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GENETIC TESTING REQUISITION 1-844-363-4357· [email protected] Schillingallee 68 · 18057 Rostock Germany Attention Patient: Please visit your nearest LifeLabs or CML Healthcare Patient Service Centre for sample collection CONTRACT # LL: K012-01/ CML: CEN Report to Physician Billing # LifeLabs Demographic Label Ordering Physician Name Physician Signature: Ordering Physician Address & Contact Info: Copy to (name & contact Address: Tel: Fax: info): Name: Contact: Bill to Contract # K012-01 (patient does not pay at time of collection) Patient Gender: (M/F) Patient DOB: (YYYY/MM/DD) Patient Name (Last, First): Patient Address: Patient Health Card: Patient Telephone: Please ship all NON-PRENATAL samples to: LifeLabs · Attn CDS Department • 100 International Boulevard• Toronto ON• M9W6J6 TEST REQUESTED LL TR # / CML TC# □ Genetic Test - Blood Sample 2 x 4mL EDTA □ Genetic Test (Pediatric) - Blood Sample 1 x 2mL EDTA □ Genetic Test - Other Sample Type 4005 4008 4014 PRENATAL SAMPLES: Please ship directly to CENTOGENE. Date Blood Collected (YYYY/MM/DD): ___________ Time Blood Collected (HH:MM)) :________ Collector Name: ___________________ GENETIC TESTING CONSENT I understand that a DNA specimen will be sent to LifeLabs for genetic testing. My physician has told me about the condition(s) being tested and its genetic basis. I am aware that correct information about the relationships between my family members is important. I agree that my specimen and personal health information may be sent to Centogene AG at their lab in Germany (address below). To ensure accurate testing, I agree that the results of any genetic testing that I have had previously completed by Centogene AG may be shared with LifeLabs. I understand that LifeLabs will contact me for a new specimen if a test result cannot be provided from the original specimen. I agree that a copy of my results will be sent to my ordering physician. I further agree that for any test(s) performed by Centogene AG, a copy of my results will also be sent to LifeLabs. I understand that once the requested test(s) has/have been completed, any remaining sample will be stored at the testing laboratory. OPTIONAL CONSENT : Please Initial where appropriate _____ I agree that my de-identified sample may be used for product development or research purposes. I understand that I will not receive any royalties, resultant payments, benefits or rights to products or discoveries. _____ I do not want my remaining sample to be stored. Please destroy any remaining sample once the final report has been issued. _____ I have had genetic testing completed in the past by the following laboratories: ___________________________________________________________________________ I agree that Centogene AG and LifeLabs may obtain a copy of these genetic test results from the testing laboratory. Patient/Substitute Decision Maker: Signature: ___________________________________________________; Date: _______________________________________________________ Printed name: ________________________________________________; Relationship to person being tested: _________________________ OR: I certify that verbal consent was obtained from the patient /substitute decision maker for the requested genetic testing Signature: ___________________________________________________; Date: _______________________________________________________ ** LIFELABS/CML STAFF: PHOTOCOPY REQUISITION AND INCLUDE 1 COPY WITH SAMPLES** Page 1/4 The minimum amount of patient information is collected for provision of the service requested. This information is considered confidential and privileged. Unauthorized use and disclosure is prohibited. Requisition V3 Jan2015 GENETIC TESTING REQUISITION REPRODUCTIVE