Laboratory Test Preparation

Serum Ferritin

Not applicable

Useful in the diagnosis of hypochromic, microcytic anemias. Decreased in iron deficiency anemia and increased in iron overload.

Used in the evaluation of iron deficiency and Iron Overload

IRMA

Special Test

No patient preparation necessary.

Red or Gold Tube

3 mL Serum

Not Applicable

24 Hours

7 Days

Not Applicable

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

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

Tuesday

Monday, 7:00AM

Friday 5:00 PM

Available upon request

None specified

Not applicable

Not applicable

•Fibrinogen/Factor 1                                                                                                        •Factor I Assay                                                                                                            •Fibrinogen Activity (Functional)                                                                                            •Fibrinogen Antigen                                                                                                              •Cardiac Fibrinogen

Not applicable

• Test is ordered as part of an investigation of a possible bleeding disorder or thrombotic episode.
• Used to diagnose Disseminated Intravascular Coagulation (DIC) or abnormal fibrinolysis.
• Used to monitor the status of a progressive disease (e.g. liver disease) over time, or to monitor treatment of an acquired condition.

Hematology

No patient preparation necessary.

• Transfer plasma into plastic satellite tube.
• Separate plasma within 30 minutes after blood extraction.
Note: Do not transfer plasma into glass satellite tube.

Citrated Blue top

1 mL Citrated Plasma

Not applicable

4 Hours

Not specified

2 months

• Sample must be sent to laboratory immediately after collection at 15-25°c
• Samples that cannot be sent to HPD laboratory within 4 hours should be stored at -20°C and should be transported with dry ice.

• Specimen in glass satellite tube.
• Improperly labeled specimens
• Hemolyzed specimens
• Quantity not sufficient
• Specimen transported outside the required temperature
• Insufficient volume of blood to anticoagulant

Daily

Monday to Saturday
• 8:00 PM

Sunday
• 3:00 PM

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

2.00~4.00 g/L (200.00~400.00 mg/dL)

Thrombolytic therapy

Not applicable

PT and INR, PTT, D-dimer, Coagulation Factors, Thrombin Time, hs-CRP,Excessive Clotting Disorders, Bleeding Disorders, Liver Disease, Cardiovascular Disease, Disseminated Intravascular Coagulation (DIC).

Not applicable

Not applicable

Used to support the diagnosis of filariasis, microfilariasis causing elephantiasis, hydrocele, chyluria and tropical pulmonary eosinophilia.

Direct Microscopic Examination -Wright-Geimsa stain

Hematology

• No patient preparation necessary.
• Collection must be done during height of fever
• Preparation of Smear:
1. Prepare a thin smear using wedge method
2. For the thick smear, place one drop of blood on the other end of the slide and spread it to make a 1-cm round smear

• EDTA (purple top)
• 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

• 2 mL EDTA Whole blood
• 2 Slides of Thick and thin Blood Smears

Not applicable

Not applicable

Not applicable

Not applicable

• Blood: Transport at 2?C - 8?C (with ice pack)
• Slides: Transport at 15?C - 25?C (room temp)

For Whole Blood:
• Exceeded sample stability requirement
• Insufficient volume
• Improperly labeled specimens

For Blood Smear
• Poorly prepared smear
• Improperly labeled specimens

Daily

Monday to Saturday
• 8:00 PM

Sunday
• 3:00 PM

2 Working Days (excluding Saturday, Sundays and holidays)

• POSITIVE (with the filarial parasite that it is consistent with)
• NEGATIVE

Timing of collection (collection must be done during height of fever).

Not applicable

Filariasis, parasitic disease

Food Intolerance

Not applicable

• To identify food specific IgG antibodies to foods that are being consumed.
• To determine individual’s abnormal reaction to certain food item that can manifest into chronic “delayed onset” symptoms.

Immunoassay based on Microarray technology

Serology

No patient preparation necessary.

