Laboratory Test Preparation

Not applicable

1. Cystic Fibrosis
2. Duchenne Muscular Dystrophy
3. Fragile X Syndrome
4. Spinal Muscular Atrophy

To determine if a patient is a carrier for up to 274 autosomal recessive and X-linked conditions. Horizon includes common conditions such as Cystic Fibrosis, Fragile X, Spinal Muscular Atrophy and Duchenne Muscular Dystrophy.

Patient can have Horizon Carrier Screening before or during pregnancy.

Next Generation-Sequencing

Special Test

• No patient preparation necessary.
• Take note that 1 kit will be used per patient.
•  If both partners will be tested, charge for the test will be twice (x2).
• Test collection container (violet top) will be provided by HPD. Branch to coordinate with Special Test (HPD Main) 2-3 days before specimen collection.
• Collect samples using one violet top (K2) tube.
• Mix by inverting 5 – 6 times.
• Do not centrifuge or freeze the specimen.
• Label with the patient’s name, date of birth, date of collection.
• Send sample immediately to HPD Del Monte for ship out within the day.

NOTE:If both partners will be tested, charge for the test will be twice (x2).

Collection Instructions :

1. Complete the “International Requisition Form”.

• Select the appropriate Horizon Screening option for the patient listed under “Test Ordering”
• Complete one form per patient. If both partners are getting screened, please use a separate requisition form and kit for each partner.
• Complete all appropriate fields on the requisition form related to Horizon. This includes patient and ordering clinician information in addition to the information about the Horizon Panel or condition selected.

2. Collect Blood Sample.

• Review sample requirements on the back of the sheet.
• Complete all information requested on the blood tube label.

3. Package sample.

• Place filled blood tube, with completed label, back in the foam holder.
• Place the foam holder with blood tube inside the biohazard bag

Horizon Collection Kit will be provided by HPD Special Test Section.

10 mL Whole Blood

Not Applicable

5 Days

Not Applicable

Not Applicable

• Transport specimen at 15°C ~25 °C (room temperature)
• Place samples in the provided Specimen Bag with gel packs and store at room temperature.
• Send sample immediately to HPD Del Monte for ship out within the day.
• Sample must reach Referral Laboratory within 5 days of sample collection.

NOTE:Double check completeness of information in the required documents prior to sending to HPD Main Laboratory to avoid delay in processing of sample.

• Incorrect storage and transport temperature of specimen 
• Improperly labeled specimen
• Incomplete documentation requirement or incompletely filled out Requisition Quantity not sufficient 
• Specimen collection kit stored/transported outside the temperature range.

Batch running 

Monday to Wednesday,  3:00 PM

• After 21 days (Excluding Saturdays, Sundays and Holidays)
• Results are NOT available online. 
• For HPD and HPD Plus branches, patients will be the one to pick up the result.

Available upon request

None specified

Q. What is Horizon Carrier Screening?

A:  Horizon looks at your genes to see if you’re a carrier for up to 274 autosomal-recessive and X-linked genetic conditions. 

Every one of us is a carrier for 4-6 changed genes that, if inherited in a double dose, could cause a genetic disorder in our children.  These disorders are rare and usually there is no family history, although certain disorders are more common in certain ethnic groups.  For most of these conditions, both parents have to be carriers for their children to be at risk (these are called autosomal recessive disorders).  Others are inherited from a mother who is a carrier (these are called X-linked disorders) and mainly affect boys.  Testing to see if you or your partners are carriers for genetic disorders is your choice, but this is testing that is usually offered to all women who are thinking about becoming pregnant, or who are already pregnant.  Horizon carrier screening offers testing for many of the most common genetic disorders.  You can choose to be tested for only 1 or 2 disorders or for as many as 274.

Q: Who should have Horizon Carrier Screening?

A:  Anyone who is pregnant or planning a pregnancy can have Horizon carrier screening. Additionally, people who are thinking about donating eggs or sperm usually have carrier screening. Ask your doctor or genetic counselor if Horizon carrier screening is right for you. Please note this testing is not available to minors in some cases. Horizon carrier screening for X-linked disorders is limited to female patients.

