Normative instruction makes it mandatory to carry out the karyotype exam in the screening of candidates for gamete donation, highlighting the importance of quality control for the reliability of the results.
On December 28th, 2022, Resolution RDC Nº. 771 was published in Brazil, which establishes the minimum technical and sanitary requirements for establishments, public or private, that carry out activities with germ cells, germ tissues and human embryos for therapeutic use in techniques of Assisted Human Reproduction (AHR).
In it, the Ministry of Health, the National Health Surveillance Agency (Anvisa) and the Collegiate Board make it mandatory to carry out the Karyotype Examination in the screening of candidates for the donation of male gametes (sperm) or female gametes (oocyte/egg), aiming at the own use or donation. The exam helps to identify infertility and allows the investigation of possible chromosomal alterations.
Controllab, as a provider of quality control solutions, offers the Proficiency Testing (PT) for the Constitutional Karyotype test. By participating in the PT, the laboratory compares its analysis with other peers and evaluates its performance to ensure the reliability of the results. Based on the evaluation, it is possible to identify failures and make it possible to take corrective or preventive actions, such as promoting training and better training of analysts.
The analysis is carried out every six months with virtual items, which guarantee the standardization of the material, the diversity of cases and the inclusion of rare cases. In addition to the G-Band Karyotype: Constitutional, the G-Band Karyotype: Fetal and Tumoral programs are also covered.
Faced with the complexity of the assisted reproduction process, the accuracy of the reports is essential to avoid the disqualification of potential donors or improper selection.
Does your laboratory carry out the Karyotype Examination? Access the Cytogenetics – Band G Karyotype PT here and implement it in your routine.