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Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

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Page 1: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive
Page 2: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive
Page 3: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Featured Assay

Total Testosterone by LC/MS/MS

Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive and specific method that is certified by the Centers for Disease Control (CDC) Hormone Standard-ization (HoST) Program. This assay provides a more accurate testosterone measurement at very low concentra-tions common among women, children, and hypogonadal men.

Ultra-high Sensitivity Using State of the Art Instrumentation

Covance has validated two total testosterone LC/MS-MS methods: One method with a curve range from 2 to 2,000 ng/dL, and an ultra-sensitive method with a curve range from 0.1 to 100 ng/dL.

Representative chromatogram of a calibrator at the LLOQ of 0.1 ng/dL (1.0 pg/mL):

This level of sensitivity is achieved using the most advanced UHPLC/MS-MS technology available: -Shimadzu Nexera Ultra-High Performance Liquid Chromatograph (UHPLC)-AB Sciex QTRAP 5500 triple quadrupole mass spectrometer

DEC2011

Page 4: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Featured Assay

CDC Certification

Covance’s total testosterone assay meets the stringent CDC Hormone Standardization (HoSt) Program criteria established in 2010. Covance obtained CDC certification on November, 2011. This certification will be pub-lished on the CDC Web site at www.cdc.gov/labstandards/doc/HoSt Report.pdf.

The Endocrine Society along with 14 professional and medical organizations have endorsed CDC’s HoSt pro-gram. The primary goal of this program is to improve the accuracy and precision of steroid hormone tests used in patient care and research for testosterone, and estradiol.

The program is a year long voluntary certification process that consists of 2 phases:

DEC2011

Page 5: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Featured Assay

Covance obtained a mean bias of 2.8% which is well within the CDC predefined bias criteria of 6.4%.

CDC certification positions Covance’s methodology among the benchmark assays for testosterone measurement.

DEC2011

Page 6: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Panels MethodologyChemistry Panel: ALT (SGPT), AST (SGOT), Albumin, Calcium, Chloride, Alkaline Phos-phatase, Bicarbonate, Cholesterol, CK, Creatinine, Direct Bilirubin, LDH, Magnesium, Globulin, Glucose, GGT, Indirect Bilirubin, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid

Varies by Analyte

Hematology Hemogram Panel:Hematocrit, Hemoglobin, MCH, MCHC, MCV, Platelets, RBC, WBC, RBC Morphology

Varies by Analyte

Hematology Differential Panel: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils

Varies by Analyte

Urinalysis Macroscopic Panel: Bilirubin, Blood, Clarity, Color, Glucose, Ketones, Leucocyte Esterase, Nitrite, pH, Protein, Specific Gravity, Urobilinogen

Varies by Analyte

Urinalysis Microscopic Panel: RBC, WBC, Casts, Crystals, Bacteria, Epithelial Cells, Yeast, Oval Fat Bodies, Fat, Mucous, Sperm, Trichomonas

Microscopy

Flow Cytometry Panel (EDTA Whole Blood) CD3, CD4, CD8, CD19, CD 16+56, CD3+4+8, CD4/CD8 Ratio, CD3/CD19 Ratio

Flow Cytometry

Urine Drug Screen - Confirmations performed in Indy/GenevaAntidepressants, Opiates, Cocaine, Benzodiazepines, Amphetamines, Barbiturates, Cannabinoids, Methadone, Phencyclidine and Propoxy-phene

Varies by Analyte

SSRI ScreenCitalopram and/or metabolite, Fluoxetine and/or metabolite,Fluvoxamine, Paroxetine, Sertraline and/or metabolite, Venlafaxine and/or metabolite and Trazodone

GC/MS

CDC Lipid Research PanelCDC Cholesterol, CDC Triglycerides (Glycerol Blanked), CDC HDL Cholesterol

Enzymatic

Page 7: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

*Special Collection DEC2011

Covance Central Laboratory Services

Analytes Methodology17 Alpha Hydroxyprogesterone Radioimmunoassay

Acetaminophen (Paracetamol) Previously validated, currently inactive

Acid Labile Subunit Previously validated, currently inactive

Acid Phosphatase/ Total and Prostatic Previously validated, currently inactive

Activated Partial Thromboplastin Time, APTT Photometric Clot Detection

Activated Protein C Resistance Clot Detection

Active Androstanediol Glucuronide (3a-diol G) Previously validated, currently inactive

Adenovirus Antigen Serotypes 40/41 Enzyme Immunoassay

Adiponectin Enzyme Immunoassay

Adiponectin Multiplex Immunoassay

Adiponectinm HMW (High Molecular Weight) Enzyme Immunoassay

ADMA, Asymmetric dimethylarginine Enzyme Immunoassay

Adrenocorticotropic Hormone, ACTH ECLIA - Electrochemiluninescence Immunoassay

Alanine Aminopeptidase, AAP Previously validated, currently inactive

Alanine Aminotransferase, ALT Enzymatic

Albumin Colorimetric

Albumin, CSF Nephelometry

Aldolase Previously validated, currently inactive

Aldosterone LC/MS/MS

Aldosterone Radioimmunoassay

Alkaline Phosphatase Colorimetric

Alkaline Phosphatase, Bone Specific Chemiluminescence

Alkaline Phosphatase Isoenzymes Colorimetric-Heat Inactivation (validating)