Q: When should I have Horizon Carrier Screening?

A:  Many couples consider having carrier screening before they become pregnant. If they are found to be at risk to have a child with a genetic disorder, they could choose to use in vitro fertilization, test the embryos for the disorder, and only transfer embryos predicted to be unaffected. If a woman is already pregnant, she and her partner can have Horizon carrier screening at any time. Most couples are found to be at decreased risk to have a child with a serious genetic disorder. Couples who are at increased risk have the opportunity to learn about the condition and plan the care of the pregnancy.

Q: What are the benefits of having Horizon Carrier Screening?

A:  Horizon can help you and your partners learn about the chance to have a child with a genetic disease before or during pregnancy. Many people do not know they are a carrier for an inherited genetic disease until they have an affected child. While there is no test that can screen for all possible genetic diseases or birth defects, genetic carrier screening can give you information to make reproductive choices that are right for you and your family.

Q: Do I need to have carrier screening more than once?

A:  Carrier screening is usually done once as your carrier status for a specific condition typically does not change. Depending on what you have been screened for in the past, your doctor or genetic counselor may recommend additional carrier screening for more conditions. So, it is possible to have carrier screening more than once. Ask your doctor or genetic counselor to find out what’s best for you.

Q: What if I have a family history of genetic disease?

A:  It is important to tell your healthcare provider about your family history. They may suggest you meet with a genetic counselor to review your history and discuss options for further testing. A Horizon carrier screen may be suggested as one way to see if your family history is a risk factor for your children.

Q: What is the chance I could have an affected child if I am a carrier?

A:  If you and your partner are both carriers for the same recessive genetic disease, you have a 1 in 4, or 25%, chance of having an affected child in each pregnancy. If a woman is a carrier of an X-linked disease, she has up to a 50% chance of having an affected child in each pregnancy.

Q:Can my partner and I get screened at the same time?

A:  You and your partner are welcome to have carrier screening at the same time. This should lessen the wait time for results if one partner is found to be a carrier and your doctor recommends the other partner have screening also. Remember, for autosomal recessive conditions, both partners must be carriers for the SAME condition in order to be at risk of having an affected child. Another choice is for the female partner to have carrier screening first. If she is found to be a carrier, then the male partner can be screened for the same condition. Your doctor or genetic counselor can recommend what’s best for you.

Q:Do I have to have the full Horizon carrier screening panel?

A:  No. Your doctor can order Cystic Fibrosis, SMA, and Tay-Sachs Enzyme individually. Your doctor can also choose from several Horizon screening panels in which a number of diseases are screened for at the same time.

Human Papilloma Virus Genotyping

Not applicable

• A qualitative in vitro test for the detection of 12 high risk HPV types and specifically for HPV16 and HPV18.
• For use in screening patients 21 years and older with atypical squamous cells of undetermined significance (ASC_US) Pap test results to determine the need for colposcopy.

Polymerase Chain Reaction (PCR)

Molecular Diagnostics Section

SurePath Preservative Fluid  

Cervical specimens collected with SurePath Preservative Fluid (10 ml)

Cervical specimens collected with COBAS PCR Cell Collection Media or ThinPrep (PreservCyt solution)

• Cervico-vaginal specimens collected in COBAS PCR Cell Collection Madia and ThinPrep (PreservCyt solution) may be stored at 2-30"C for up to 6 months after the date of collection.
• Cervico-vaginal specimens collected in SurePath Preservative Fluid may be stored at 2-8'Ç for up to 6 months or at 15-30''C for up to 14 days after the date of collection.
• In consideration of co-testing with Surepath liquid-based cytology, HPD will retain specimens collected in Surepath Preservative Fluid for One (1) month. Those who wish to proceed testing with HPV Genotyping can request to use the same specimen for testing if requested within a month.

• Cervico-vaginal specimens collected in SurePath Preservative Fluid may be stored at 15-30''C for up to 14 days after the date of collection.