EDTA tube

Note:1 piece 4ml capacity EDTA tube

1-2mL plasma

Not Applicable

Not Specified

Not Specified

14 Days

• Blood specimen should be transported at 15°C to -20°C to HPD Main Laboratory within 24 hours.
• Storage at HPD Laboratory is at -20 °C

• Any degree of hemolysis
• Icteric samples
• Lipemic samples
• Quantity not sufficient
• Improperly labeled transport tube
• Exceeded sample stability requirement

Batch running; Tuesday and Friday

Not Applicable

• After9 working  days(7 daysTAT for Test Analysis and2 daysTAT for shipment of results) excluding Saturdays, Sundays and Holidays
• Results are not available online.
• Patient will be the one to pick up the result.

NEGATIVE: <24 U/mL

BORDERLINE: 24-30 U/mL

POSITIVE: >30 U/mL

Food Intolerance Test is recommended for age two (2) years old and above.

1.  I have been avoiding a food for several months/years. Will this affect my test results?

This test is based on the immune system’s ability to produce antibodies in response to certain food. If a food has been avoided for more than 3 months, it is likely that IgG antibody levels will be insufficient to be detected by the test and may give a normal result. To test intolerance to a certain food, it should be included in the daily diet, or at least every other day, for 4-6 weeks before testing. However, if the food concerned is known to cause extreme symptoms/discomfort, do not reintroduce it.

2. Do I need to visit a nutritionist to discuss the test results?

Once you have received your test results, it is advisable to consult a nutritionist who can help advise on dietary changes and provide a supplement program. They may also offer support and encouragement with regular progress checks, as it can be quite a daunting task to persevere with a new diet on your own.

3. If Cow’s Milk is elevated, does this mean that I am lactose intolerant?

No. Lactose intolerance is the inability to digest lactose, the major sugar found in milk, and is caused by a deficiency of the enzyme lactase. The Food Intolerance Test detects IgG-mediated food intolerance caused by specific proteins found in milk, but does not detect the lactase enzyme and, therefore cannot diagnose lactose intolerance.

4. Is this test suitable for testing children?

Yes, but we recommend a minimum age limit of 2 years.

5. Do I need to have a re-test after a few months?

Most people do not need to have a re-test, but if you would like to take another test, we advise a period of 6 months between tests. If symptoms have improved and you have successfully re-introduced “problem” food, a re-test is necessary.

6. Why do I react against a food that I have never eaten?

It is occasionally observed that patients react to food that they are convinced they have never eaten. Although not unusual, it is attributable to a false positive result, but instead a “cross-reaction” with another food. Some food contain identical antigens (food proteins), even though they are not related to each other and/or do not belong to the same food group. These identical proteins will be detected by the same antibody, thus producing an elevated result.

7. What if I don’t experience any improvement at all?

If, after changing your diet according to test results, improvements have not been achieved after 3 months, food intolerance is unlikely to be the cause of your symptoms and other investigations should be undertaken. Results of the Food Intolerance Test are intended as a guide to diet alteration only and should be complementary to advice from a healthcare professional.

Food Hypersensitivity, Non-IgE mediated, Delayed Hypersensitivity, IgG mediated Allergy

• Béagyne®
• Triflucan®

Not Applicable

Fluconazole is commonly used in the treatment of various types of fungal infections. Due to the fact it is readily soluble in water it can be administered in relatively large amounts to patients. An antifungal commonly prescribed for cryptococcal infections (especially neuromeningitis in AIDS patients) and candidiasis, mainly systemic (both disseminated and visceral), esophageal and urinary tract forms.

Liquid Chromatography–Mass Spectrometry (LCMS)

Special Test

• No patient preparation necessary.
• Ask for Specific Information Form (R8-INTGB) at Special Test Section atleast one day prior submission of sample.

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

3 mL Serum

Not Applicable

24 Hours

5 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

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

Available upon request

None Specified

Not Applicable

Antifungal medication

• Fluorine Concentration

Not applicable

• Assayed for therapeutic monitoring or in the event of occupational exposure.

