Laboratory Test Preparation

• Mumps virus - IgG/IgM serology
• Mumps paramyxovirus - IgG/IgM serology

Not applicable

For the determination of IgM Class antibodies to Mumps virus in human serum.

Mumps is a viral infection that is transmitted through respiratory secretions or saliva. After a 2 to 3 week incubation period, an infected person typically develops flu-like symptoms such as a headache, muscle aches, and fever that are followed by characteristic parotitis – swelling of the salivary (parotid) glands below one or both ears.

Chemiluminescence

Special Test

No patient preparation necessary.

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

Blood sample will be drawn every friday until 4pm only.

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

Batch Running

Friday 4:00 PM

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

Available upon request

None specified.

Not Applicable

Measles Antibody, IgM and IgG, Measles Viral Culture, Measles by RT-PCR,Mumps Viral Culture, Mumps by RT-PCR

Homologous Recombination Deficiency

1. Tumor Mutation Status: BRCA1 and BRCA2 Analysis (detect somatic and germline mutations but it does not distinguish between the two)

a.       Sequence Variants

b.      Large Rearrangements

2. Genomic Instability Status:

a.       Loss of Heterozygosity (LOH)

b.      Telometric Allelic Imbalance (TAI), and

c        Large-scaleStateTransitions (LST)

Myriad myChoice® HRD is used to detecthomologous recombination deficiency (HRD)by assessing Genomic Instability Status and Tumor Mutation Status in genomic DNA extracted from tumor specimens. This test may aid in identifying patients with positive HRD and should be used in accordance with the approved therapeutic product labeling. Analytical validation has been performed on the genomic instability score and the following genes: BRCA1, BRCA2. Homologous Recombination Deficiency (HRD) is present in approximately 48% of ovarian cancer tumors, some causes of HRD are well established while others remain unknown.

Note:The analytical assay used for myChoice HRD has been developed and validated in accordance with FDA Quality System Requirements (QSR) and is the same analytical assay used with the FDA approved myChoice CDx test.

Next Generation Sequencing (NGS) of Single-Nucleotide Polymorphism (SNPs)

Special Test 

• No patient preparation necessary.
• Patient should submit their slides and blocks with corresponding Histopathological Report.

NOTE:To avoid delay in processing of specimen, the following documentations must be completely filled – out:

1. MyChoice HRD Test Request Form (TRF)
2. Consent Form

• Samples 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 patient’s clinical information
• Ask for MyChoice HRD Test Request Form (TRF) and Consent Form at Special Test Section at least 1 day prior to test.

NOTE: KINDLY INFORM YOUR PATIENT THAT REFERRING LABORATORY WILL BE NO LONGER RETURN UNUSED SLIDES FROM PERFORMED TEST TO THE SUBMITTING PATHOLOGISTS

• 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.

NOTE: KINDLY INFORM YOUR PATIENT THAT REFERRING LABORATORY WILL BE NO LONGER RETURN UNUSED SLIDES FROM PERFORMED TEST TO THE SUBMITTING PATHOLOGISTS

• 1 (one) Formalin-fixed paraffin-embedded (FFPE) tissue block with 20% tumor by pathologic review (Breast and Ovarian type of tumor only)

Note:Samples can be from biopsies or ascites fluid.

• Histopathology report for the submitted tissue slide and block.

2-30 Slides that contain at least 40 microns of tumor (Breast and Ovarian type of tumor only)

5 years 

5 years 

Not Applicable

• Transport at room temperature (15 °C – 30 °C).
• Avoid exposure to direct sunlight. 

• Incorrect/Incomplete information in the Request Form.
• Improper/Incorrect labeling of tissue blocks or slides.
• Tissue blocks and slides do not correspond to its histopathology report.
• Inadequate tissue available on the tissue block.
• Other type of tumor except for Breast and Ovarian Tumor.
• Biopsies from brain, bone (depending on the decalcification method), and endometrium.
• Baked slides or use of adhesives.