• Cervico-vaginal specimens collected in SurePath Preservative Fluid may be stored at 2-8'Ç for up to 6 months

Unacceptable

Cervico-vaginal specimen collected with the COBAS PCR Cell Collection Media, ThinPrep (PreservCyt solution) and SurePath Preservative Fluid can be transported at 2-30''C

• Unlabeled or mislabeled specimens.
• No detachable brush in SurePath vials.
• Incorrect storage and transport temperature of specimen.
• Incomplete information in Cytology Request Form (for SurePath HPV PCR)

Batch running of 22 samples

Requires completion of a batch of 22 samples

Bloody sample

Q: Is HPV a STD?

A: HPV is the most common sexually transmitted infection (STI). HPV is a different virus than HIV and HSV (herpes). ... There are many different types of HPV. Some types can cause health problems including genital warts and cancers.

High risk HPV Cervical cancer screening, High risk HPV, HPV DNA, HPV RNA, hrHPV, Genital Human Papilloma Virus, Sexually Transmitted Disease

HSV 1&2

Not applicable

• Diagnose genital infection with herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2);

• Detect coinfection Assess prognosis and define appropriate counseling

Real-Time Polymerase Chain Reaction (RT-PCR)

Special Test

No patient preparation necessary.

Sterile Container

2 mL CSF

2 mL Serum

48 Hours

7 Days

40 Days

Transport specimen at 2 – 8 °C (with cold packs)

• Quantity Not sufficient
• Improperly labeled specimen
• Incorrect container used

Batch Running

Monday, 12:00 PM

2 weeks after cut-off (excluding Saturdays, Sundays and Holidays)

Not Applicable

None specified

Not applicable

Herpes Culture, Herpes Simplex Viral Culture, HSV DNA, HSV by PCR, HSV-1 or HSV-2 IgM or IgG, HSV-1, HSV-2, HHV1, HHV2, Herpes Simplex Virus, Type 1 and Type 2

• Herpes simplex virus 1 and 2 IgM (CLIA)
• HSV 1/2 IgM (CLIA)
• HSV-1 and 2 IgM Serology
• Herpes Viridae
• Herpes Simplex Virus 1/2 IgM (CLIA)

HSV Type 1 and Type 2

Detects recent infection with Herpes Simplex Virus

Enzyme-linked Immunosorbent Assay (ELISA)

Special Test

Take note of patient’s medical history, clinical diagnosis and medications currently taken, if any.

Take note if patient is pregnant

Red or Gold

3 mL Serum

Not Applicable

Not Applicable

5 days

Not Applicable

Store and transport specimen at 2 ⁰C to ⁰C (with cold packs).

• Improperly labeled specimens
• Hemolyzed specimens
• Lipemic specimens
• Quantity not sufficient
• Specimen storage and transport exceeded required temperature

Monday to Friday

Monday to Friday, 7:00 AM

3 days after cut-off (excluding Saturdays, Sundays and Holidays)

None Specified.

Bacterial contamination or heat inactivation of the specimen may affect the test results.

Q: Why get tested?

A:To screen for or diagnose infection with the herpes simplex virus (HSV)

Q: When to get tested?

A:If you have symptoms of an infection with HSV, such as blisters in the genital area, or symptoms of viral meningitis; if you have certain risk factors

Q: When it is ordered?

A:A herpes culture (or HSV DNA testing) may be ordered when someone has a blister (vesicle) on the genitals.

Herpes Culture, Herpes Simplex Viral Culture, HSV DNA, HSV by PCR, HSV-1 or HSV-2 IgG, HHV1, HHV2,TORCH, CSF Analysis

Herpes Simplex Virus 1&2 Quali IgM

Not Applicable

Used for Qualitative detection and screening of antibodies to Herpes Simplex Virus 1&2

Immunochromatography

Serology

No patient preparation necessary.

Red or Gold tube

1-2mL Serum

1-2mL Plasma (EDTA)

Not Specified

3 Days

>3 Days

Transport specimen at 2 – 8 °C (with cold packs)

• Improperly labeled specimens
• Hemolyzed specimens
• Lipemic specimens
• Quantity not sufficient
• Specimen storage and transport exceeded required temperature

Daily

Monday to Saturday
• 8:00 PM

Sunday
• 3:00 PM

ROUTINE
• 3 hours after receipt of specimen/ arrival of messenger
STAT
• 1½ hours from extraction/messenger arrival

NEGATIVE

None identified.