Alpha 1 Acid Glycoprotein, AAG Nephelometry

Alpha-1-Antitrypsin, AAT Nephelometry

Alpha 1 Microglobulin Nephelometry

Alpha 2 Macroglobulin Nephelometry

Alpha Crosslaps, Urine Enzyme Immunoassay

Alpha-Fetoprotein, AFP Chemiluminescence

Alpha Glutathione S Transferase Enzyme Immunoassay

Amylase, Total Enzymatic

Amylase, Pancreatic Enzymatic

Amyloid A Enzyme Immunoassay

Androstenedione LC/MS/MS (validating)

Angiotensin Converting Enzyme Previously validated, currently inactive

Angiotensin II Radioimmunoassay

Anti-cardiolipin IgG Enzyme Immunoassay

Anti-cardiolipin IgM Enzyme Immunoassay

Anti-CCP (Cyclic Citrullinated Peptide) ECLIA-Electrochemiluminescence

Anti-Double Stranded DNA, IgG Fluorescent Microparticle Immunoassay

Antimicrobial Susceptibility Testing (Customized MICs, Agar dilution,Clindamycin Disk induction, yeast MICs, Kirby Bauer, E-test, SIT/SBT, Hodge test, etc)

MIC/KB

Antinuclear Antibody, ANA Indirect Fluorescent Antibody

Anti-pneumococcal Capsular Polysaccaride, IgG Enzyme Immunoassay

Antistreptolysin O Antibody, ASO Previously validated, currently inactive

Page 8: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyAntithrombin III Activity Chromogenic

Antithrombin III Previously validated, currently inactive

Apolipoprotein A-1 Nephelometry

Apolipoprotein B Nephelometry

Apolipoprotein B48 Enzyme Immunoassay (validating)

Apolipoprotein B Total Nephelometry

Apolipoprotein B100 (Calculation only): Apolipoprotein B Total - Apolipoprotein B48

Calculation only

Apolipoprotein A2 Turbidimetric Immunoassay

Apolipoprotein A4 Enzyme Immunoassay (validating)

Apolipoprotein C2 Previously validated, currently inactive

Apolipoprotein C3 Turbidimetric Immunoassay

Apolipoprotein E Turbidimetric Immunoassay

Arginine Vasopressin, ADH Previously validated, currently inactive

Aspartate Aminotransferase, AST Enzymatic

Bacteriology - cultures (Sputum, urine, stool, etc) and IsolateIdentification

Microbiology

BDNF, Brain-derived Neurotrophic Factor Previously validated, currently inactive

Beta Carotene Previously validated, currently inactive

Beta Crosslaps ECLIA - Electrochemiluninescence

Beta Human Chorionic Gonadotropin, B-hCG, Qualitative Chemiluminescence

Beta Hydroxybutyrate Previously validated, currently inactive

Beta 2-Microglobulin Nephelometry

Beta Quantification - LDL, VLDL by ultracentrifugation Ultracentifugation/Enzymatic

Bicarbonate Enzymatic

Bile Acids Enzymatic

Bilirubin, Direct Colorimetric

Bilirubin, Total Colorimetric

Blood Urea Nitrogen, BUN Enzymatic

Bone Specific Alkaline Phosphatase Chemiluminescence

BRAF Mutation Validating

Brain Natriuretic Peptide, BNP Chemiluminescence

CA -125 Chemiluminescence

CA 19-9 Chemiluminescence

CA 27.29 Previously validated, currently inactive

Calcitonin Chemiluminescent Immunometric

Calcium Colorimetric

Calcium, Urine Colorimetric

Calprotectin (See Fecal Calprotectin)

Carbamazepine Previously validated, currently inactive

Carbamazepine and 10,11 Epoxide Previously validated, currently inactive

Carbamazepine, Free Previously validated, currently inactive

Carbohydrate Deficient Transferrin % Previously validated, currently inactive

Carboxyhemoglobin Spectrophotometry

Page 9: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyCarboxyterminal telopeptide Type I Collagen, ICTP Radioimmunoassay

Carcinoembryonic Antigen, CEA Chemiluminescence

Carnitine, Free Previously validated, currently inactive

Cartilaps (CTX-II), C-terminal telopeptides of type II collagen, Urine Previously validated, currently inactive

Catecholamines - Norepinephrine only Previously validated, currently inactive

CCR5 Receptor Occupancy Validating

CCR5 Delta 32 RealTime PCR Laboratory Developed Method

CD138 Magnetic Cell Separation (Bone Marrow) Miltenyi Biotec Microbeads

CD34 Magnetic Cell Separation (Bone Marrow) Miltenyi Biotec Microbeads

CD34 Magnetic Cell Separation (Whole Blood) Miltenyi Biotec Microbeads

CD19 Magnetic Cell Separation Miltenyi Biotec Microbeads

CD4/CD8 - See Flow Cytometry Panel

CD45RA, CD45RO, etc - See Flow Cytometry Custom Markers

CellSearch Assay, Circulating Tumor Cells Previously validated, currently inactive

Cell Separation / Enrichment - RosetteSep Product Rosette Sep Method

Centromere B Antibodies Previously validated, currently inactive

Ceruloplasmin Nephelometry

cAMP (Cyclic Adenosine Monophosphate) Previously validated, currently inactive

cGMP (Cyclic Guanosine Monophosphate) Previously validated, currently inactive

Chlamydia Pneumoniae Antibody IgA Immunofluorescence

Chlamydia Pneumoniae Antibody IgG Immunofluorescence

Chlamydia Pneumoniae Antibody IgM Immunoflourescence

Chlamydia Trachomatis DNA Chemiluminescence

Chloride Ion Selective Electrode

Chloride, Urine Ion Selective Electrode

Cholesterol Enzymatic

Cholesterol, HDL Enzymatic Colorimetric

Cholesterol, HDL2 and HDL3 Previously validated, currently inactive

Chylomicron Remnants (calulation only)

