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GENETIC TEST REQUISITION FORM

TR ID: Test Code: Test Name:

TR ID: Test Code: Test Name:

TR ID: Test Code: Test Name:

PATIENT DETAILS

GENETIC TEST REQUISITION FORM - RD & RH

MRN No: Patient Name: DOB: D D M M Y Y Y Y

Age: Sex: M F Marital Status: Ethnicity: Affected: Unaffected:

*
Spouse Name : Age: Sex: M F Ethnicity:
(NA in case of single sample sent)

DOB: D D M M Y Y Y Y Marital Status: Contact No.:

Address:

Email ID: Pincode:

In case of Prenatal Gestational Age: (in weeks) Consanguinity: Y N Last Menstrual Period (LMP): D D M M Y Y Y Y
(Mandatory Form G to be attached)

EDD (By USG): D D M M Y Y Y Y EDD (By LMP): D D M M Y Y Y Y

*To be filled when sending Couple sample

ADDITIONAL FAMILY MEMBERS INFORMATION**

Name Affected Relation with Patient DOB Age Sex

Y D D M M Y Y Y Y M F

Y D D M M Y Y Y Y M F

Y D D M M Y Y Y Y M F

Y D D M M Y Y Y Y M F
** To be filled if more than one family member’s sample sent for testing

CLINICIAN INFORMATION

Referring Clinician: Clinician Contact:

Referring Hospital:
Email ID:
Address:

SAMPLE COLLECTION INFORMATION

Date & Time of Collection: D D M M Y Y Y Y H H M M Date of Consent: D D M M Y Y Y Y

Sample collected by: Clinical History/Previous Report Attached: Y N

SLS/GEN/TRF-RH&RD/02, V1

DETAILS OF SAMPLE SENT TO THE LAB

Strand Life Sciences Pvt. Ltd.

SEND SAMPLES TO Ground Floor, UAS Alumni Association Building, Veterinary College Campus, Hebbal, Bangalore - 560024
(Monday to Saturday only)
Phone: +91 99 8044 8044, Email: [email protected]

FOR OFFICIAL USE ONLY

Sales person: Region:

Bill type (for internal use only):

1
Strand Life Sciences Pvt. Ltd. Ground Floor, UAS Alumni Association Building, Bellary Road, Hebbal, Bengaluru - 560024
 +91 9980448044
[email protected]
strandls.com

SAMPLE TYPE & COLLECTION INFORMATION

Tick Mark Sample Types Sample Collection & Shipping Instructions

Whole Blood (Purple top) tube - >2ml in cool packs

Cord Blood (Purple top) tube - >2ml in cool packs

Buccal Swab In the collection kit provided by Strand. Shipped at ambient temperature

Cheek Swab In the collection kit provided by Strand. Shipped at ambient temperature

Saliva In the collection kit provided by Strand. Shipped at ambient temperature

Purified Genomic DNA Source _____, DNA (>1 microgram) in 10 mM Tris buffer (No EDTA) in cool packs

GENETIC TEST REQUISITION FORM - RD & RH

Dried Blood Spot (DBS) 2-3 drops of blood per circle in the blood stain card provided by Strand. Shipped at ambient temperature
Chorionic Villi Sample(CVS) 20-30mg in sterile tube with transport media provided from Strand in cool packs

Amniotic Fluid (AF) 20-25ml in the sterile tube provided from Strand in cool packs

Maternal Blood (Purple top) tube - >2ml in cool packs

Product of Conception (POC) 2-5mm tissue sample in a Sterile tube provided by Strand. Shipped in a cool pack

Others Others

TEST DETAILS

Tick Mark Test Codes Test Names MCC# Raw Data*

(Tick Mark if required) (Tick Mark if required)

SLS166001 Whole Exome

SLS166004 ExomePlus
SLS166002 Rapid ExomePlus
SLS166188 Rapid Whole Exome
SLS166185 Whole Exome Test (Raw Data Only) NA
SLS166003 ExomePlus (Raw Data Only) NA
SLS165530 Trio Whole Exome Sequencing
SLS165526 ExomePlus Trio
SLS166000 Clinical Exome Test
SLS165531 Couple Whole Exome Sequencing NA
SLS165511 Couple ExomePlus Sequencing NA
SLS165510 Couple Carrier Sequencing (2000 Genes) NA
SLS165509 Couple Carrier Screening Comprehensive NA
SLS161000 Germline BRCA1 & BRCA2 NA
SLS161003 HBOC Comprehensive Panel (19 Genes) NA
SLS161013 Hereditary Cancer Panel NA

