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Fetal Medicine Foundation extended the license of OSCAR test for the Fetal Ultrasound Center until 14 July 2020

04.08.2019

Dr. Marek Šois successfully passed the OSCAR test’s annual mandatory external audit and examination.

 

To pass the exam, one had to:

 

  1. submit the results of 608 OSCAR tests performed in the Fetal Ultrasound Center during the period of 30 July 2018-12 July 2019;

      2. to take a short internet-based theoretical exam;

  1. provide 3 control images for each ultrasound marker.

 

Dr. Marek Šois was certified for all five ultrasound markers of the OSCAR test:

 

  1. fetal nuchal fold;

      2. fetal nasal bone;

 

      3. venous duct’s blood flow;

 

      4. tricuspid valve’s blood flow;

 

  5. uterine arteries’ blood flow.

 

 

The OSCAR test license and the right to use the FMF Risk Calculation Program for all ultrasound markers was extended until 14 July 2020 and the name of the doctor was included on the list of audited ultrasound specialists on the website of the Fetal Medicine Foundation.

 

 

 

In 2018, 711 OSCAR studies were performed in the Fetal Ultrasound Center. Twenty-five women who were expecting twins (i.e. 3.5%) and 68 women who were pregnant with IVF (i.e. 9.6%) passed the OSCAR test.

 

During this period in the Fetal Ultrasound Center, the OSCAR test diagnosed:

 

4 retentions of pregnancy

7 severe fetal developmental defects

  • neural tube defect (rare variety of spina bifida aperta - myeloschisis)
  • central nervous system pathology (hydrocephalus due to cerebrovascular developmental disorder)
  • central nervous system pathology (alobar holoprocephaly - absence of anterior hemispheres)
  • congenital combined heart failure (three-flap valve underdevelopment, ventricular septal defect, large blood vessels transposition)
  • skeletal pathology (sirenomyelia or mermaid syndrome - fused legs)
  • abdominal anterior wall pathology (umbilical hernia)
  • Multiple abnormalities [early growth restriction, neck area translucency (NT) 4 mm, umbilical hernia, bilateral cleft lip, and cleft palate, an extra toe, one umbilical artery, venous duct absence].

7 fetuses with Down syndrome

1 fetus with Klinefelter syndrome

 

A very rare MPPH syndrome was diagnosed [megalocephaly (large cranium), polymicrogyria (convolutional pathology), polydactylia (too many fingers), hydrocephalus] due to a heterozygous mutation in the CCND gene. To date in the world, this serious, non-life-sustaining syndrome has been reported in only 60 cases.

 

Between 2011 and 2018, during which 5423 OSCAR tests were performed, the sensitivity of the test has been 100%. This means that no fetuses with Down's disease were left undetected. In 2018, the number of false-positive tests was 22 (3.1%).

 

A good screening test is characterized by a high detection rate of chromosomal diseases and by the minimal number of false-positive responses, which minimizes the need for invasive procedures that may potentially endanger the fetal life (chorionic biopsy, amniotic fluid test).

 

Internationally, it is considered acceptable when a screening test detects 75% of fetuses with Down's disease among 3% of false-positive screening tests.

 

Fetal Ultrasound Center’s OSCAR test meets these requirements.

 

The external audit (UK NEQAS) performed in the Edinburgh Reference Laboratory was successfully passed also by Synlab Estonia, a partner of the Fetal Ultrasound Center, which analyzes I-trimester hormones (PAPP-A, β-HCG, PLGF).

 

By controlling the quality of our work, we create a sense of security for our patients that the quality of the OSCAR test provided by the Fetal Ultrasound Center is guaranteed.

 

 

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