CK-18 Fragments (Cytokeratin - PEVIVA M30 Apoptosense Kit) Enzyme Immunoassay

CK-18 Total (Cytokeratin - PEVIVA M65 Apoptosense Kit) Enzyme Immunoassay

CK Isoenzymes Electrophoresis

CK-MB Chemiluminescence

Clostridium Difficile Cytotoxicity Cell Culture

Clostridium Difficile Toxin Enzyme Immunoassay

Clusterin Enzyme Immunoassay (active for serum only)

Complement C3 Nephelometry

Complement C4 Nephelometry

Complement, Total, CH50 Hemolytic Assay

Cortisol Chemiluminescence

Cortisol Previously validated, currently inactive

Cortisol, Urinary Free High Performance Liquid Chromatography

Corticosteroid Binding Globulin Previously validated, currently inactive

Cotinine , Serum (Qualitative or Semiquantitative) Enzyme Immunoassay

Cotinine, Serum LC/MS/MS (validating)

Cotinine, Urine Enzyme Immunoassay

C-Peptide Chemiluminescence

C-Reactive Protein, CRP Nephelometry

Creatine Kinase, CK Enzymatic

Page 10: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyCreatine, Jaffe Colometric / Rate-blanked

Creatinine, Urine Colormetric (TKffe)

Creatinine, Enzymatic Enzymatic

Creatinine, Enzymatic (Urine) Enzymatic

Crosslaps, Type I Collagen Specific (CTX) ELISA

Crosslaps, Type I Collagen Specific (CTX), Urine Previously validated, currently inactive

CXCL12 (See SDR-1 alpha)

Cyclosporine Previously validated, currently inactive

CYP2C9 xTAG Mutation Detection

CYP2C19 xTAG Mutation Detection

CYP2D6 Autogenomics Infiniti - Validating

CYP3A5 Validating

Cystatin C Nephelometry

Cystatin C, Urine Enzyme Immunoassay

Cytokine Inflammatory Panel by Flow Cytometry (CBA) - Can include 1or all: IL-1 Beta, TNF alpha, IL-6, IL-8, IL-10 and IL-12 (p70)

Flow Cytometry

Cytokine TH1/TH2 Panel by Flow Cytometry (CBA) - Can included 1 orall: TNFalpha, IFN gamma, IL-2, IL-4, IL-5 and IL-10

Flow Cytometry

Cytomegalovirus, CMV IgG Chemiluminescence

Cytomegalovirus, CMV IgM Chemiluminescence

Cytomegalovirus (CMV) PCR Validating

Cytopathology *** Preferred Relationship with Reference Lab Consult Medical Affairs

D-Dimer Enzyme Immunoassay

Deoxypyridinoline Enzyme Immunoassay

DHEA - Dehydroepiandrosterone LC/MS/MS

DHEA-S, Dehydroepiandrosterone Sulfate Chemiluminescence

DHPG - Dihydroxyphenylglycol (must be performed with Catecholamines)

Previously validated, currently inactive

DHT, Dihydrotestosterone LC/MS/MS

Digoxin Chemiluminescence

Dilute Russell Viper Venom Test Screen and confirmation (LupusAnticoagulant)

Photometric Clot Detection

Diphtheria Antitoxoid Antibody, IgG Enzyme Immunoassay

DNA Isolation DNA Isolation

DNA Isolation, Bone Marrow Validating

DNA Isolation, Buccal Cells Validating

DNA Extraction, Granulocytes QIAamp DNA Blood

DNA Isolation, Saliva DNA Isolation

DNase-B Antibodies Previously validated, currently inactive

EBV VCA, IgG (Epstein-Barr Virus-Viral Capsid Antigen, IgG) Chemiluminescence

EBV VCA, IgM (Epstein-Barr Virus-Viral Capsid Antigen, IgM) Chemiluminescence

Ecarin Clotting Time, ECT Photometric Clot Detection

EGFR Mutation Real-time PCR

ENA-78 (Epithelial Neutrophil Activating Peptide 78) Enzyme Immunoassay

Endogenous Thrombin Potential, ETP Previously validated, currently inactive

Endomysial Antibody, IgA Validating

Endothelin 1 Enzyme Immunoassay

Eosinophil Cationic Protein (ECP) Previously validated, currently inactive

Eosinophil Protein X Previously validated, currently inactive

Eosinophil Stain Light Microscopy

Page 11: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyErythrocyte Sedimentation Rate (ESR) Modified Westergren

Erythropoietin Chemiluminescent Immunometric

E-Selectin Mulitplex Immunoassay

Estradiol Chemiluminescence

Estradiol LC/MS/MS

Estrone LC/MS/MS

Estrone sulfate Previously validated, currently inactive

Ethanol, Qualitative GC/FID

Ethanol, Quantitative GC/FID

Ethosuximide Previously validated, currently inactive

Factor II Mutation Genotyping Light Cycler

Factor V Genotyping Light Cycler

Factor VII Activity Previously validated, currently inactive

Factor VIII Activity Previously validated, currently inactive

Factor Xa (Low Molecular Weight Heparin) Previously validated, currently inactive

