Acceptance criteria


General request and acceptance criteria

For the Centre for Medical Genetics to perform a test, five basic criteria need to be met.

  1. Doctors (the applicant) must request a test. For this we need your identification details and the signed request.
     
  2. The nature and the origin of the sample on which the test needs to be performed must be clear. In case of any discrepancy between this information, testing is not possible.
     
    • The sample clearly specifies the patient's name and/or identification
    • The same information must be specified on the application form.
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  3. An indication must be entered on the request form. You can choose between general or discipline-specific indications. Any additional clinical and/or genetic info as well as family data and other details can be specified or added to the request. In any case, the indication must be clear. If not, a certified geneticist may request more information from the applicant, e.g. additional clinical data.
     
    • In any case, the provided clinical/genetic data must correspond with the requested tests: the latter must be the logical consequence of the clinical issue. Or in other words: the patient's symptoms must correspond with the clinical signs of the genetic defects for which the tests are requested. For the evaluation please see the Online Mendelian Inheritance in Man (OMIM).
       
    • It must also be clear whether the request concerns diagnostic testing, carrier testing or presymptomatic testing.
       
      • The diagnostic objective of every test is to confirm or exclude a specific clinical diagnosis.
         
      • Carrier testing is performed on healthy individuals to find out whether they are (still) carriers of genetic defects with a risk for their descendants.
        • It is performed for autosomal recessive, X-bound and chromosomal disorders.
        • The result has no implications for the examined person's state of health. It only provides information about the genetic risks for the descendants. Preferably tests are not performed on children (younger than 18) unless international guidelines (Eurogen test) permit it or the geneticist deems it necessary following genetic counselling.
           
      • Presymptomatic or predictive testing focuses chiefly on healthy people. The aim is to determine whether an examined person runs a risk of developing genetic defects at a later age. Examples: Huntington's disease, (family) breast cancer.
        • In accordance with international guidelines one or several genetic consultations must always precede predictive testing, preferably by a multidisciplinary team.
        • The test also requires the informed consent of the person in question.
        • Predictive testing also requires genetic testing on 2 independently obtained samples.
        • In general, predictive testing is not performed on children (younger than 18) unless preventive or therapeutic means can be used at a very young age to prevent or cure the disease.
           
  4. The genetic test must be possible. A specific situation occurs when the test is only possible in a foreign lab. In that case the request is evaluated as a function of the motivation, the cost price of the test, the need for the patient's informed consent and the reliability of the lab. Usually this requires consultation with the applicant or referral of the patient to the consultation.

    Testing is not possible in the following cases:
    • If there is no known laboratory that performs this test.
    • If a genetic test is not possible for the disorder, e.g. because the causal gen is still unknown.
    • If the genetic test is too complex and too many different genes need to be analysed.
       
  5. The request must meet the criteria for testing. These indications are specified on the request form (for testing CF and FMR1, postnatal cytogenetic tests, prenatal array test, NIPT, etc.). They are also available on the website of BeSHG. To test cancer predisposition genes, specific criteria apply, as specified on this website, and the patient must make an appointment for a medical genetics consultation where an extensive family tree analysis and genetic counselling are performed.

    The genetic test is always refused in the following cases:
  • Unidentified non-valuable samples
  • The request concerns a predictive test in children (-18), unless justified
  • The test cannot be performed, no test available
  • No adequate clinical reasons exist to perform the test
  • The test has already been performed in the past
  • several tests under the same nomenclature (see genetic testing under art. 33) have been requested together

In the other cases when the basic criteria have not been met, the request shall be branded as unsatisfactory. We will request the applicant for the necessary information or action before we start testing.

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Lab analysis delayed

The secretaries are responsible for preparation and for following up applications.

  • They check whether the information on the application form submitted with a sample has been completed correctly and in full. If this has not been done, the laboratory cannot start the required tests.
  • If a sample has been taken incorrectly, is too old or was not enclosed with the application, this will delay the laboratory test until we receive a new sample. 

In any situation where information is missing or we do not have samples of adequate quality to begin the test, we will inform you of this in writing. In these cases the analysis will be delayed until the application details are complete or a suitable sample has been delivered.

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