Laboratory Test Preparation

| Test | : | Hepa B Genotyping |
| Other Test Request Name | : |
|
| Test Composition | : | Not Applicable |
| Intended Use | : | To determine genotype of Hepatitis B Virus. Determining the genotype of the particular virus can be useful for predicting efficacy and for deciding which drugs and what dose to prescribe. |
| Methodology | : | Sequencing |
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : |
|
| Collection/Sample Container | : | Red or Gold Tube (2pcs) |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 6 mL of Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | 24 Hours |
| • Refrigerated Temperature (2-8°C) | : | 7 Days |
| • Freezer Temperature (-20°C) | : | 28 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 months after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Not Applicable |
| Limitations/Interferences | : | None Specified |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | HBV Tests, Hep B, anti-HBs, Hepatitis B Surface Antibody, HBsAg, Hepatitis B Surface Antigen, HBeAg, Hepatitis B e Antigen, anti-HBc, Hepatitis B Core Antibody, anti-HBc, IgM, anti-Hbe, Hepatitis B e Antibody, HBV DNA, Hepatitis B Virus Testing |
| Test | : | Hepatitis A & B Profile |
| Other Test Request Name | : | Not applicable |
| Test Composition | : | •HbsAg with Titer (CMIA) |
| Intended Use | : | Used to assess phase of Hepatitis B infection and screen for Hepatitis A. |
| Methodology | : | Chemiluminescent Microparticle Immunoassay (CMIA) |
| Laboratory Section | : | Immunology |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3-5 mL Serum |
| Alternative Specimen and Volume Requirement | : | 3-5 mL Plasma (Na-citrate, K-EDTA, Na-Heparin) |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | Not specified |
| • Refrigerated Temperature (2-8°C) | : | 7 Days |
| • Freezer Temperature (-20°C) | : | 3 Freeze-Thaw cycles |
| Transport Temperature | : | Transport specimen at 2°C – 8 °C (with cold packs) |
| Rejection Criteria | : | • Hemolyzed specimen |
| Running Day | : | Tuesday, Wednesday, Thursday, Friday, Saturday |
| Cut Off Time | : | Monday to Saturday:10:00 PM Sunday:6:00PM |
| TAT/Releasing of Results | : | ROUTINE (on running days) |
| Reference Interval/Result Interpretation | : | See individual tests |
| Limitations/Interferences | : | • 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 that employ mouse monoclonal antibodies. |
| Frequently Asked Questions (FAQs) | : | Not applicable |
| Related Words/Test | : | HAV-Ab IgM; HAV-Ab IgG; HAV-Ab total; Anti-HAV, Viral Hepatitis A Antibody, HBV Tests; Hep B; anti-HBs; Hepatitis B Surface Antibody; HBsAg; Hepatitis B Surface Antigen; HBeAg; Hepatitis B e Antigen; anti-HBc; Hepatitis B Core Antibody; anti-HBc, IgM; anti-HBe; Hepatitis B e Antibody; HBV DNA, Hepatitis B Virus Testing |
| Test | : | Hepatitis A,B,C Profile |
| Other Test Request Name | : | Not applicable |
| Test Composition | : | •HbsAg with Titer (CMIA) |
| Intended Use | : | Used to assess phase of Hepatitis B infection and screen for Hepatitis A & C. |
| Methodology | : | Chemiluminescent Microparticle Immunoassay (CMIA) |
| Laboratory Section | : | Immunology |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3-5 mL Serum |
| Alternative Specimen and Volume Requirement | : | 3-5 mL Plasma (Na-citrate, K-EDTA, Na-Heparin) |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | Not specified |
| • Refrigerated Temperature (2-8°C) | : | 7 Days |
| • Freezer Temperature (-20°C) | : | 3 Freeze-Thaw cycles |
| Transport Temperature | : | Transport specimen at 2°C – 8 °C (with cold packs) |
| Rejection Criteria | : | • Hemolyzed specimen |
| Running Day | : | Tuesday, Wednesday, Thursday, Friday, Saturday |
| Cut Off Time | : | Monday to Saturday:10:00 PM Sunday:6:00PM |
| TAT/Releasing of Results | : | ROUTINE (on running days) |
| Reference Interval/Result Interpretation | : | See individual tests |
| Limitations/Interferences | : | • 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 that employ mouse monoclonal antibodies. |
| Frequently Asked Questions (FAQs) | : | Not applicable |
| Related Words/Test | : | HAV-Ab IgM; HAV-Ab IgG; HAV-Ab total; Anti-HAV, Viral Hepatitis A Antibody, HBV Tests; Hep B; anti-HBs; Hepatitis B Surface Antibody; HBsAg; Hepatitis B Surface Antigen; HBeAg; Hepatitis B e Antigen; anti-HBc; Hepatitis B Core Antibody; anti-HBc, IgM; anti-HBe; Hepatitis B e Antibody; HBV DNA, Hepatitis B Virus Testing, Hepatitis C Antibody; Anti-HCV; HCV-PCR; HCV-RNA; Hepatitis C Viral LoadViral Hepatitis C Antibody Screen; Viral Hepatitis C RNA by PCR; Hepatitis C Virus Genotype |
