Immunology
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Immunology Document Transcript

  • 1. www.cap.org Immunology Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services Immunology Analyte ANA ASO CRP HCG IM IMW RF RFX RUB RUBX IL Challenges per Shipment Antinuclear antibody (ANA)* „ „ 5 Anti-streptolysin O (ASO)** „ „ 5 C-reactive protein (qualitative and quantitative) „ „ 2 hCG, serum (qualitative and quantitative) „ „ 5 Infectious mononucleosis „ „ 5 Infectious mononucleosis, waived „ 3 Rheumatoid factor** „ „ „ 5 Rubella** „ „ „ 5 * Antinuclear antibody (ANA) is regulated and graded for qualitative methods. The quantitative methods are graded but do not meet regulatory requirements. Titer results will be ungraded/educational in this Survey and do not meet regulatory requirements. **Anti-streptolysin O (ASO), Rheumatoid factor, and Rubella are regulated analytes and graded for both qualitative and quantitative methods. Semi-quantitative and/or titer results for these analytes are ungraded/ educational in this Survey and do not meet regulatory requirements. Product Information Each of the seven analytes listed in the above Immunology Surveys are designed to be ordered separately and can be combined as needed to meet your laboratory’s individual testing requirements. The CRP Survey is not designed for high-sensitivity CRP methods. See page 144 for the High-Sensitivity C-reactive Protein Survey (hsCRP). Note: Survey IL is also available for laboratories requiring proficiency testing for all seven analytes. Each shipment of Surveys ANA and RUB will include five 0.5-mL serum specimens. Survey CRP will include two 0.5-mL serum specimens. For Surveys ASO, hCG, and RF each shipment will include five 1.0-mL serum specimens. Survey IM will include five 0.6-mL serum specimens. Survey IMW will include three 0.6-mL serum specimens. Survey IL will contain all the specimens with the exception of IMW. Survey RFX will include ten 1.0-mL serum specimens. Survey RUBX will include ten 0.5-mL serum specimens. Product Fulfillment Group S 2008 Surveys & Anatomic Pathology Education Programs Immunology 143
  • 2. 800-323-4040 Option 1 for Customer Contact Center Immunology (General) IG, IGX Analyte IG IGX Challenges per Shipment Alpha-1-antitrypsin „ „ 5 Complement C3 „ „ 5 Complement C4 „ „ 5 Haptoglobin „ „ 5 IgA „ „ 5 IgE „ „ 5 IgG „ „ 5 IgM „ „ 5 Kappa/Lambda ratio „ „ 5 Product Information With each shipment of Survey IG, participants will receive five 1.0-mL serum specimens for quantitation of immunoglobulins, haptoglobin, kappa/lambda ratios, and alpha-1-antitrypsin; and five 1.0-mL lyophilized serum specimens for complement C3 and C4. Survey IGX will include ten 1.0-mL liquid serum specimens and ten 1.0-mL lyophilized serum specimens. Product Fulfillment Group S High-Sensitivity C-reactive Protein hsCRP Analyte hsCRP Challenges per Shipment High-sensitivity C-reactive protein „ 3 Product Information Survey hsCRP is designed for participants performing high-sensitivity C-reactive protein testing, ie, less than 50 mg/L. Each shipment will include three 0.5-mL serum specimens. Product Fulfillment Group CR College of American Pathologists 144 Immunology
  • 3. www.cap.org Immunology (Special), Immunology (Special, Limited), H. Pylori IgG Antibody S2, S4, S5 Challenges per Shipment Analyte S2 S4 S5 A B C Anti-DNA antibody (ds) „ „ 1 1 1 Anti-glomerular basement membrane antibody „ 1 1 Antimitochondrial antibody „ 1 1 1 Antineutrophil cytoplasmic antibody (ANCA, anti-MPO, anti-PR3) „ 1 1 Anti-RNP antibody „ 1 1 1 Anti-Sm antibody „ 1 1 1 Anti-Sm RNP antibody NEW „ 1 1 1 Anti-smooth muscle antibody „ 1 1 1 Anti-SSA antibody „ 1 1 Anti-SSB antibody „ 1 1 Anti-SSA/SSB antibody NEW „ 1 1 Antithyroglobulin antibody „ „ 1 1 1 Antithyroid microsomal antibody „ „ 1 1 1 Antithyroid peroxidase antibody „ „ 1 1 1 Ceruloplasmin „ „ 1 1 Haptoglobin „ „ 1 1 Helicobacter pylori, IgG antibody „ „ 1 1 „ 2 2 IgD „ „ 1 1 1 IgG „ „ 1 1 IgG subclass proteins „ „ 1 1 Kappa/lambda ratio „ „ 1 1 Prealbumin (transthyretin) „ „ 1 1 Transferrin „ „ 1 1 Product Information The S4 and S5 Survey options are provided for laboratories that peform limited special immunology testing. Each shipment of Survey S2 will include a minimum of five (0.5-to 1.0-mL per vial) serum specimens and two (0.5- to 1.0-mL per vial) lyophilized serum specimens. Each shipment of Survey S4 will include a minimum of three (0.5- to 1.0-mL per vial) serum specimens. Each shipment of Survey S5 will include two 1.0-mL serum specimens. Product Fulfillment Group S2 2008 Surveys & Anatomic Pathology Education Programs Immunology 145
