Presenting the results of the National Contingent-NIPT project at the official meeting of the Iran Academy of Medical Sciences
Contingent-NIPT project
The national plan "determining the use of NIPT test in the screening of chromosomal abnormalities in the first trimester of pregnancy based on the Contingent protocol using the Reflex DNA Testing method" was completed in September 1401. The implementers of the project in line with the advancement of the goals of this national plan and after holding numerous meetings and negotiations and collecting the opinions of professors, experts and health trustees of the country, including Mr. Dr. Malek Afzali, representatives of the Ministry of Health and Medical Education, representatives of forensic medicine and also the country's medical system organization in a meeting that was held on December 21 and hosted by the Academy of Medical Sciences discussed the results of this plan with the professors and scholars of the field. They paid health.
At the beginning of this meeting, which was held at 10 am on Monday, December 21 and was chaired by Mr. Dr. Shahriari, the executive team of the project in the Health and Nutrition Commission of the Academy of Medical Sciences, in the presence of Mr. Dr. Malek Afzali, Mr. Dr. Kazem Mohammad, Mr. Dr. Iftikhar, Dr. Masadaghi Nia, Dr. Sari, Dr. Akbari, Dr. Raoufian, Dr. Farzami, Dr. Baghersad, Dr. Sheikh-ul-Islam, Dr. Wathouq, Dr. Farhoud And Mr. Dr. Ramzan Khani introduced and provided additional explanations regarding the results and achievements of the National Contingent-NIPT plan.
Explaining the objectives of the study
Honorable Mr. Dr. Khorram Khurshid, Director of the Contingent-NIPT National Project, the reasons for starting this study in 2017 and at the Research Center for Fetal Growth and Development Disorders of Hope Generation Medical Institute and the Genetic Research Center of the University of Rehabilitation Sciences and Social Health with the aim of updating new screening methods, markers Biochemistry and new ultrasound indexes for screening common chromosomal diseases in the first trimester of pregnancy, upgrading the technology of ultrasound devices in the fields of software and hardware, new laboratory kits and devices, induced demand for performing NIPT tests in high numbers, increasing the number of performing invasive tests such as amniocentesis, feeling the need They considered increasing the knowledge of specialists in the field of screening in the first quarter in order to reduce false positive results leading to aggressive tests and the lack of monitoring of the country's active centers in the field of screening.
In another part of his speech, Dr. Khorram Khurshid pointed out that this project after obtaining permission from the Research Council of the University of Rehabilitation Sciences and also submitting the permission of the Ethics Committee to the Research Deputy of the Ministry of Health, explaining the country's current method for screening common chromosomal abnormalities (Combined). The main goals of the project were described as checking the time of NIPT test, reducing the time of announcing the results in order to reduce worries for pregnant mothers and checking the new screening methods in the world.
Explaining how to implement the plan by the executives
In another part of this meeting, the members of the executive team of the National Contingent-NIPT plan explained how to implement and the results of this national plan. Mr. Engineer Farrokhi gave some points regarding the goals of this national project, determining the location of the NIPT test, reducing screening costs using new methods, the cut offs used in the plan and the use of four protocols to compare them in the first line of screening, the number of tests performed stated the results and accuracy of the experiments in this design.
Statement of questions by respected members of the Academy of Medical Sciences
After presenting the explanations of the project managers, the professors and experts present in the meeting raised their questions and discussed and exchanged opinions about the implementation method and the results and achievements of the National Contingent-NIPT project. According to the order of the chairman of the meeting, all the questions were raised first and at the end of the appropriate time, the answers were given to the project managers.
Mr. Dr. Kazem Mohammad raised questions regarding the costs and the usefulness of this plan and asked for more explanations about the recommendations after detecting this plan and the reason for the uneven number of samples in the four protocols. He said that usually comparing the four protocols is expensive. And it will be complicated. What has been done to prevent this issue? Did we implement the use of these four protocols or did other centers also do this? Also, according to the studies carried out in this project, what is the advice of the project managers to the medical, laboratory, insurance, family and expectant mother community?
Mr. Dr. Akbari while emphasizing that this project is at the same level as the global studies, considering that in the first step, the results of the four protocols have been determined, this study needs several more steps to become a protocol and a policy document. and help the politician. Also by raising the question whether any of these four protocols are cost-effective or not? They asked for information on the total cost for 4700 people.
Dr. Iftikhar raised a question about the relationship between this research work and what is being done in the society, and considering the emphasis of this project on reducing the number of amniocentesis and invasive tests, how many pregnant mothers were subjected to this in the past? They were asked to perform these tests. He also stated that this research plan will have an impact on identifying non-chromosomal abnormalities such as spina bifida, nervous system disorders, meningocele, meningomyelocele, microcephaly, macrocephaly, hydrocephaly, etc.? Are some other chromosomal abnormalities such as dislocations, deletions, and fractures identified in this study? And what is the relationship between this research plan and the youth law of the population?
Next, Mr. Dr. Malek Afzali explained that this protocol should be implemented and translated in a practical way in the country's healthcare system and the role of different departments in it should be determined, and he asked a question about whether this plan They discussed how it is compatible with the youth law of the population, which does not have a basis for encouraging screening.
In a similar question, Mr. Dr. Masadaghinia also asked about the connection of this project and its results with the Youth Law of the Population and also asked about the publication or non-publication of this project in another scientific journal.
His Excellency Mr. Dr. Shahriari also raised his question that according to the abortion laws and the time limit for pregnant mothers, at what age of pregnancy should this plan be done? Is it possible to get the required kits and equipment from within the country or should it be purchased from outside Iran?