Not Applicable

Newborn Infection, Herpes Culture; Herpes Simplex Viral Culture; HSV DNA; HSV by PCR; HSV-1 or HSV-2 IgM or IgG; HHV1; HHV2,

• Western blot HTLV
• HTLV-1 and -2 - anti-antibodies

Not Applicable

HTLV (Human T-Lymphotropic Virus) Type I and Type II belong to the Retroviridae family but are distinct from HIV. HTLV-I causes T-cell leukemia and tropical spastic paraparesis. HTLV-II has been implicated in an unusual form of hairy cell leukemia. The viral genome can be detected by PCR assay but diagnosis mainly depends on serological screening followed by confirmation by Western Blotting.

Immunoblot

Special Test

No patient preparation necessary.

Red or Gold Tube

3 mL Serum

Not Applicable

8 Hours

7 Days

28 Days

Transport specimen at 2 – 8 °C (with cold packs)

• Hemolyzed specimen
• Markedly lipemic specimen
• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimen
• Improper collection tube used

Batch Running

Friday, 12:00 PM

2 weeks after cut-off (excluding Saturdays, Sundays and Holidays)

Not Applicable

None Specified

Not Applicable

Human T-cell Lymphotropic Virus; HTLV-I/II Antibodies; HTLV-I/II by PCR, Human T-Lymphotropic Virus Types I/II Antibodies; Human T-cell Lymphotropic Virus Types I/II by PCR

• Human T-cell Lymphotropic Virus
• HTLV-I/II Antibodies
• Human T-Lymphotropic Virus Types I/II Antibodies
• HTLV 1 and 2 Anti antibodies

Not Applicable

Is intended to be used as an aid in the diagnosis of HTLV-I and HTLV-II infection and as screening test to prevent transmission of HTLV-I and HTLV-II to recipients of blood, blood components, cells, tissue and organs.

HTLV (Human T-Lymphotropic Virus) Type I and Type II belong to the Retroviridae family but are distinct from HIV. HTLV-I causes T-cell leukemia and tropical spastic paraparesis. HTLV-II has been implicated in an unusual form of hairy cell leukemia. The viral genome can be detected by PCR assay but diagnosis mainly depends on serological screening followed by confirmation by Western Blotting.

Chemiluminescence

Special Test

No patient preparation necessary.

Red or Gold tube

3 mL Serum

Not Applicable

8 Hours

7 Days

28 Days

Transport specimen at 2°C – 8 °C (with cold packs)

• Hemolyzed specimen
• Markedly lipemic specimen
• Specimen stored/transported outside the temperature range
• Quantity not sufficient
• Improperly labeled specimens

Batch running

Friday, 12:00 PM

2 weeks after cut-off (Saturday, Sunday and Sunday)

Available upon request

Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.

Not Applicable

Complete Blood Count, WBC Differential, Immunophenotyping, Bone Marrow Aspiration and Biopsy

i-FINDER (Chronic Disease Screening)

1. Algorithm
2. Total Protein
3. Albumin
4. Bilirubin
5. AST
6. ALT
7. ALP
8. GGT
9. Vitamin D
10. TSH
11. LIPID
12. BUN
13. Creatinine
14. Uric Acid
15. HBA1C
16. CBC with Platelet Count

i–FINDER Chronic Screening is a safe and easy way to screen for8 major chronic lifestyle diseases

This test informs about the risk of chronic lifestyle diseases such as metabolic syndrome, cardiovascular diseases, and diabetes. The objective of the test is to help realize any improper lifestyle habits and manage them wisely before one suffers from these diseases.

Unlike conventional blood tests. the risks of 8 major chronic lifestyle diseases can be identified comprehensively and stereologically by using various markers including important markers.

Peptide Biomarker Analysis

Special Test

• Algorithm

Hematology

• CBC with Platelet Count
• HBA1C

Chemistry/Immunology

• Total Protein
• Albumin
• Bilirubin
• AST
• ALT
• ALP
• GGT
• Vitamin D
• TSH
• LIPID
• BUN
• Creatinine
• Uric Acid

For Hematology tests:

• No sample preparation is required.

