Laboratory Test Preparation

• Epidermal Growth Factor Receptor
• Epidermal Growth Factor Receptor Mutation Analysis
• HER-1
• erbB-1

Not applicable

To identify patients with advanced NSCLC whose tumors harbor mutations in exons 18, 19, 20 and 21 of the EGFR gene, and to select patients for treatment with small molecule tyrosine kinase inhibitors (TKIs) that target EGFR.

Polymerase Chain Reaction (PCR)

Molecular Diagnostics (PCR)

No patient preparation required.

• Microscope slides should be placed in slide holders or mailer and should be adequately padded before placing in 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.

Human non-small cell lung cancer (NSCLC) Formalin-fixed  paraffin-embedded (FFPET) tissue specimens 

Not applicable

•  Human non-small cell lung cancer (NSCLC) Formalin-fixed paraffin-embedded (FFPET) tissue specimens can be stored at 15°C to 30°C for up to 12 months after date of tissue collection.
• A 5 microns sections mounted on slides may be stored at 15°C to 30°C for up to 60 days.

• Ensure that tissue blocks are stored and transported within the required temperature. Avoid direct sunlight and high temperature during shipping/send-out.

 Not applicable

 Not applicable

•  Ensure that tissue blocks are stored and transported within the  required temperature of 15°C to 30°C to avoid melting. Avoid direct  sunlight and high temperature during shipping/send-out.

• Exceeded sample stability requirement
• Improperly labeled specimen
• Tissue sample not sufficient
• Incomplete EGFR enrollment form data (for patient enrolled in Oncology Program)
• No recent Histopathology result submitted
• Melted or disoriented tissue sample
• Inadequate tissue available on the tissue block

Batch of 3 samples

Saturday, 6:00 PM

14 days excluding Saturday, Sundays & Holidays

Not applicable

Detection of a mutation is dependent on the number of copies present in the specimen and may be affected by specimen integrity, amount of isolated DNA, and the presence of interfering substances.

Q : What is EGFR Mutation testing for?

A:The Cobas EGFR Mutation Test is a real-time PCR test for the qualitative detection and identification of mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from tissue block sample

Mutation Targeted Therapy for NSCLC Companion diagnostic for TKIs, Tumor Markers, Genetic Tests for Targeted Cancer Therapy, KRAS Mutation, ALK Mutation

• Hb electrophoresis
• Hgb electrophoresis
• Thalassemia electrophoresis
• Hemoglobinopathy electrophoresis
• Hemoglobin fractionation

• Hemoglobin A
• Hemoglobin A2

• Used to evaluate the types of hemoglobin present in the blood.
• Useful in the diagnosis of thalassemias.

Capillary Electrophoresis

Serology

No patient preparation necessary.

EDTA (purple top)

2 mL EDTA whole blood

Not applicable

Not applicable

7 Days

Not applicable

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

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

Batch Running

No Cut Off

• 14 Working Days (excluding Saturday, Sundays and holidays)

Hb A: 95-98%
Hb A2: 2-3%

• Cold agglutinins

Not applicable

Hemoglobin variant, Beta-thalassemia, Alpha-thalassemia, Sickle cell Anemia, Iron deficiency anemia

• Protein ELP
• SPE
• SPEP

1. Total Protein
2. Albumin
3. Alpha 1
4. Alpha 2
5. Beta 1
6. Beta 2
7. Gamma

• Used in the evaluation of patients with multiple myeloma, macroglobulinemia, and primary amyloidosis
• Used in the evaluation of various diseases including chronic liver disease, chronic inflammation, nephrotic syndrome, and osteoporosis.

Capillary Electrophoresis

Serology

No patient preparation necessary.

Gold tube

2-3 mL Serum (2 gold tubes)

(2) Red top

Not applicable

7 Days

30 Days

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

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

Batch Running

No Cut Off

• 14 Working Days (excluding Saturday, Sundays and holidays)

Albumin 55.80 ~ 66.10%
Alpha 1 2.90 ~ 4.90%
Alpha 2 7.10 ~ 11.80%
Beta 1 4.70 ~ 7.20%
Beta 2 3.20 ~ 6.50%
Gamma 11.10 ~ 18.80%

• Presence of other proteins other than the target proteins.
• Normal serum protein electrophoresis does not rule out disease.