HEALTH & INFERTILITY 1-844-363-4357· [email protected] Schillingallee 68 · 18057 Rostock Germany Patient Name: Sample Type: Patient DOB (YYYY/MM/DD): □ *Blood (EDTA: 5mL for single gene, 10mL for panel) □ DNA (single gene:1-10ug, panel 10-100ug) □ *Filter card (1 card/30 exons: Available by request) □ Saliva (Oragene OG-510: Available by request) □ Fibroblast/Skin Biopsy (0.5cm ) □ Cultured cells (1 flask, min 25cm , 80-90% confluent) □ **Amniotic fluid (10mL) □ **Chorionic Villus (10 villi, cleaned) □ Other: _________________________________________________________ LifeLabs Demographic Label 2 2 * Exact amount depends on size of panel, see www.centogene.com ** Please contact us prior to sending cells Billing Status: Institution Billing ONLY: □ Ministry of Health Approved (Approval letter attached) □ Institution (Complete information below) □ Ministry of Health Approval Pending □ Private Pay (Complete information below) Institution Name: ___________________________________ Contact Name: _____________________________ Address: Phone: ( Private Pay ONLY: ) Credit Card Type: - Fax: ( ) □ MasterCard - Email: _______________________________ □ Visa Card Number_________________________________________ Exp Date(MM/YY)_____________________ Name (as it appears on credit card)__________________________________________________________ I understand that my credit card will be charged for the full amount of testing not paid for by my provincial health plan Cardholder Signature: _______________________________________ Date (DD/MM/YYYY)________________ Patient Information: Gender: □M □ F Ethnicity: ___________________________ Additional patient medical information: Relevant Family history: Have other family members submitted samples to Centogene for analysis? □Y If yes, Name:_______________________ □N Relationship to patient _________________________ DOB (YYYY/MM/DD):____________________ Familial Mutation Testing Gene:______________ Mutation (HGVS):_____________________ □Familial Report attached Testing Instructions: (ex: Reflex order) ** PLEASE INCLUDE A COPY OF REQUISITION WITH SAMPLES ** Page 2/4 The minimum amount of patient information is collected for provision of the service requested. This information is considered confidential and privileged. Unauthorized use and disclosure is prohibited. Requisition V3 Jan2015 GENETIC TESTING REQUISITION REPRODUCTIVE HEALTH & INFERTILITY 1-844-363-4357· [email protected] Schillingallee 68 · 18057 Rostock Germany Patient Name: Patient DOB (YYYY/MM/DD): Please indicate requests for Hot Spot (H), Exon (E), Sequencing (S), Repeat Expansion (R) and/or Deletion/Duplication (D) analysis Infertility : Tests for Males & Females Microarray: S Genomic microarray NGS Panels: D S D S Infertility panel Kallmann syndrome panel (LHB, FSHB, LHCGR, FSHR) (CHD7, FGFR1, FGF8, GNRHR, GNRH1, KAL1, KISS1R, PROK2, PROKR2, SEMA3A, TAC3, Colorectal canceTACR3) Single genes: D D D D D D D D D D D S S S S S S S S S S S Androgen insensitivity (AR) Aromatase deficiency (CYP19A1) Disorders of sex development with cleft palate (FOXF2) Follicle-stimulating hormone deficiency, isolated (FSHB) Hydatidiform mole (NLRP7) Hydatidiform mole (KHDC3L) Hypogonadotropic hypogonadism (KISS1) Hypogonadotropic hypogonadism (KISS1R) Hypogonadotropic hypogonadism (LHB) Hypogonadotropic hypogonadism (NSMF) Hypogonadotropic hypogonadism 7 with or without anosmia (GNRHR) D D D D D D D D D D D S S S S S S S S S S S Hypogonadotropic hypogonadism 11 with or without anosmia (TACR3) Hypogonadotropic hypogonadism 12 with or without anosmia (GNRH1) Hypogonadotropic hypogonadism type 14 (WDR11) Kallmann syndrome type 1 (KAL1) Kallmann syndrome type 2 (FGFR1) Kallmann syndrome type 3 (PROKR2) Kallmann syndrome type 4 (PROK2) Kallmann syndrome type 5 (CHD7) Kallmann