The pros and cons of NIPT certified and non-certified facilities [supervised by a doctor]

Introduction

The thing that mothers worry about most during pregnancy is the health of the baby inside their womb. The health of the fetus also has a significant impact on the health of the mother.

Previous prenatal testing involved inserting a needle into the mother’s abdomen to collect amniotic fluid and other fluids to test for congenital diseases and chromosomal abnormalities in the fetus. Naturally, this test does involve some damage to the fetus, and there is a risk of miscarriage. However, NIPT (a new prenatal test) only involves collecting maternal blood, so it is said to be almost completely invasive (damage-free) to the fetus.

Currently, the number of facilities that perform NIPT (non-invasive prenatal testing) is increasing, but there are two types of facilities: “certified facilities” and “non-certified facilities.” Of course, both are medical institutions and have doctors on staff, so please rest assured. However, certified and non-certified facilities each have their own advantages and disadvantages.

To help you have a healthy pregnancy, which is full of hope and anxiety, understand NIPT (non-invasive prenatal testing) and the difference between NIPT (non-invasive prenatal testing ) certified and uncertified facilities, and get the test that’s best for you.

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What is NIPT (new type prenatal testing)?

NIPT ( non-invasive prenatal genetic testing) is an abbreviation for non-invasive prenatal genetic testing. As the word “non-invasive” suggests, this is a prenatal test that causes very little damage to the mother and fetus.

Previous prenatal testing consisted of amniocentesis and chorionic villus sampling . Both are important definitive tests to check for chromosomal abnormalities and congenital diseases in the fetus, but they involve inserting a needle into the mother’s abdomen to collect amniotic fluid, or transvaginally to collect chorionic villus tissue. For this reason, amniocentesis has a 1/300 risk of miscarriage, while chorionic villus sampling has a 1/100 risk of miscarriage.

NIPT (New Prenatal Testing) can be performed using only maternal blood. Blood is taken in the same way as blood tests performed during health checkups, and the fetal DNA contained in the blood is analyzed. As a result, there is almost no direct invasion (damage) to the fetus, and NIPT (New Prenatal Testing) has a sensitivity of 99.9% and a specificity of 99.90% in testing for trisomy 21 (Down syndrome) , making it possible to more accurately detect abnormal chromosomes in the fetus.

In addition, NIPT (new prenatal testing) can be performed earlier than the 10th week of pregnancy. By performing NIPT (new prenatal testing) early in pregnancy , it is possible to know the possibility of premature birth or miscarriage risk caused by chromosomal abnormalities in the fetus.

NIPT (new prenatal testing) is an important test for knowing the health of the fetus early in pregnancy and for ensuring a safer pregnancy and birth .

Points to note about NIPT (new prenatal testing)

NIPT (non-invasive prenatal testing) is a test that is performed only by taking blood from the mother. It is considered a highly accurate prenatal test with almost no invasiveness (damage) to the mother and fetus. However, NIPT (non-invasive prenatal testing) is a “non-definitive test” that detects the possibility of chromosomal abnormalities or congenital disease risks in the fetus. Therefore, if abnormalities are found in NIPT (non-invasive prenatal testing) , “definitive tests” such as amniocentesis and chorionic villus sampling are required to detect the presence or absence of chromosomal abnormalities or congenital diseases.

NIPT (new type prenatal diagnosis) , amniocentesis, and chorionic villus sampling are not covered by insurance. Therefore, even if NIPT (new type prenatal diagnosis) detects a risk of fetal chromosomal abnormalities, moving on to amniocentesis, which is a definitive test, will be at your own expense, so please be careful to check the cost.

Hiro Clinic NIPT Amniocentesis Support System

In order to reduce the burden on mothers, Hiro Clinic NIPT has set up an amniotic fluid testing support system run by an affiliated testing institution. By using the Hiro Clinic NIPT amniotic fluid testing support , if the NIPT (new type of prenatal diagnosis) test result is positive, the cost of amniotic fluid testing can be subsidized up to 200,000 yen (tax included). For more information, please visit the Hiro Clinic NIPT website or consult with staff.

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What is a NIPT (new type prenatal testing) certified facility?

There are two types of facilities that can perform NIPT (new prenatal testing) : certified facilities (licensed facilities/accredited facilities) and non-certified facilities (unlicensed facilities/unlicensed facilities/unaccredited facilities).