SLS150001 Mutation Specific Testing (Sanger) NA

SLS150002 HBB Gene Analysis NA

SLS140024 MLPA CYP21A2 NA

SLS140027 MLPA DMD NA

SLS140028 MLPA SMA NA

Others

*Fastq data (Tick Mark for additional data files) VCF BAM #If MCC done elsewhere, mandatorily attach the report
SLS/GEN/TRF-RH&RD/02, V1

MUTATION SPECIFIC TESTING DETAILS

Patient Name for MST:

Patient 1

Patient Name for MST:

Patient 2

Specific Mutation Identified Gene: Variant:

Family Member Name: Relation:
(Proband Name)

DOB: D D M M Y Y Y Y Sample sent: D D M M Y Y Y Y

Patient Disease Status: Symptomatic Asymptomatic

Proband tested at Strand: Yes No (If No, then attach the proband report)
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Strand Life Sciences Pvt. Ltd. Ground Floor, UAS Alumni Association Building, Bellary Road, Hebbal, Bengaluru - 560024
 +91 9980448044
[email protected]
strandls.com

CLINICAL PROFORMA

NEUROLOGICAL CRANIOFACIAL CARDIOVASCULAR

Agenesis of corpus callosum Macrostomia Left ventricular non-compaction
Basal ganglia abnormality Microcephaly Long QT interval
Cerebral atrophy Micrognathia Myocardial infarction
Cerebellar atrophy Microstomia Short QT interval
Cortical dysplasia Nose abnormality Syncope
Dandy-Walker malformation Other* ______________________ Tetralogy of Fallot
Dementia Valve abnormality
Encephalopathy NEPHROLOGY Ventricular septal defect
Febrile seizures Proteinuria Cardiomyopathy

GENETIC TEST REQUISITION FORM - RD & RH

Generalized seizures Hematuria Coarctation of aorta
Hydrocephalus Increased serum creatinine Pulmonary arterial hypertension (PAH)
Hypomyelination Increased urinary creatinine Other* ______________________
Infantile spasms Increased urinary oxalate
OPHTHALOMOLOGIC / AUDITORY
Leukodystrophy Cystic kidney
Lissencephaly Dysplastic kidney Abnormal eye movements
Neural tube defect Hydronephrosis Cherry red spot
Neuropathy Acute kidney injury Cataract
Pachygyria Other* ______________________ Coloboma
Periventricular leukomalacia Corneal opacity
Polymicrogyria BEHAVIOURAL / COGNITIVE Glaucoma
Schizophrenia Anxiety Microphthalmia
Sclerosis Attention deficit Myopia
Stroke Autistic spectrum Night blindness
Tongue fasciculations Cognitive deficit Nystagmus
Other* ______________________ Delayed speech Ophthalmoplegia
Intellectual disability Optic atrophy
ABNORMAL EEG Ptosis
Hyperactivity
Skeletal Lethargy Retinitis
Clubfoot Psychiatric anomaly Sensorineural hearing loss
Ectrodactyly Self-injurious behaviour Tunnel vision
Hip dysplasia Hand flapping Vision loss
Joint contractures Echolalia Visual impairment
Limb malformation Aggresive Other* ______________________
Polydactyly Hyperphagia SKIN / HAIR / CONNECTIVE TISSUE
Scoliosis Other* _______________________
Short stature Hair abnormality
Skeletal dysplasia
HEMATOLOGIC / IMMUNOLOGICAL Nail abnormality
Syndactyly Alopecia
Allergy
Vertebral anomaly Blisters on skin/mucosa
Anemia
Other* ______________________ Hemangioma
Enlarged lymph nodes
Hirsutism
MOVEMENT Immune deficiency
Hyperkeratosis
Neutropenia
Abnormal gait Hyperpigmentation
Pancytopenia
Ataxia Hypopigmentation
Recurrent infections
Cerebral palsy Ichthyosis
Sickle-shaped cells
Chorea Skin rashes
Thrombocytopenia
Spasticity Café-au-lait spots
Thrombosis
Tremors Other* ______________________
Thymic hypoplasia
Other* ______________________ Other* ______________________ GENITOURINARY
DEVELOPMENTAL MUSCULAR Ambiguous genitalia
Delayed motor development Abnormality of external genitalia
Abnormal muscle biopsy
Dysarthria Glomerulonephritis
Dystonia
Global developmental delay Glomerular sclerosis
Exercise intolerance
Failure to thrive Hematuria
Hyperextensibility
Learning diability Hydronephrosis
Hypertonia
Intellectual disability Hypogenitalism
Hypotonia
Neuroregression Hypospadias
Joint hyperflexibility
Other* ______________________ Infertility
Joint hypermobility
Kidney dysfunction
SLS/GEN/TRF-RH&RD/02, V1