For Chemistry/Immunology tests:

• 10 - 12 hours of fasting
• NOTE:must be protected from light

NOTE:

• Prolonged fasting is highly discouraged since various metabolic changes associated with starvation may begin to develop. Water intake is acceptable.
• Note in clinical info if patient drank more than 4 glasses of water during fasting period, ask patient for medical history as this is rather unusual.
• Note in clinical info in case patient overfasts and insists on proceeding test.
• Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration

• Do not draw specimens during dialysis

• 2 pcs 5mL Gold Tube
• 1 pc 4mL EDTA Tube

• 5 ml serum in 2 pcs transfer tube (palin tube) (2.5 mL each tube)
• 4 mL whole blood

Not Applicable

4 hours

3 days

4 days

Transport specimen at 2 – 8 °C (with cold packs)

• Insufficient volume
• Incorrect storage temperature of specimen
• Incorrect collection container used
• Clotted sample
• Hemolyzed
• Lipemic
• Incompletely filled out questionnaire form
• Samples with inadequate centrifugation

Batch running

Monday, 3:00 PM

2 weeks after cut off (excluding Saturdays, Sundays and Holidays)

Sample result may be requested from Special Test Section if needed.

Not applicable

Q: What is Smart Cancer Screening?

A: Assess risk of 8 major types of cancers (Lung, Liver, Stomach, Colon, Pancreatic, Prostate, Breast and Ovarian) with small amount of blood.

Shows higher possibility of detecting cancers than conventional methods based on propriety big data.

Q: Why Smart Cancer Screening Test?

A: Smart Cancer Screening test is safe no unnecessary radiation exposure and endoscopy.

High chance of detection.

Helps your healthy life by effective early cancer screening.

Q: What are the advantages of I-Finder Smart Screening?

A: Requires only small amount of blood

No exposure to radiation.

Needs for diet of enemas.

Early cancer screening.

High detection rates.

No fear of receiving an endoscopy.

i-FINDER (Classic)

1. Algorithm
2. Total PSA (Male only)
3. CA 15-3 (Female only)
4. CEA
5. CA19-9
6. CA125
7. CYFRA21-1
8. HE4
9. D-dimer,
10. hsCRP
11. β2-microglobulin
12. Apo B
13. sVCAM-1
14. Prealbumin
15. Apo A-I
16. Apo A-II
17. Apo A-IV
18. RANTES
19. EGFR
20. AFP
21. Pepsinogen II

i–FINDER Classic Smart-Cancer Screening is a safe and easy way to screen for8 major cancers  of the Lung, Liver, Stomach, Colon, Pancreatic, Prostate, Breast and Ovarian using a small amount of blood.

The test not only detects cancer, but also evaluates new blood vessel proliferation, overall immune system health and metabolism flow to assess cancer risk high specificity. 

Peptide Biomarker Analysis

Special Tests

Required Documents for HPD Clinician:

• I-Finder Test Requisition Form

Required Documents for Patients:

• Patient Information Collection and Sharing Consent
• Health Questionnaire

Required Documents for Patients:

• Patient Information Collection and Sharing Consent
• Health Questionnaire

1. The clinician (In-house) should fill out the I-Finder Requisition Form.
2. The patient should only fill out the Health Questionnaire and Patient Information Collection and Sharing Consent.
3. Patient to fill out the Health Questionnaire completely.

1. The Health Questionnaire consists of a health common assessment table, a female health assessment table, and a cancer assessment table.
2. The Cancer Assessment table is only for a patient with a cancer diagnosis history.
3. FOR MALE : Common Health Assessment and Patient Information Collection and Sharing Consent
4. FOR FEMALE : Common Health Assessment, Patient Information Collection and Sharing Consent and Female Assessment
5. FOR MALE WITH HISTORY OF CANCER : Common Health Assessment, Patient Information Collection and Sharing Consent Form and Cancer Assessment
6. FOR FEMALE HISTORY OF CANCER: Common Health Assessment, Patient Information Collection and Sharing Consent, Cancer Assessment and Female Assessment.