| Test | : | Hepatitis B Full Panel |
| Other Test Request Name | : | Not applicable |
| Test Composition | : | •HbsAg with Titer (CMIA) |
| Intended Use | : | Used to assess phase of Hepatitis B infection, example, if infectious and/or recovery phase. |
| Methodology | : | Chemiluminescent Microparticle Immunoassay (CMIA) |
| Laboratory Section | : | Immunology |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3-5 mL Serum |
| Alternative Specimen and Volume Requirement | : | 3-5 mL Plasma (Na-citrate, K-EDTA, Na-Heparin) |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | Not specified |
| • Refrigerated Temperature (2-8°C) | : | 7 Days |
| • Freezer Temperature (-20°C) | : | 3 Freeze-Thaw cycles |
| Transport Temperature | : | Transport specimen at 2°C – 8 °C (with cold packs) |
| Rejection Criteria | : | • Hemolyzed specimen |
| Running Day | : | Tuesday, Wednesday, Thursday, Friday, Saturday |
| Cut Off Time | : | Monday to Saturday:10:00 PM Sunday:6:00PM |
| TAT/Releasing of Results | : | ROUTINE (on running days) |
| Reference Interval/Result Interpretation | : | See individual tests |
| Limitations/Interferences | : | • 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 that employ mouse monoclonal antibodies. |
| Frequently Asked Questions (FAQs) | : | Not applicable |
| Related Words/Test | : | Hepatitis B, HBV, HBV Tests; Hep B; anti-HBs; Hepatitis B Surface Antibody; HBsAg; Hepatitis B Surface Antigen; HBeAg; Hepatitis B e Antigen; anti-HBc; Hepatitis B Core Antibody; anti-HBc, IgM; anti-HBe; Hepatitis B e Antibody; HBV DNA, Hepatitis B Virus Testing |
| Test | : | Hepatitis B Screening |
| Other Test Request Name | : | Not applicable |
| Test Composition | : | •HbsAg with Titer (CMIA) |
| Intended Use | : | Used to screen for Hepatitis B and if patient needs vaccine/booster for Hepatitis B. |
| Methodology | : | Chemiluminescent Microparticle Immunoassay (CMIA) |
| Laboratory Section | : | Immunology |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 1-3 mL Serum |
| Alternative Specimen and Volume Requirement | : | 1-3mL Plasma (Na-citrate, K-EDTA, Na-Heparin) |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | Not specified |
| • Refrigerated Temperature (2-8°C) | : | 7 Days |
| • Freezer Temperature (-20°C) | : | 3 Freeze-Thaw cycles |
| Transport Temperature | : | Transport specimen at 2°C – 8 °C (with cold packs) |
| Rejection Criteria | : | • Hemolyzed specimen |
| Running Day | : | Daily |
| Cut Off Time | : | Monday to Saturday:10:00 PM Sunday:6:00PM |
| TAT/Releasing of Results | : | ROUTINE (on running days) |
| Reference Interval/Result Interpretation | : | See individual tests |
| Limitations/Interferences | : | • 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 that employ mouse monoclonal antibodies. |
| Frequently Asked Questions (FAQs) | : | Not applicable |
| Related Words/Test | : | HBV Tests; Hep B; anti-HBs; Hepatitis B Surface Antibody; HBsAg; Hepatitis B Surface Antigen; HBeAg; Hepatitis B e Antigen; anti-HBc; Hepatitis B Core Antibody; anti-HBc, IgM; anti-HBe; Hepatitis B e Antibody; HBV DNA, Hepatitis B Virus Testing |
| Test | : | Hepatitis C Genotyping |
| Other Test Request Name | : |
|
| Test Composition | : | Not Applicable |
| Intended Use | : | Hepatitis C is a viral infection that causes inflammation of the liver. Genotype is a predictor of the outcome of anti-HCV therapy with interferon based treatment regimens. Genotype is also helped to determine treatment. |
| Methodology | : | Real-Time Polymerase Chain Reaction (RT-PCR) |
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : |
|
| Collection/Sample Container | : | Red or Gold Top |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 4 mL Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | 24 Hours |
| • Refrigerated Temperature (2-8°C) | : | 5 Days |
| • Freezer Temperature (-20°C) | : | 28 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 weeks after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Not Applicable |
| Limitations/Interferences | : | None Specified |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | Hepatitis C Antibody, Anti-HCV, HCV-PCR, HCV-RNA, Hepatitis C Viral Load, Viral Hepatitis C Antibody Screen, Viral Hepatitis C RNA by PCR, Hepatitis C Virus Genotype |