Muscle wasting
CRANIOFACIAL Micropenis
Muscle weakness
Abnormality of hairline Obstructive renal disease
Elevated CPK
Broad facies Polycystic kidneys
Abnormal EMG
Cleft lip Reduced glomerular filtration rate
Other*______________________
Cleft palate Renal dysplasia
Coarse facies CARDIOVASCULAR Renal failure
Synophrys Abnormal ECG Renal hypoplasia
Downslanting palpebral fissures Abnormal ejection fraction Uterine abnormality
Flat facies Aborted cardiac arrest Other* ______________________
Flat or prominent occiput Aortic stenosis GASTROINTESTINAL
Frontal bossing Arrhythmia
Hypertelorism Abdominal wall defects
Atrial septal defect
Hypotelorism Constipation
Cardiac hypertrophy
Diarrhea

3
Long palpebral fissures Conduction system defect
Macrocephaly Gastroschisis
Congenital heart defect

Strand Life Sciences Pvt. Ltd. Ground Floor, UAS Alumni Association Building, Bellary Road, Hebbal, Bengaluru - 560024 *(Specify if not found in list)
 +91 9980448044
[email protected]
strandls.com

GASTROINTESTINAL PRENATAL / PERINATAL HISTORY METABOLIC

Gastrointestinal reflux Hypoplastic left heart Hepatic failure
Omphalocele Intrauterine growth restriction Hepatic cysts
Pyloric stenosis Midline pelvic structure Hepatomegaly
Recurrent vomiting Nuchal edema Hypercalcemia
Perforations Oligohydramnios Hyperglycemia
Fistula Polyhydramnios Hyperlipidemia
Other* ______________________ Prematurity Hypoalbuminemia
Prosencephaly Hypocalcemia
ENDOCRINE
Recurrent miscarriage Hypoglycemia
Hypoparathyroidism Increased NT Intestinal blockage
Hypothyroidism Absent nasal bone Jaundice

GENETIC TEST REQUISITION FORM - RD & RH

Overgrowth Flat facial features Ketosis
Pituitary defect Long bone short Lactic acidemia
Other*__________________ IUGR Organic aciduria
Other* _____________________ Proteinuria
PRENATAL / PERINATAL HISTORY
Splenomegaly
Abdominal wall defect METABOLIC Metabolic acidosis
Cystic hygroma Abnormal plasma carnitine Persistent increased lactate
Echogenic calcification Albuminuria Other* ______________________
Hydrops fetalis Elevated alanine
Hyperechogenic bowel Elevated pyruvate
*(Specify if not found in list)

ADDITIONAL CLINICAL INDICATIONS/PEDIGREE/FAMILY HISTORY (ATTACH SEPARATELY IF DETAILED PEDIGREE)

SLS/GEN/TRF-RH&RD/02, V1

4
Strand Life Sciences Pvt. Ltd. Ground Floor, UAS Alumni Association Building, Bellary Road, Hebbal, Bengaluru - 560024
 +91 9980448044
[email protected]
strandls.com

INFORMED CONSENT FOR GENETIC TESTING

• If the proband is over 18 years of age, ‘You’ in this form refers to the proband or your authorized personnel for a period of 3 months. For requests beyond
• If the proband is a minor or differently-abled, ‘You’ in this form refers to the Legal that period we may charge an additional cost, as per institutional policy.
Guardian of the proband 12. Our laboratory does not return any leftover sample after completion of
testing under any circumstances. The only exception to the above is in the
• ‘We’, ‘Our’, ‘Us’ refers to Strand Life Sciences Pvt. Ltd.
case of FFPE tumor blocks which can be returned upon request by you or
You hereby consent to undergo testing offered by us and understand that: your ordering physician within a period of 6 months. Any left over DNA (if
1. Your biological sample(s) will be collected using generally accepted techniques. available), regardless of the sample type, can be requested by you for up to
The sample(s) could be blood, saliva, tumor tissue, or any other biological sample a period of 3 months, provided you bear the transportation costs.
as needed. 13. Samples collected as part of routine care with potential for future genetic
2. You understand that the sample(s) may be used to determine if you and/or your research will be stored by our laboratory in accordance with ICMR guidelines