Batch Running

Mondat to Friday, 12:00 PM

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

Not Applicable

• This test identifies germline and somatic variants in the tumor but does not distinguish between the two.
• Reduced hybridization efficiency of DNA fragments spanning long insertions and deletions (indels) or rearrangements may result in under-representation of mutant DNA molecules in the final sequencing library. This will result in a reduction in the observed frequency of sequence reads spanning the mutation
• Indels > 25 bp in length can be detected by this assay. However, the ability to detect any particular indel may be impacted by the location and nature of the mutation, the local sequence context, the DNA quality, and the non-tumor DNA content in the sample provided.
• This test has been designed to detect genomic rearrangements including large rearrangements (LRs) involving the promoter and coding exons of BRCA1 and BRCA2, however, the detection of large rearrangement deletions and duplications is dependent on the quality of the submitted specimen.
• Whole gene duplications and deletions may not be detected by this assay.
• Other terminal duplications are reported as variants of uncertain significance.
• This analysis is believed to rule out the majority of abnormalities in the genes analyzed. There may be uncommon genetic abnormalities such as specific insertions, inversions, and certain regulatory mutations that will not be detected by this assay.

Q: What is homologous recombination?

A:Homologous recombination is the only error proof mechanism that restores double?stranded DNA breaks to their original state.

Q: What is homologous recombination deficiency (HRD)?

A:Homologous recombination deficiency is when the homologous recombination mechanism becomes deficient causing the inability to accurately repair double?stranded DNA breaks.

Approximately half of all ovarian cancer tumors have homologous recombination deficiency.

Q: What is genomic instability?

A:Genomic instability (also referred to as genetic or genome instability) is a high frequency of chromosomal rearrangements (or mutations) present in the DNA of a cell.

Q: What role does HRD play in PARPI treatment response?

A:PARP is a family of proteins that repair single-stranded DNA breaks. Inhibiting PARP leads to an accumulation of single-stranded DNA breaks and the accumulation of these breaks results in programmed cell death.

Q: How is platinum sensitivity defined?

A:Platinum sensitivity means that the cancer responded to platinum-based chemotherapy and that there was no recurrence for at least 6 months after completion of treatment.

Not Applicable

Not applicable

Not applicable

• For the determination of IgG Class antibodies to Mycoplasma pneumoniae in human serum.
• Mycoplasma pneumoniae is an etiologic agent of febrile primary atypical pneumonia. Upper respiratory tract infections (nasopharyingitis and tracheitis) are common in both adults and children and more rarely, cardiac (pericarditis), neurological (acute idiopathic polyneuritis and meningoencephalitis) and mucocutaneous (erosive dermosis) symptoms have been attributed to this bacterium.

Chemiluminescence

Special Test

Blood sample will be drawn every Every Thursday and Friday from 8am-3pm.

Red or Gold Tube

3 mL Serum

Not Applicable

4 Days

7 Days

Not applicable 

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 4:00 PM

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

Available upon request

None specified.

Not Applicable

Mycoplasma by PCR, Mycoplasma pneumoniae IgG Antibodies

Not applicable

Not applicable

• For the determination of IgM Class antibodies to Mycoplasma pneumoniae in human serum.
• Mycoplasma pneumoniae is an etiologic agent of febrile primary atypical pneumonia. Upper respiratory tract infections (nasopharyingitis and tracheitis) are common in both adults and children and more rarely, cardiac (pericarditis), neurological (acute idiopathic polyneuritis and meningoencephalitis) and mucocutaneous (erosive dermosis) symptoms have been attributed to this bacterium.

ELISA

Special Test

Red or Gold Tube

3 mL Serum

Not Applicable

Not applicable 

<5 Days

Not applicable 

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-Friday

Mon-Fri 7am

3 Working days (excluding Saturdays, Sundays and Holidays)

Available upon request

None specified.

Not Applicable

Mycoplasma by PCR, Mycoplasma pneumoniae IgG Antibodies

The concentration of MBP is often increased in patients with demyelinating diseases such as multiple sclerosis and may be increased in patients with head injury, CNS trauma, tumor, stroke, and viral encephalitis.