| Test | : | Hepatitis D Viral RNA |
| Other Test Request Name | : |
|
| Test Composition | : | Not Applicable |
| Intended Use | : | Hepatitis Delta Virus (HDV) is a defective RNA virus which depends on certain functions of the hepatitis B virus for its replication. Therefore, HDV infection is only possible in subjects simultaneously or previously infected with HBV. The HDV antigen is usually detectable over a period of one week to one month during the acute phase. HDV-specific IgM antibodies can be detected 2 to 5 weeks after the beginning of the infection and sometimes this is the only evidence. In chronic infection, these IgM antibodies sometimes persist. A positive anti-HDV antibody test result is evidence of previous exposure to the virus. Now, a PCR-based assay for HDV RNA is available to measure viral activity. |
| Methodology | : | Real-Time Polymerase Chain Reaction (RT-PCR) |
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : |
|
| Collection/Sample Container | : | Red or Gold Tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3 mL Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | 24 Hours |
| • Refrigerated Temperature (2-8°C) | : | 5 Days |
| • Freezer Temperature (-20°C) | : | 28 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 3 weeks after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Not Applicable |
| Limitations/Interferences | : | None Specified |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | HBV Tests, Hep B, anti-HBs, Hepatitis B Surface Antibody, HBsAg, Hepatitis B Surface Antigen, HBeAg, Hepatitis B e Antigen, anti-HBc, Hepatitis B Core Antibody, anti-HBc, IgM, anti-Hbe, Hepatitis B e Antibody, HBV DNA, Hepatitis B Virus Testing |
| Test | : | Hepatitis Delta IgM |
| Other Test Request Name | : |
|
| Test Composition | : | Not Applicable |
| Intended Use | : | • HDV (or hepatitis delta virus) is a defective RNA virus which depends on certain functions of the hepatitis B virus for its replication. Therefore, HDV infection is only possible in subjects simultaneously or previously infected with HBV. The HDV antigen is usually detectable over a period of one week to one month during the acute phase. HDV-specific IgM antibodies can be detected 2 to 5 weeks after the beginning of the infection and sometimes this is the only evidence. In chronic infection, these IgM antibodies sometimes persist. A positive total anti-HDV antibody test result is evidence of previous exposure to the virus. Now, a PCR-based assay for HDV RNA is available to measure viral activity. |
| Methodology | : | Enzyme-immunoassay
|
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold Tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3 mL Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | 24 Hours |
| • Refrigerated Temperature (2-8°C) | : | 5 Days |
| • Freezer Temperature (-20°C) | : | 30 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 weeks after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Available upon request |
| Limitations/Interferences | : | None Specified |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | HBV Tests, Hep B, anti-HBs, Hepatitis B Surface Antibody, HBsAg, Hepatitis B Surface Antigen, HBeAg, Hepatitis B e Antigen, anti-HBc, Hepatitis B Core Antibody, anti-HBc, IgM, anti-Hbe, Hepatitis B e Antibody, HBV DNA, Hepatitis B Virus Testing |
| Test | : | Hepatitis Delta Total Ab |
| Other Test Request Name | : |
|
| Test Composition | : | Not Applicable |
| Intended Use | : | Hepatitis D Virus (HDV) infection occurs in association with HBV infection. A positive result for HDV total antibody may indicate either acute or chronic HDV infection.HDV (or hepatitis delta virus) is a defective RNA virus which depends on certain functions of the hepatitis B virus for its replication. Therefore, HDV infection is only possible in subjects simultaneously or previously infected with HBV. The HDV antigen is usually detectable over a period of one week to one month during the acute phase. HDV-specific IgM antibodies can be detected 2 to 5 weeks after the beginning of the infection and sometimes this is the only evidence. In chronic infection, these IgM antibodies sometimes persist. A positive total anti-HDV antibody test result is evidence of previous exposure to the virus. Now, a PCR-based assay for HDV RNA is available to measure viral activity.
