Johns Hopkins Medical Laboratories 600 North Wolfe Street

• • • Johns Hopkins Medical Laboratories 600 North Wolfe Street Meyer B-130 Baltimore, MD 21287 -7070 Phone 410 -955 -2405 Fax 410 -614 -0455

JHML Services • • Blood Disorders & Special Coagulation 临检和凝血 Clinical Chemistry 生化 Cytokine 细胞因子 HIV Specialty Services HIV筛查 Immunology 免疫 Medical Microbiology 医学微生物 Molecular Pathology & Cytogenetics分子病理和细胞基因 Neoplastic Hematopathology & Flow Cytometry血液病理 和流式细胞仪 • Transfusion Medicine 血库

Cardiovascular Panel心血管项目组合 Test abnormalities in this panel correlate with an increased risk of cardiovascular disorders. Factor VII Activity Fibrinogen Activity Homocysteine (special collection) Lipoprotein (a) Plasminogen Activator Inhibitor-1 (PAI-1) Prothrombin Fragment 1. 2 Tissue Plasminogen Activator Antigen

Circulating Anticoagulant and Lupus Anticoagulant循环抗凝和狼疮抗凝 • A basic screening panel for factor deficiencies and the detection of inhibitors. APTT Mixing Studies (APTT) Mixing Studies (PT) PT (Prothrombin Time) Platelet Neutralization d-RVVT, with confirm Anti-cardiolipen Antibody, Ig. G, Ig. M, Ig. A Anti-B 2 GP 1 antibodies, Ig. G, Ig. M, Ig. A

Abnormal PT and/or APTT Evaluation一般 凝血检查 • This panel is used to evaluate the cause of an abnormal protime or activated partial thromboplastin time. APTT Mixing Studies Hepzyme (Test for heparin contamination) PT (Prothrombin Time) Mixing Studies Platelet Neutralization

DDAVP Challenge血管加压素耐受性 • The panel is used to evaluate the response of mild hemophilia and von Willebrand disease patients to DDAVP. Factor VIII Activity Ristocetin Co. Factor assay WF Antigen HEME-8 (pre - post)

DIC Screen. DIC筛查 • The DIC screen is useful in the diagnosis and follow-up of disseminated intravascular coagulation . APTT D-dimer (Quantitative) Fibrinogen Prothrombin Time

Extrinsic Pathway Panel外凝血通路组合 • Panel used to evaluate and identify the cause of an abnormal . Factor VII Activity Factor X Activity Factor V Activity Factor II Activity prothrombin time

Intrinsic Pathway Panel内 凝血通路组合 • Panel can be used to evaluate and identify the cause of an abnormal activated partial thromboplastin time. Factor XII Activity Factor XI Activity Factor IX Activity Factor VIII Activity

Fibrinolysis Panel纤维蛋白溶解组合 • The fibrinolysis panel may be used to monitor or diagnose acquired or congenital abnormalities of the fibrinolytic system . alpha-2 -Antiplasmin D-dimer Quantitative Fibrinogen Degradation Products Plasminogen Activator Inhibitor-1 (PAI-1) Plasminogen Activity Tissue Plasminogen Activator Antigen

Lupus Anticoagulant (Antiphospholipid Screen)狼疮抗凝(抗磷脂筛查 • A basic screening panel for the detection of lupus-like inhibitors. The profile may also be used for patients with an unexplained prolonged prothrombin time or APTT. Anticardiolipin Antibody (ELISA) APTT and Mixing Studies D-RVVT (Dilute Russell Viper Venom) and Mixing Studies PT (Prothrombin Time) and Mixing Studies Platelet Neutralization Test if evidence for an inhibitor

Platelet Function Panel 血小板功能组合 • Panel used to identify platelet function problems. PFA-100 Bleeding Time Clot Retraction Platelet Aggregation Platelet Secretion (ATP release) Flow cytometry studies if indicated Prothrombin Consumption Test