Fecal Calprotectin Enzyme Immunoassay

Fecal Leukocytes (See Lactoferrin)

Fecal Occult Blood Color Development

Fecal Occult Blood Chromatographic Immunoassay

Ferritin Chemiluminescence

FGF-23 C-terminal Enzyme Immunoassay

FGF-23 Intact Enzyme Immunoassay

Fibroblast Growth Factor Basic, FGF Basic Previously validated, currently inactive

Fibrinogen Degradation Product, FDP Previously validated, currently inactive

Fibrinogen Photometric Clot Detection

Flow Cytometry Custom Markers:CCR5 FoxP3 TregCD3/CD8/CD28/CD57CD16/56 (NK)NK-Cell ActivityNKT-Like CellsCD8/CD38/HLADR (T cells)CD4/CD38/HLADR (T cells)CD4/25 (T cells)CD7/26 (T cells)CD45/CD14/CD16CD20/22 (B cells)CD19/27 (B cells)CD19/27 (B cells)CD19/lgD/27/38 (B cells)CD19/lgD/27/38 (B cells)CD45/CD19/CD5/CD38 (B cells)CD3/CD10/Kappa/Lambda/CD19/CD45SEMA4DIgG4 PanelNK CD69 Panel

Flow Cytometry

Folate Chemiluminescence

Folate, RBC Previously validated, currently inactive

Follicle Stimulating Hormone, FSH Chemiluminescence

Free Fatty Acids Non-esterified Enzymatic

Free Insulin Previously validated, currently inactive

Free Light Chains (Freelite), Kappa and Lambda Nephelometry

Free PSA Chemiluminescence

Free T3 Chemiluminescence

Page 12: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyFree T4 Chemiluminescence

Free Testosterone (%) LC/MS/MS Equilibrium Dialysis

Fructosamine Colorimetric

Gabapentin Previously validated, currently inactive

Gamma Glutyamyl Transferase, GGT Colorimetric

Gastrin Chemiluminescent Immunometric

Gene Resistance Testing, PCR: PVL, MecA and SEC Mec Polymerase Chain Reaction

Gentamicin Previously validated, currently inactive

Giardia Specific Antigen Previously validated, currently inactive

Glucagon Radioimmunoassay

Glucagon Like Peptide-1, Total (GLP-1 Total) Microparticle Immunoassay

Glucose Enzymatic

Glucose, Urine Colorimetric

Glutamic Acid Decarboxylate Antibodies, GAD Antibodies Radioimmunoassay

Glycerol, Free Previously validated, currently inactive

“GlycoMark”, 1,5 Anhydroglucitol Enzymatic

Gram Stain Light Microscopy

Growth Hormone Chemiluminescence

Growth Hormone (For Pediatric Studies) Chemiluninescent -Immunometric

Haptoglobin Nephelometry

HDL Cholesterol PEG Enzyme Colorimetric

HDL Lipoparticle Size Gradient Gel Electrophoresis

Helicobacter Pylori, IgG Previously validated, currently inactive

Haemagglutination Titer Test (HA Titer Test) for Influenzae A&B Consult Lab

Hemoglobin A1c High Performance Liquid Chromatography

Hepatitis A Antibody Chemiluminescence

Hepatitis A IgM Antibody Chemiluminescence

Hepatitis B Core Antibody Chemiluminescence

Hepatitis B Core IgM Antibody Chemiluminescence

Hepatitis Be Antibody Enzyme Immunoassay

Hepatitis Be Antigen Enzyme Immunoassay

Hepatitis B Surface Antibody, Qualitative Chemiluminescence

Hepatitis B Surface Antibody, Quantitative Chemiluminescence

Hepatitis B Surface Antigen Chemiluminescence

Hepatitis B Viral DNA, Quantitative Real-Time Quantitative PCR

Hepatitis B Genotyping Line Probe Assay (validating)

Hepatitis C Antibody Chemiluminescence

Hepatitis Delta Antibody Previously validated, currently inactive

Hepatitis C Viral RNA, Quantitative Real-Time Quantitative PCR (TaqMan)

Hepatitis C Viral RNA, Quantitative Real-Time Quantitative PCR (Abbott)

Hepatitis C Genotyping DNA Sequencing

Hepatitis C Genotyping Line Probe Assay

Hepcidin, Urine Previously validated, currently inactive

HER-2/neu Chemiluminescence

Herpes Simplex Screen, IgG Previously validated, currently inactive

HHPV-8 (Human Herpes Virus-8), Qualitative RT-PCR, ABI 7900

Histamine Previously validated, currently inactive

Page 13: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyHistone Antibodies Previously validated, currently inactive

HIV-1 Genotyping Previously validated, currently inactive

HIV-1(RNA) PCR Real time PCR (TaqMan)

HIV-1(RNA) PCR Real-Time Quantitative PCR (Abbott)

HIV-1 Western Blot Western Blot

HIV-1/HIV-2 Antibody Chemiluminescence

HLA B27 Genotyping To be determined (validating)

HLA B5701 Genotyping To be determined (validating)

Homocysteine Chemiluminescence

HTR2A rs7330461 Genotype Real time PCR Laboratory Developed

HTLV I/HTLVII Antibodies Previously validated, currently inactive

HTLV I/HTLVII confirmation assay Previously validated, currently inactive

Human Anti Mouse Antibody, IgG, HAMA Previously validated, currently inactive

Hyaluronic Acid Previously validated, currently inactive

iBig Endothelin Previously validated, currently inactive

ICTP, [see Carboxyterminal Telopeptide Type I Collagen]