Not applicable

Inflammation, Multiple Myeloma, Chronic liver disease, Chronic inflammation

• Endomysium - anti-IgA antibodies
• Anti gluten IgA antibodies
• Celiac Disease Antibody Test
• tTG
• EMA
• Anti-deamidated Gliadin Peptides
• DGP
• Antireticulin Antibodies
• ARA
• Quantitative Immunoglobulin A
• Immunoglobulin A
• Tissue Transglutaminase Antibody
• Anti-Reticulin Antibodies
• Deaminated Gliadin Peptide Antibodies
• Anti-Endomysium Antibodies IgA
• Anti-Endomysial Antibodies

   

   

   

   

Not Applicable

The only anti-endomysium antibodies of interest are those of the IgA class which are a marker for celiac disease (more specific than anti-gliadin). They disappear once the patient has changed his or her diet.

Celiac disease is an autoimmune disorder characterized by an inappropriate immune response to gluten, a  protein found in wheat, and related dietary proteins in rye and barley. Celiac disease antibody tests help diagnose and monitor the disease and a few other gluten-sensitive conditions. These tests detect autoantibodies in the blood that the body produces as part of the immune response.

Immunofluorescence

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, 4:00 PM

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

Not Applicable

None Specified

Q: Why get tested?

A:To help diagnose celiac disease and to evaluate the effectiveness of a gluten-free diet

Q: When to get tested?

A:When you have symptoms suggesting celiac disease, such as chronic diarrhea, bloating, abdominal pain, anemia, and weight loss; when an infant is chronically irritable or fails to grow at a normal rate; when a close family member has celiac disease; when you are being treated for celiac disease

Q: When is it ordered?

A:Celiac disease tests are ordered when someone has signs and symptoms suggesting celiac disease, malnutrition, and/or malabsorption. The symptoms are often nonspecific and variable, making the disease difficult to spot. The symptoms may, for a time, be mild and go unnoticed and then progressively worsen or occur sporadically. The condition can affect different parts of the body.

Anti-tissue Transglutaminase Antibody; tTG; tTGA; Endomysial Antibody; EMA; DGP; ARA; Total IgA, Tissue Transglutaminase Antibody; Deaminated Gliadin Peptide Antibodies; Anti-Endomysial Antibodies; Anti-Reticulin Antibodies; Quantitative Immunoglobulin A, Immunoglobulins (IgA, IgM, IgG), Fecal Fat, Total Protein, Albumin-Globulin (A/G) Ratio, Albumin, Calcium, Vitamin b12 and Folate, Autoantibodies, Vitamin D Tests, Complete Blood Count, Comprehensive Metabolic Panel (CMP), Iron Tests,

Not applicable

• Breast Cancer Gene Expression Profile
• Initial Treatment Planning (10 Year Prognostic)
• Initial Treatment Planning (Adjuvant Chemotherapy Benefit)

Used for determining the prognosis of breast cancer patients.

EndoPredict is a multi-gene test for breast cancer patients. It determines whether a patient needs chemotherapy, or whether solely anti-hormonal therapy constitutes sufficient treatment.

Polymerase Chain Reaction (PCR)

Special Test

• EndoPredict is only appropriate for patients with estrogen-receptor (ER) positive and HER2/Neu-negative breast cancer
• Patient should submit their slides and blocks with corresponding Medical Abstract.
• Ask for ENDOPREDICT TEST REQUEST FROM (TRF) (ENDO_TRF_23_07_20_EN) at Special Test Section
• EndoPredict Test Request Form to be completely filled out  the Ordering Physician
• Provide Pathology Report
• Double check completeness of information in the required documents prior to sending to HPD Main Laboratory to avoid delay in processing of sample.

NOTE:

• The portion of the tumor should be at least 30% which represents the ratio of invasive tumor tissue to total tissue area (adipose tissue is not to be taken into account as tissue)
• A minimum of 10 mm of tumor is required (a single section or multiple equally to a 10 mm section)
• The portion of the tumor should be determined using the adjacent H&E (Hematoxylin and Eosin unstained) section

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

Endopredict Kit to will be provided by HPD Special Test Section.

