Laboratory Test Preparation

Not applicable

Not applicable

There are a total of 20 amino acids. Of these, 8 are referred to as essential (leucine, isoleucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine) because they can only be obtained from food and therefore must be present in the diet. Amino acid levels are highly variable and their metabolism is dependent on hormonal, metabolic and dietary factors. Pathological modifications of amino acids may be due to either metabolic problems (impaired kidney or liver function) or enzyme deficiencies.

High Performance Liquid Chromatography (HPLC)

Special Test

No patient preparation necessary.

Green or Heparin Tube

3 mL Plasma

Not Applicable

Not applicable

7 Days

30 Days

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

• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimen
• Improper collection tube used
• Clotted Sample
• Over-filled or Under-filled tube

Batch Running

Friday 4:00 PM

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

Available upon request

None specified.

Not applicable

A product of the urea cycle, Putrescine

Not Applicable

Not Applicable

Evaluation of the differential diagnosis of hyperammonemia and hereditary orotic aciduria

Gas chromatography with Mass Spectrometry

Special Test

No patient preparation necessary.

Collection instruction:

Patient is advised to collect first morning or random midstream clean-catch urine sample. “Midstream collection” is performed by passing the first portion of the urine into the bedpan or toilet and collecting the midportion in the appropriate specimen container without contaminating the container.

Clean leak Proof Container

100 mL Random Urine

Not Applicable

24 Hours

7 Days

28 days

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

• Quantity not sufficient
• Improperly labeled specimen
• Improper urine collection

Batch Running

Friday, 4:00 PM

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

Pregnant women will normally excrete up to twice the upper limit of the adult reference range.

Blood Osmolality Test

Not applicable

Serum osmolality is used to check a body’s salt/water balance. Helps in assessment of:

• dehydration
• hypo or hyper natremia
• kidney damage
• poisoning from certain substances, such as ethanol, ethylene glycol, or methanol

Freezing Point Depression

Chemistry

No patient preparation necessary.

Red or Gold Tube

1-3 mL Serum

Plasma (Heparin)

Not acceptable

2 Days

>/=3 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

Tuesday and Friday

Monday to Saturday: 10:00 PM

Sunday: 6:00PM

ROUTINE(on running day)
• 4 hours after receipt of specimen/ arrival of messenger

STAT(on running day)
• After 2½ hours from extraction/messenger arrival

275–290 mmol/kg H2O (mOsm/kg H2O)

Samples that contain large amounts of glucose or sugars, etc. can cause fluctuations in the formation of ice crystals due to their viscosity.

Q: What is Osmolality?

A:  Osmolality is a measure of the number of dissolved particles in a fluid. A test for osmolality measures the amount of dissolved substances such as sodium, potassium, chloride, glucose and urea in a sample of blood and sometimes in urine.

Q: When is it ordered?

A: Testing may be ordered when a person has an unexplained low blood sodium or signs and symptoms that a healthcare practitioner suspects may be due to low blood sodium such as:

• Excessive thirst
• Confusion
• Nausea
• Headache
• Lethargy
• In severe cases, seizures or coma

A urine osmolality test may be ordered along with blood testing when a health practitioner wants to compare urine results with the serum osmolality and/or when the person being tested is producing increased or decreased amounts of urine.

Sodium, Hyponatremia, Hypernatremia, dehydration, Kidney function

Not applicable

Not applicable

Evaluate hemolytic anemia, especially hereditary spherocytosis, evaluate immune hemolytic states.

Manual Modified Sanford

Special Test

• No patient preparation necessary.
• Inform Special Test Section 1 day before the scheduled sample collection.
• Request Container to Special test section 2 days prior to collection.
• Specimen should be at Laboratory at exactly 7AM
• Verify if INCUBATED OR UNINCUBATED Osmotic Fragility test

Sodium Heparin Tube

2 pcs. 4 mL Sodium Heparinized whole blood

Not Applicable

6 Hours

Not applicable

Not applicable

Transport specimen at 15°C ~25 °C (room temperature)

• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimen
• Improper collection tube used
• Clotted Sample
•  Over-filled or Under-filled tube

Monday to Friday

7:00 AM 

Unincubated - 3 days after running day (excluding Saturdays, Sundays and Holidays)

Incubated -5days after running day (excluding Saturdays, Sundays and Holidays)

Available upon request

None specified.

Not applicable

Hereditary spherocytosis and thalassemia

• Bone GLA Protein
• BGP

Not applicable

Resullts are not diagnostic of osteoporosis. Bone mineral densitometry is the gold standard for the diagnosis of osteoporosis. Results may be helpful in monitoring drug, exercise and/or hormone treatment of osteoporosis.

chemiluminescence

Special Test

No patient preparation necessary.

Red or Gold Tube

4 mL Serum

Not Applicable

24 Hours

3 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

Monday to Friday

Friday, 7:00 AM

5 days after running day (excluding Saturdays, Sundays and Holidays)

Available upon request

None specified.