|
| Methodology | : | Enzyme Immunoassay (EIA) |
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold Tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3 mL Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | 24 Hours |
| • Refrigerated Temperature (2-8°C) | : | 5 Days |
| • Freezer Temperature (-20°C) | : | 30 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 weeks after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Available upon request |
| Limitations/Interferences | : | None Specified |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | HBV Tests, Hep B, anti-HBs, Hepatitis B Surface Antibody, HBsAg, Hepatitis B Surface Antigen, HBeAg, Hepatitis B e Antigen, anti-HBc, Hepatitis B Core Antibody, anti-HBc, IgM, anti-Hbe, Hepatitis B e Antibody, HBV DNA, Hepatitis B Virus Testing |
| Test | : | Hepatitis E IgG (EIA) |
| Other Test Request Name | : |
|
| Test Composition | : | Not Applicable |
| Intended Use | : | Hepatitis E virus (HEV) belongs to the Calcivirus family. It is a polyadenylated single-strand RNA non-enveloped virus. Its epidemiology is similar to that of hepatitis A: transmission by the faecal-oral route and incidence in epidemic or sporadic form. The incubation period is 15 to 64 days. The disease is not endemic in Western Europe or North America. The cases described consist of travellers having stayed in endemic areas (Indies, Central and North Africa, Peru, Mexico, China, Nepal, Russia, Pakistan). The clinical profile is comparable to that of Hepatitis A. Cases generall progress towards recovery, with no chronic form or progression to hepatocarcinoma. High mortality in pregnant women |
| Methodology | : | Enzyme-immunoassay (EIA) |
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold Tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3 mL Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | 24 Hours |
| • Refrigerated Temperature (2-8°C) | : | 5 Days |
| • Freezer Temperature (-20°C) | : | 28 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 weeks after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Available upon request |
| Limitations/Interferences | : | None Specified |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | Provide at least short-term protection against disease. |
| Test | : | Hepatitis E IgM (EIA) |
| Other Test Request Name | : |
|
| Test Composition | : | Not Applicable |
| Intended Use | : | Hepatitis E causes an acute, self-limiting infection. Antibody IgG is detected after Antibody IgM is detected, typically 1 month post-infection. Antibody IgM is detected 1-4 weeks post-infection. Hepatitis E Virus (HEV) is the major etiologic agent of enterically transmitted non-A, non-B hepatitis worldwide and has a high case-fatality rate in pregnant women. Both IgM and IgG antibody to HEV (anti-HEV) are produced following infection. The titer of IgM anti-HEV declines rapidly during early convalescence; IgG anti-HEV persists and appears to provide at least short-term protection against disease |
| Methodology | : | Enzyme-immunoassay (EIA) |
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : | No patient preparation necessary. |
| Collection/Sample Container | : | Red or Gold Tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3 mL Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | 24 Hours |
| • Refrigerated Temperature (2-8°C) | : | 5 Days |
| • Freezer Temperature (-20°C) | : | 28 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 weeks after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Available upon request |
| Limitations/Interferences | : | None Specified. |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | Liver inflammation |
| Test | : | Hepatitis E RNA (PCR) |
| Other Test Request Name | : | HEP E RNA |
| Test Composition | : | Not Applicable |
| Intended Use | : | Hepatitis E Virus (HEV) is the major etiologic agent of enterically transmitted non-A, non-B hepatitis worldwide and has a high case-fatality rate in pregnant women. Both IgM and IgG antibody to HEV (anti-HEV) are produced following infection. The titer of IgM anti-HEV declines rapidly during early convalescence; IgG anti-HEV persists and appears to provide at least short-term protection against disease. |
