Nagasaki University Sato Laboratory (Japan CSF 14-3-3, tau and RT-QuIC service for CJD Surveillance Committee)

Key facts

• The laboratory performs CSF testing for human prion disease in cooperation with, and on behalf of, the MHLW prion disease research group (Takao Group on the English page, Yamada group on the Japanese page) and the CJD Surveillance Committee.
• Standard tests are offered free for now: 14-3-3 and total tau ELISA through the committee, with RT-QuIC requested separately; both pages warn that fees or cost sharing may be introduced.
• Quoted turnaround is about 2 to 3 weeks for 14-3-3 and total tau and about 2 months for RT-QuIC; urgent cases get 14-3-3, total tau and RT-QuIC within one week of sample arrival, and the applicant is invoiced by the university.
• The urgent fee is shown as 25,000 yen on the English page (notices to April 2023) and as 30,000 yen plus consumption tax and shipping on the Japanese page (notice dated 6 July 2026).
• Total tau can also be subcontracted to the commercial laboratory SRL under insurance reimbursement, per the Japanese page.
• Only physicians may apply: they email the laboratory for a procedure number, complete a surveillance questionnaire and ship frozen CSF (minimum 0.6 mL) with dry ice or at about minus 20 degrees; patients cannot apply and results are not given to patients, families or by phone.
• The pages state that RT-QuIC has about 90 to 95 percent sensitivity and near 100 percent specificity for CJD, warn that results cannot confirm a diagnosis alone, and list pitfalls: CSF protein above 100 mg/dL, heavy blood contamination, repeated freeze-thaw, and false positives in epilepsy.
• The lab also collects plasma for research on neurofilament light chain (NfL) as a prognostic marker, and collects brain MRI in DICOM format for a standardisation study managed by a radiologist at a Tokushima University hospital.
• The work is funded through the MHLW intractable disease research programme; the Japanese Consortium of Prion Disease (JACOP), which gathers natural history data for future trials, is linked to the committee on the same pages.
• The laboratory's shipping address for samples changed in March 2021, and it announced a testing closure for 7 to 17 August 2026, which shows the service was still operating in mid 2026.
• Authors from the laboratory (Atarashi, Satoh and others, 17 in total) published the first CSF RT-QuIC paper in Nature Medicine in February 2011.
• In a prospective cohort of 177 prion disease patients and 123 non-patients, a hair root and scalp RT-QuIC test had 52.5 percent sensitivity and 100 percent specificity; the university quotes 80 to 90 percent sensitivity for the CSF method.
• Nagasaki University hosted the Asian Pacific Prion Symposium on 27 and 28 November 2025, chaired by Satoh, with a talk on a 10-year prospective study of CSF biomarkers for early diagnosis.

Timeline

1. 2011Nature Medicine paper describing RT-QuIC for CSF published online (print February 2011), with the laboratory's authors.
2. 2021Sample shipping address changed.
3. 2023Latest dated notice on the English service page (inspection holiday).
4. 2025Hair root and scalp RT-QuIC study published in Scientific Reports.
5. 2025Asian Pacific Prion Symposium opens in a two-day programme hosted by the department (to 28 November).
6. 2026Nagasaki University news post on the hair root and scalp test.
7. 2026Notice that testing closes 7 to 17 August 2026.