• 2 FFPE Tumor Block
• 2 H&E slide (2-5 microin thickness) - Charged Slide
• 5 slides (10 microns thickness - Uncharged Slide

NOTE:

• The portion of the tumor should be at least 30% which represents the ratio of invasive tumor tissue to total tissue area (adipose tissue is not to be taken into account as tissue)
• A minimum of 10 mm of tumor is required (a single section or multiple equally to a 10 mm section)
• The portion of the tumor should be determined using the adjacent H&E (Hematoxylin and Eosin unstained) section

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)

• Portion of the tumor is less than 30%
• Tumor size is less than 10mm
• Unlabelled sample
• If tumor slide is baked or adhesive is used

Batch Running

Monday to Friday, 12:00 PM

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

Not Applicable

None Specified

Q: Who is eligible for EndoPredict?

A:EndoPredict can be used for patients with newly diagnosed breast cancer. The tumor must be hormone receptor-positive and Her2/neu-negative. The test is suitable when no lymph nodes are infiltrated, as well as with up to three positive lymph nodes.

Q: What does Endopredict do?

A:EndoPredict is a risk assessment test which gives two types of result= HIGH RISK or LOW RISK. If a patient is said to be HIGH RISK, the accepted form of treatment is Chemotherapy. If a patient is said to be LOW RISK- the doctor may suggest other hormonal therapies that the patient can undergo instead of subjecting her to Chemotherapy. So a patient can be spared from undergoing chemotherapy. Not just save money from chemotherapy treatments but also spare her from the mental and emotional trauma.

Q: When is EndoPredict used?

A:EndoPredict can be used as soon as a tissue sample of the invasive tumour is available. The sample can be taken either by core needle biopsy or during surgery. The test will be used to provide additional decision support as to whether chemotherapy is necessary or not.

Q: How much tumour material is needed for testing? Sample type:

A:Only one section (tumour content 30 %) of a tissue block is needed. The tumour resection or needle biopsy must be fixed in neutral buffer/10 % formalin and embedded in paraffin. A 10µm section of resected tissue will suffice, provided that it exhibits at least 30% of the tumour. A 10µm section will also suffice for a needle biopsy in most cases; the yield is generally less than that of resected tissue. Therefore, a second section of a needle biopsy might be needed in some cases. An HPD staff will call the client if there will be such a requirement.

Q: Who performs the test?

A:The test is carried out in several specially qualified molecular pathology labs in Germany, Austria and Switzerland. If there is no local pathology lab to offer the test, the tumour sample can also be sent to one of these institutions. The result may thereby be delayed by a few days. Hi Precision Diagnostics will send out the specimen to a German laboratory.

Breast Cancer, gene expression test, chemotherapy or anti hormonal treatment

Environmental analysis

Not applicable

Identification and quantification of the presence of microorganisms on air or on a particular surface that can present a considerable threat to health and safety.

1. Air Sampling - Plate Exposure Method
2. Swab Sampling - Surface Swab Method

Bacteriology

Instructions to Send-in Clients:
Indicate the site and manner of collection in the request forms (eg. OR - Air Sampling; Laboratory sink - Swab Sampling) - wala bang need na address or something?

Sampling/Collection Procedure:
A. Plate Exposure (Air Sampling)
1. Vacate the area when sampling is on-going.
2. Place the blood agar plate (BAP) on a flat surface in the test location and remove the lid.
3. Leave the agar exposed for atleast 30 minutes and up to 1 hour. Monitor the exposure time with a timer.
4. Replace the lid and seal the plate using parafilm.
5. Place the plates in a sterile plastic bag, seal and label clearly with location, date and duration of exposure.
6. Submit the plates to the laboratory as soon as possible.

B. Surface Swab (Swab Sampling)
1. Wash and dry hands thoroughly.
2. Aseptically open the Amies transport swab container.
3. Hold the swab by the handle, applying firm pressure, and using up and down movements, swab the entire surface of the material or equipment for evaluation.
4. Aseptically return the the swab to its sterile container.
5. Seal the container and label clearly with the sampling source, date and time of sampling.
6. Submit the Amies transport swab to the laboratory as soon as possible.

• Plate Exposure method (Air sampling): Blood Agar Plate (BAP)
• Surface swab method (Swab Sampling): AMIES Transport swab

• Plate Exposure method (Air sampling): One Blood Agar Plate (BAP) per location.
• Surface swab method (Swab Sampling): One AMIES Transport swab per sampling source

Not applicable

24 Hours

Not applicable

Not applicable

Transport specimens immediately to HPD Laboratory at room temperature (15-25°C)

NOTE: Do not delay transport of samples.

• Incorrect label
• Incorrect Agar plate/Transport media
• Exceeded sample stability and storage requirement
 

Daily

7:00 PM

NEGATIVE: 48 hours
POSITIVE: Additional 2-3 days from the day bacterial growth is detected.