  • 4. 800-323-4040 Option 1 for Customer Contact Center Viscosity V Analyte V Challenges per Shipment Viscosity „ 2 Product Information Each shipment will include two 10.0-mL serum specimens. Anti-Parietal Cell Antibody APC Analyte APC Challenges per Shipment Anti-parietal cell antibody „ 2 Product Information Each shipment will include two 1.0-mL serum specimens. Product Fulfillment Group GIH Antimitochondrial M2 Antibody H Analyte H Challenges per Shipment Antimitochondrial M2 antibody (AMA-M2) „ 2 Product Information Each shipment will include two 0.5-mL serum specimens. Product Fulfillment Group GIH College of American Pathologists 146 Immunology
  • 5. www.cap.org Liver-Kidney Microsomal Antibody (Anti-LKM) LKM Analyte LKM Challenges per Shipment Liver-kidney microsomal antibody (Anti-LKM) „ 2 Product Information Each shipment will include two 1.0-mL serum specimens. Product Fulfillment Group GIH Anti- Saccharomyces cerevisiae Antibody ASC Analyte ASC Challenges per Shipment Anti-Saccharomyces cerevisiae antibody „ 2 Product Information Each shipment will include two 1.0-mL serum specimens. 2008 Surveys & Anatomic Pathology Education Programs Immunology 147
  • 6. 800-323-4040 Option 1 for Customer Contact Center Rheumatic Disease Special Serologies RDS Analyte RDS Challenges per Shipment Anti-Jo-1 (anti-histidyl t-RNA synthetase) „ 1 Anti-Scl-70 (anti-DNA topoisomerase) „ 1 Product Information Each shipment will include two 1.0-mL serum specimens. Product Fulfillment Group RDS Cyclic Citrullinated Peptide Antibody (Anti-CCP) CCP Analyte CCP Challenges per Shipment Anti-CCP „ 2 Product Information Each shipment contains two 1.0-mL serum specimens. Product Fulfillment Group RDS College of American Pathologists 148 Immunology
  • 7. www.cap.org Celiac Serology CES Challenges per Shipment Analyte CES A B Antiendomysial antibody (IgA) „ 2 3 Antiendomysial antibody (IgG) „ 2 3 Antigliadin antibody (IgA) „ 2 3 Antigliadin antibody (IgG) „ 2 3 Antigliadin deaminated peptide antibody (IgG) NEW „ 2 3 Antigliadin deaminated peptide antibody (IgA) NEW „ 2 3 Antitissue transglutaminase antibody (IgA) „ 2 3 Antitissue transglutaminase antibody (IgG) „ 2 3 Product Information Each shipment will include the appropriate number of 0.3-mL serum specimens. Antiphospholipid Antibody ACL Analyte ACL Challenges per Shipment Anticardiolipin antibody „ 3 Beta-2-glycoprotein I „ 3 Product Information Each shipment will include three 0.5-mL lyophilized serum specimens. 2008 Surveys & Anatomic Pathology Education Programs Immunology 149
  • 8. 800-323-4040 Option 1 for Customer Contact Center Syphilis Serology G Analyte G Challenges per Shipment Syphilis „ 5 Product Information Survey G can be used for VDRL, RPR, MHA-TP, FTA-ABS, USR, and EIA methods. Laboratories performing syphilis serology testing on cerebrospinal fluid only may also use this Survey. Each shipment will include five 1.5-mL serum specimens. Diagnostic Allergy SE Analyte/Procedure SE Challenges per Shipment IgE, total „ 5 IgE multi-allergen screen (qualitative) „ 5 Specific allergens „ 25 Educational challenges „ 2 per year Product Information Survey SE is designed to provide the allergy laboratory with allergen-specific IgE and total serum IgE. Common allergens are selected from North America, as well as less frequently tested allergens. Survey specimens are prepared from individual allergic sera that have been based on a clinical history and/or skin test reactivity of the donors. Each shipment will contain five 2.0-mL serum specimens, each to be tested for five specific IgE antibodies and total IgE. Twice a year, an additional educational allergen challenge will be included. College of American Pathologists 150 Immunology
  • 9. www.cap.org Flow Cytometry Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS). Flow Cytometry FL, FL1, FL2 Procedure FL FL1 FL2 Challenges per Shipment DNA content and cell cycle analysis „ „ 3 Lymphocyte immunophenotyping* „ „ 3 *CD3/CD8 (% and absolute) and CD3/CD4 (% and absolute) are graded. Other markers are ungraded/educational. Product Information Surveys FL, FL1, and FL2 are designed to test the ability of participating laboratories to correctly identify and enumerate subpopulations of lymphocytes and/or perform DNA content and cell cycle analysis. Survey FL1 shipments will include three whole blood specimens for lymphocyte immunophenotyping and enumeration of lymphocyte subsets. Survey FL2 shipments will contain two fixed cell-line specimens and one calibrator for DNA content and cell cycle analysis. Survey FL shipments will include specimens from both Surveys FL1 and FL2. Product Fulfillment Group FL Flow Cytometry—Immunophenotypic FL3, FL3CD Category 1 CM E Analyte