Ionometry

Special Test

No patient preparation necessary.

Red Tube only

2 mL Serum

Not Applicable

Not Applicable

7 Days

30 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 (with gel separator)

Batch Running

Friday 4:00 PM

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

Not Applicable

None specified.

Not applicable

Not applicable

• Fluorine overload

Not applicable

• Assayed for therapeutic monitoring or in the event of occupational exposure.

Ionometry

Special Test

No patient preparation necessary.

Plastic leak proof clean container

50 mL Random Urine

Not applicable

Not applicable

10 Days

Not applicable

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

•Quantity not sufficient
• Received room temperature
•Improperly labeled specimen
• Improper urine collection

Batch Running

Friday, 4:00 PM

14 Days after cut-off (excluding Saturdays, Sundays and Holidays)

Available upon request

None specified.

Not applicable

Not applicable

• Fine Needle Aspiration Biopsy

• Not applicable

• Used to aid in the diagnosis of cancer, but also helps in the diagnosis of certain infectious diseases and other inflammatory conditions
• Used on samples of free cells or tissue fragments, in contrast to histopathology, which studies whole tissues.

• Papanicolau Staining

• Histopathology

• Fix the specimen first with 95% alcohol (10-20 dips) before packaging
• Indicate the laterality, and the number of slides submitted

• 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

• 7 Days (If properly fixed)

• Not applicable

• Not applicable

• Transport speciments at 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

• 7:00 PM

• 3 to 5 days after receipt of specimen (with reading/interpretation)
• 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.

• Not applicable

• Not applicable

• Not applicable

• FNAB
• Cytology

• Fine Needle Aspiration Biopsy
• Impression smear

• Not applicable

• Used to aid in the diagnosis of cancer, but also helps in the diagnosis of certain infectious diseases and other inflammatory conditions of animal specimens
• Used on samples of free cells or tissue fragments, in contrast to histopathology, which studies whole tissues.

• Papanicolau Staining

• Histopathology

• Fix the specimen first with 95% alcohol (10-20 dips) before packaging
• Indicate the laterality, and the number of slides submitted
• Complete the Histopathology Request form (HPD_F_258)

• 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

• 7 Days (If properly fixed)

• Not applicable

• Not applicable

• Transport speciments at 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

• 7:00 PM

• 7 days after receipt of specimen (with reading/interpretation)
• Note: Additional 2 days may be necessary if specimen needs further evaluation and confirmation by another Pathologist.

• Not applicable

• Not applicable

• Not applicable

• FNAB
• Cytology
• Impression smear

• Folacin
• Folate
• Pteroylglutamic acid
• Vitamin B9

Not applicable

Folic acid is vitamin B-9, which is essential for the production of healthy red blood cells. These cells deliver oxygen to the entire body, so they’re vital for maintaining overall health. Folic acid is also important for the normal development of a fetus. It helps with cell and tissue growth as well as the creation of DNA, which carries genetic information. This is why folic acid is particularly critical for women who are pregnant or who are planning to become pregnant.

Chemiluminescent Microparticle Immunoassay (CMIA)

Immunology

• 8 Hours Fasting
• Protect sample from light by wrapping the sample tube with aluminum foil or carbon paper. Send sample to HPD Main lab immediately.

NOTE:
Put label both on tube and on top of wrapping material to avoid mislabeling and unnecessary exposure of sample to light

Red or Gold tube

1-3 mL Serum

1- 3 mL Plasma (Li-heparin)

Not specified

7 Days

30 Days

NOTE: Remove serum/plasma from red cells or gel separator. Sample must be stored protected from light.