Not applicable

Bone gamma-carboxyglutamic acid-containing protein (BGLAP), noncollagenous protein

Not applicable

• Apolipoprotein A1
• HE-4
• CA-125
• Transferrin
• Follicle Stimulation Hormone

• Overa is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery may be considered.
• Overa is intended to aid in assessing whether a woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy as part of the preoperative evaluation.
NOTE: The Overa test must be interpreted in conjunction with an independent clinical and imaging evaluation. Do not use without an independent clinical and imaging evaluation. The test is NOT intended as a screening or stand-alone diagnostic assay to determine whether a patient should proceed to surgery. Incorrect use of the Overa test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
NOTE: The Overa test is not a screening test.

Immunoturbidimetric assay
• Apolipoprotein A-1
• Transferrin

Electrochemiluminescence Immunoassay (ECLIA)
• Follicle Stimulation Hormone
• HE-4
• CA-125

Special Test

• The Overa test is not indicated for patients with a diagnosis of malignancy within the last 5 years.
• 12 hours fasting is required.

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.

Red or Gold tube

2-3 mL Serum

Not applicable

Not Specified

8 Days

Not specified

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

• Hemolyzed specimen
• Quantity not sufficient
• Incorrect collection container used
• Improperly labeled specimen
• Specimen stored/transported outside the temperature range

Batch Running (14 working days excluding Sat, Sun and Holidays)

6:00 PM

14 working days excluding Sat, Sun and Holidays

Overa Risk Score:
• Risk Score <5.0: Low Risk of Ovarian Malignancy
• Risk Score >/=5.0: Elevated Risk of Ovarian Malignancy

• For common assay-interference information, refer to each of the tests’ information.
• Prescription and commonly used medications (including over-the-counter preparations) that can be found at significant concentrations may interfere either directly or indirectly with the Overa test. For example, cimetidine, clomiphene, digitalis, levodopa, phenothiazines, estrogen (hormone therapy) and birth control pills (that contain estrogen or progesterone or both) could confound Overa risk score by altering FSH level.
• The Overa test is not a screening test.
• The Overa test must be interpreted in conjunction with an independent clinical and imaging evaluation. The test is not intended as a screening or stand-alone diagnostic assay.
• A low risk result on the Overa test, in the setting of a positive pre-surgical assessment, should not preclude oncology referral.
• The Overa test is not indicated for patients with a diagnosis of malignancy within the last 5 years.

Q: Who can be tested?
A: Overa test can be used in women who meets the following criteria:
- Greater than (>) 18 Years Old
- Have an ovarian adnexal mass
- Considered for surgery
- Have not been referred to a gynecologic oncologist
- Have not had cancer in the past five years
- Have a rheumatoid factor concentration of <250 IU/mL

Q: What kind of results will I get from Overa test?
A: The report will have a risk score between 0.00 and 10.00
- Risk Score <5.0: Low Risk of Ovarian Malignancy
- Risk Score >/=5.0: Elevated Risk of Ovarian Malignancy

Q: How does Overa test work?
A: Overa is a qualitative serum test that combines the results of five immunoassays (Apo A1, Transferrin, HE-4, CA 125, FSH) into a single numeric result using a proprietary algorithm to generate an Overa risk score between 0.0 and 10.0.

Apo A1, Transferrin, HE-4, CA 125, FSH, Ovarian Cancer

Oxycodone Qualitative Urine (Screening)

Not Applicable

This drug screen is for medical use only. Results are screen-only and positives have not been confirmed by a second independent chemical method.

Immunoassay (IA)

Special test

Np patient preparation required.

Plastic Leak proof container

100 mL random urine

Not Applicable

5 days

7 days

28 days

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

• Urine with preservative
• Insufficient volume
• Improperly labeled specimens
• Exceeded sample stability requirement

Batch Running

Monday, 12:00 PM

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

Available upon request

None Specified.

Not Applicable

Not Applicable

EGFR T790M

Not Applicable

For Selection of non-small cell lung cancer (nsclc) patients who did not respond or develop resistance to first-line EGFR tyrosine kinase inhibitor (TKI) therapy.

Droplet Digital PCR Technology

Special Test Section

• No patient preparation necessary.
• Inform laboratory 1 day before extraction for schedule.
• Request Kit to Special test section

p-EGFR Test Collection Kit will be provided by HPD Special Test Section.

Kit includes:

1. 2 pcs. of cell-free DNA Streck Tubes
2. p-EGFR Screen Requisition Form
3. p- EGFR Consent Form Non-invasive Patient Consent Form

20 mL (Whole Blood)

Not Applicable

7Days

Not Applicable

Not Applicable

Transport immediately to HPD laboratory at room temperature (15°C~25°C)

·         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.

For HPD-CDO

Ship samples directly to Sanomics. Instructions can be found inside the kit. 

•     Sample must reach Sanomic Laboratory within 7 days of sample collection.

• Insufficient volume
• Incorrect collection container used
• Clotted blood specimen
• Incomplete documentation requirement
• Broken Streck tube condition
• Refrigerated samples

Batch running

Friday ,3:00 PM

Note: We will be receiving samples on Mondays to Friday only.

If patient insists on Saturday and Sunday, accept sample and send on Monday early morning.

• After 7 days  excluding Saturdays, Sundays and Holiday
• Results will be sent directly to patients’ requesting physician via email by Sanomics.
• Results are not available both hard copy and online.