IL-1 a ( Interleukin 1 Alpha) Previously validated, currently inactive

IL-1B, Human Interleukin 1 Beta See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-1ra, Human IL-1 Receptor antagonist Enzyme Immunoassay

IL-2 See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-2 sR alpha (Interleukin 2 Soluble Receptor Alpha) Enzyme Immunoassay

IL-4 See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-5 See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-6 See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-6, Interleukin 6 Enzyme Immunoassay

IL-6 s Receptor Previously validated, currently inactive

IL-8 Enzyme Immunoassay

IL-10, Interleukin 10 See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-12 p40 Previously validated, currently inactive

IL-12 p70 See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-12 Total, Interleuking 12 Previously validated, currently inactive

IL-13, Interleukin 13 See Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel

IL-15, Interleukin 15 Previously validated, currently inactive

IL-17, Interleukin 17 Enzyme Immunoassay

IL-17F, Interleukin 17F Previously validated, currently inactive

IL-28b Mutation RealTime PCR, Laboratory Developed

Immunofixation, Myeloma Studies Immunofixation

Immunofixation, Myeloma Studies (Urine) Immunofixation

Immunoglobulin A, IgA Nephelometry

Immunoglobulin D, IgD Nephelometry

Immunoglobulin E, IgE Chemiluminescence

Immunoglobulin G, IgG Nephelometry

Immunoglobulin G, IgG (urine) Nephelometry

Immunoglobulin G Subclasses (IgG Subclasses) Nephelometry

Immunoglobulin M, IgM Nephelometry

Influenza A IgG Antibody Enzyme Immunoassay

Influenza B IgG Antibody Enzyme Immunoassay

Influenza Virus detection by PCR Artus Real-Time PCR

Page 14: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyInhibin B Enzyme Immunoassay

Insulin Antibodies Validating

Insulin, Free Previously validated, currently inactive

Insulin,Total Chemiluminescence

Insulin-Like Growth Factor I (IGF-1) Chemiluminescent Immunometric

Insulin-Like Growth Factor I (IGF-1) Enzyme Immunoassay

Insulin-Like Growth Factor II (IGF-II) Previously validated, currently inactive

Insulin-Like Growth Factor Binding Protein 3, IGFBP3 Chemiluminescent Immunometric

Interferon Gamma Mulitplex Immunoassay

Intracellular Adhesion Molecule, sICAM Multiplex Immunoassay

Ionized Calcium Medica EasyLyte

IP-10/CXXL10 (Interferon gamma inducible protein 10 ) Enzyme Immunoassay (validating)

Iron, Total Colorimetric

JAK-2 Mutation PT-PCR (validating)

Jo-1 (histidyl t-RNA synthetase) Antibodies Previously validated, currently inactive

KIM-1, Kidney Injury Molecule-1 Enzyme Immunoassay

KRAS Mutation Real-time PCR

Lactate Enzymatic

Lactate Dehydrogenase, LD Enzymatic

Lactate Dehydrogenase, Urine Previously validated, currently inactive

Lactoferrin, Qualitative (Fecal Leukocytes) Chromatographic Immunoassay

Lactoferrin, Quantitative (Stool) Enzyme Immunoassay

Lactoferrin (Plasma) Previously validated, currently inactive

Lamotrigine Previously validated, currently inactive

LD isoenzymes Electrophoresis

LDL Direct Enzymatic

LDL Lipoparticle size Electrophoresis

Legionella pneumophilia Antibody Indirect Fluorescent Antibody

Legionella Urinary Antigen Immunochromatography

Leptin Enzyme Immunoassay

Lipase Colorimetric

Lipoprotein a Nephelometry

Lipoprotein Remnant - Apo B Previously validated, currently inactive

Lipoprotein Remnant - Cholesterol Previously validated, currently inactive

Lithium Ion Selective Electrode

LpA1 Previously validated, currently inactive

LpE Previously validated, currently inactive

Lp CIII, Lipoprotein C-III Electroimmunodiffusion

Lp-PLA2 , Lipoprotein-associated phospholipase A2 Enzyme Immunoassay

Luminex Bio-Rad Pro Human Cytokine 10-Plex Panel: IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12 (p70), IL-13, TNF alpha and IFN gamma

Multiplex Immunoassay (Consult Medical Affairs/Immunology)

Luminex LINCOplex Panel: Adiponectin, MMP-9, MPO, sE-selectin, sICAM-1 and sVCAM-1

Multiplex Immunoassay (Consult Medical Affairs/Immunology)

Lupus Anticoagulant (See Dilute Russell Viper Venom Test)

Luteinizing Hormone, LH Chemiluminescence

Magnesium Colorimetric

Magnesium, Urine Colorimetric

Mannitol Previously validated, currently inactive

MCP-1, Monocyte Chemotactic Protein 1 Enzyme Immunoassay

Page 15: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyMethaqualone Confrimation Gas Chromotography/Mass Spectometry

