Information on the Ring Trial Interphase-FISH Tumour

Aim

The objective of the interlaboratory test is to evaluate the technical performance of the FISH technique, the microscopic evaluation, the reporting and the interpretation of the FISH results in order to simulate a real diagnostic setting.

Performance interval

Once per year.

Procedure

1-ml cryotubes with the cell suspension fixed in methanol-acetic acid is sent out together with clinical information of a fictitious patient and a diagnostic question. Under normal transport conditions by mail (shipping to destinations outside of Germany by courier service), aliquoted samples are stable for up to 5 days. The diagnostic question and therewith the FISH probes that have to be applied change. As soon as the application period opens the FISH probes necessary for the upcoming interlaboratory test are announced.

Method

The FISH test should be carried out according to the own laboratory SOP. A diagnostic report has to be provided which includes the result of the FISH analysis and the interpretation in relation to the diagnostic question.

Criteria

Correctness of the qualitative and quantitative result and of the overall findings, hybridization efficiency: none of the probes must show > 10 % without any signal of control sample.

Certificate

A certificate will be provided that states whether or not the criteria according to RiLiBÄK are fulfilled (hybridization efficiency) and whether or not the participation was successful (correctness of the qualitative FISH result). The certificate is valid for two years.

Ring trial management

Prof. Dr. med. Claudia Haferlach
MLL Münchner Leukämie Labor GmbH
Max-Lebsche-Platz 31
81377 München
Tel. 089 99017 400
Fax 089 99017 409
claudia.haferlach@mll.com

Dipl.-Biol. Jinda Holzwarth
MLL Münchner Leukämie Labor GmbH
Max-Lebsche-Platz 31
81377 München
Tel. +49 89 990 17480
Fax +49 89 990 17489
jinda.holzwarth@mll.com