4. The “I AGREE” box of the Patient Information Collection and Sharing Consent must be checked.
5. When the examinee submits the health questionnaires, please review them to ensure that questions are answered properly. If any blank questions occur, ask the patient to fill out the blank.

HPD Del Monte – Special Test Section Staff

• All questionnaires must be scanned and emailed to bio-infrastructure clinic.

HPD Staffs

1. Draw 8 mL blood into 2 pieces 5 mL SST tube provided by HPD.
2. Complete information on blood tube label.
3. After blood sampling, mix the tube up and down procedure five times (5x).
4. Leave the tube on the rack vertically and at room temperature (15⁰C~25⁰C) for 30 minutes.

Warning:  If you leave it for too little or too much time, this will affect the test result

For Patient:

1. Fast for at least 6~8 hours before the test. During the fasting period, do not consume any food or drink except for a small amount of water.
2. Female patients should not take the test while menstruating or for 2-3 days before and after.

1. Please do not consume any alcohol for at least 24 hours prior to the test. In addition, please avoid excessive drinking the week of the test.  
2. If you are currently taking any anti-hypertensive, anti-arrhythmic, or anticonvulsant medication, please take it with water as usual. If you regularly take any other medication, please take it after the test.
3. If you are currently taking a temporary medication (e.g., antibiotics) due to acute disease (e.g., infection), please delay taking the test until three days after the course of medication has been completed. 
4. A family doctor or medical practitioner should fill out a test request form.
5. The examinee should only fill out the health questionnaire and Patient Information Collection and Sharing Consent.

5 mL Gold Tube 

5 mL serum in 2 pcs transfer tube (plain tube) (2.5ml each tube)

Not Applicable 

24 Hours

30 Days 

• Insufficient volume requirement
• Incorrect storage temperature of specimen
• Incorrect collection container used
• Hemolyzed
• Lipemic
• Incompletely filled out questionnaire form
• Samples with inadequate centrifugation

Batch running

Monday, 12:00 PM

2 weeks after cut off (excluding Saturdays, Sundays and Holidays)

Available upon request.

Not Applicable

Q: What is Smart Cancer Screening?

A:Assess risk of 8 major types of cancers (Lung, Liver, Stomach, Colon, Pancreatic, Prostate, Breast and Ovarian) with small amount of blood.

Shows higher possibility of detecting cancers than conventional methods based on propriety big data.

Q: Why Smart Cancer Screening Test?

A:Smart Cancer Screening test is safe no unnecessary radiation exposure and endoscopy.

High chance of detection.

Helps your healthy life by effective early cancer screening.

Q: What are the advantages of I-Finder Smart Screening?

A:Requires only small amount of blood

No exposure to radiation.

Needs for diet of enemas.

Early cancer screening.

High detection rates.

No fear of receiving an endoscopy.

• IgG Subclasses and Total IgG
• Immunoglobulin G Subclasses Panel

• Immunoglobulin G Subclasses 1, 2, 3, 4
• IgG (Immunoglobulin G)

Diagnose IgG subclass deficiency in patients with recurrent bacterial infections

Diagnose IgG monoclonal gammopathy

Immunoturbidimetric Assay

Special Test

No patient preparation necessary.

Red or Gold Tube

3 mL Serum

Not applicable

24 Hours

7 Days

28 Days

Transport specimen at 2 – 8 °C (with cold packs)

• Hemolyzed specimen
• Markedly lipemic specimen
• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimen
• Improper collection tube used

Batch Running

Monday, 12:00 PM

2 weeks after cut-off (excluding Saturdays, Sundays and Holidays)

Available upon request

None Specified

Not Applicable

Total Immunoglobulins, Immunoglobulin A, IgA, Immunoglobulin G, IgG, Immunoglobulins, Quantitative, Immunoglobulin M, IgM

Alpha feto-protein 

Not applicable 

A major plasma protein in the fetus, where it is produced by the yolk sac and liver

Immunohistochemistry (IHC)

Special test 

All specimens must be LABELED properly and legibly. The label must match the information on the test request form and on the provided histopathology report.

- Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.

- FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

- Formalin-fixed paraffin-embedded (FFPE) tissue block

- H&E stained slide, representative of the submitted tissue block.