Not applicable

Improper sample collection.

Not applicable

Not applicable

EBV VCA:

• Epstein- Barr Virus Viral Capsid Antigen
• Human Herpes  Virus 4

EBV EBNA:

• Epstein-Barr Virus (EBV)
• Epstein-Barr Nuclear Antigen-1 (EBNA-1)

• EBV VCA  IgG
• EBV EBNA-1 IgG

Aids in the diagnosis of EBV infection, the most common cause of infectious mononucleosis and in determining the stage of EBV infection.

Chemiluminescent microparticle immunoassay (CMIA)

Immunology

No patient preparation necessary.

Gold or Red Tube

1-3 mL Serum

Plasma (K2 EDTA, K3 EDTA, Li-Heparin, Na-Heparin, Na-Citrate)

3 Days

14 Days

Not applicable

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

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

Saturday

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

EBV VCA:

• Non Reactive  <0.75
• Grayzone 0.75 - <1.00
• Reactive  ≥1.00

EBV EBNA:

• Non Reactive  <0.50
• Grayzone  0.50 to <1.00
• Reactive ≥ 1.0

• Heterophilic antibodies in human serum can react with reagent immunoglobulins, interferingin vitroimmunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.
• Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Specimens containing HAMA may produce anomalous values when tested with assay kits (such as Alinity I EBV EBNA-1 IgG) that employ mouse monoclonal antibodies.

Q: When is EBV IgG test ordered?

A:  EBV antibody tests may be ordered when someone has symptoms suggesting infectious mononucleosis but a negative test and when a pregnant woman has flu-like symptoms and her healthcare provider wants to determine whether the symptoms are due to EBV or another microbe. Some signs and symptoms associated with infectious mononucleosis include:

• Extreme weakness or fatigue
• Fever
• Headache
• Sore throat
• Swollen lymph glands in the neck and/or armpits
• Enlarged spleen and/or liver (sometimes)

Testing may be ordered when a healthcare practitioner wants to establish previous exposure to EBV. Testing may occasionally be repeated when the healthcare provider wants to track antibody concentrations/titers and/or when the first test was negative but the healthcare practitioner still suspects that the person's symptoms are due to EBV.

EBV Antibodies, EBV IgM Ab; EA-D IgG Ab, Epstein-Barr Virus Antibody to Early D Antigen IgG, Heterophile Antibodies, Infectious Mononucleosis (IM)

• EBV - VCA IgA
• EBV
• IMN
• Infectious Mononucleosis
• Epstein-Bar Virus EBV-VCA IgA Serology
• EBV Antibodies
• EBV Viral Capsid Antigen Antibody (VCA) IgM, IgG Ab
• EBV Nuclear Antigen Antibody EBNA-IgG Ab
• EBV Ab to Early Antigen D, EA-D IgG Ab
• Epstein-Barr Virus Antibodies
• VCA - IgA serology

Not Applicable

Primary infection by EBV causes Infectious Mononucleosisi, usually a self-limiting disease in children and young adults.

Epstein-Barr virus (EBV) is a virus that typically causes a mild to moderate illness. Blood tests for Epstein-Barr virus detect antibodies to EBV in the blood and help establish a diagnosis of EBV infection.

Immunoflourescence

Special Test

No patient preparation necessary.

Red or Gold Top

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)

Not Applicable

None Specified

Q: Why get tested?

A:To help diagnose infectious mononucleosis (mono); to distinguish between an Epstein-Barr virus (EBV) infection and another illness with similar symptoms; to help evaluate susceptibility to EBV

Q: When to get tested?

A:When you have symptoms of mono but a negative mono test; when a pregnant woman has flu-like symptoms; occasionally when an asymptomatic person has been exposed to someone with mono; or possibly as a means to check immune system function

Q: When is it ordered?