GENETIC TEST REQUISITION FORM - RD & RH

family members have variants in your gene(s). Results may indicate affected 2017, clause 10.3.7.
status, increased risk of being affected in future, inherited risk of disease, 14. Samples can also be shared with collaborators within or outside the country
somatic mutations in tumor tissue, or other such findings. in line with existing relevant guidelines, in accordance with ICMR guidelines
3. Genetic tests are relatively new and are being improved and expanded 2017, clause 10.3.8.
continuously. You are aware of the risks and limitations of genetic testing. 15. You understand and agree to the use of your data and biological sample for
4. You may need to share your relevant health records to correlate the findings from future research by us and our collaborators. We will use your samples and
the genetic testing. data in anonymised or aggregated form, such that it will be incapable of
5. The genetic test report will be usually released within the Turnaround Time (TAT) identifying you. By voluntarily signing this consent form you agree to provide
specified by us for the test. broad or blanket consent for the storage and use of your samples and data
6. A positive test result is an indication that the individual being tested has a as specified by ICMR guidelines 2017. You can opt out of this clause by
genomic variant that might have implications for their health or their progeny’s ticking this box here.
health. Consultation may be sought from any physician of your choice. You may 16. Sharing of data with our collaborators will be bound under a data access
also consider independent testing and consultation in addition. agreement that will maintain individual confidentiality. Your personal identity
7. The report will be shared with your authorized physician where applicable, or will not be revealed in any information shared with third parties or published;
shared to your registered email ID, or shared on our secure portal, or a hard copy your data will be coded accordingly.
of the report can be shared upon request to the address provided in this form. 17. The future use of your data or sample in research may result in commercial
8. It is possible that knowledge of genetic information of an individual might be gains. Based on the nature of research outcomes, further investments by us
misused if it is in the wrong hands. Hence, we cannot reveal the genetic may be needed to commercialize these outcomes. You will not have the right
information even to family members without your explicit written authorization to to participate in any direct monetary gains resulting from any future
do so. We will maintain complete confidentiality of the test results, as genetic test commercial activity.
results can have social implications. 18. You understand and agree to being re-contacted in the future if there is new
9. Genetic testing has its limitations. A repeat or alternative tests might be information available on your genomic variants or new research envisaged
recommended by your treating physician accordingly. that you could benefit from.
10. Genetic testing might identify secondary findings in genes outside of the original 19. You have the full rights to decide whether or not you wish to provide consent,
test genes as defined by the American College of Medical Genetics. nobody can coerce you into providing consent. You can also choose to
You can opt out from receiving secondary findings by ticking this box here. withdraw your consent at a later stage if you so wish, you need to notify us
11. All laboratory raw data are confidential and will not be released unless a special regarding the same.
written request is made by you or the consulting clinician on record, or a valid 20.In case you have any concerns or perceive any conflict of interest, you may
court order is received by us. VCF, FASTQ and BAM files can be provided to you seek clarification on institutional policy from relevant authorities.

Name of Individual/Legal Guardian: Date: DD/MM/YYYY Signature:

STATEMENT OF PHYSICIAN
• I have explained the genetic testing suitable for this individual and the individual has had the opportunity to ask questions.
• I have addressed the limitations outlined above, and I have answered this person's questions.
• I have obtained consent from the patient or the legal guardian for this testing. I confirm that the individual has given consent willingly.
• I allow Strand Life Sciences to contact the aforementioned patient for clinical history, treatment plan, and other details relevant to this test.
• I undertake to maintain the privacy and confidentiality of the patient's genetic data obtained from Strand Life Sciences and will remain
solely responsible for any wrongful acts and/or omissions arising out of, or in relation to my use of the patient's genetic data.

Name: Date: DD/MM/YYY (Physician) Signature:

SLS/GEN/TRF-RH&RD/02, V1

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Strand Life Sciences Pvt. Ltd. Ground Floor, UAS Alumni Association Building, Bellary Road, Hebbal, Bengaluru - 560024
 +91 9980448044
[email protected]
strandls.com

FORM OF CONSENT (FORM G)

I_____________________________________________________, aged ________ years, wife/daughter of __________________________________ residing at,

___________________________________________________________________________________________________________________________________________
(Address)

hereby state that I have been explained fully the probable side effects and after-effects of the prenatal diagnostic procedures in my
interest, to find out the possibility and abnormality (i.e. deformity or disorder) in the child.

I undertake not to terminate the pregnancy if the pre-natal procedure and any pre-natal tests conducted show the absence of
deformity or disorders. I understand that the sex of the fetus will not be disclosed to me.

GENETIC TEST REQUISITION FORM - RD & RH

I understand that breach of this undertaking will make me liable to penalty as prescribed in the Prenatal Diagnostics Technique
(Regulation and Prevention of Misuse) Act, 1994 (57 of 1994).

Date: DD/MM/YYYY Signature: Place:

I have explained the contents of the above consent form to the patient and/or her companion:

____________________________________________________of_____________________________________________________________________________________
(Name) (Address)

__________________________________________________________________, ___________________________________ in a language she/they understand.

(Relationship)

Date: DD/MM/YYYY Place:

Name, Signature & Registration No.

of the Gynecologist/Radiologist/
Registered Medical Practicioner

SLS/GEN/TRF-RH&RD/02, V1

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Strand Life Sciences Pvt. Ltd. Ground Floor, UAS Alumni Association Building, Bellary Road, Hebbal, Bengaluru - 560024