Methaqualone Screen Immunoassay

Microalbumin, Quantitative Nephelometry

miRNA Isolation RNA Isolation

Mitochondrial Antibodies Immunofluorescence

MMP-1 ( see pro MMP-1) Previously validated, currently inactive

MMP-2 Previously validated, currently inactive

MMP-3 Previously validated, currently inactive

MMP-9 Multiplex Immunoassay

MMP-13 Previously validated, currently inactive

Mumps Antibody, IgG Enzyme Immunoassay

Mycobacteriology Consult Lab

Mycology Consult Lab

Mycoplasma culture Microbiology

Mycoplasma pneumoniae Antibody, IgG Indirect Fluorescent Antibody

Mycoplasma pneumoniae Antibody, IgM Indirect Fluorescent Antibody

Myeloperoxidase, MPO Multiplex Immunoassay

Myoglobin Nephelometry

Myoglobin, Urine Point of Care Instrument

NAT2 Genotyping Previously validated, currently inactive

Neisseria gonorrhoeae DNA Chemiluminescence

N-acetyl-B-D-glucosamidase, NAG Colorimetric

Neopterin Previously validated, currently inactive

NGAL (Neutrophil Gelatinase-associated lipocalin) Enzyme Immunoassay

Nitrites/Nitrates Previously validated, currently inactive

N-Telopeptides (NTx) ELISA

N-Telopeptides (NTx), Urine ELISA

NT-proBNP ECLIA - Electrochemiluminescence Immunoassay

NT-proBNP Chemiluminescent Immunometric

Osmolality Freezing Point Depression

Ostase (see Alkaline Phosphatase, Bone Specific)

Osteocalcin ECLIA - Electrochemiluminescence Immunoassay

Ova and Parasite Examination Light Microscopy

Oxalate Previously validated, currently inactive

Oxidized LDL ELISA

Paracetamol (Acetaminophen) Previously validated, currently inactive

Parathyroid Hormone, Intact Chemiluminescence

Parvovirus IgG Previously validated, currently inactive

Parvovirus IgM Previously validated, currently inactive

PBMC Purification, Peripheral Blood Mononuclear Cells Histopaque/Lymphoprep

Pentraxin 3 Enzyme Immunoassay (validating)

Pepsinogen I Enzyme Immunoassay

Pepsinogen II Enzyme Immunoassay

Phenobarbital Previously validated, currently inactive

Phenytoin, Free Previously validated, currently inactive

Phenothiazines Confirmation Gas Chromotography/Mass Spectometry

Phenothiazines Screen Immunoassay

Phenytoin Previously validated, currently inactive

Phospholipids, Total Previously validated, currently inactive

Page 16: Featured Assay - Covance Assay Total Testosterone by LC/MS/MS Covance’s total testosterone by liquid chromatography and tandem mass spectrometry (LC/MS-MS) is a highly sensitive

Covance Central Laboratory Services

*Special Collection DEC2011

Analytes MethodologyPhosphorus Colorimetric

Phosphorus, Urine Colorimetric

PI3K Mutation RealTime PCR

PINP, Aminoterminal Propeptide of Type I Procollagen ECLIA - Electrochemiluminescence

Placental Growth Factor, PLGF Enzyme Immunoassay

Plasma Renin Activity, PRA Radioimmunoassay

Plasmin Alpha 2-Antiplasmin Complex (PAPc) Previously validated, currently inactive

Plasminogen Activity Previously validated, currently inactive

Plasminogen Activator Inhibitor 1 Activity, PAI-1 Enzyme Immunoassay

Plasminogen Activator Inhibitor 1 Antigen (PAI-1 Ag) Previously validated, currently inactive

PMN Elastase Enzyme Immunoassay

Pneumococcal Capsular Polysaccharide Antibody, IgG Enzyme Immunoassay

Pneumococcal Urinary Antigen Immunochromatography

Potassium Ion Selective Electrode

Potassium, Urine Ion Selective Electrode

Prealbumin Nephelometry

Primidone Previously validated, currently inactive

Procalcitonin ECLIA - Electrochemiluminescence Immunoassay

Procollagen Type I, CICP Enzyme Immunoassay

Procollagen Type III, PIIINP Chemiluminescence (validating)

Progesterone Chemiluminescence

Proinsulin Radioimmunoassay

Prolactin (for pediatric studies) Chemiluminescence Immunometric

Pro MMP-1 Previously validated, currently inactive

Prostate Specific Antigen, PSA Chemiluminescence

Protein C Activity Clot Detection

Protein Electrophoresis Electrophoresis

Protein Electrophoresis, Urine Electrophoresis

Protein S Activity Clot Detection

Protein, Total Colorimetric

Protein, Total - Urine Colorimetric

Protein, Total - Urine Colorimetric

Prothrombin Time, PT Photometric Clot Detection

Prothrombin Fragment 1.2 Enzyme Immunoassay

Pseudo/Ephedrine Screen and Confirmation Thin-Layer Chromatography

Pulsed Field Gel Electrophoresis PFGE

Pyridinium Crosslinks, Pyrilinks Enzyme Immunoassay

Pyridinoline Previously validated, currently inactive

PYY, Total (Peptide YY) Previously validated, currently inactive

QuantiFERON-TB Enzyme Immunoassay

Quinidine Previously validated, currently inactive

Ranitidine Previously validated, currently inactive

RANKL1, Soluble Receptor Activator of Nuclear Factor KappaB Ligand Previously validated, currently inactive

