Y Chromosome Microdeletions PT program

The objectives of the PT scheme:

• To maintain accurate Y chromosome microdeletions tests.
• Provide you feedback on your laboratory’s Y chromosome microdeletions testing procedure.
• Provide you guidance and recommendations for your Y chromosome microdeletions testing and suggest possible procedure improvements.

Y chromosome microdeletion PT Laboratory Practice

• The laboratory will treat the PT test item as if it was a routine Y deletion test in the laboratory.
• The Y chromosome microdeletion testing procedure will be carried out by the materials and protocols, routinely used in the laboratory.

PT material storage instructions Y chromosome

• The DNA sample should be stored at 4°C.

The Y chromosome microdeletion PT Program

Twice a year, QualiGene sends one pre-characterized DNA sample in TE buffer, potentially harboring Y chromosomal microdeletion, which leads to spermatogenic impairment. The laboratory needs to determine the sample’s specific microdeletion and submits the results to QualiGene for evaluation. QualiGene in-turn verifies the accuracy of the analysis and reports its findings back to the participating laboratory.

The Y chromosome microdeletion PT Protocol

• QualiGene will inform all participating laboratories two weeks before sample shipment.
• A submission date will be set for 90 days from delivery day. (The delivery day will be announced and late submission, without a prior approval for extension by QualiGene, will result in grade reduction).
• The results will be submitted by fax or e-mail, on a form provided by QualiGene.
• The lab will submit the test’s raw data attached to the result form (fsa files).
• The participating laboratory will receive QualiGene’s evaluation and feed-back within four weeks from the results submission deadline.
• The grades will not be reported back until all participants have submitted their results.
• At the end of each year, the registered labs will receive a certificate attesting to their participation in the PT program.
• Following each PT round, QualiGene will publish a report containing Y chromosomal microdeletions PT- related statistics, general information and conclusions.

Appeals

• Each participating laboratory may appeal the grade, reported back by QualiGene, up to one week from result receipt.
• Appeals should be submitted by e-mail, specifying the appeal arguments and reasons.
• QualiGene will re-evaluate the results submitted by the participating laboratory and will report its decision to the laboratory up to 10 days from appeal receipt.

Confidentiality

• All participating laboratories’ names are kept confidential.
• QualiGene’s evaluation and grading is confidential and will be submitted back only to the laboratory manager.
• Statistics and grades published in the newsletter are anonymous.
• Grades of Israeli participating laboratories are reported to the MOH, annually.

Grading (percent of total grade)

• Correct identification of the Y chromosomal microdeletion – 50%
• Correct selection of markers and analysis quality – 40%
• Timely submission of results – 10%