Thrombotic Risk Panel 血栓风险组合 • The thrombotic risk panel is a comprehensive group of tests for evaluating patients with hypercoagulable states. Activated Protein C Resistance and Factor V Leiden Antithrombin III Activity Dilute Russell's Viper Venom (D-RVVT) Fibrinogen Activity, Fibrinogen Antigen Homocysteine (special collection) Lipoprotein (a) Lupus Anticoagulant Screen Plasminogen Activator Inhibitor 1 (PAI-1) Plasminogen Activity C Activity Protein C Antigen Protein S Activity Protein S Antigen Total Thrombin Time Tissue Plasminogen Activator Antigen Prothrombin Gene Mutation

Thrombotic Risk Screen血栓风险筛检 • A group of basic tests used to screen patients for only the most common causes of thrombosis. Activated Protein C Resistance Antithrombin III Activity D-RVVT Homocysteine (special collection) Protein C Activity Protein S Activity

von Willebrand Panel血管性血友病因子 • This panel is for the evaluation of suspected von Willebrand . APTT Factor VIII Activity Ristocetin Cofactor v. WF Antigen v. WF Multimers as needed disease

• Markers of Hyper-Coagulation高凝状态标志物 • Prothrombin fragment 1, 2 Plasma p-Selectin Thromboxane Beta-Thromboglobulin PF 4 • Miscellaneous Bleeding Disorders各种出血紊 乱 • Factor XIII Activity

Protein Tests 特种蛋白 • • • • Cryoglobulin Screen with reflex to immunofixation electrophoresis for positives CSF Ig. G Index by nephelometry CSF Ig. G (Ig. G/ Total Protein as %) Electrophoresis, Protein, serum with immunoglobulin quantitations and immunofixation electrophoresis Electrophoresis, Protein, 24 -hour urine or random urine: includes total protein, immunoglobulin quantitations and immunofixation electrophoresis Electrophoresis, Bence Jones Protein, 24 -hour urine or random urine includes total protein and immunofixation electrophoresis Haptoglobin by nephelometry Ig. A, Serum by nephelometry Ig. G, Serum by nephelometry Ig. M, Serum by nephelometry Prealbumin by nephelometry

Autoimmune Disease Tests自身免疫 • ANA Screen with reflex to titer and pattern for positives by IFA • C 3 by nephelometry • C 4 by nephelometry • Cyclic Citrullinated Peptide (CCP) Ig. G by EIA • ds. DNA Screen with reflex to titer for positives by IFA • Jo-1 antibody by EIA • Mitochondrial antibody with reflex to titer for positives by IFA

• • Rheumatoid Factor by nephelometry Scleroderma antibody (Scl-70) by EIA Sjogren’s antibody (SS-A) by EIA Sjogren’s antibody (SS-B) by EIA Sm antibody by EIA RNP antibody by EIA Smooth Muscle antibody with reflex to titer for positives by IFA

Infectious Disease Serology Tests各种传 染病细菌学检查 • • • Anti-Streptolysin O by nephelometry CMV Ig. G by EIA CMV Ig. M by MEIA EBV Ig. G (EA, VCA, EBNA) by EIA EBV Ig. M by IFA Helicobacter pylori Ig. G by EIA HSV Ig. M by EIA Lyme Disease by EIA with reflex to Western Blot for positive and equivocal results

• • • Mononucleosis Screen by agglutination Mumps Ig. G by EIA Rubella Ig. G by MEIA Rubeola Ig. G (measles) by EIA Syphilis Serology by RPR with reflex to titer and FTA if positive Toxoplasma Ig. G by MEIA Toxoplasma Ig. M by MEIA VZV (Varicella zoster) Ig. G by EIA VDRL by microflocculation West Nile Ig. M by EIA

• HIV-1 p 24 Antigen Testing (Direct and ICD) • Qualitative and Quantitative HIV-1 Plasma and PBMC Culture Test • Qualitative DNA PCR Testing • Quantitative HIV-1 RNA Testing

• Molecular Diagnostics Laboratory We provide a multitude of clinical testing for leukemia, lymphoma, solid tumors, colorectal cancer predisposition, and hematologic mutations. • Leukemia白血病 • RFLP - This test is performed on bone marrow transplant (BMT) patients and their donors before BMT to identify an informative probe, and then after BMT on the patient to monitor the status of the graft. Ig. H PCR - This test identifies B-cell clonality in leukemia and lymphoma. TCR-Gamma PCR - This test identifies T-cell clonality in leukemia and lymphoma. BCR-ABL RT-PCR - This test identifies the t(9: 22) BCR/abl gene translocation (Philadelphia chromosome) present in more than 99% of CML and frequently in all.