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

• Hemolyzed specimen (may significantly increase folate values due to high concentrations of folate in red blood cells)
• Markedly lipemic specimen
• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimen
• Improper collection tube used

Wednesday

Monday to Saturday:10:00 PM

Sunday:6:00PM

ROUTINE (on running days)
• 4 hours after receipt of specimen/ arrival of messenger
STAT (on running days only)
• 2½ hours from extraction/messenger arrival

7.00~46.40 nmol/L

• Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Such specimens may show either falsely elevated or depressed values when tested with assay kits that employ mouse monoclonal antibodies.
• Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.
• Serum or plasma containing red blood cells may give falsely elevated folate levels. These samples should be centrifuged prior to use.
• Serum or plasma samples that are hemolyzed will give falsely elevated folate levels.
• Serum and plasma specimens from patients with renal impairment or failure (including dialysis patients) may exhibit varying degrees of falsely depressed folate values. Therefore, to evaluate folate patients with renal impairment or failure, it is recommended that low Folate values be confirmed by an alternate folate method such as the RBC Folate assay.
• Methotrexate, aminopterin, and folinic acid (Leucovorin) are chemotherapeutic agents whose molecular structures are similar to folate. These agents cross react with folate binding protein in folate assays.

Not applicable

Complete Blood Count, Methylmalonic Acid, Homocysteine, B Vitamins, Intrinsic Factor Antibody, Parietal Cell Antibody, Reticulocyte Count, Blood Smear

Foundation One Companion Diagnostics

Foundation One Cdx with PDL-1 (free)

• FoundationOne CDx is a tissue based comprehensive genomic profiling service for all solid-tumors to help support efficient-personalized treatment decisions.
• The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies in accordance with the approved therapeutic product labeling. Additionally, F1CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.

Next Generation Sequencing (NGS)

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
• Ask for FMI Test Order Form (Provided by Special Test Section) to be fill up by patient's ordering physician.
• Ensure that all requested information are provided completely to avoid delays in processing of the sample.
• Require the ordering Physician to fill out the Foundation Medicine Test Order Form (Please see attached form).

NOTE: PDL-1 Testing is FREE and included on the offcial results

·         Microscopic slide 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.

·         Tissue block

·         1 original (not recut) H&E slideOR10 unstained slides (positively charged and unbaked at 4-5 microns thick) 1 original (not recut)H&E slide.

        •         Histopathology Report

Not Applicable

• Room Temperature (15-25°C) :  Indefinite
• FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15°C~30°C).
• 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.

Not Applicable

Not Applicable

Transport specimens at 15°C to 30°C

• Fixative used Bouins, B5, AZF and Holland’s.
• Used of strong acids e.g Hydrochloric Acid, Sulfuric Acid, and Picric Acid.
• Incorrect/Incomplete information in the 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

Batch running

Monday to Friday, 12:00 PM

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

• For in vitro diagnostic use
• For prescription use only. This test must be ordered by qualified medical professional in accordance with clinical laboratory regulations.
• A negative result does not rule out the presence of a mutation below the limits of detection of the assay.

         • Samples with <25% tumor may have decreased sensitivity for the detection of CAN’s including ERBB2.

Q: What is FoundationOne CDx?

A: FoundationOne CDx is a tissue based comprehensive genomic profiling service for all solid-tumors to help support efficient-personalized treatment decisions.

FoundationOne CDx is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations and copy number alterations in 324 genes and select gene rearrangements as well as genomic signatures including tumor mutational burden  (TMB) and microsatellite  instability (MSI) using DNA isolated from formalin-fixed embedded (FFPE) tumor tissue specimens.

Q: Do all results lead to actionable treatment options?

A: Each individual cancer is unique and test results vary depending on the tumor type. When applicable, test results may help identify :

1.       A therapy approved to treat your specific tumor type and shown to be effective in targeting one or more of the alterations found by the test.

2.       A therapy approved in another tumor type but possibly effective in targeting one or more of the genomic alterations found by the test

             3.       A clinical trial evaluating therapies under development which may work by targeting an alteration found by the test.

Q: Do the test apply to all types of cancer?

