Immunology

Immunology 143

2008 Surveys & Anatomic Pathology Education Programs

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Analyte ANA ASO CRP HCG IM IMW RF RFX RUB RUBX IL Challenges per Shipment

Antinuclear antibody (ANA)* ❚ ❚ 5Anti-streptolysin O(ASO)** ❚ ❚ 5C-reactive protein (qualitative andquantitative) ❚ ❚ 2hCG, serum (qualitativeand quantitative) ❚ ❚ 5Infectious mononucleosis ❚ ❚ 5Infectious mononucleosis, waived ❚ 3Rheumatoid factor** ❚ ❚ ❚ 5Rubella** ❚ ❚ ❚ 5

Product InformationEach 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

Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services

Immunology

* 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.

Immunology

144 Immunology

College of American Pathologists

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Analyte hsCRP Challenges per ShipmentHigh-sensitivity C-reactive protein ❚ 3

Product InformationSurvey 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

Analyte IG IGX Challenges per ShipmentAlpha-1-antitrypsin ❚ ❚ 5Complement C3 ❚ ❚ 5Complement C4 ❚ ❚ 5Haptoglobin ❚ ❚ 5IgA ❚ ❚ 5IgE ❚ ❚ 5IgG ❚ ❚ 5IgM ❚ ❚ 5Kappa/Lambda ratio ❚ ❚ 5

Product InformationWith each shipment of Survey IG, participants will receive five 1.0-mL serum specimens for quantitation ofimmunoglobulins, haptoglobin, kappa/lambda ratios, and alpha-1-antitrypsin; and five 1.0-mL lyophilized serumspecimens for complement C3 and C4. Survey IGX will include ten 1.0-mL liquid serum specimens and ten 1.0-mLlyophilized serum specimens.

Product Fulfillment Group S

Immunology (General) IG, IGX

High-Sensitivity C-reactive Protein hsCRP

Immunology 145


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Challenges per ShipmentAnalyte S2 S4 S5 A B CAnti-DNA antibody (ds) ❚ ❚ 1 1 1

Anti-glomerular basement membrane antibody ❚ 1 1Antimitochondrial 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 1Ceruloplasmin ❚ ❚ 1 1Haptoglobin ❚ ❚ 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 1Transferrin ❚ ❚ 1 1

Product InformationThe 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

Immunology (Special), Immunology (Special, Limited), H. Pylori IgG Antibody S2, S4, S5

146 Immunology



Analyte H Challenges per ShipmentAntimitochondrial M2 antibody (AMA-M2) ❚ 2

Product InformationEach shipment will include two 0.5-mL serum specimens.

Product Fulfillment Group GIH

Analyte APC Challenges per ShipmentAnti-parietal cell antibody ❚ 2



Analyte V Challenges per ShipmentViscosity ❚ 2


Antimitochondrial M2 Antibody H

Anti-Parietal Cell Antibody APC

Viscosity V

Immunology 147


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Analyte ASC Challenges per ShipmentAnti-Saccharomyces cerevisiae antibody ❚ 2


Analyte LKM Challenges per ShipmentLiver-kidney microsomal antibody (Anti-LKM) ❚ 2



Anti-Saccharomyces cerevisiae Antibody ASC

Liver-Kidney Microsomal Antibody (Anti-LKM) LKM

148 Immunology



Analyte CCP Challenges per ShipmentAnti-CCP ❚ 2

Product InformationEach shipment contains two 1.0-mL serum specimens.

Product Fulfillment Group RDS

Cyclic Citrullinated Peptide Antibody (Anti-CCP) CCP

Analyte RDS Challenges per ShipmentAnti-Jo-1 (anti-histidyl t-RNA synthetase) ❚ 1Anti-Scl-70 (anti-DNA topoisomerase) ❚ 1


Product Fulfillment Group RDS

Rheumatic Disease Special Serologies RDS

Immunology 149


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Analyte ACL Challenges per ShipmentAnticardiolipin antibody ❚ 3Beta-2-glycoprotein I ❚ 3

Challenges per ShipmentAnalyte CES A BAntiendomysial antibody (IgA) ❚ 2 3Antiendomysial antibody (IgG) ❚ 2 3Antigliadin antibody (IgA) ❚ 2 3Antigliadin antibody (IgG) ❚ 2 3Antigliadin deaminated peptide antibody (IgG) NEW ❚ 2 3Antigliadin deaminated peptide antibody (IgA) NEW ❚ 2 3Antitissue transglutaminase antibody (IgA) ❚ 2 3Antitissue transglutaminase antibody (IgG) ❚ 2 3

Product InformationEach shipment will include the appropriate number of 0.3-mL serum specimens.

