neoBona (NIPT) - Aneuploidies chromosomes 21, 18, 13 + fetal sex, whole blood

Erased test and Result format Modification

Test code: 5289 - neoBona (NIPT) - Aneuploidies chromosomes 21, 18, 13 + fetal sex, whole blood

Nemonic code: NB

Test code: 5290 - NeoBona  Advanced (NIPT) - Aneuploidies chromosomes 21, 18, 13, X, Y + fetal sex, whole blood

Nemonic code: NBA

Alternative:

Test code: 8956 - NEOBONA (NIPT) - ANEUPLOIDIES CHROMOSOMES 21,18,13, X, Y + FETAL SEX, WHOLE BLOOD

Nemonic code: NBB

Test code: 8895 -  NEOBONA GENOMEWIDE 

Nemonic code: NB2

For requests regarding to patient brochure, technical data sheet, petitionary and informed consent should be adressed to customer.service-international@synlab.es.

We inform you that there has been a change in the way of reporting the results for aneuploidy screening in the neoBona non-invasive prenatal test reports.

As of June 30, instead of “presence of” the result is indicated as “high risk of” and “absence of” is replaced by “low risk of”.

This does not imply any other type of change, since the methodology used and the entire procedure is executed exactly the same way as before and with the same maximum quality.

The reason for this change is due to the demand received in recent months to issue the report in these terms, with the aim of following the guidelines in force in the United Kingdom (1), and which, after evaluating by the Medical area, has decided to assume since it is also aligned with the guidelines published so far (2).

Likewise, and bearing in mind that the way of informing up to this moment is perfectly correct and acceptable according to the guidelines (as reflected by the good result obtained in the evaluation of the results of the external controls sent by GenQA, Genomic Quality Assessment), it has been considered appropriate to unify the text for all the reports issued and in the different languages, this being the main reason for the change.

We remain at your disposal for any aclaration.

References:

(1):  Deans et al., 2017. Recommended practice for laboratory reporting of non-invasive prenatal testing of trisomies 13, 18 and 21: a consensus opinion. Prenatal Diagnosis 2017, 37, 699–704

(2):  https://www.gov.uk/government/publications/screening-for-downs-syndrome-edwards-syndrome-and-pataus-syndrome-non-invasive-prenatal-testing-nipt/screening-for-downs-syndrome-edwards-syndrome-and-pataus-syndrome-nipt#no-result

Effective update from 11/07/2022