EBV Antibodies; EBV VCA-IgM Ab; EBV VCA-IgG Ab; EBNA-IgG Ab; EA-D IgG Ab, Epstein-Barr Virus Antibody to Viral Capsid Antigen, IgM, IgG; Epstein-Barr Virus Antibody to Nuclear Antigen, IgG; Epstein-Barr Virus Antibody to Early D Antigen, IgG; Heterophile Antibodies, Mononucleosis (Mono) Test, Complete Blood Count, White Blood Coun, Blood Smear, CMV Tess, Toxoplasmosis Testing

• IMN
• Infectious mononucleosis
• EBV
• VCA - IgM serology
• Epstein-Barr Virus - EBV - VCA IgM Serology - Serum

Not Applicable

Useful in investigation Infectious Mononucleosis. Epstein-Barr virus (EBV) is a herpesvirus with a tropism for B-lymphocytes. It is transmitted in saliva and infection is very widespread in the population. Primary infection usually occurs during childhood and is either asymptomatic or the symptoms are non-specific. Infectious mononucleosis indicates late primary infection, usually observed in adolescents or young adults. After primary infection, the virus establishes latency and reactivation can be completely silent. In immunodeficient patients, EBV infection can cause severe clinical symptoms, including polyneuritis, meningoencephalitis, hepatitis and oral hairy leukoplasia. EBV is an oncogenic virus and is associated with certain neoplasias, including nasopharyngeal carcinoma (NPC), Burkitt's lymphoma and, in immunodeficient patients (e.g. patients with AIDS or on immunosuppressant therapy following transplantation) lymphoblastic B-cell lymphoma. Isolation of the virus is difficult in practice but detection of viral DNA by PCR assay in the blood, CSF or liver biopsy material is indicative of active viral infection. Conventional serological analysis involves assaying for anti-VCA IgG and IgM antibodies and anti-EBNA IgG antibodies. IgM antibodies are present for the first three months and when they disappear, anti-EBNA IgG antibodies appear. Assaying anti-EA antibodies can be of use in active infections. High titers of anti-VCA and anti-EA IgA antibodies are associated with NPC. EBV virus may be involved in meningoencephalitis (immunodeficient subject) or some forms of myelitis.

Chemiluminescence

Special Test

No patient preparation necessary.

Red or Gold Tube

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

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

Not Applicable

None Specified

Not Applicable

EBV Antibodies; EBV VCA-IgM Ab; EBV VCA-IgG Ab; EBNA-IgG Ab; EA-D IgG Ab, Epstein-Barr Virus Antibody to Viral Capsid Antigen, IgM, IgG; Epstein-Barr Virus Antibody to Nuclear Antigen, IgG; Epstein-Barr Virus Antibody to Early D Antigen, IgG; Heterophile Antibodies

EPO

Not applicable

This test may be used to help determine the cause of anemia, polycethemia (high red blood cell count) or other bone marrow disorders/hormone produced by the kidney that promotes the formation of red blood cells by bone marrow.

Chemiluminescence

Special Test

No patient preparation necessary.

Red or Gold Tube

3 mL Serum

Not Applicable

48 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

Available upon request

None specified

Not applicable

Cause of anemia, polycythemia (high red blood cell count) or other bone marrow disorders.

• Sedimentation Rate
• Erythrocyte Sedimentation Rate
• Sed Rate                                                                                                                        •Westergren Sedimentation Rate                                                                             •Wintrobe Sedimentation Rate

Not applicable

Used to monitor the response to therapy in certain inflammatory diseases such as temporal arteritis, polymyalgia rheumatica and rheumatoid arthritis.

Sedimentation

Hematology

No patient preparation necessary.

LPA Italiana SPA tube (peach top) 0.8 mL whole blood

0.8 mL whole blood

Not applicable

Peach top: 4 hours

Peach top: 12 hours

Unacceptable

Transport specimen at 2 – 10 °C (with cold packs)

• Improperly labeled specimens
• Clotted blood
• Quantity not sufficient
• Specimen transported outside the required temperature.
• Incorrect collection tube use

Daily

Monday to Saturday
• 6:00 PM

Sunday
• 3:00 PM

ROUTINE
• 3 hours after receipt of specimen/ arrival of messenger

Male : 0-15 mm/hr
Female : 0-20 mm/hr

• Polycythemia vera
• Anisopoikilocytosis
• Anisocytosis

Not applicable

Inflammation, CRP, ANA, Rheumatoid Factor, Fibrinogen, Protein Electrophoresis, Immunofixation Electrophoresis, Autoimmune Diseases,Vasculitis, Lupus, Arthritis, Chronic Fatigue Syndrome.