- Histopathology report for the submitted tissue block and slide

- Completely filled out HPD Histopathology Request Form (HPD_F_258)

Note:Submit to HPD Main Laboratory all tissue blocks and slides received.

Not Applicable

- FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15^oC~30^oC).

- Hi-Precision Diagnostics will store FFPE tissue blocks and H&E slides for 10 years, after which samples will be disposed properly according to biosafety disposal guidelines.

Indefinite

Not Applicable

Not Applicable

Transport specimen at 15^oC -30^oC

- Incorrect/Incomplete information in the HPD Histopathology Request Form

- Improper or insufficient labeling of tissue blocks or slides

- Inadequate tissue available on the tissue block

- Tissue blocks and slides do not correspond to its histopathology report

- Specimen stored and transported outside the required temperature

Tuesday and Thursday 

Monday 7am and wednesday 7am 

10 working days (excluding saturdays, sundays and holidays) 

- The clinical interpretation of any staining, or absence of staining, must be complemented by histological studies and evaluation of proper controls.

- Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.

Not Applicable

Not Applicable

Not Applicable

VENTANA ALK (D5F3) CDx Assay

Not applicable

- VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC)

- It is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib), ZYKADIA (ceritinib), or ALECENSA (alectinib).

Immunohistochemistry (IHC)

Histopathology

All specimens must be LABELED properly and legibly. The label must match the information on the test request form and on the provided histopathology report

- Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.

- FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

- Formalin-fixed paraffin-embedded (FFPE) tissue block

- H&E stained slide, representative of the submitted tissue block.

- Histopathology report for the submitted tissue block and slide

- Completely filled out HPD Histopathology Request Form (HPD_F_258)

Note:Submit to HPD Main Laboratory all tissue blocks and slides received.

Not Applicable

- FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15^oC~30^oC).

- Hi-Precision Diagnostics will store FFPE tissue blocks and H&E slides for 10 years, after which samples will be disposed properly according to biosafety disposal guidelines.

Indefinite

Not applicable

Not applicable

Transport specimen at 15^oC -30^oC

- Incorrect/Incomplete information in the HPD Histopathology Request Form

- Improper or insufficient labeling of tissue blocks or slides

- Inadequate tissue available on the tissue block

- Tissue blocks and slides do not correspond to its histopathology report

- Specimen stored and transported outside the required temperature

Monday to Saturday

12:00 PM

- With Reading - 3 to 5 days after receipt of specimen/ messenger arrival

- For Processing Only - 1 day after receipt of specimen/ messenger arrival

Note: Additional 2 days may be necessary if specimen needs further evaluation and confirmation by another Pathologist

- The clinical interpretation of any staining, or absence of staining, must be complemented by histological studies and evaluation of proper controls.

- Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.

- Ventana recommends fixation in 10% NBF for 6-48 hours.

- Fixation for less than 6 hours is not recommended.

- The use of Bouin’s, and alcohol fixatives, such as AFA and 95% Ethanol, is not recommended due to weaker staining.

Q. What is Immunohistochemistry?

A.Immunohistochemistry or IHC refers to the process of detecting antigens (e.g., proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues.

Q. Why do we need to undergo Immunohistochemistry test?

A. - Confirm a pathologic diagnosis

      - Differentiate between benign or malignant tumor

      - Detect among different types of tumor

      - Monitor prognosis response to treatment

Q: What causes ALK gene mutation?

A:These mutated genes in turn code for proteins that are abnormal and perform abnormal functions such as driving the growth of a cancer. Discovered in 2007, an ALK mutation is a mutation in a gene called ALK (anaplastic lymphoma kinase).

Q: Does everyone have the ALK gene?

A:Everyone has two copies of the ALK gene, which we randomly inherit from each of our parents. Mutations in one copy of the ALK gene can increase the chance for you to develop certain types of cancer and/or non-cancerous tumors in your lifetime.

Q:  What is ALK test?