A: Our suite of comprehensive genomic profiling (cGP) assays can help deliver meaningful molecular insights across the broad spectrum of tumor types including but not limited to :

1. Foundation One CDx : Solid tumors, including Non-Small Cell Lung (NSCLC), colorectal, Breast, Ovarian and Melanoma
2. Foundation One Liquid : Solid Tumors including Lung, Breast, Prostate, Gastro-Intestinal, Melanoma and Brain
3. Foundation One Heme : Luekemias, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Sarcomas.

• F1
• F1CDx

Not Applicable

Foundation One Heme with PDL-1 (free)

FoundationOne Heme is a comprehensive genomic profiling test for hematologic malignancies and sarcomas, and provides physicians with clinically actionable information to help with diagnostic subclassification, prognosis assessment and targeted therapy selection.

Next Generation Sequencing, RNA Sequencing

Special Test

• Patient’s clinical diagnosis is required and copies of Pathology Report or other supporting documents. 
• Ask for FMI Test Order Form (Provided by Special Test Section) to be fill up by patient's ordering physician.
• Ensure that all requested information are provided completely to avoid delays in processing of the sample.
• Require the ordering Physician to fill out the Foundation Medicine Test Order Form. (Please see attached form).

NOTE: PDL-1 Testing is FREE and included on the offcial results

  ·         Microscopic slide 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.

FFPE block or 1 H&E slide + 16 unstained slides @ 5 microns each, charged and unbaked with minimum 20% tumor content.  Label block/slides with patient’s name and date of birth.  Ship at room temperature.

Not Applicable

• Indefinite
• FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15°C~30°C).
• 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.

Not Applicable

Not Applicable

Transport specimens at 15°C to 30°C

•    Fixative used Bouins, B5, AZF and Holland’s.
• Used of strong acids e.g Hydrochloric Acid, Sulfuric Acid, and Picric Acid.
• Incorrect/Incomplete information in the 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

Batch Running

Monday to Friday, 12:00 PM

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

Not Applicable

• For in vitro diagnostic use.
• For prescription use only.
• A negative result does not rule out the presence of a mutation outside the limits of detection of the assay.

Q:  What is Foundation One Heme?

A:  Foundation One Heme is a comprehensive genomic profiling for hematologic malignanices and sarcomas.  Test results provide information about clinically relevant alterations, potential targeted therapies, available clinical trials, and quantitative biomarkers that may support immunotherapy clinical trial enrollment.

Q:  How does genomic testing differ from genetic testing?

A: Genomic testing looks at mutations in the tumor itself.  Genetic testing looks at inherited mutations that are in all cells.  Foundation Medicine testing is genomic testing, which looks at the mutations in the tumor.  The mutations in the tumor are what may impact tumor growth, spread and response to therapy.

Not Applicable

Testosterone free - Serum

Not applicable

Helps evaluate secretion of male sex hormone

Free testosterone corresponds to the fraction not bound to albumin, transcortin or TEBG which represents about 2% of total testosterone in males and 1% in females. Reduced levels are observed in males with hypogonadism, hyperthyroidism or being treated with LHRH analogs. Increased levels are seen in females with hyperandrogenism (hirsutism and Stein-Leventhal syndrome).

Radio Immuno Assay (RIA)

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

Friday, 12:00 PM

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

Available upon request

None Specified.

Not Applicable

Androgenic hormone, secondary sexual characteristics, Total Testosterone, Free Testosterone, Bioavailable Testosterone, Testosterone

FTI

Not applicable

FTI is considered to be a more reliable indicator of thyroid status in the presence of abnormalities in plasma protein binding. This test is rarely used now that reliable free thyroxine (FT4) and free triiodothyronine (FT3) assays are routinely available.

Calculation from T3 Uptake & T4

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

Tuesdays, Wednesday, Fridays

A day before running day, 7:00 AM

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

Available upon request

None specified

Not applicable

Thyroid Function Test, TSH, Free T3 or Total T3, Thyroid Panel, Thyroid Antibodies, Calcitonin, Total T4