Radioimmunoassay (RIA)

Special Test

CSF must be clear.

Do not centrifuge.

CSF collection tube #4 is preferred. Submitting 4th lumbar puncture collection tube minimizes blood contamination.

Plastic leak proof sterile container (screw cap) 

NOTE: Sample must be properly packed (trtiple packaging)

3 ML CSF

7 days

14 days

21 days

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

• Not sufficient specimen
• Beyond stability
• Not properly labeled container
• Gross Hemolysis
• Grossly Lipemic

Batch Running

Monday, 12:00 PM

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

Not Applicable

Not applicable

Found in the cytoplasm of striated muscle cells (skeletal and cardiac muscle).

This test is particularly useful in the investigation of massive destruction of muscle tissue e.g serious trauma, rhabdomyolysis, crush syndrome and electrocution.

Electrochemiluminescence

Special Test

Collection Procedures :

1. Instruct the patient to void at the beginning of collection period and discard the specimen.
2. Collect all urine including the final specimen voided at the end of collection period.
3. Mix 24 hour urine collected.
4. Label the bottle with patient name, date & time collection started, date & time collection ended and total volume measured.
5. Note total volume.
6. Submit the specimen to HPD

Plastic leak proof clean container without preservative

100 mL of 24 hour Urine

Not Applicable

Not applicable

48 Hours

28 Days

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

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

Available upon request

None specified.

Not applicable

Striated Muscle, Muscle tissue

Urine Myoglobin Screening Assay

Not applicable

Found in the cytoplasm of striated muscle cells (skeletal and cardiac muscle).

This test is particularly useful in the investigation of massive destruction of muscle tissue, e.g. serious trauma, rhabdomyolysis, crush syndrome and electrocution. A combination of high serum myoglobin (over 1,000 ug/L) with a low level in the urine may well indicate acute renal insufficiency.

Special Test

No patient preparation necessary.

Plastic leak proof clean container

60 mL Random Urine

Not Applicable

Not applicable

72 Hours

72 Hours

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

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

Monday to Friday

Monday to Friday, 7:00 AM

After 3 Days (excluding Saturdays, Sundays and Holidays)

Available upon request

None specified.

Not applicable

Striated Muscle, Muscle tissue

Not applicable

Assessment of skeletal muscle breakdown (rhabdomyolysis).

Enzyme - Immunoassay

Special Test

No patient preparation necessary.

Red or Gold Tube

3 mL Serum

Not Applicable

7 Days

14 Days

35 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 4:00 PM

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

Not Applicable

None specified.

Not applicable

Not Applicable

8 Important Cancers :

• Breast
• Ovarian
• Gastric
• Colorectal
• Pancreatic
• Melanoma
• Prostate
• Endometrial

25 Genes :

• APC
• ATM
• BARD1
• BMPR1A
• BRCA1
• BRCA2
• BRIP1
• CDH1
• CDK4
• CDKN2A (p16INK4a and p14ARF)
• CHEK2
• MLH1
• MSH2
• MSH6
• MUTYH
• NBN
• PALB2
• PMS2
• PTEN
• RAD51C
• RAD51D
• SMAD4
• STK11
• TP53

The MyRisk Hereditary Cancer Panel is a 25-gene panel that identifies an elevated risk for eight (8) important cancers: Breast, Ovarian, Gastric, Colorectal, Pancreatic, Melanoma, Prostate, Endometrial. Helps to determine if patient has a significantly increased risk of developing certain cancers or diseases.

Next Generation Sequencing (NGS) and Microarray

Special Test

• No patient preparation necessary.
• Inform laboratory 1 day before sample collection for schedule.
• Blood collection must be done every Monday only.
• Must completely filled-out all the forms (TRF and Consent Form)

Instruction to Customer Service/Encoders:

1. Patient may proceed with the test if there is already an available doctor’s request. Kindly confirm that patient has consulted with a Physician.