A NIPT (non-invasive prenatal testing) certified facility is a NIPT (non-invasive prenatal testing) testing facility that has been certified (approved/certified) by the Japan Medical Association. In order to receive certification, the facility must meet certain conditions, such as having a clinical geneticist who is familiar with prenatal testing, including NIPT (non-invasive prenatal testing) , and having a specialized outpatient clinic.

What are the conditions that increase the frequency of diseases for which the Japan Medical Association provides guidelines?

According to the guidelines of the Japan Medical Association,NIPT(new prenatal diagnosis)The following conditions are considered to increase the frequency of occurrence of the diseases covered by this test for pregnant women for whom receiving the test is an option.

• Older pregnant women 
• Pregnant women whose fetuses are suspected to have numerical chromosomal abnormalities as a result of maternal serum marker testing 
• Pregnant women with a history of pregnancy with a numerical chromosomal abnormality
• Pregnant women whose parents have a balanced Robertsonian translocation, suggesting the possibility of the fetus having trisomy 13 or trisomy 21.
• Pregnant women whose fetuses are suspected to have numerical chromosomal abnormalities as a result of fetal ultrasound examination

Pregnant women in these conditions do not necessarily need to undergo NIPT (non-invasive prenatal testing) . However, if they are worried about the fetus having chromosomal abnormalities even after receiving genetic counseling, the decision to undergo testing is at the discretion of the pregnant woman.

In addition, the testing items for NIPT (non-invasive prenatal testing) performed at certified facilities are limited to only trisomy 21 (Down syndrome) , trisomy 18 (Edwards syndrome) , and trisomy 13 (Patau syndrome) .

Non-certified NIPT (non-invasive prenatal testing) facilities are not illegal

Non -NIPT (non-invasive prenatal testing) certified facilities are not illegal facilities.

Terms such as uncertified, unlicensed, unaccredited, and unapproved give the negative impression that non -NIPT (non-prenatal testing) certified facilities are illegal facilities, but like certified facilities, non -NIPT (non-prenatal testing) certified facilities are medical institutions with doctors on staff who properly perform medical procedures such as blood sampling. It is said that there is no difference in the test accuracy of non-certified facilities compared to certified facilities.

When NIPT (new type prenatal testing) is performed at non-certified facilities , anyone can choose the tests they need, so it can be said that NIPT (new type prenatal testing) can be performed with a high degree of freedom.

However, in some non-certified facilities, counseling and testing are often performed by doctors with little knowledge of prenatal testing, including NIPT . If you are considering having NIPT at a non-certified facility due to your own circumstances, it is a good idea to carefully compare and confirm whether or not there is a gynecologist on staff, whether the specimen testing facility is domestic or overseas, and whether there is any follow-up care after NIPT .

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Ministry of Health, Labor and Welfare’s new certification system for NIPT (non-invasive prenatal testing)

In March 2021, the Ministry of Health, Labor and Welfare held a specialist committee on NIPT (non-invasive prenatal testing) . The government also proposed a new certification system that would involve the screening of NIPT (non-invasive prenatal testing) facilities, and discussions will continue on the policy of strengthening the information provision system to enable pregnant women to make appropriate decisions regarding childbirth.

Since testing is also being considered at medical institutions that provide genetic counseling and obstetrics and gynecology clinics, there may be changes in the way NIPT (non-invasive prenatal testing) facilities are described as certified or non-certified in the future.

In addition, NIPT (non-invasive prenatal testing) is a standard test included in general prenatal checkups in the United States and other countries. In Japan, due to the increase in older pregnancies and births, it has been decided that infertility treatment will be covered by insurance under certain conditions in 2022. For these reasons, NIPT (non-invasive prenatal testing), which respects “healthier pregnancies and births” and “pregnant women’s right to know,” is likely to attract more attention in the future.

NIPT (New Prenatal Test) by Hiro Clinic NIPT

Hiro Clinic NIPT is a clinic specializing in NIPT (new type prenatal testing) and has NIPT facilities across the country .

We have a Japan Society of Obstetrics and Gynecology specialist, a prenatal consulting pediatrician, and a clinical geneticist who are all well versed in NIPT (non-invasive prenatal testing) . In order to respect the “right of pregnant women and their families to know,” our clinic can perform NIPT (non-invasive prenatal testing) even on pregnant women who have given up on NIPT (non-invasive prenatal testing) due to the conditions of certified facilities .

Hiro Clinic NIPT also conducts sample testing at the Tokyo Hygienic Laboratory, which is located in Japan. Barcode-managed sample transportation allows for rapid test results with minimal human error. We also offer a wide range of testing plans, from low-cost individual tests to tests for all chromosomes.

