement of IVDs was set as one of the COVID-19 national committee priorities. In this regard, necessary measures have been taken, such as need assessment and proper distribution of the equipment required for SARS-CoV2 molecular and antigen testing in public laboratories and premarket evaluation of the equipment.
Inspecting the performance of the COVID-19 molecular diagnostic laboratory network:
Alongside expanding the capacity of the laboratory services, the quality of the laboratories’ results has been seriously considered. The assessment checklists were developed and published to facilitate performance evaluation of the COVID-19 laboratory network. The department of laboratory affairs in all medical universities was assigned to perform a periodic inspection of COVID-19 molecular diagnostic laboratories (at least twice a year) as part of their annual operational plan. Moreover, all COVID-19 molecular diagnostic laboratories were required to participate in SARS-CoV2 external quality assessment scheme (EQAS) every 3 to 6 months provided by Pasteur institute. Issuance and renewal of the laboratories’ licenses have been conditioned on obtaining successful results in the EQAS.
Managing the laboratory data and information:
The integrated laboratory information system is essential for managing the COVID-19 pandemic effectively. RHL has collaborated with the Statistics and Information Technology Management directorate of the MOHME on launching a data registration and information exchange system in order to gather and analyze COVID-19 laboratory test information from public and private sectors throughout the country
Conclusion
Establishing a nationwide network of COVID-19 molecular diagnostic laboratories with 433 laboratories from the public and private sectors was a valuable achievement that enabled our health system to provide timely access to quality laboratory services during the COVID-19 pandemic. COVID-19 laboratory services must be ongoing, uninterrupted, and in accordance with the health system requirements and national guidelines. There should be a systematic approach to predicting and providing necessary funds, equipment, experienced workforce, and other resources to ensure sustainable and reliable laboratory services. Adopting more advanced technologies, such as Next Generation Sequencing (NGS), to detect mutant viruses is crucial. Finally, establishing an integrated system for aggregation and analyzing laboratories’ information will enable our healthcare system to make evidence-based decisions.
Practical Implications of Research
This article tried to highlight parts of the activities the Iranian healthcare system performed to manage laboratory services amid the COVID-19 pandemic and offer suggestions and practical solutions for providing access to quality laboratory services in this ongoing COVID-19 pandemic.
Ethical Considerations
The Reference Health Laboratory of the MOHME is a leading member of the national COVID-19 laboratory committee and has a vital role in the policy-making and management of the COVID-19 molecular diagnostic laboratory network. Evidence and documents provided in this article are not confidential, and in the text, all the stakeholders of this program are mentioned.
Conflict of Interest
There is no conflict of interest in this study. The explanations are listed in the ethical considerations section.
Acknowledgment
The authors would like to express their gratitude to the deputies of health and curative affairs of MOHME, Pasteur institute, and members of the national COVID-19 laboratory committee. We also thank RHL experts, authorities, directors, managers of laboratory affairs in medical universities and all our colleagues in clinical laboratories throughout Iran who play a part in establishing the SARS-CoV-2 molecular diagnostic laboratory network.