None Specified

Not Applicable

Not Applicable

EGFR Mutation

Fecal Elastase • Elastase stool •  Fecal Pancreatic Elastase •  Human Fecal Elastase - 1 •  FE-1 •  

Not Applicable

• Gold standard for non-invasive, in-vitro diagnostic pancreatic function testing. It is useful for the diagnosis/ exclusion of pancreatic involvement in association with gastrointestinal symptoms, abdominal pain, maldigestion, steatorrhea, diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), obesity and osteoporosis.
• It is also useful for the diagnosis/ exclusion of exocrine pancreatic insufficiency caused by Chronic Pancreatitis , diabetis mellitus, Cholelithiasis (gallstone), Cystic fibrosis, Pancreatic cancer, papillary Stenosis, Coeilac Diasese.

Immunochromatography

Clinical Microscopy

No patient preparation necessary

Sterile container

Pea sized stool ( size of 25 centavo coin)

Not applicable

• Room temperature (15°C to 25°C): 7 days
• Refrigerated temperature (2°C – 8 °C): 7 days
• Freezer temperature (-20°C): 1 year

• Room temperature (15°C to 25°C): 7 days

Refrigerated temperature (2°C – 8 °C): 7 days

Freezer temperature (-20°C): 1 year

Transport specimen at Room temperature (15°C to 25°C):

•       Improper sample container used

•       Specimen stored/transported outside the temperature range

•       Quantity not sufficient

•       Improperly labeled specimen

Daily

Sunday
6:00 PM

ROUTINE
• 4 hours after receipt of specimen/ arrival of messenger
STAT
• After 2½ Hours from messenger arrival

Normal pancreatic elastase 1 :  >200 ug/g

Low pancreatic elastase 1: <200 ug/g (indicates exocrine pancreatic insufficiency)

Watery stools can lead to false results due to a dilution effect.

Not applicable

Exocrine pancreatic function, pancreatic function testing, pancreatic cancer

• Panorama Prenatal Basic
• Trisomy
• Down Syndrome

Screens for chromosomes 13, 18, 21, X & Y ,Triploidy and 22q

• Panorama is a non-invasive prenatal screening test (NIPT) for fetal chromosomal abnormalities

• Panorama provides screening for IVF conceived pregnancy.

• Panorama provides more comprehensive screening for twin pregnancies:

• Zygosity information
• Individual fetal fractions for dizygotic twins
• Fetal sex for each twin
• Likelihood of monosomy X for monozygotic twins.
• ForMONOZYGOTIC twinsonly, 22q11.2 deletion maybe ordered.

• for twin pregnancies, surrogate or egg donor.

• Screens for chromosomes 13, 18, 21, X & Y, Triploidy and 22q

NOTE:

Structural anomalies are not detected by panorama. Only the specified chromosomal anomalies or microdeletions. Structural anomalies are usually detected using ultrasound.

SNP-based sequencing and Next-Generation Aneuploidy Test Using SNPs

Special Test

• Test is the same as Panorama Prenatal Panel (Extended) in the Request Form (OB-GYN)
• Obtain 1 Week Old Ultrasound from the patient

NOTE: EDD based on UTZ report NOT BASED ON PATIENTS LMP

Instruction to Customer Service/Encoders/ Home Service:

1. General inquiries can be entertained by any In-house Doctor who attended the training. Doctor should inform patients to consult with their Attending Physician regarding this test.
2. Inform Special Test Section one (1) day before the scheduled sample collection.
3. Sample collection can only be done from Monday to Wednesday: up to 3:00 PM ONLY.
4. If patient needs more details and decides to proceed with test, an appointment with Dr. Lalaine Macatangay (HPD Del Monte) can be scheduled.
5. Always indicate doctors complete name and clinic address prior to sending of official results.

Instruction to Phlebotomists:
Mother’s Blood:

1. Use 20-21 gauge needles during extraction. Do not use butterfly needles.
2. Gently mix samples by sample inversion (10x).
3. Place sample inside the gel wrap provided.

Test Limitations and Risks:
Prior to blood extraction, ask the patient about the following conditions because the test cannot be performed on:

1. Patients who are carrying multiple babies (triplets etc.)
2. Pregnancies in which the mother has a prior bone marrow transplant
3. Patients who have partners related by blood (e.g. cousins), or if the mother has parents who are related by blood.
4. Surrogate or egg donor preganancy.

Panorama Prenatal Screen Collection Kit will be provided by HPD Special Test Section.

Kit includes:

1. 2 pcs. of cell-free DNA Streck Tubes
2. Panorama Prenatal Screen Requisition Form
3. Panorama Non-Invasive Prenatal Test Patient Consent Form
4. Collection Directions
5. 1 pc. Plastic Specimen Bag
6. 1 pc. Metallic Envelope with 2 pcs gel pack
7. 2 pcs. sleeves
    

20 mL Maternal whole blood

Document Requirements:
1. Copy of patient’s Sonographic Report
2. Panorama Requisition Form (completely filled up)
3. Patient Consent Form (completely filled up)

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.