| Methodology | : | Polymerase Chain Reaction (PCR) |
| Laboratory Section | : | Special Test |
| Special Instructions/Patient Preparations | : |
|
| Collection/Sample Container | : | EDTA or Violet Tube |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3 mL Plasma |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | Not Applicable |
| • Refrigerated Temperature (2-8°C) | : | 4 Hours |
| • Freezer Temperature (-20°C) | : | 28 Days |
| Transport Temperature | : | Transport specimen at 2 – 8 °C (with cold packs) |
| Rejection Criteria | : |
|
| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 weeks after cut-off (excluding Saturdays, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Not Applicable |
| Limitations/Interferences | : | None Specified |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | Small virus with positive sense, Single stranded ribonucleic acid genome |
| Test | : | Hepatobiliary Ultrasound |
| Other Test Request Name | : | Not Applicable |
| Test Composition | : | Not Applicable |
| Intended Use | : | Ultrasound imaging or sonography is considered to be a non-invasive procedure and does not involve ionizing radiation which is usual in X-rays. An ultrasound scan is not only useful in assessing the structure of organs and different internal structures but can also show the movement of organs in real time. It may be used to assess the size and location of organs and structuresof the following:
|
| Methodology | : | Not Applicable |
| Laboratory Section | : | Not Applicable |
| Special Instructions/Patient Preparations | : | PREPARATION
|
| Collection/Sample Container | : | Not Applicable |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | Not Applicable |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | Not Applicable |
| • Refrigerated Temperature (2-8°C) | : | Not Applicable |
| • Freezer Temperature (-20°C) | : | Not Applicable |
| Transport Temperature | : | Not Applicable |
| Rejection Criteria | : | Not Applicable |
| Running Day | : | Not Applicable |
| Cut Off Time | : | Not Applicable |
| TAT/Releasing of Results | : | - |
| Reference Interval/Result Interpretation | : | - |
| Limitations/Interferences | : | Not Applicable |
| Frequently Asked Questions (FAQs) | : | - |
| Related Words/Test | : | Not Applicable |
| Test | : | HER2 IQFISH |
| Other Test Request Name | : | HER2 FISH |
| Test Composition | : | Not Applicable |
| Intended Use | : | - Used to quantitatively determine amplification of the HER2/NEU gene in formalin-fixed paraffin-embedded (FFPE) breast cancer tissue. - Serves as a companion diagnostic for identifying breast cancer patients who may be eligible for treatment with Herceptin. |
| Methodology | : | Fluorescence in-situ hybridization (FISH) |
| Laboratory Section | : | Histopathology |
| Special Instructions/Patient Preparations | : | All samples must be LABELED properly and legibly. The label must match the information on the test request form and on the provided Histopathology and Immunohistochemistry Reports. |
| Collection/Sample Container | : | - 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. |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | - Formalin-fixed paraffin-embedded (FFPE) breast cancer tissue block - 1 H&E stained slide representative of the submitted tissue block - One IHC (Immunohistochemistry) Her2/Neu slide - Histopathology report for the submitted tissue slide and block - IHC (Immunohistochemistry) report of the submitted tissue slide and block Note: Please ensure that HPD Histopathology Request Form (HPD_F_258) is completely filled out. |
| Alternative Specimen and Volume Requirement | : | Not applicable |
| Specimen Stability | - FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15oC - 30oC). - 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. | |
| • Room Temperature (15-25°C) | : | Formalin-Fixed Paraffin Embedded (FFPE) tissue blocks - indefinite |
| • Refrigerated Temperature (2-8°C) | : | Not applicable |
| • Freezer Temperature (-20°C) | : | Unacceptable |