syndrome type 6 (FGF8) Kallmann syndrome, SEMA3A related (SEMA3A) Leydig cell hypoplasia type 1 (LHCGR) D D D D D D D D D S S S S S S S S S Spermatogenesis dysfunction (SOHLH1) Oligozoospermia and/or tetratazoospermia(FSHR) Oligo-astheno-teratozoospermia (NANOS1) Spermatogenic failure type 4 (SYCP3) Spermatogenic failure type 5 (AURKC) Spermatogenic failure type 6 (SPATA16) Spermatogenic failure type 7 (CATSPER1) Spermatogenic failure type 8 (NR5A1) Spermatogenic failure type 9 (DPY19L2) R D S Premature ovarian failure/Fragile X Syndrome (FMR1) H H D D S S Noonan syndrome type 6 (NRAS) Noonan syndrome type 7 (BRAF) Noonan syndrome-like disorder with or without juvenile meylomonocytic leukemia (CBL) Polycystic kidney disease type 1, autosomal recessive (PKHD1) Polycystic kidney disease type 1, autosomal dominant (PKD1) Polycystic kidney disease type 2, autosomal dominant (PKD2) Usher syndrome type 1D/F (PCDH15) Usher syndrome type 1D/F (CDH23) Usher syndrome type 3A (CLRN1) Usher syndrome type IJ (CIB2) Infertility : Tests for Males* Single genes: H D D D D D D D D D S S S S S S S S 46XX sex reversal 1 (SRY) Autosomal nonsyndromic male infertility (CATSPER2) Azoospermia induced by Y chromosome microdeletions (AZF region) Cystic fibrosis/Congenital Bilateral Absence of the Vas Deferens (CFTR) Deafness and male infertility (STRC) Oligo-astheno-teratozoospermia (NANOS1) Persistent mullerian duct syndrome type 1 (AMH) Persistent mullerian duct syndrome type 2 (AMHR2) Pseudohermaphroditism with gynecomastia (HSD17B3) *Gender is based on phenotype which may not be consistent with a patient’s genotypic gender Infertility: Tests for Females* Single genes: D D S S Ovarian dysgenesis 1 (FSHR) Oogenesis dysfunction (SOHLH1) *Gender is based on phenotype which may not be consistent with a patient’s genotypic gender Additional Genetic Syndromes with Infertility NGS Panels: D S Polycystic kidney panel (BICC1, PKD1, PKD2, NOTCH2, PKHD1) Single genes: E E D D S S Adrenal hypoplasia (NR0B1) Denys-Drash syndrome (WT1) D S Frasier syndrome (WT1) D S D R R D D D D S Myotonic dystrophy type 1 (DMPK) Myotonic dystrophy type 2 (CNBP) Noonan syndrome like (SHOC2) Noonan syndrome type 1 (PTPN11) Noonan syndrome type 3 (KRAS) Noonan syndrome type 4 (SOS1) Noonan syndrome type 5 (RAF1) D D D D D D D S S S S S S S S S S S H H Page 3/4 The minimum amount of patient information is collected for provision of the service requested. This information is considered confidential and privileged. Unauthorized use and disclosure is prohibited. Requisition V3 Jan2015 GENETIC TESTING REQUISITION REPRODUCTIVE HEALTH & INFERTILITY 1-844-363-4357· [email protected] Schillingallee 68 · 18057 Rostock Germany Patient Name: Patient DOB (YYYY/MM/DD): Population Screening Tests NGS Panels: Advanced Ashkenazi (Sanger) panel S *includes BRCA1/BRCA2 analysis. To opt out, please indicated in the “Test Instructions” GBA (8 mut), CFTR (26 mut), HEXA (7mut), IKBKAP (2 mut), ASPA (4 mut), G6PC (2 mut) ABCC8 (2 mut), MCOLN1 (2 mut), BCKDHB (3mut), FANCC (2 mut), DLD (2 mut), SMPD1 (4 mut), CLRN1 (1 mut), PCDH15 (1mut), BLM (1mut), NEB (1 mut), BRCA1 (2 mut), BRCA2 (1 mut) S Basic Ashkenazi (Sanger) panel (HEXA (7 mutations), IKBKAP (2 mut), ASPA (4 mut),MCOLN1 (2 mut), FANCC (2 mut), SMPD1 (4 mut), BLM (1 mut)) Single genes: D D D S S S Cystic fibrosis (CFTR) Hemochromatosis classical (HFE) Sickle cell anemia (HBB) D D D D Page 4/4 S S S S Thalassemia, alpha (HBA1) Thalassemia, alpha (HBA2) Thalassemia, delta-beta (HBB) Spinal muscular atrophy (SMA) (SMN1) The minimum amount of patient information is collected for provision of the service requested. This information is considered confidential and privileged. Unauthorized use and disclosure is prohibited. Requisition V3 Jan2015