The information contained herein also applies to the Patient Consent Form and Test Request Form for Non-invasive prenatal Genetic Testing for Fetal Chromosomal Aneuplodies (“NIFTY™”) available at http://www.niftytest.com/education-hub/download-center/ (“Patient Consent Form”).
Information Contained on the Site
General informational and educational nature of information on the Site
The information, and materials on the Site relate to products, and services offered by BGI (“Services”). It is intended for informational and educational purposes only. It does not constitute medical advice, nor is it a substitute for medical advice from a qualified healthcare provider. BGI does not practice medicine or provide medical services or advice. Prior to undergoing any testing or treatment, you should consult with a qualified health care professional regarding any risks, diagnoses, treatment, and/or any other potentially relevant healthcare issues.
Furthermore, healthcare information is constantly developing, and recommended standards and practices may change quickly. Therefore, it is always best to consult with and confirm any and all information obtained from the Site with your healthcare professional.
Please note that BGI does not administer NIFTY™ tests directly. Rather, NIFTY™ tests are administered by BGI’s local partners throughout Europe. You should consult with your qualified healthcare professional, and BGI’s local partner regarding whether the NIFTY™ test is right for you, and whether there is additional information available regarding the NIFTY™ test.
Furthermore, the Site may contain information about products or Services that are not available or authorized in your country.
Basic information regarding the NIFTY™ test
NIFTY™ stands for Non-Invasive Fetal TrisomY test. It is a genetic screening test that pregnant women can take beginning at week 10 of their pregnancy.
The NIFTY™ test is a means of evaluating the risk of a baby having trisomy 21, trisomy 18 or trisomy 13. The term “trisomy” is used to describe the presence of an extra chromosome—three instead of the usual pair.
Specifically, trisomy 21 (Down syndrome) occurs when a baby is born with three copies of chromosome 21, trisomy 18 (Edwards syndrome) when a baby is born with three copies of chromosome 18, and trisomy 13 (Patau syndrome) when a baby is born with three copies of chromosome 13.
NIFTY™ also offers additional testing for other genetic disorders, including certain sex chromosomal aneuploidies and deletion syndromes, as well as gender information. These tests are offered as optional extras at no additional cost.
NIFTY™ test limitations
NIFTY™ is NOT a diagnostic test. In order to definitively confirm whether a tested for condition is present, a diagnostic procedure such as amniocentesis is required. It is recommended that HIGH RISK results be confirmed by a diagnostic procedure.
The accuracy of NIFTY™ can also be affected by several conditions, including blood transfusion, transplant surgery, immunotherapy or stem cell therapy prior to sampling.
Mosaicism (mixtures of chromosomally normal and abnormal cells in the pregnancy) can also affect the accuracy of the NIFTY™ results.
In the case of twin pregnancy testing, ‘vanishing twin syndrome’ can also affect the accuracy of the NIFTY™ results.
You should consult with a qualified healthcare provider whether any of these conditions apply to you.
Results should, therefore, always be interpreted in the context of other clinical and family information in consultation with a healthcare provider.
The result of the NIFTY™ does not eliminate the possibility of other abnormalities in the tested chromosomes, nor does it test for other genetic disorders or birth defects.
Consult with a qualified healthcare professional prior to obtaining a NIFTY™ test. A healthcare provider can supply more information about the chromosomal conditions being tested for, and whether a patient should consider testing.
Although the NIFTY™ test is highly accurate, the NIFTY™ test may result in a false positive or false negative result, and under certain circumstances should not be relied upon in place of a diagnostic test. Consult with a qualified healthcare professional regarding your NIFTY™ test results, and as to whether any diagnostic testing is recommended to confirm your NIFTY™ test results.
You should never make decisions regarding your pregnancy without prior consultation with a qualified healthcare professional who is aware of the healthcare regulations relevant to your country of residence.
Consultation with a qualified healthcare professional
As stated above, you should consult with a qualified healthcare professional prior to receiving any NIFTY™ test and thereafter to understand the result, their implications and any follow-up diagnostic testing that may be recommended.
In the event that you have not engaged a qualified healthcare professional, you can contact BGI at firstname.lastname@example.org to find a NIFTY™ test partner and healthcare professional in your country.
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