| Transport Temperature | : | - Transport at room temperature (15 °C – 30 °C) - Avoid exposure to direct sunlight. - Keep samples dry. |
| Rejection Criteria | : | - FFPE tissue blocks other than breast cancer tissue - Inadequate tissue available on the tissue block - Improper or insufficient labeling of tissue blocks or slides - Incomplete documents/forms submitted |
| Running Day | : | Upon completion of batch of 3 samples |
| Cut Off Time | : | 12:00 noon |
| TAT/Releasing of Results | : | 14 working days excluding Saturdays, Sundays and Holidays |
| Reference Interval/Result Interpretation | : | - HER2 signal not detected: INDETERMINATE; additional testing or specimen may be required. - HER2/CEP17 ratio < 2.0: NEGATIVE for HER2 amplification; Patient is NOT eligible for HER2-targeted therapy - HER2/CEP17 ratio > 2.0: POSITIVE for HER2 amplification; Patient is eligible for HER2-targeted therapy |
| Limitations/Interferences | : | The following factors may affect the outcome of your results: - Cold ischemic time over 1 hour - Duration of fixation over 72 hours - Fixation in non-formalin fixatives |
| Frequently Asked Questions (FAQs) | : | Q: What is HER2? A:HER2 is a gene that, when overexpressed, plays an important role in the development and progression of certain types of breast cancer. Q: I feel/have a lump in my breast. Will this test tell me if I have cancer? A:No, it won’t. You will need to have your doctor check whether that lump in your breast is malignant or not. Q: I am male and have breast cancer. Will I benefit from this test? A:Yes. Q: What is Herceptin? A:Herceptin is a monoclonal antibody that is designed to target HER2. Q: Why do I need to be HER2 positive to be eligible for Herceptin treatment? A:Herceptin works by attaching itself to HER2. Only cancer cells with overamplified HER2 will benefit from Herceptin. Moreover, Herceptin is expensive and toxic to your cells. Taking Herceptin if you don’t really need it could lead to a potentially toxic, costly and ineffective therapy. Q: I’m HER2 positive, but I can’t afford Herceptin. Can I be treated with drug X instead? A:HER2 positive breast cancer is associated with a more aggressive disease, poorer patient outcome and decreased survival. Treatment with Herceptin has shown a significant clinical benefit. Treatment with other types of drugs will not give similar clinical outcome. |
| Related Words/Test | : | Companion diagnostic for Herceptin, Targeted therapy for breast cancer, Fluorescence In Situ Hybridization, breast Cancer, HER2, HER2 gene |
| Test | : | Herpes Simplex Virus 1/2 IgG (CLIA) |
| Other Test Request Name | : |
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| Test Composition | : | Not Applicable |
| Intended Use | : | Used for the qualitative determination of specific IgG antibodies to Herpes Simplex Virus Type 1 and 2 in human serum or plasma samples |
| Methodology | : | Flow Immunofluorimetry |
| Laboratory Section | : | special test |
| Special Instructions/Patient Preparations | : | No special patient preparation |
| Collection/Sample Container | : | Red / Gold top |
| Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 3 mL Serum |
| Alternative Specimen and Volume Requirement | : | Not Applicable |
| Specimen Stability | ||
| • Room Temperature (15-25°C) | : | Not applicable |
| • Refrigerated Temperature (2-8°C) | : | 7 days |
| • Freezer Temperature (-20°C) | : | >7 days |
| Transport Temperature | : | Store and transport specimen at 20C to 80C (with cold packs). |
| Rejection Criteria | : |
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| Running Day | : | Batch Running |
| Cut Off Time | : | Friday, 12:00 PM |
| TAT/Releasing of Results | : | 2 weeks after after cut-off( except Saturday, Sundays and Holidays) |
| Reference Interval/Result Interpretation | : | Not Applicable |
| Limitations/Interferences | : | Bacterial contamination or heat inactivation of the specimen may affect the test results. |
| Frequently Asked Questions (FAQs) | : | Not Applicable |
| Related Words/Test | : | Herpes Culture, Herpes Simplex Viral Culture, HSV DNA, HSV by PCR, HSV-1 or HSV-2 IgM, HHV1, HHV2 |