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Choose the NIPT (new type prenatal test) that’s best for you, regardless of whether it’s certified or not.

There are many NIPT (new type prenatal testing) facilities in Japan, both certified and uncertified . As the Ministry of Health, Labor and Welfare’s new certification system progresses, the number of facilities is likely to increase in the future. Please do not get caught up in the words certified or uncertified, and choose the NIPT (new type prenatal testing) that is best suited to you.

Hiro Clinic NIPT (New Prenatal Testing) has opened NIPT (New Prenatal Testing) facilities nationwide to ensure “mothers and families have the right to know” and to help ensure healthier pregnancies and births . In addition , taking into consideration the delicate physical condition of pregnant women, all interviews and consent forms are conducted online. If you have any questions or concerns about NIPT (New Prenatal Testing) , please feel free to contact Hiro Clinic NIPT .

Q&A

• Q

  What is a NIPT-certified facility?
  A NIPT-certified facility is a medical institution approved by the Japan Medical Association that has a clinical genetic specialist on staff and meets the requirements to provide genetic counseling.
• Q

  Are non-NIPT certified facilities illegal?
  No. Non-NIPT-certified facilities are legitimate medical institutions with physicians on staff, and are not illegal. However, they may differ in the conditions under which they provide genetic counseling and in the flexibility of test items.
• Q

  What are the test items included in NIPT at a certified facility?
  At certified facilities, testing is primarily performed for 21 trisomies (Down syndrome), 18 trisomies (Edwards syndrome), and 13 trisomies (Pattou syndrome).
• Q

  What tests are available at non-certified facilities?
  In addition to the three chromosomal abnormalities listed above, non-certified facilities may be able to test for a wide range of other chromosomal abnormalities, including sex chromosomes, other chromosomal abnormalities, and microdeletion syndromes.
• Q

  What is the difference between certified and non-certified facilities?
  Certified facilities meet the standards of the Japan Medical Association, and genetic counseling is mandatory. On the other hand, non-certified facilities offer more flexibility in test items and may offer lower additional costs, but may not offer genetic counseling.
• Q

  What are the advantages of choosing a NIPT-certified facility?
  The advantage of choosing a NIPT-certified facility is that you will receive genetic counseling by a specialist, which will provide you with accurate information and advice about the test results.
• Q

  What are the advantages of choosing a non-NIPT certified facility?
  A Non-certified facilities offer a wider selection of test items and a variety of price ranges, making it easier for you to get a test that meets your individual needs.
• Q

  How much does a NIPT-certified facility cost?
  The cost for a certified facility is generally around 200,000 yen.
• Q

  What is the cost of a NIPT test at a non-certified facility?
  At non-certified facilities, the cost ranges widely from 80,000 yen to 200,000 yen, and depends on the test items selected.
• Q

  Can anyone take a test at a NIPT-certified facility?
  Pregnant women who meet certain criteria, such as age and number of weeks of pregnancy, may be eligible for testing at certified facilities.
• Q

  Are there age restrictions at non-certified facilities?
  No. There are no age restrictions at non-certified facilities, and all pregnant women are eligible for testing.
• Q

  Can gender determination be performed at NIPT-certified facilities?
  In most cases, certified facilities do not perform gender determination.
• Q

  Can I receive gender determination at a non-certified facility?
  Yes, gender determination may be possible at non-certified facilities by selecting a plan that includes sex chromosome testing.
• Q

  What kind of genetic counseling is offered at NIPT-certified facilities?
  Genetic counseling includes interpretation of test results, explanation of genetic risks, and a detailed explanation of what to expect in the future.
• Q

  Can I receive genetic counseling at a non-certified facility?
  Some non-certified facilities may offer genetic counseling as an option.
• Q

  How accurate are the test results at certified facilities?
  There is no significant difference in accuracy between certified and non-certified facilities.
• Q

  What should I be aware of when taking a test at a non-certified facility?
  It is important to check the availability of genetic counseling and follow-up services at non-certified facilities in advance.
• Q

  How long does it take for a certified facility to report test results?
  It generally takes one to two weeks to receive the results at certified facilities.
• Q

  Do non-certified facilities sometimes provide test results sooner?
  Yes, non-certified facilities that perform in-country inspections may offer plans that provide faster results.
• Q

  Should I choose a certified or non-certified facility?
  Whether you should choose a certified or non-certified facility should be based on factors such as the need for genetic counseling, your preference for test items, and cost.