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Background: Serological surveillance of COVID-19 through conducting repetitive population-based surveys can be useful in estimating and monitoring changes in the prevalence of infection across the country. This paper presents the protocol of nationwide population-based surveys of the Iranian COVID-19 Serological Surveillance (ICS) program. Methods: The target population of the surveys is all individuals ≥6 years in Iran. Stratified random sampling will be used to select participants from those registered in the primary health care electronic record systems in Iran. The strata are the 31 provinces of the country, in which sampling will be done through simple random sampling. The sample size is estimated 858 individuals for each province (except for Tehran province, which is 2574) at the first survey. It will be recalculated for the next surveys based on the findings of the first survey. The participants will be invited by the community health workers to the safe blood sampling centers at the district level. After obtaining written informed consent, 10 mL of venous blood will be taken from the participants. The blood samples will be transferred to selected reference laboratories in order to test IgG and IgM antibodies against COVID-19 using an Iranian SARS-CoV-2 ELISA Kit (Pishtaz Teb). A serologically positive test is defined as a positive IgG, IgM, or both. After adjusting for the measurement error of the laboratory test, nonresponse bias, and sampling design, the prevalence of COVID-19 will be estimated at the provincial and national levels. Also, the approximate incidence rate of infection will be calculated based on the data of both consecutive surveys. Conclusion: The implementation of these surveys will provide a comprehensive and clear picture of the magnitude of COVID-19 infection and its trend over time for health policymakers at the national and subnational levels.
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Background & Objective: Providing equitable access to good quality, timely, and affordable laboratory testing has always been a top priority for the Ministry of Health and Medical Education (MoH-ME) and the Reference Health Laboratory (RHL). Considering the significant role of medical laboratories in disease surveillance, RHL developed a strategic plan to manage laboratory services during the COVID-19 pandemic based on the "Strategic Framework for strengthening health laboratory services, 2016-2020" proposed by the World Health Organization (WHO). This article describes the steps taken to establish the strategic framework in Iran. Methods: Firstly, a National Laboratory Committee was formed in MoH-ME and a situation analysis was conducted to explore the strengths, weaknesses, opportunities, and threats in different components of our laboratory system. Gaps and resources needed to address those gaps were determined; then, RHL outlined operational processes and mechanisms for monitoring the activities. Results: The WHO strategic roadmap and its six strategic goals concerning leadership, quality, human resources, safety and security, laboratory networking, and rational use of laboratory testing, helped us to promote national laboratory services in accordance with health system requirements in the COVID-19 pandemic. Conclusion: The establishment of a national molecular laboratory network with more than 500 laboratories from different sectors may result in timely access to countrywide laboratory services and would be beneficial for future COVID-19 and/or other viral outbreaks. Continual evaluation of the COVID-19 laboratories' performance, production of PCR test kits by the local manufacturers, and development of a platform for virtual training would be other accomplishments that Iran achieved in coping with the recent pandemic.
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OBJECTIVES: This study aims to estimate the prevalence of coronavirus disease 2019 (COVID-19) in the general population of Iran. METHODS: The target population was all Iranian people aged 6 years and older in the country. A stratified random sampling design was used to select 28 314 people from among the individuals registered in the electronic health record systems used in primary health care in Iran. Venous blood was taken from each participant and tested for the IgG antibody against COVID-19. The prevalence of COVID-19 was estimated at provincial and national levels after adjusting for the measurement error of the laboratory test, non-response bias and sampling design. RESULTS: Of the 28 314 Iranians selected, 11 256 (39.75%) participated in the study. Of these, 5406 (48.0%) were male and 6851 (60.9%) lived in urban areas. The mean (standard deviation) participant age was 35.89 (18.61) years. The adjusted prevalence of COVID-19 until 20 August 2020 was estimated as 14.2% (95% uncertainty interval 13.3%-15.2%), which was equal to 11 958 346 (95% CI 11 211 011-12 746 776) individuals. The adjusted prevalences of infection were 14.6%, 13.8%, 16.6%, 11.7% and 19.4% among men, women, urban population, rural population and individuals aged 60 years or more, respectively. Ardabil, Golestan and Khuzestan provinces had the highest prevalence and Alborz, Hormozgan and Kerman provinces had the lowest. CONCLUSIONS: Based on the study results, a large proportion of the Iranian population had not yet been infected by COVID-19. The observance of hygienic principles and social restrictions should therefore continue until the majority of the population has been vaccinated.