• Clotted blood specimen
• Incomplete documentation requirement
• Insufficient volume
• Incorrect storage temperature of specimen
• Incorrect collection container used

Test cannot be performed on:

• Pregnancies in which the mother has a prior bone marrow transplant.
• Patients who have partners related by blood (e.g cousins) or if the mother has parents who are related by blood.

Batch Running

Tuesday, 12:00 PM

Note:We will be receiving samples on Mondays and Tuesdays only.

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

Not Applicable

Panorama cannot be done on:
1. Pregnancies in which the mother has a prior bone marrow transplant
2. Patients who have partners related by blood (e.g. cousins), or if the mother has parents who are related by blood.

Q: Who should get Natera’s Panorama screening test?
A: Many pregnant women have concerns about the health of their baby. If you have concerns, you should talk with your healthcare professional. He or she will advise you as to what tests you might want to have to help give you peace of mind. Some women have a higher chance for chromosome abnormalities because of their age, family history, or other screening test results. The American College of Obstetricians and Gynecologists recommends these women be offered a non-invasive prenatal test like the Panorama test (Committee Opinion No. 545, Dec 2012). These women may choose to have the Panorama test to help them decide if they want a CVS or amniocentesis. Most women who have the Panorama screening test will find out their baby is at low risk for the conditions tested. This means that the chance of the baby having one of these conditions is very low, which can be reassuring. When the test result shows a high risk, it is important to talk with your healthcare provider about your next steps.

Q: Who can be tested and when?
A: The Panorama test is made for women of any age and ethnicity who are at least 9 weeks pregnant. It is not meant for women who are carrying more than one baby (twins or triplets), or for women who have used a donor egg, or have received a bone marrow transplant.This test cannot be performed on patients who have partners related by blood (e.g. cousins), or if the mother has parents who are related by blood.

Q: What kind of results will I get from Panorama screening test?
A: The report will have one of these results:
• LOW-RISK RESULTS: Means the chance that your baby has one of the chromosome conditions screened for is very low.
• HIGH-RISK RESULTS: Means there is an increased risk that your baby has that condition. Your healthcare provider will talk to you about follow-up options that can tell you for sure.
There is also a slim chance that no results will be obtained from your initial sample. In this case we may recommend sending us another sample.
Q: How does the Panorama screening test work?
A: During pregnancy, some of the DNA from the baby crosses into mom’s bloodstream. DNA is organized in structures known as chromosomes, which carry the baby's genetic information. Natera™ has a laboratory test called Panorama™ that uses a blood sample from the mother that analyzes the baby’s DNA for certain chromosome conditions that could affect the baby’s health.

The Panorama screening test is a non-invasive prenatal test (NIPT). This means that the Panorama test is safe for you and your baby. To have the test done, a sample of blood will be drawn from your arm. Fathers’ cheek swab sample will be taken also as an option together with blood. Including the father’s sample may improve the chance of obtaining results of the test in certain circumstances, but does not impact accuracy.

Q: How accurate is the Panorama screening test?
A: Panorama is a screening test, not a diagnostic. A positive test result does not necessarily mean that your baby is affected with that condition. False positives and false negative may occur. Please read consent form upon signing for more details.

Microdeletion syndromes: 22q11.2 deletion syndrome, Prader Willi syndrome, Angelman syndrome, Cri du Chat syndrome, and 1p36 deletion syndrome, Down Syndrome, Chromosal abnormality, Screening test for Babies, chromosomal disorder

NIPT

Non invasive prenatal testing

• Panorama Prenatal Extended
• Trisomy
• Down Syndrome
• Microdeletion

Screens for chromosomes 13, 18, 21, X & Y, Triploidy and Microdeletions 22q11.2, 1p36, Cri-du-chat, Angelman, and Prader-Willi

• Panorama is a non-invasive prenatal screening test (NIPT) for fetal chromosomal abnormalities.

• Thefive Microdeletion Panelis only available for singleton (one baby) pregnancies where there is no egg donor or surrogate.

• It isNOT AVAILABLEfor twins or pregnancies achieved with an egg donor or surrogate.

NOTE:

Structural anomalies are not detected by panorama. Only the specified chromosomal anomalies or microdeletions. Structural anomalies are usually detected using ultrasound.

SNP-based sequencing and Next-Generation Aneuploidy Test Using SNPs

Special Test

• Test is the same as Panorama Prenatal Panel (Extended) in the Request Form (OB-GYN)
• Obtain 1 Week Old Ultrasound from the patient

NOTE: EDD based on UTZ report NOT BASED ON PATIENTS LMP

Test is the same as Panorama Prenatal Panel (Extended) in the Request Form (OB-GYN)


Test Limitations and Risks:
Prior to blood extraction, ask the patient about the following conditions because the test cannot be performed on:
1. Patients who are carrying multiple babies (twins, triplets etc.)
2. Pregnancies that used a donor egg or surrogate
3. Pregnancies in which the mother has a prior bone marrow transplant
4. Patients who have partners related by blood (e.g. cousins), or if the mother has parents who are related by blood.

Panorama Prenatal Screen Collection Kit will be provided by HPD Special Test Section.

