COVID-19 pandemic caused by the newly emerged Coronavirus was first detected in China in December 2019 and rapidly spread throughout the world. With the rapid spread of the disease, all countries involved in accordance with their capacities took necessary measures to identify 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 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. In spite of 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. Taking into account the capacity for performing SARS CoV-2 Rapid Antigen testing, at the moment, we are able to provide more than 100,000 COVID-19 diagnostic tests per day. However, due to continuation of the pandemic and in accordance with the needs of the health system, it is necessary to plan and carry out more activities for diagnostic testing of COVID-19. The purpose of this paper is to introduce the process of establishing the COVID-19 laboratory diagnostic network to manage the COVID-19 pandemic in Iran.
Keywords: COVID-19 Testing, Clinical Laboratory Services, Diagnostic Techniques, Diagnostic Procedures, Laboratories, COVID -19
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 the laboratory services in detection of infected individuals, providing nationwide access to laboratory services was set as a top priority for the healthcare system in spite of the limitations caused by strict sanctions imposed on our country. Technical experts, specialized equipment and other needed resources were gathered from different sectors all around the country to establish a SARS-CoV-2 molecular diagnostic laboratory network. This article, represents the process of establishment of laboratory diagnostic network to manage the COVID-19 pandemic in Iran.Measures taken in the country to establish and manage a laboratory diagnostic network in the COVID-19 pandemic:For integrated management of the laboratory services in 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 molecular diagnostic laboratory network. The main strategic plans developed and implemented in the country are as follows:Increasing laboratory capacity for COVID-19 diagnosis: At the beginning of the pandemic in Iran, in February 2020, there were only two laboratories in Pasteur institute and National Influenza Laboratory capable of performing SARS-CoV2 molecular diagnostic tests. Gradually, the number of the laboratories increased. In the first step, fifteen public health laboratories, were set up for performing SARS CoV2 molecular testing. Consequently, some academic and research molecular laboratories joined the SARS CoV2 laboratory network. In a further step, laboratories from private sector which fulfilled certain professional standards were granted a license to provide COVID-19 molecular testing as a member of the molecular laboratory network. Implementation of “Iran COVID-19 Emergency Response Project” (ICERP), supported by World Bank and WHO, has also played an important part in promoting COVID-19 laboratory testing capacity. Applying SARS CoV2 antigen rapid diagnostic testing (Ag-RDT) has dramaticly expanded the capacity of laboratory diagnosis in COVID-19 pandemic. Additionally, putting emphasis on indications, interpretation and limitations of the COVID-19 diagnostic tests leaded to rational test ordering and prevented wasting the resources.Ensuring quality of COVID-19 diagnostic laboratory services:To improve the quality of laboratory services in COVID-19 pandemic; firstly, improving knowledge and skills of technical staff was taken into consideration. Reference Health Laboratoty spent considerable time and effort to improve staff capabilities. One of the most effective measures was launching virtual training programs to make it possible for all laboratories’ staff, even in remote provinces, to use these training materials. Considering the fact that 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 as well as premarket evaluation of these equipment. Inspecting the performance of the COVID-19 molecular diagnostic laboratory network:Alongside expanding capacity of the laboratory services, the quality of the laboratories’ results has been taken into serious consideration. The assessment checklists were developed and published to facilitate performance evaluation of COVID-19 laboratory network. The department of the laboratory affair in all medical universities were assigned to perform periodic inspection on 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 providing 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 have 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.
Establishment of a nationwide network of COVID-19 molecular diagnostic laboratories with 433 laboratories from public and private sectors was a valuable achievement that enabled our health system to provide timely access to quality laboratory services in the COVID-19 pandemic. COVID-19 laboratory services need to be ongoing, uninterrupted and in accordance with the health system requirements and national guidelines. There should be a systematic approach to predict and provide 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, establishment of an integrated system for aggregation and analysis of laboratories’ information will enable our health care system to make evidence-base decisions.
Practical Implications of Research
This article tried to highlight parts of the activities performed by Iranian healthcare system to manage laboratory services amid COVID-19 pandemic, and offer suggestions and practical solutions for providing access to quality laboratory services in this ongoing COVID-19 pandemic.
Reference Health Laboratory of the MoHME is a leading member of the national COVID-19 laboratory committee and has a vital role in policy making and management of COVID-19 molecular diagnostic laboratory network. Evidence and documents provided in this article are not confidential and, in the text, all the stakeholders and 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.
The authors express their gratitude to deputies of health and curative affairs of MoHME, pasteur institute, members of the national COVID-19 laboratory committee, all RHL experts, authorities, directors, managers of laboratory affairs in medical universities and all our colleagues in clinical laboratories throughout Iran who play part in establishment of SARS CoV-2 molecular diagnostic laboratory network.