FL3 FL3CD Challenges per Shipment CE Leukemia/lymphoma „ 2 Leukemia/lymphoma list-mode challenge (CD-ROM) „ 2 Product Information Survey FL3 allows participants to evaluate their performance by comparing their results with those laboratories using similar instruments and reagents. Survey FL3 contains two whole blood specimens and/or cell lines simulating leukemia/lymphoma. Photopages of tissue sections or bone marrow smears and clinical histories are also provided. Survey FL3CD is a CD-ROM-based educational module. This CD-ROM contains list-mode files from cases of leukemia and lymphoma and allows the user to examine gating strategies and interpretation of antibody staining patterns. The files are in standard FCS 2.0 format and work well with Cell Quest, System II, Expo 32, and other software capable of reading the FCS 2.0 files. Survey FL3CD is provided on a single CD-ROM disk per shipment and includes two cases, each with clinical histories, photomicrographs, and ungated list-mode files. An education activity is planned for the FL3CD Survey that includes reading material found in the Participant Summary/Final Critique and online learning assessment questions. All laboratory staff can participate individually and earn CME/CE credit without leaving the laboratory. 2008 Surveys & Anatomic Pathology Education Programs Flow Cytometry 151
  • 10. 800-323-4040 Option 1 for Customer Contact Center Analyte Flow Cytometry—CD34+ FL4 Shipment FL4 Challenges per Analyte FL4 Challenges per Shipment CD34+ „ 2 Product Information This Survey is designed to test the ability of participating laboratories to correctly enumerate CD34+ cells. Survey FL4 will include two shipments per year, each containing two stabilized human CD34+ specimens. Flow Cytometry—Immunophenotypic Characterization of Paroxysmal Nocturnal Hemoglobinuria PNH, PNHW Analyte PNH PNHW Challenges per Shipment PNH RBC analysis (CD55/CD59) „ 2 PNH WBC analysis (CD55/CD59, FLAER)NEW „ 2 Product Information Survey PNH is designed for laboratories performing PNH testing by flow cytometry using CD55 and CD59 on red blood cell populations. Survey PNHW is intended for PNH testing by flow cytometry using white blood cells (WBC). Each shipment of PNH will contain two 1.0-mL red blood cell specimens. Each shipment of PNHW will contain two cell lines. Product Fulfillment Group PNH College of American Pathologists 152 Flow Cytometry
  • 11. www.cap.org Fetal Red Cell Determination HBF Analyte/Procedure HBF Challenges per Shipment F cell value „ 2 Hemoglobin F, qualitative (fetal screen) „ 2 Hemoglobin F, quantitative „ 2 Hemoglobin F, qualitative (fetal screen) „ 2 Product Information The F cell value is compatible with flow cytometry methods. Qualitative (screen) Hemoglobin F is compatible with E-rosette testing for D(Rho) fetal red blood cells in the maternal circulation. Quantitative Hemoglobin F is compatible with Kleihauer-Betke and flow cytometry methods. Each shipment will include two 1.2-mL liquid stabilized red blood cell specimens. For competency assessment of technologists’ ability to perform fetal red cell quantitation, please refer to Survey TMCAF, Transfusion Medicine Competency Assessment–Fetal Red Cell Quantitation, in Chapter 16. Analyte M. tuberculosis Stimulated Infection Detection QF FL4 Challenges per Shipment New Analyte QF Challenges per Shipment M. tuberculosis infection detection „ 2 Product Information Survey QF is designed for laboratories detecting M. tuberculosis using the QuantiFERON®TB method. Each shipment will include two 1.0 mL specimens for the qualitative detection of cell mediated immune response through release of gamma interferon to M. tuberculosis. 2008 Surveys & Anatomic Pathology Education Programs Flow Cytometry 153
  • 12. Evolving to Meet Your Needs Just as the laboratory has “evolved” over time to meet the demands for new testing methods, the CAP is evolving to meet your needs. With the increased use of digital and online media for staff education and patient result reporting, the CAP is pleased to offer you new and improved color photographs with the Clinical Microscopy and the Hematology Blood Cell Identification Surveys in 2008. With the new color photographs you will receive: • Larger images for more accurate proficiency testing reporting • Quicker access to images and easier storage for your files • A supplemental CD-ROM that gives you the ability to digitally project and view the images in greater detail, as well as to easily share for internal educational purposes Here at the CAP we strive to continue the “evolution” of our products just as you continue to strive to ensure patient safety in all the testing you perform!