• Oestradiol
• E2
• 17-B-estradiol

Not applicable

• The biologically most active estrogen is 17-B Estradiol. The determination of estradiol is utilized clinically in the elucidation of fertility disorders in the hypothalamus-pituitary-gonad axis, gynecomastia, estrogen-producing ovarian and testicular tumors and in hyperplasia of the adrenal cortex. Further clinical indications are the monitoring of fertility therapy and determining the time of ovulation within the framework of in vitro fertilization (IVF).
• Used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
• Diagnostic applications of estradiol assays include assessment of ovarian function in a wide variety of situations (menstrual disorders, precocious or delayed puberty, assisted reproduction protocols).
• For men, estradiol measurement may be useful in the evaluation of gynecomastia

Electrochemiluminescence Immunoassay (ECLIA)

Immunology

• For patients taking high biotin doses (i.e. >5 mg/day), sample should be taken at least 8 hours from last biotin administration.
• Samples should not be taken from patients being treated with Fulvestrant - a drug treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy.
• Samples should not be taken from patients who have been exposed to vaccines containing rabbit serum or when keeping rabbits as pet animals.

Red or Gold tube

1-3mL Serum

1-3mL Plasma (Li-heparin/ K2-, K3- EDTA)

12 Hours

2 Days

6 Months (Freeze only once)

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

• Hemolyzed specimen
• Markedly lipemic specimen
• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimens
• Samples from patients receiving Biotin therapy and Fulvestrant treatment.

Monday, Wednesday, Friday

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

Female:
Follicular phase:12.40-233.00 pg/mL
Ovulation phase: 41.00-398.00 pg/mL
Luteal Phase: 22.30-341.00 pg/mL
Post Menopause: <5.00-138.00 pg/mL

Pregnant Women:
1st trimester: 154.00-3243.00 pg/mL
2nd trimester: 1561.00-21280.00 pg/mL
3rd trimester: 8525.00->30000.00 pg/mL

Male in pg/mL: 25.80-60.70 pg/mL

•Erroneous test results may be obtained from samples taken from patients who have been exposed to vaccines containing rabbit serum or when keeping rabbits as pet animals.
•Due to the risk of cross reactivity, this assay should not be used when monitoring Estradiol levels in patients being treated with Fulvestrant.

Q: Is Estradiol same with Estrogen?
A: No, we have a different testing method for determining Estrogen level - Estrogen (RIA), Test Code: ESTRI9, under Special Test Section.

Fertility Testing, Placental/ Ovarian Function, Estrogen Fractions/ Fractionated, Estrone (E1), Estriol (E3), Estrogenic Hormones, Estrogens, FSH, LH, Progesterone, Testosterone, Second Trimester Maternal Serum Screening, SHBG, Androstenedione, DHEA

• E2

Not applicable

• Females : Assess hypothalamic-pituitary ovarian axis. High levels are observed in feminizing-type ovarian tumors and ovarian cysts. This test also provides an assessment of the ovarian response to stimulation therapy.
• Males : Investigate unexplained gynecomastia in men, high levels are found in patients with gonadotropin-secreting or androgen-secreting tumors (e.g of the testis or the adrenal gland)

Radio Immuno Assay (RIA)

Special Test

No patient preparation necessary.

Red or Gold Tube

3 mL Serum

Not Applicable

7 Days

7 Days

6 Months

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

Friday 8:00AM

Thursday 4:00 PM

Tuesday 6:00 PM

Available upon request

None specified

Not applicable

Estrogen Fractions/fractionated; Estrone (E1); Estradiol (E2); Estriol (E3); Estrogenic Hormones, Estrogens; Estrone; Estradiol; Estriol

Not applicable

Not applicable

Used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)

Special Test

No patient preparation necessary.

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

3 mL Serum

Not Applicable

48 Hours

7 Days

2 Years

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

14 Days (excluding Saturdays, Sundays and Holidays)

Available upon request

None specified

Not applicable

Estrogen Fractions/fractionated; Estrone (E1); Estradiol (E2); Estriol (E3); Estrogenic Hormones, Estrogens; Estrone; Estradiol; Estriol

Not applicable

Not applicable

• Diagnostic applications of estradiol assays include assessment of ovarian function in a wide variety of situations (menstrual disorder, precocious or delayed puberty, assisted reproduction protocols)
• For men, estradiol measurement maybe useful in the evaluation of gynocomastia

Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)

Special Test

No patient preparation necessary.

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

3 mL Serum

Not Applicable

48 Hours

7 Days

2 Years

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

14 Days (excluding Saturdays, Sundays and Holidays)

Available upon request

None specified

Not applicable

Postmenopausal women, men, and children and adolescents