A:ALK mutation analysis is used primarily to determine if a person with adenocarcinoma non-small cell lung cancer is likely to respond to an ALK kinase inhibitor drug therapy, such as crizotinib. This testing detects the presence of ALK gene rearrangements in tumor tissue

- ImmunoHistoChemistry (IHC)

- VENTANA ALK (D5F3) CDx Assay

- Non-small cell lung carcinoma (NSCLC)

B-cell lymphoma 2

Not applicable

- BCl-2 is helpful in distinguishing follicular lymphoma from reactive follicular hyperplasia.

-  Overexpression of Bcl-2 is common in many types of cancer, including non-Hodgkin's lymphoma and leukaemias, adenocarcinomas (e.g., prostate, colorectum, stomach, and lung), squamous cell carcinoma, small cell carcinoma, neuroblastoma and various sarcomas. Among the latter, strong Bcl-2 positivity has particularly been demonstrated in gastrointestinal stromal tumor, solitary fibrous tumor, and synovial sarcoma, while fibromatosis and "malignant fibrous histiocytoma" are usually negative.

- Among malignant lymphomas, Bcl-2 protein overexpression is often caused by chromosomal translocation with Bcl-2 gene rearrangement. This is especially seen in follicular lymphoma. Bcl-2 is expressed in almost 100% of the grade I lymphomas, in >80% of the grade II and in 75% of the grade III lymphomas. Follicular lymphoma of the skin is often bcl-2 negative.

Immunohistochemistry (IHC)

Histopathology

All specimens must be LABELED properly and legibly. The label must match the information on the test request form and on the provided histopathology report

- Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.

- FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

- Formalin-fixed paraffin-embedded (FFPE) tissue block

- H&E stained slide, representative of the submitted tissue block.

- Histopathology report for the submitted tissue block and slide

- Completely filled out HPD Histopathology Request Form (HPD_F_258)

Note:Submit to HPD Main Laboratory all tissue blocks and slides received.

Not Applicable

- FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15^oC~30^oC).

- Hi-Precision Diagnostics will store FFPE tissue blocks and H&E slides for 10 years, after which samples will be disposed properly according to biosafety disposal guidelines.

Indefinite

Not applicable

Not applicable

Transport specimen at 15^oC -30^oC

- Incorrect/Incomplete information in the HPD Histopathology Request Form

- Improper or insufficient labeling of tissue blocks or slides

- Inadequate tissue available on the tissue block

- Tissue blocks and slides do not correspond to its histopathology report

- Specimen stored and transported outside the required temperature

Monday to Saturday

12:00 PM

- With Reading - 3 to 5 days after receipt of specimen/ messengers arrival or 10 working days (if with special test)

- For Processing Only - 1 day after receipt of specimen/ messengers arrival

Note: Additional 2 days may be necessary if specimen needs further evaluation and confirmation by another Pathologist

- The clinical interpretation of any staining, or absence of staining, must be complemented by histological studies and evaluation of proper controls.

- Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.

- Ventana recommends fixation in 10% NBF for 6-48 hours.

- Fixation for less than 6 hours is not recommended.

Q. What is Immunohistochemistry?

A.Immunohistochemistry or IHC refers to the process of detecting antigens (e.g., proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues.

Q. Why do we need to undergo Immunohistochemistry test?

A. - Confirm a pathologic diagnosis

      - Differentiate between benign or malignant tumor

      - Detect among different types of tumor

      - Monitor prognosis response to treatment

- ImmunoHistoChemistry (IHC)

- Bcl-2

-B-cell lymphoma 2

Not applicable

Not applicable

• The pathologic diagnosis of malignant mesothelioma is often difficult, even with the benefit of special studies such as histochemistry, electron microscopy, and immunohistochemistry. 

Immuno Histochemistry

Special Test

No patient preparation necessary.

Slide holders or mailers for microscope slides; FFPE tissue blocks can either be wrapped in paper or placed in a box.

• Formalin-fixed paraffin-embedded (FFPE) tissue block
• 1 H&E stained slide representative of the submitted tissue block.
• Histopathology report for the submitted tissue block

Not Applicable

Indefinite

Not applicable

Not applicable

• Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

• Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)

batch Running

Day before running day

14 Days (excluding saturdays, Sundays and Hildays.)

Not Applicable

None specified.

Not Applicable