2. An appointment with Dra. Lalaine Macatangay (HPD Del Monte) may be scheduled prior to proceeding with the test ONLY IF:

3. General inquiries can also be entertained by In-house doctor who attended the training. Doctor should inform patient to consult with her personal Physician regarding this test.

4. Ask for MYRISK TEST REQUEST FROM                         (TRF) (UHC_TRF_01_08_18_EN) and CONSENT FORM (HC_CONS_02_08_18_EN) at Special Test Section 

5. Ensure completeness of signatures and information on the Test Request Form. Incomplete forms will cause delay in processing of sample.

3 pcs of 4mL EDTA or Violet Top (Provided by HPD)

9 mL Whole Blood Edta

Not Applicable

5 Days

Not Applicable

Not Applicable

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

• Clotted blood specimen
• Incomplete Test Request Form
• Insufficient volume
• Incorrect storage temperature of specimen
• Incorrect collection container used

Batch Running

Monday, 12:00 PM

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

Not Applicable

None Specified.

Not Applicable

Inherited cancers, breast, ovarian, colon, skin (melanoma), uterine (endometrial), pancreatic, gastric and prostate cancer, genetic cancer

Neisseria Meningitidis IgG

Not applicable

This assay measures serum IgG antibodies recognizing polysaccharide antigens from the four Neisseria meningitidis serogroups included in the licensed meningococcal vaccine. The meningococcal vaccine response is best evaluated by testing pre-vaccination and post-vaccination samples in parallel. A two-fold or greater increase for at least two serogroups is expected when comparing post-vaccination to pre-vaccination results. N. Meningitidis IgG levels peak approximately one month post-vaccination, but decline markedly by two years.

Multi-Analyte Immunodetection (MAID)

Special Test

No patient preparation necessary.

Red or Gold Tube

3 mL Serum

Not Applicable

5 Days

14 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

Batch Running

Monday, 12:00 PM

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

Available upon request

None specified.

Not applicable

Gram negative bacterium, Meningococcemia, a life-threatening sepsis

Ni

Not applicable

Nickel toxicity is associated with allergy, asthma, urticaria, erythema multiforme, contact dermatitis, and hand eczema.

Inductively Coupled Plasma/Mass Spectrometry

Special Test

• Blood sample will be drawn every Monday - Wednesday from 8am-3pm.
• Request Container to Special test section
• Carefully clean skin prior to venipuncture. Avoid worksite collection.

Instruction to Phlebotomists:Specimen Collection and  Handling

1. Wash the collection site with soap and water, followed by an alcohol swab.
2. Collect the trace metal tube last if other tubes are to be collected from the same site.
3. Label the complete name of patient on the EDTA Royal blue tube upon extraction.       
4. After blood extraction, invert EDTA Royal Blue tube 8-10 times to prevent clotting.
5. Verify and record the name, date of birth, age, gender and employment history of each patient in the Clinical Information.
6. Note if the patient is pregnant.
7. After blood collection, do not open specimen tubes at any time prior to shipment. Do not use iodine-containing disinfectants.

6 mL Royal Blue Top - Edta - (Request Container to Special test section)

2 Pcs of  6 mL wholeblood Royal Blue - Edta

Not Applicable

7 Days

7 Days

Not applicable

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
• Only one (1) Edta royal blue tube submitted
• Over-filled or Under-filled tube

Batch Running

Monday, 12:00 PM

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

Available upon request

None specified.

Not applicable

Allergy skin test

Neuroblastoma RAS

Not applicable

N-RAS mutations have been described in 12% of leukemias, 18% of skin cancers, 18% of small intestine cancers, 3% of colon cancers, and 7% of thyroid cancer.

Pyrosequencing

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

• Incomplete information in the Request Form
• Improper or insufficient labeling of tissue blocks or slides
• Inadequate tissue available on the tissue block

Batch Running

Monday to Friday, 12:00 PM

After 14 days (excluding Saturdays, Sundays and Holidays)

Not Applicable

None specified.

Not applicable

Cancer, Gene mutation, Mutation targeted therapy