Kit includes:
1. 2 pcs. of cell-free DNA Streck Tubes
2. 1 pc. 21 gauge vacutainer needle
3. 1 pc. vacutainer adaptor
4. Panorama Prenatal Screen Requisition Form
5. Panorama Non-Invasive Prenatal Test Patient Consent Form
6. Collection Directions
7. 1 pc. Plastic Zip Lock Specimen Bag
8. 1 pc. Metallic Envelope with 2 pcs gel pack
9. 2 pcs. sleeves
10. Panorama Requisition Form
11. Patient Consent Form
12. Collection Directions

20mL Maternal whole blood

Document Requirements:
1. Copy of patient’s Sonographic Report
2. Panorama Requisition Form (completely filled up)
3. Patient Consent Form (completely filled up)

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.

• Clotted blood specimen
• Incomplete documentation requirement
• Insufficient volume
• Incorrect storage temperature of specimen
• Incorrect collection container used

• Test cannot be performed on:

• • It is NOT AVAILABLE for twins or pregnancies achieved with an egg donor or surrogate.

• Pregnancies in which the mother has a prior bone marrow transplant.
• Patients who have partners related by blood (e.g cousins) or if the mother has parents who are related by blood.

Batch Running

Tuesday, 12:00 PM

Note: We will be receiving samples on Mondays and Tuesdays only.

• After 14 days excluding Saturdays, Sundays and Holidays
• Results are not available online.
• Indicate in the Clinical Information if Official Results will be delivered to Doctor’s clinic. (Please provide the complete address).

Not Applicable

Panorama cannot be done on:
1. Patients who are carrying multiple babies (twins, triplets etc.)
2. Pregnancies that used a donor egg or surrogate
3. Pregnancies in which the mother has a prior bone marrow transplant
4. Patients who have partners related by blood (e.g. cousins), or if the mother has parents who are related by blood.

Q: Who should get Natera’s Panorama screening test?
A: Many pregnant women have concerns about the health of their baby. If you have concerns, you should talk with your healthcare professional. He or she will advise you as to what tests you might want to have to help give you peace of mind. Some women have a higher chance for chromosome abnormalities because of their age, family history, or other screening test results. The American College of Obstetricians and Gynecologists recommends these women be offered a non-invasive prenatal test like the Panorama test (Committee Opinion No. 545, Dec 2012). These women may choose to have the Panorama test to help them decide if they want a CVS or amniocentesis. Most women who have the Panorama screening test will find out their baby is at low risk for the conditions tested. This means that the chance of the baby having one of these conditions is very low, which can be reassuring. When the test result shows a high risk, it is important to talk with your healthcare provider about your next steps.

Q: Who can be tested and when?
A: The Panorama test is made for women of any age and ethnicity who are at least 9 weeks pregnant. It is not meant for women who are carrying more than one baby (twins or triplets), or for women who have used a donor egg, or have received a bone marrow transplant.This test cannot be performed on patients who have partners related by blood (e.g. cousins), or if the mother has parents who are related by blood.

Q: What kind of results will I get from Panorama screening test?
A: The report will have one of these results:
• LOW-RISK RESULTS: Means the chance that your baby has one of the chromosome conditions screened for is very low.
• HIGH-RISK RESULTS: Means there is an increased risk that your baby has that condition. Your healthcare provider will talk to you about follow-up options that can tell you for sure.
There is also a slim chance that no results will be obtained from your initial sample. In this case we may recommend sending us another sample.
Q: How does the Panorama screening test work?
A: During pregnancy, some of the DNA from the baby crosses into mom’s bloodstream. DNA is organized in structures known as chromosomes, which carry the baby's genetic information. Natera™ has a laboratory test called Panorama™ that uses a blood sample from the mother that analyzes the baby’s DNA for certain chromosome conditions that could affect the baby’s health.

The Panorama screening test is a non-invasive prenatal test (NIPT). This means that the Panorama test is safe for you and your baby. To have the test done, a sample of blood will be drawn from your arm. Fathers’ cheek swab sample will be taken also as an option together with blood. Including the father’s sample may improve the chance of obtaining results of the test in certain circumstances, but does not impact accuracy.

Q: How accurate is the Panorama screening test?
A: Panorama is a screening test, not a diagnostic. A positive test result does not necessarily mean that your baby is affected with that condition. False positives and false negative may occur. Please read consent form upon signing for more details.

Microdeletion syndromes: 22q11.2 deletion syndrome, Prader Willi syndrome, Angelman syndrome, Cri du Chat syndrome, and 1p36 deletion syndrome, Down Syndrome, Chromosal abnormality, Screening test for Babies, chromosomal disorder

NIPT

Non invasive prenatal testing

- Cervical Smear

- Cervico-vaginal Cytology

- Cervical/Vaginal Cytology

- Papanicolaou Test

Not applicable

- For screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnosis.

- A Pap smear involves collecting cells from your cervix — the lower, narrow end of your uterus that's at the top of your vagina.

- Detecting cervical cancer early with a Pap smear gives you a greater chance at a cure. A Pap smear can also detect changes in your cervical cells that suggest cancer may develop in the future. Detecting these abnormal cells early with a Pap smear is your first step in halting the possible development of cervical cancer.