Rapamycin Previously validated, currently inactive

Renin, Plasma Renin Activity, PRA Radioimmunoassay

Renin, Direct/Active Previously validated, currently inactive

Reticulocyte Count Flow Cytometry

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*Special Collection DEC2011

Covance Central Laboratory Services

Analytes Methodology Reticulocyte Hemoglobin Content, CHr Light Scattering

Retinol Binding Protein Nephelometry

Rheumatoid Factor, RF Nephelometry

RLP (Remnant Lipoprotein) Cholesterol ELISA

RNA Integrity Agilent 2100

RNA Isolation, Blood RNA Isolation

RNA Isolation, Bone Marrow Validating

RNA Isolation, Tissue RNA Isolation

RNP Antibodies Fluorescent Microparticle Immunoassay

Rotovirus Group A Antigen Enzyme Immunoassay

RPR, Rapid Plasma Reagin Particle Agglutination

Rubella Antibody, IgG Chemiluminescence

Salicylate Previously validated, currently inactive

sCD30 Previously validated, currently inactive

SAA (Serum Amyloid A) on HDL by PEG Enzyme Immunoassay

Scl-70 (Scleroderma) Antibodies Previously validated, currently inactive

SDF-1/CXCL12 (Stromal cell-derived factor 1 alpha) Enzyme Immunoassay

Sex Hormone Binding Globulin, SHBG Chemiluminescent Immunometric

Shiga Toxins 1 & 2 Immunochromatography

Sm Antibodies Fluorescent Microparticle Immunoassay

Small Dense LDL Apolipoprotein B Immunoturbidimetry

Small Dense LDL Cholesterol Enzymatic Colorimetric

Smooth Muscle Antibodies Immunofluorescence

Sodium Ion Selective Electrode

Sodium, Urine Ion Selective Electrode

Soluble Thrombomodulin Previously validated, currently inactive

Soluble Transferrin Receptor Nephelometry

Soluble Tumor Necrosis Factor Receptor 1(sTNF RI) Previously validated, currently inactive

Soluble Tumor Necrosis Factor Receptor II (sTNF RII) Previously validated, currently inactive

SSA (Ro) Antibodies Fluorescent Microparticle Immunoassay

SSB (La) Antibodies Fluorescent Microparticle Immunoassay

T3, Total Chemiluminescence

T4, Total Chemiluminescence

TARC, Thymus and Activation-Regulated Chemokine Enzyme Immunoassay

Tetanus Antitoxoid Antibody, IgG Enzyme Immunoassay

Testosterone, Total Chemiluminescence

Testosterone, Total LC/MS/MS

Testosterone, Total (Low Sensitivity - LLOQ 2,00 ng/dl) LC/MS/MS

TGF Alpha (Transforming Growth Factor Alpha) Previously validated, currently inactive

TGF Beta 1 (Transforming Growth Factor Beta 1) Enzyme Immunoassay

TGF Beta 2 (Transforming Growth Factor Beta 2) Previously validated, currently inactive

Theophylline Chemiluminescence

Thrombin Time Clot Detection

Thrombin-Antithrombin III Complex ELISA

Thrombomodulin, Urine Previously validated, currently inactive

Thrombopoietin ELISA

Thyroglobulin Chemiluminescent Immunometric

Thyroglobulin Antibodies Chemiluminescent Immunometric

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Covance Central Laboratory Services

*Special Collection DEC2011

Analytes Methodology Thyroid Stimulating Hormone, TSH Chemiluminescent

Thyroperoxidase (TPO) Antibodies Chemiluminescent Immunometric

Thyroxine Binding Globulin, TBG Previously validated, currently inactive

Tissue Inhibitors of Metalloproteinase I, TIMP-1 Previously validated, currently inactive

Tissue Plasminogen Activator (tPA) Antigen Previously validated, currently inactive

Tissue Transglutaminase IgA Previously validated, currently inactive

TNF-a, Tumor Necrosis Factor-alpha Enzyme Immunoassay

TNF-a, Tumor Necrosis Factor-alpha See Luminex Bio-Rad Pro Human Cytokine 10 Plex Panel

Topiramate Previously validated, currently inactive

Transferrin Nephelometry

Transforming Growth Factor Beta 1 (TGF Beta 1) Previously validated, currently inactive

Trichomonas Vaginalis Test Microbiology

Triglycerides Enzymatic

Troponin I Chemiluminescence

Troponin T ECL - Electrochemiluminescence

Troponin T, high sensitivity ECL-Electrochemiluminescence (validating)

Trypsin-like Immunoreactivity, TLI Radioimmunoassay

Tryptase Previously validated, currently inactive

T-Uptake Chemiluminescence

Unbound Iron Binding Capacity, UIBC Colorimetric

uPA, Urokinase-type Plasminogen Activator Enzyme Immunoassay

Urea Nitrogen, BUN Enzymatic

Urea Nitrogen, Urine Enzymatic

Ureaplasma Culture Microbiology

Uric Acid Colorimetric

Uric Acid, Urine Colorimetric

Valproic Acid Chemiluminescence

Valproic Acid, Free Previously validated, currently inactive

Vancomycin Previously validated, currently inactive

Varicella zoster IgG Antibody Chemiluminescence

(Soluble) Vascular Cell Adhesion Molecule I , sVCAM-1 Multiplex Immunoassay

Vascular Endothelial Growth Factor, VEGF ELISA

Vascular Endothelial Growth Factor Receptor I, VEGF-R1 Previously validated, currently inactive

Vascular Endothelial Growth Factor Receptor 2, VEGF-R2 Previously validated, currently inactive