Mrs. Dr. Baghersad, the head of the Department of Genetics of the Ministry of Health, stated that this plan needs a national protocol to be implemented at the national level, in which things such as cost effectiveness, feasibility, and the degree of dependence on buying equipment from abroad should be specified.
Ms. Dr. Farzami, head of the health reference laboratory of the Ministry of Health, also stated that each of these tests has its own complexities and has several stages, and in the process of doing it, a lot of coordination is needed between the laboratory, sonographers and obstetricians. The implementation of this protocol does not mean the exact implementation of all the tests specified in it. In this regard, it is necessary to pay attention to the fair access of all people to the tests, the current facilities of the country and the dependence on the import of equipment from abroad.
Also, Mr. Dr. Farhoud, while emphasizing that these plans have been implemented worldwide in millions of samples and the results are clear, said that we should not repeat the process. The world is moving towards Whole Exome Sequencing and Whole Genome Sequencing and it is necessary for us to move towards advanced processes.
Mr. Dr. Raufian, the head of the genetics and serology laboratory of forensic medicine, while pointing out that this project was implemented with four established protocols, why instead of using all four protocols, the test accuracy coefficient in screening the intermediate group was only with the fourth protocol. Subtraction of various factors has not been investigated? They asked a question.
The presenters' answers to the questions of the members of the Academy of Medical Sciences
In response to the questions raised by Mr. Dr. Saatchi, the sample size included in this national plan and the studies conducted in it were consistent with the research conducted in the world, especially in England, and the reasons for the difference in the sample size in the four protocols in practical becoming) and ethical (moral). He stated the impossibility of conducting some specialized tests such as determining the size of NT in low consumption provinces as another reason for the difference in sample size in the four protocols of the plan.
Dr. Saatchi stated that cost-effectiveness is one of the proposals of the plan's executives, which has been paid attention to in different parts of the implementation.
Full coordination of the National Contingent-NIPT plan with the Youth Population Act
In response to the questions raised regarding the coordination of this study with the youth population law, Dr. Khorram Khurshid pointed out that although the study of this project was carried out in 1997, when there was no youth population law at that time, but according to experts and experts, it is most coordinated with this There is a law. He further referred to Article 53, in relation to the providers, including effective training, updating and legalizing the provision of services, monitoring and evaluating performance and issuing or canceling the relevant service licenses in the implementation of the provisions of this law, and announced that all these cases are under study. This plan is included. The issue of cost-effectiveness of this plan needs to be taken into consideration. Mr. Dr. Khorram Khurshid, referring to the regulations approved by the Ministry of Health regarding the establishment and establishment of comprehensive centers for multispecialty genetic services, considered the action in this field as an important step towards carrying out this project in an integrated manner in the said centers.
In response to a question regarding the diagnosis of other chromosomal abnormalities, he described this type of screening as lacking this capability. Also, while pointing out that this test was performed from the 11th to the 13th week of pregnancy and taking two blood samples from the pregnant woman, including a serum sample for biochemical tests and a plasma sample for the NIPT test, he ruled out the issue of the time limit for legal abortion.
Mr. Dr. Hamidian, in response to a question regarding the diagnosis of anomalies other than chromosomal anomalies, in this test, while pointing to the progress of sonography in the direction of the diagnosis of second trimester anomalies in the first trimester, this issue is possible by increasing the training of sonographers and the use of new technologies. They knew that it reduced the psychological and financial burden on the pregnant mother and the family. Dr. Hamidian stated that in addition to the factors for the diagnosis of chromosomal abnormalities in the 11-13 week of pregnancy, the evaluation factors of non-chromosomal diseases such as NTD diseases, meningoceles, heart abnormalities or organ abnormalities are also included in this plan, after observing the fetus including these non-chromosomal disorders. , the patient was excluded from the plan and focused only on common chromosomal diseases. Dr. Hamidian considered the lack of sufficient monitoring of the screening method in the past years as the reason for raising the possibility of the complete elimination of screening.He described the need to prevent this subject by focusing on training in ultrasound, improving test methods and using standard equipment.
Further, Dr. Hamidian pointed out that if we intend to have a healthy young population and encourage people to procreate, we must be able to guarantee that we will bring them a healthy fetus and a healthy child, and also considering the economic conditions and the cost of living. Providing health services at this level can increase the family's motivation to have children.
Regarding the time of diagnosis of abnormalities during pregnancy, he added: From the time of performing the screening test under the 14th week of pregnancy, the pregnant mother can refer to the forensic medicine within two weeks at most and in case of diagnosis of chromosomal and non-chromosomal abnormalities, although the diagnosis of some disorders in the 13th week of pregnancy with current methods It is not possible to move towards the use of advanced ultrasound tests such as transvaginal ultrasound for this issue.
Proposals of Contingent-NIPT national plan implementers
At the end of the meeting, Mr. Dr. Madbari suggested the proposals of the Contingent-NIPT national project managers regarding the standardization and updating of chromosomal abnormality screening methods based on the establishment of coordination between the National Population Headquarters, the Medical System Organization, the Forensic Medicine Organization, the Health Reference Laboratory, the Ministry of Health's Vice President of Health, Medical treatment and education and study group. Mr. Dr. Medbari, while referring again to the proposals of the plan's executives
Preparation and compilation of regulations for the screening program for chromosomal abnormalities based on the findings of this plan
Conducting additional studies in order to expand and implement this project at the country level
Creating a software under the title of National Screening Network to record laboratory information and human products of the Ministry of Health, Treatment and Medical Education.
Conducting a cost-effectiveness study of the costs of using this technique in different patterns and choosing the best and most economical pattern of using these four protocols in the country
called for the formation of a working group consisting of representatives of relevant organizations to implement the second phase of the study of this national plan with the aim of organizing and creating a single national protocol to implement the results of this national plan in the community health system.