Papanicolau Staining

Histopathology

- Avoid intercourse, douching, or using any vaginal medicines or spermicidal foams, creams or jellies for two days before having a Pap smear, as these may wash away or obscure abnormal cells.

- Try not to schedule a Pap smear during your menstrual period. It's best to avoid this time of your cycle, if possible.

- Slides should be placed in slide holders or mailers before placing in a packaging container

- In cases wherein slide mailers/ holders are not available, place slides in a hard cardboard to prevent breakage

Not applicable

Not applicable

Stable at room temperature for 7 days if properly fixed

7 Days (If properly fixed)

Not applicable

Not applicable

Transport specimens at 15°C to 30°C immediately after collection.

- Incomplete information in the Histopathology Request form (HPD_F_258) or Histopathology Service Request Form (HPD_F_259)

- Improperly labeled specimens

- Quantity not sufficient

- Exceeded sample stability requirement.

Daily

None

- 3 days upon receipt of specimen

- 1 day for Metro Manila clients and 2 days for Provincial clients (processing only)

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

Normal results- If only normal cervical cells were discovered during your Pap smear, you're said to have a negative result. You won't need any further treatment or testing until you're due for your next Pap smear and pelvic exam.

Abnormal results- If abnormal or unusual cells were discovered during your Pap smear, you're said to have a positive result. A positive result doesn't mean you have cervical cancer. What a positive result means depends on the type of cells discovered in your test.

Here are some terms your doctor might use and what your next course of action might be:

• Atypical squamous cells of undetermined significance (ASCUS). Squamous cells are thin and flat and grow on the surface of a healthy cervix. In the case of ASCUS, the Pap smear reveals slightly abnormal squamous cells, but the changes don't clearly suggest that precancerous cells are present. With the liquid-based test, your doctor can reanalyze the sample to check for the presence of viruses known to promote the development of cancer, such as some types of human papillomavirus (HPV). If no high-risk viruses are present, the abnormal cells found as a result of the test aren't of great concern. If worrisome viruses are present, you'll need further testing.
• Squamous intraepithelial lesion.This term is used to indicate that the cells collected from the Pap smear may be precancerous. If the changes are low grade, it means the size, shape and other characteristics of the cells suggest that if a precancerous lesion is present, it's likely to be years away from becoming a cancer. If the changes are high grade, there's a greater chance that the lesion may develop into cancer much sooner. Additional diagnostic testing is necessary.
• Atypical glandular cells.Glandular cells produce mucus and grow in the opening of your cervix and within your uterus. Atypical glandular cells may appear to be slightly abnormal, but it's unclear whether they're cancerous. Further testing is needed to determine the source of the abnormal cells and their significance.
• Squamous cell cancer or adenocarcinoma cells. This result means the cells collected for the Pap smear appear so abnormal that the pathologist is almost certain a cancer is present. "Squamous cell cancer" refers to cancers arising in the flat surface cells of the vagina or cervix. "Adenocarcinoma" refers to cancers arising in glandular cells. If such cells are found, your doctor will recommend prompt evaluation.

If your Pap smear is abnormal, your doctor may perform a procedure called colposcopy using a special magnifying instrument (colposcope) to examine the tissues of the cervix, vagina and vulva.

Your doctor also may take a tissue sample (biopsy) from any areas that appear abnormal. The tissue sample is then sent to a laboratory for analysis and a definitive diagnosis.

Not applicable

Q.Why do we need to have a pap test?

A.A Pap smear is used to screen for cervical cancer.

The Pap smear is usually done in conjunction with a pelvic exam. In women older than age 30, the Pap test may be combined with a test for human papillomavirus (HPV) — a common sexually transmitted infection that can cause cervical cancer. In some cases, the HPV test may be done instead of a Pap smear.

Q.Who should have a Pap smear?

A.You and your doctor can decide when it's time for you to begin Pap testing and how often you should have the test. In general, doctors recommend beginning Pap testing at age 21.

Q.How often should a Pap smear be repeated?

A.Doctors generally recommend repeating Pap testing every three years for women ages 21 to 65. Women age 30 and older can consider Pap testing every five years if the procedure is combined with testing for HPV. Or they might consider HPV testing instead of the Pap test. If you have certain risk factors, your doctor may recommend more-frequent Pap smears, regardless of your age. These risk factors include:

• A diagnosis of cervical cancer or a Pap smear that showed precancerous cells
• Exposure to diethylstilbestrol (DES) before birth
• HIV infection
• Weakened immune system due to organ transplant, chemotherapy or chronic corticosteroid use
• A history of smoking

You and your doctor can discuss the benefits and risks of Pap smears and decide what's best for you based on your risk factors.

Q.Who can consider stopping Pap smears?

A.In certain situations a woman and her doctor may decide to end Pap testing, such as:

• After a total hysterectomy. After a total hysterectomy — surgical removal of the uterus including the cervix — ask your doctor if you need to continue having Pap smears. If your hysterectomy was performed for a noncancerous condition, such as uterine fibroids, you may be able to discontinue routine Pap smears. But if your hysterectomy was for a precancerous or cancerous condition of the cervix, your doctor may recommend continuing routine Pap testing.
• Older age. Doctors generally agree that women can consider stopping routine Pap testing at age 65 if their previous tests for cervical cancer have been negative. Discuss your options with your doctor and together you can decide what's best for you based on your risk factors. If you're sexually active with multiple partners, your doctor may recommend continuing Pap testing.

