To medical institutions considering the
introduction of NIPT
If you are considering introducing NIPT, please check the following flow and contact the TOKYO CLINICAL LABORATORY.
About the flow of the inspection
Blood collection (partner clinic)
Please collect 10ml of your mother's blood.
Samples are sent to the Tokyo Sanitation Laboratory.
It is shipped from each clinic.
Inspected by TOKYO CLINICAL LABORATORY
We will analyze it using the Illumina sequencer at the TOKYO CLINICAL LABORATORY.
We will inform the medical institution of the inspection results from the TOKYO CLINICAL LABORATORY.
The inspection results will be sent from the TOKYO CLINICAL LABORATORY to medical institutions.
Report to patients
We will send the inspection report to the medical institution by mail.
What kind of tests are you doing?
|13.18.21. Chromosome||Sex chromosome||All-chromosomal doterogenous||Micro-deletion||Micro-deletion of all regions (duplicate)|
Chromosomes 13, 18, 21 / Determination tests for sex chromosomes / Whole chromosome tests / Microreseous syndrome tests
*Gender cannot be determined.
In order to request NIPT testing from an overseas inspection company, it is always possible to transport specimens after going through a sanitary laboratory. (If you fail here, you will be punished [From Article 15-3, paragraph 1 of the Medical Law)) The consignment application to each hygiene inspection station is in Japanese.It is thought that it will correspond in English from the application to the inspection office of the foreign country to the inspection result.
At the TOKYO CLINICAL LABORATORY, we conduct inspections in Japan from consignment (application) to results report, so we can do everything in Japanese.
Its accuracy is about the same as that used in overseas clinical practice.For busy teachers on a daily basis, the TOKYO CLINICAL LABORATORY will fully support your NIPT inspection.
If you would like to know a detailed explanation, please contact us by e-mail.
Revision of the Medical Law
In the past, specimens could be transported directly overseas, but in order to improve the accuracy of the inspection, From December 2018, due to the revision of the Medical Law, specimens containing blood tests can no longer be sent directly from medical institutions such as hospitals and clinics.
The new prenatal diagnosis (NIPT) has taken similar measures. Please note that medical institutions who are directly commissioned by overseas inspection companies will be subject to punishment.
This health inspection office conforms to the standards specified by the Ordinance of the Ministry of Health, Labour and Welfare and is registered.
[Article 15-3, paragraph 1 of the Medical Care Act]
When an administrator of a hospital, clinic, or midwifery center intends to outsource the work of specimen testing, he/she shall entrust it to the following persons.
The person who established a sanitary inspection facility registered under Article 20-3, paragraph (1) of the Act on Clinical Laboratory Technicians, etc.
A person who performs specimen testing at a hospital or clinic or other place specified by ordinance of the Ministry of Health, Labour and Welfare, and who conforms to the standards specified by the Ordinance of the Ministry of Health, Labour and Welfare as necessary for the proper implementation of the operation of specimen testing, such as the structural equipment, management organization, methods for ensuring the accuracy of specimen testing, and other matters of the facility where the person conducts the work of specimen testing.
|Check item name||NIPT (non-massive default default genetic testing)|
|Inspection method||SBS method|
|Materials/Containers||Strec Tube 10ml|
|Specimen type||Whole blood|
|Storage temperature||Room temperature|
|Conditions that can be inspected||10 weeks and 0 days pregnant|
|Number of days required||6th to 15th|
Things to keep in mind
- This inspection cannot detect mosaics and locus.Except number 1,4,5,15,22 Microdexia syndrome cannot be detected.
- It can also be tested with twin pregnancy and in vitro fertilization (IVF).However, in the case of three or more multi-pregnancy, It has not been verified and cannot be verified.
- Depending on the type of medicine you are taking, we ask you to stop it.
- If you have a disease, be sure to declare it.
- If you have a blood transfusion history and transplant history, be sure to declare it.
Inspection contract conditions
(1) Be an obstetrician and gynecologist.
(2) Understand NIPT.Be willing to understand.
(3) Do not advertise NIPT (including the WEB).
(4) Perform amniotic fluid testing for positive cases.
The inspection shall be entrusted only where the above conditions are met, and if it deviates from the above conditions, the inspection contract shall be canceled.
About the date of receipt of the specimen
*Samples cannot be received on Saturdays, Sundays, and public holidays.
(Medical institutions considering the introduction of NIPT)