Post on 20-Dec-2021
CLINIC NAME CLINIC ID
REFERRING CLINICIAN
PHONE FAX EMAIL
ADDRESS
CITY POST CODE COUNTRY
CLINICAL AND TEST DETAILS
NAME SURNAME
DATE OF BIRTH (DD/MM/YY) ID
PHONE EMAIL
ADDRESS
CITY POST CODE COUNTRY
PATIENT INFORMATION REFERRAL INFORMATION
AFFIX BARCODE LABEL — SIF
HERE
I hereby grant consent for my referral doctor for the collection and transport of a blood sample to NIPD Genetics laboratories. I also grant permission to NIPD Genetics to use this blood sample for the test requested on this form. I attest that I have read, or have had read to me, the Patient Informed Consent and that I understand it. I have had the opportunity to have counseling about the VERACITY test and to discuss with my referral doctor any aspect of this consent form including the benefits, risks and limitations of the VERACITY test, as well as the reasons for performing the test and availability of alternative testing options to my satisfaction.I agree that my referral doctor collects my personal and clinical details such as is needed to complete the sample information form and that such details are provided to NIPD Genetics for the purposes of performing the VERACITY test. I affirm that all information provided is true to the best of my knowledge and that I will not hold NIPD Genetics responsible for any consequences as a result of untrue or inaccurate information.I authorize NIPD Genetics to code, store and use leftover sample and test data for quality improvement and/or research purposes.
I do not authorize NIPD Genetics to store and use my coded sample and test data as described above.
PATIENT CONSENT
CLINICIAN ATTESTATION
I certify that the patient has been counseled about the test and informed of the content of the informed consent including the benefits, risks, and limitations of the VERACITY test, and have obtained informed consent from the patient for performing the VERACITY test.I attest the need to perform the VERACITY test to determine the risk for trisomies of 13,18,21, and upon request aneuploidies of X,Y, select microdeletions (DiGeorge, 1p36 deletion, Smith-Magenis, Wolf Hirschhorn) and fetal gender as part of the patient’s medical care.
PATIENT SIGNATURE DATE
CLINICIAN SIGNATURE DATE
FOR LABORATORY USE ONLYORDER NUMBER LAB ID NUMBER KIT LOT NUMBER
COMMENTS
Neas Engomis 31, Nicosia, 2409 Cyprus Phone: +357 22266888 Fax: +357 22266899
Web: http://www.nipd.comEmail: info@nipd.com
SAMPLE INFORMATION FORM
CLINICIAN COMMENTS
TICK ONLY ONE BOX BELOW
FOR SINGLETON PREGNANCIES
TICK APPROPRIATE BOX & ADD COMMENTS
PATIENT/FAMILY HISTORYABNORMAL ULTRASOUND
ADVANCED MATERNAL AGESERUM SCREEN RISK
OTHER
REQUESTED TEST TEST INDICATIONS
T21 RISK SCORE: 1 in
COLLECTION DATE (DD/MM/YY)TEST INFORMATION
REDRAW TEST: YES NO
TRISOMIES 13, 18, 21TRISOMIES 13, 18, 21; PRESENCE OF YTRISOMIES 13, 18, 21; PRESENCE OF Y; ANEUPLOIDIES X, YTRISOMIES 13, 18, 21; PRESENCE OF Y; ANEUPLOIDIES X, Y; MICRODELETIONS
FOR TWIN/VANISHED TWIN PREGNANCIES
TRISOMIES 13, 18, 21TRISOMIES 13, 18, 21; PRESENCE OF YTRISOMIES 13, 18, 21; PRESENCE OF Y; MICRODELETIONS
T18 RISK SCORE: 1 in
T13 RISK SCORE: 1 in GESTATIONAL AGE (WEEK + DAY) HEIGHT (CM)WEIGHT (KG)MATERNAL INFORMATION
CLINICAL INFORMATIONCOMPLETE ALL SECTIONS BELOW
IVF PREGNANCY: YES NO
SELF DONOR AGE AT EGG RETRIEVAL
IVF INFORMATION
SURROGATE: YES NO
IF IVF, EGG USED:
1 FETUS
MONOCHORIONIC TWIN DICHORIONIC TWIN
NUMBER OF FETUSES
1 FETUS – VANISHED TWIN
2 FETUSES
Collect 4 weeks after the vanishing event
RECEIVED BYDATE & TIME OF RECEIPT(DD/MM/YY HH:MM)
PATIENT INFORMED CONSENT
VERACITY is a laboratory-developed Non-Invasive Prenatal Test (NIPT) for trisomies of 13,18,21, and upon request
aneuploidies of X, Y, select microdeletions (DiGeorge, 1p36 deletion, Smith-Magenis, Wolf Hirschhorn) and fetal
gender. The test is safe for both the fetus and the mother. It requires two tubes of blood (20ml) from the pregnant
woman using standard phlebotomy practices.
VERACITY is available for singleton and twin pregnancies including in-vitro fertilization (IVF) pregnancies of at least
10 weeks of gestation. Singleton pregnancies conceived by IVF with egg donation are also eligible. Twin pregnancies
in which loss of one fetus (vanished twin) occurred are eligible for testing after the 10th week of gestation and 4
weeks after the vanishing event. Information related to the number of fetuses and IVF status is mandatory and affects
testing. Twin pregnancies and vanished twin pregnancies are not eligible for X and Y aneuploidy detection. Patients
with malignancy or a history of malignancy, patients with bone marrow or organ transplant are not eligible for the
test. Twin pregnancies and vanished twin pregnancies conceived through in-vitro fertilization (IVF) with egg donation
or use of a surrogate mother are not eligible for the test. In a small number of cases the amount of fetal DNA present
in maternal blood (fetal fraction), is not sufficient for analysis and a redraw may be requested.
The VERACITY non-invasive prenatal test is not intended and is not validated for the detection of mosaicism,
triploidy, partial trisomy or translocations. A positive result for twin pregnancies indicates high risk for the presence
of at least one affected fetus. In twin pregnancies, detection of Y indicates the presence of at least one Y chromosome.
Although this test is highly accurate, there is still a possibility for false positive and false negative results. This is due
to technical limitations and/or biological limitations, including but not limited to confined placental mosaicism (CPM)
or other types of mosaicism, maternal constitutional or somatic chromosomal abnormalities, residual cfDNA from
a vanished twin or other rare molecular events. The test will not identify all deletions associated with each
microdeletion syndrome. This test has been validated on full region deletions and may be unable to detect smaller
deletions. The VERACITY test is not diagnostic but a screening test and results should be considered in the context
of other clinical criteria. The referring health professional is responsible for counselling before and after the test
including the provision of advice regarding the need for additional prenatal invasive genetic testing. It is recommended
that a positive result is confirmed by amniocentesis.
Samples collected will be used for the purposes of performing the VERACITY test as requested on the sample
information form. No additional clinical testing will be performed by NIPD Genetics. However, some sample may
remain. As NIPD Genetics requires samples and test data for quality improvement and/or ongoing research efforts,
an option is available in ‘Patient Consent’ to grant permission to ‘code’ the remaining sample and test-data for such
use. This means upon completion of the test; all personal information and details are removed, and the sample and
test results are anonymized. No personal information will be associated with studies or publications.
NIPD Genetics Public Company Ltd, 31 Neas Engomis Street, 2409 Engomi, Nicosia,
Customer service: Tel. + (357) 22266888; Fax. + (357) 22266899; Email: info@nipd.com;
Web page: www.nipd.com