- Pap smear

- Papanicolau smear

- HPV, Human Papilloma Virus

- Surepath

- Liquid-based cytology

- Liquid-based Pap smear

Not applicable

- For screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnosis.

- A Pap smear involves collecting cells from your cervix — the lower, narrow end of your uterus that's at the top of your vagina.

- Detecting cervical cancer early with a Pap smear gives you a greater chance at a cure. A Pap smear can also detect changes in your cervical cells that suggest cancer may develop in the future. Detecting these abnormal cells early with a Pap smear is your first step in halting the possible development of cervical cancer.

Liquid-based Pap Smear using BD Prepstain Surepath System

Histopathology

-Avoid intercourse, douching, or using any vaginal medicines or spermicidal foams, creams or jellies for two days before having a Pap smear, as these may wash away or obscure abnormal cells.

-Try not to schedule a Pap smear during your menstrual period. It's best to avoid this time of your cycle, if possible.

Surepath vial with preservative fluid and brush head

Not applicable

Not applicable

Surepath vial can preserve cells for up to 6 months if refrigerated (2oC to 8oC) or up to 1 month at room temperature

1 month

6 months

Not applicable

Transport specimens at 2°C to 8°C or 15°C to 30°C

- Incomplete information in the Histopathology Request form (HPD_F_258) or Histopathology Service Request Form (HPD_F_259)

- Improperly labeled specimens

- Quantity not sufficient

- Exceeded sample stability requirement.

Daily

3:00 PM

- 3 days upon receipt of specimen

- 1 day for Metro Manila clients and 2 days for Provincial clients (processing only)

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

Normal results- If only normal cervical cells were discovered during your Pap smear, you're said to have a negative result. You won't need any further treatment or testing until you're due for your next Pap smear and pelvic exam.

Abnormal results- If abnormal or unusual cells were discovered during your Pap smear, you're said to have a positive result. A positive result doesn't mean you have cervical cancer. What a positive result means depends on the type of cells discovered in your test.

Here are some terms your doctor might use and what your next course of action might be:

• Atypical squamous cells of undetermined significance (ASCUS). Squamous cells are thin and flat and grow on the surface of a healthy cervix. In the case of ASCUS, the Pap smear reveals slightly abnormal squamous cells, but the changes don't clearly suggest that precancerous cells are present. With the liquid-based test, your doctor can reanalyze the sample to check for the presence of viruses known to promote the development of cancer, such as some types of human papillomavirus (HPV). If no high-risk viruses are present, the abnormal cells found as a result of the test aren't of great concern. If worrisome viruses are present, you'll need further testing.
• Squamous intraepithelial lesion.This term is used to indicate that the cells collected from the Pap smear may be precancerous. If the changes are low grade, it means the size, shape and other characteristics of the cells suggest that if a precancerous lesion is present, it's likely to be years away from becoming a cancer. If the changes are high grade, there's a greater chance that the lesion may develop into cancer much sooner. Additional diagnostic testing is necessary.
• Atypical glandular cells.Glandular cells produce mucus and grow in the opening of your cervix and within your uterus. Atypical glandular cells may appear to be slightly abnormal, but it's unclear whether they're cancerous. Further testing is needed to determine the source of the abnormal cells and their significance.
• Squamous cell cancer or adenocarcinoma cells. This result means the cells collected for the Pap smear appear so abnormal that the pathologist is almost certain a cancer is present. "Squamous cell cancer" refers to cancers arising in the flat surface cells of the vagina or cervix. "Adenocarcinoma" refers to cancers arising in glandular cells. If such cells are found, your doctor will recommend prompt evaluation.

If your Pap smear is abnormal, your doctor may perform a procedure called colposcopy using a special magnifying instrument (colposcope) to examine the tissues of the cervix, vagina and vulva.

Your doctor also may take a tissue sample (biopsy) from any areas that appear abnormal. The tissue sample is then sent to a laboratory for analysis and a definitive diagnosis.

Not applicable

Q.Why do we need to have a pap test?

A.A Pap smear is used to screen for cervical cancer.

The Pap smear is usually done in conjunction with a pelvic exam. In women older than age 30, the Pap test may be combined with a test for human papillomavirus (HPV) — a common sexually transmitted infection that can cause cervical cancer. In some cases, the HPV test may be done instead of a Pap smear.

Q.Who should have a Pap smear?

A.You and your doctor can decide when it's time for you to begin Pap testing and how often you should have the test. In general, doctors recommend beginning Pap testing at age 21.

Q.How often should a Pap smear be repeated?

A.Doctors generally recommend repeating Pap testing every three years for women ages 21 to 65. Women age 30 and older can consider Pap testing every five years if the procedure is combined with testing for HPV. Or they might consider HPV testing instead of the Pap test. If you have certain risk factors, your doctor may recommend more-frequent Pap smears, regardless of your age. These risk factors include:

• A diagnosis of cervical cancer or a Pap smear that showed precancerous cells
• Exposure to diethylstilbestrol (DES) before birth
• HIV infection
• Weakened immune system due to organ transplant, chemotherapy or chronic corticosteroid use
• A history of smoking

You and your doctor can discuss the benefits and risks of Pap smears and decide what's best for you based on your risk factors.