Virology Consult Lab

Vitamin A and E High Performance Liquid Chromatography

Vitamin B12 Chemiluminescence

Vitamin D, 25-Hydroxyvitamin D Chemiluminescence

Vitamin D, 1,25-Dihydroxyvitamin D Radioimmunoassay

Vitamin K High Performance Liquid Chromatography

Warfarin Sensitivity (includes CYP2C9 and VKORC1 Genotyping) xTAG Mutation Detection

VKORC1 Genotyping (See Warfarin Sensitivity)

Von Willebrand Factor Antigen Previously validated, currently inactive

Zolpidem Previously validated, currently inactive

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*Special Collection DEC2011

Covance Central Laboratory Services

Capabilities

Antibody development, antibody characterization & qualification, assaydevelopment

Assay development

Biacore

Capillary electrophoresis

Cell-based assays

Chemiluminescence

Chromatography - GC

Chromatography - GC/MS

Chromatography - HPLC

Chromatography - UPLC

Chromatography - HRMS

Chromatography - LC/MS

Chromatography - LC/MS/MS

Clinical pathology testing

Custom organic synthesis

ECG

ECG Digitography

ECL-A (Electrochemiluminescence assay)

ELISA - Enzyme Linked ImmunoSorbent Assay

Extraction techniques

FACS (Flow Cytometry)

Fluorescence Microscopy

FISH - Fluorescent In-Situ Hybridization

Genotyping - SNP analysis (Single-Nucleotide Polymorphisms)

Genotyping - Viral

Interphase FISH

Imaging

Immunoassays (other)

Immunochemistry

Immunofluorescence

Immunogenicity

IHC (Immunohistochemistry)ISH (In situ Hybridization)

In vitro ADME (Adsorption, Distribution, Metabolism and Excretion)

Immunofluorescence

IP/Western (ImmunoPrecipitation/Western Blot)

IRMA

KIRA

Microarray - DNA/RNA

Microarray - Tissue

Molecular assays

Multiplex immunoassays

New procedure development and validation

PCR/Sequencing

qRT-PCR (Quantitative Real Time PCR)

RT-PCR

Regulatory submission

Report and abstract preparation

RIA

RNA / DNA Isolation and Banking

Sample analysis

Sequencing

If you have any questions, please contact your Covance Account Executive using the information below.

THE AMERICAS +1-888-COVANCE (+1-888-268-2623) +1-609-419-2240

EUROPE/AFRICA +800-2682-2682 +44-1423-500888

ASIA PACIFIC +800-6568-3000 +65-6-5677333

EMAIL [email protected] WEB SITE www.covance.com

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18

Additional Expertise

Small Molecule Large Molecule

Covance has extensive experience working with the following compounds. Currently these methods are inactive and may require additional time and/or fees to reactivate.

25-Desacetylrifampin

5-Fluorouracil

9-Hydroxyrisperidone

Alendronate

Atenolol

Cimetidine

Ciprofloxacin Hydrochloride

Cisapride

Cisplatin

Clarithromycin

Clonidine

Desmethyl Selegiline

Dihydrotestosterone

Diltiazem

Fentanyl

Fexofenadine

Fluconazole

Gemfibrozil

Griseofulvin

H2G

Haloperidol

Hydrochlorothiazide

Hydroxybutyrate, gamma

Ibuprofen

Ibuprofen (R-)

Ibuprofen (S-)

Ketoprofen

Ketoprofen (R-)

Ketoprofen (S-)

Levetiracetam

Lidocaine

Lovastatin

Lovastatin Acid

Menthol

Methadone (R-)

Methadone (S-)

Methyl Salicylate

Metoprolol

Mirtazapine

Modafinil (R-)

Modafinil (S-)

Modafinil acid (R-)

Modafinil acid (S-)

Modafinil sulfone

Naltrexol, beta

Naltrexone

Nifedipine

Nitrosamine, free

Nitrosamine, total

NNAL, free

NNAL, total

Norethindrone

Norfluoxetine

Norhydrocodone

Oxaliplatin

Oxycodone

Oxymorphone

Paracetamol

Prilocaine

Protriptyline

Ranitidine

Rapamycin

Rifampin

Risperidone

Salicylic Acid

Selegiline

Terfenadine

Theobromine

Trimethoprim

Adrenocorticotropic Hormone, (ACTH)

Anti-PEG antibodies

Bone-Specific Alkaline Phosphatase

Calcitonin

Chorionic Gonadotropin, beta subunit

Chorionic Gonadotropin, whole molecule

Creatine Kinase

Corticotropin Releasing Factor

C-Peptide

C-Reactive Protein

cTroponin I

cTroponin T

Cystatin C

Estradiol (E2)

Exendin

FABP3

Factor IX

Factor VII

Factor VIIa

Factor VIII

Factor VIII inh

Ferritin

Growth Hormone

Hepatocyte Growth Factor

IgA

IgE

IGF-BP3

IGF-I

IgG, total

IgG1

IgG2

IgG3

IgG4

IgM

Insulin (RIA and ELISA)

Insulin Glargine

Insulin LisPro

Insulin, TOSOH

Kim-1

Lysozyme

Myl3

Neopterin

N-Telopeptide (Procollogen N-Term)

Osteocalcin

Osteoprotegrin

P1NP

Parathyroid Hormone

Parvalbumin

Prolactin

Pyrilinks (Pyridinium)

Pyrilinks-D (Deoxypyridinium)

Sema4D

sRANKL

Thyroid Stimulating Hormone (TSH)

Thyroxine (T4)

TIMP-1

Tobramycin

TRAP-5b

Triiodothryonine (T3), total

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