Product InformationEach shipment will include three 0.5-mL lyophilized serum specimens.

Antiphospholipid Antibody ACL

Celiac Serology CES

150 Immunology



Analyte/Procedure SE Challenges per ShipmentIgE, total ❚ 5IgE multi-allergen screen (qualitative) ❚ 5Specific allergens ❚ 25Educational challenges ❚ 2 per year

Product InformationSurvey 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 skintest 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.

Analyte G Challenges per ShipmentSyphilis ❚ 5

Product InformationSurvey G can be used for VDRL, RPR, MHA-TP, FTA-ABS, USR, and EIA methods. Laboratories performing syphilisserology testing on cerebrospinal fluid only may also use this Survey. Each shipment will include five 1.5-mL serumspecimens.

Diagnostic Allergy SE

Syphilis Serology G

Flow Cytometry 151


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Procedure FL FL1 FL2 Challenges per ShipmentDNA content and cell cycle analysis ❚ ❚ 3Lymphocyte immunophenotyping* ❚ ❚ 3

Product InformationSurveys 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 shipmentswill include three whole blood specimens for lymphocyte immunophenotyping and enumeration of lymphocytesubsets. Survey FL2 shipments will contain two fixed cell-line specimens and one calibrator for DNA content and cellcycle analysis. Survey FL shipments will include specimens from both Surveys FL1 and FL2.

Product Fulfillment Group FL

Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).

Flow Cytometry

Analyte FL3 FL3CD Challenges per ShipmentLeukemia/lymphoma ❚ 2Leukemia/lymphoma list-mode challenge (CD-ROM) ❚ 2

Product InformationSurvey FL3 allows participants to evaluate their performance by comparing their results with those laboratories usingsimilar instruments and reagents. Survey FL3 contains two whole blood specimens and/or cell lines simulatingleukemia/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 leukemiaand lymphoma and allows the user to examine gating strategies and interpretation of antibody staining patterns. Thefiles are in standard FCS 2.0 format and work well with Cell Quest, System II, Expo 32, and other software capable ofreading 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 ParticipantSummary/Final Critique and online learning assessment questions. All laboratory staff can participate individually andearn CME/CE credit without leaving the laboratory.

*CD3/CD8 (% and absolute) and CD3/CD4 (% and absolute) are graded. Other markers are ungraded/educational.

Flow Cytometry FL, FL1, FL2

Flow Cytometry—Immunophenotypic FL3, FL3CD Category 1 CME

CE

152 Flow Cytometry



Analyte FL4 Challenges per ShipmentAnalyte FL4 Challenges per ShipmentCD34+ ❚ 2

Product InformationThis Survey is designed to test the ability of participating laboratories to correctly enumerate CD34+ cells. Survey FL4will include two shipments per year, each containing two stabilized human CD34+ specimens.

Analyte PNH PNHW Challenges per ShipmentPNH RBC analysis (CD55/CD59) ❚ 2PNH WBC analysis (CD55/CD59, FLAER)NEW ❚ 2

Product InformationSurvey PNH is designed for laboratories performing PNH testing by flow cytometry using CD55 and CD59 on redblood 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

Flow Cytometry—CD34+ FL4

Flow Cytometry—Immunophenotypic Characterization ofParoxysmal Nocturnal Hemoglobinuria PNH, PNHW

Flow Cytometry 153


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Analyte/Procedure HBF Challenges per ShipmentF cell value ❚ 2Hemoglobin F, qualitative (fetal screen) ❚ 2Hemoglobin F, quantitative ❚ 2Hemoglobin F, qualitative (fetal screen) ❚ 2

Product InformationThe 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 toSurvey TMCAF, Transfusion Medicine Competency Assessment–Fetal Red Cell Quantitation, in Chapter 16.

Fetal Red Cell Determination HBF

Analyte FL4 Challenges per ShipmentAnalyte QF Challenges per ShipmentM. tuberculosis infection detection ❚ 2

Product InformationSurvey 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.

M. tuberculosis Stimulated Infection Detection QF New

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Just as the laboratory has “evolved” over time to meet the demands fornew testing methods, the CAP is evolving to meet your needs. With theincreased use of digital and online media for staff education and patientresult reporting, the CAP is pleased to offer you new and improved colorphotographs with the Clinical Microscopy and the Hematology Blood CellIdentification 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 justas you continue to strive to ensure patient safety in all the testing youperform!

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Immunology