Q.Who can consider stopping Pap smears?

A.In certain situations a woman and her doctor may decide to end Pap testing, such as:

• After a total hysterectomy. After a total hysterectomy — surgical removal of the uterus including the cervix — ask your doctor if you need to continue having Pap smears. If your hysterectomy was performed for a noncancerous condition, such as uterine fibroids, you may be able to discontinue routine Pap smears. But if your hysterectomy was for a precancerous or cancerous condition of the cervix, your doctor may recommend continuing routine Pap testing.
• Older age. Doctors generally agree that women can consider stopping routine Pap testing at age 65 if their previous tests for cervical cancer have been negative. Discuss your options with your doctor and together you can decide what's best for you based on your risk factors. If you're sexually active with multiple partners, your doctor may recommend continuing Pap testing.

- Pap smear

- Papanicolau smear

- HPV, Human Papilloma Virus

Pregnancy Associated Plasma Protein A

Not applicable

Is a glycoprotein secreted from trophoblastic tissues of the placenta commonly used in combination with free BHCG and NT in screening of Down syndrome. In affected pregnancies, low levels of PAPP-A can be associated with pre-eclampsia, Down’s syndrome, Edward’s syndrome and Cornelia de Lange Syndrome.

Time-resolved Fluoroimmunoassay

Immunology

No patient preparation required.

Red or Gold tube

1-3 mL Serum

Not applicable

Not specified

*Must be separated from red cells or serum separature tube gel plugs.

6 Days

*Must be separated from red cells or serum separature tube gel plugs.

Not specified (Freeze only once)

*Must be separated from red cells or serum separature tube gel plugs.

• Separate the serum from clot or gel separator ASAP after centrifugation.
• Transported specimen at 2⁰C to 8⁰C (with cold packs)

• Improperly labeled specimens
• Hemolyzed specimens
• Lipemic specimens
• Improper collection tube used
• Specimen transported outside the required temperature.
• Quantity not sufficient

1st And 3rd Monday Of The Month

Friday, 6:00PM

3 Days After Running Day

No Reference Range established. Must be used in conjunction with other tests and information to calculate/assess risk for pre-eclampsia.

• Samples containing heterophilic antibodies give falsely elevated results
• Bicarbonate and HIGH Protein concentrations interferes with the assay
• PLASMA samples is NOT acceptable
• Complement activation may in some rare cases give falsely low results

Q: Who should be screened for pre-eclampsia?

A: All pregnant women should be assessed early on in their pregnancy to prevent the development of pre-eclampsia. They should also have access to screening even if there are no maternal risk factors or history of pre-eclampsia.

Q: Why does all pregnant women need to be assessed for pre-eclampsia?

A: The benefit of detecting and treating pre-eclampsia early in the pregnancy always outweighs the conventional wait-and-see approach to pre-eclampsia management.

Q: What should women know?

A: While pre-eclampsia screening is critical to protecting the health of mother and child, many women are unaware of pre-eclampsia or combined pre-eclampsia screening with the PlGF 1-2-3 assay. They need to know that pre-eclampsia can affect any pregnancy. They should also be informed that some pregnancies are more at risk of developing pre-eclampsia than others. Combined pre-eclampsia screening with the PlGF 1-2-3 assay is an effective way to assess this risk. In fact, women with a history of pre-eclampsia have a three to four times greater risk of developing chronic hypertension than mothers with no history of pre-eclampsia and double the risk of ischemic heart disease, venous thromboembolism and stroke.

Q: What do the results mean?

A:Low risk- Low risk means that there is minimal risk of developing pre-eclampsia later in pregnancy. While it is possible to develop pre-eclampsia regardless of low risk status, the pregnancy can continue as normal and the mother can rest assured that there is little or no reason for concern.

High risk– If the risk of developing pre-eclampsia later in pregnancy is high, the doctor can start treatment at the optimum time and monitor the pregnancy more closely. While not all women in the high-risk group develop pre-eclampsia, doctors can now offer the best possible care early in the pregnancy and significantly improve the outcome for mother and child:

• Trimester 1 – Start preventive actions
• Trimester 2 –Close monitoring
• Trimester 3 – Prepare for early delivery and needed actions.

Not applicable

• Acetaminophen
• Anacin-3
• Tylenol
• Datril
• Panado
• Tempra
• NAPA
• Excedrine
• Phenaphen

Not applicable

In order to establish a diagnosis of paracetamol over dosage, to assess risk of liver damage and to decide on the need for protective, antidotal therapy

Spectrometry

Special Test

No patient preparation necessary.

Note the following info:

• Dosage
• Date and Time of last dose intake
• Date and Time of extraction

Red tube (DO NOT USE GOLD TUBE or any other type of tube with gel separator)

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

Monday to Friday

Monday to Friday, 7:00 AM

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

Available upon request

None specified.

Not applicable

Fever, pain