• Lymphoma淋巴瘤 • BCL 2/Ig. H PCR - This test identifies the t(14: 18) BCL 2/Ig. H gene translocation (major and minor breakpoint regions) seen in follicular lymphoma and large cell lymphoma. • Specialty tests特殊检查 • APC I 1307 K -This test identifies the hereditary predisposition for colorectal cancer in the Ashkenazi Jewish population.

• Leukemia白血病 • Flow Cytometry (Phenotypic Characterization, Residual Disease Detection) Morphology Consultations -- Blood and Marrow Cytogenetics (in collaboration with the Cytogenetics Laboratory) Molecular Diagnostics (in collaboration with the Molecular Diagnostics Laboratory) • Lymphoma淋巴瘤 • Flow Cytometry (Phenotypic Characterization, Staging, Residual Disease Detection, Fine Needle Aspirates) Morphology Consultations -- Lymph Node and other Tissue Biopsies Immunohistochemistry Molecular diagnostics (in collaboration with the Molecular Diagnostic Laboratory) • Specialty Tests特殊检查 • CD 34 Counting PNH (Paroxysmal Nocturnal Hemoglobinuria) Diagnosis阵发性睡 眠性血红蛋白尿

• • • Bacteriology 细菌 Molecular Microbiology 分子微生物 Mycobacteriology 结核菌 Mycology 真菌 Parasitology 寄生虫 Virology 病毒

• Special Pathogen Detection – Actinomyces spp. : Culture; PCR – Bordetella pertussis: Culture; PCR – Legionella pneumophila: Culture; Direct fluorescent antibody; PCR – Mycoplasma pneumoniae: PCR – Mycoplasma hominis/Ureaplasma urealyticum: Culture – Bartonella spp. : Culture; PCR – Chlamydia pneumoniae: PCR – Chlamydia trachomatis: Culture; PCR – Ehrlichia/Anaplasma: PCR – Borrelia burgdorferi: Culture; PCR – Neisseria gonorrheae: Culture; PCR

• Bacterial Identification – Gas-liquid chromatography of glucose metabolic end products for anaerobe identification. – Cell wall fatty acid analysis for speciation of nonfermenting or uncommon isolates. – 16 S ribosomal RNA gene sequence analysis for identification. • Toxin Testing – Staphylococcus aureus Panton-Valentine leukocidin – Shiga-like toxins 1 and 2 – Clostridium difficile toxin by antigen and cytotoxic methods

• Antibiotic Susceptibility Testing and Monitoring – – – – Agar dilution susceptibility testing (MIC) Antibiotic bacteriocidal determination (MIC/MBC) Antibiotic serum activity (Schlichter test - MID/MBD) Antibiotic synergy testing Antibiotic serum level determinations Molecular determination of antibiotic resistance genes Methicillin resistance (mec. A) Vancomycin resistance (van. A; van. B; van. C) • Molecular Epidemiology – Pulsed-field gel electrophoresis (PFGE) – Restriction fragment-length polymorphisms (RFLP)

• Epstein-Barr virus (EBV) detection and quantification by PCR • Parvovirus B 19 PCR detection • BK virus detection and quantification by PCR • JC virus detection by PCR • Cytomegalovirus (CMV) PCR detection • Varicella-Zoster virus (VZV) PCR detection • Hepatitis C virus (HCV) quantification by PCR • HCV genotype identification by direct sequencing • Hepatitis B virus quantification by PCR

• • • Adenovirus detection by PCR Enterovirus detection by PCR High Risk HPV detection (HC-2, Digene) Ehrlichia chaffeensis and Anaplasma phagocytophila (HGE agent) PCR detection Atypical pneumonia pathogen detection by PCR (Mycoplasma pneumoniae, Legionella pneumophila, Chlamydia pneumoniae) Bacterial identification by 16 S ribosomal RNA gene sequencing Molecular epidemiology by PFGE or RFLP Staphylococcus enterotoxin and TSST-1 gene and Shiga -like toxin gene identification by PCR Bordetella pertussis PCR Detection

• Mycobacteriology • Mycobacteria species identification and susceptibility testing, especially for patients with multiply resistant pathogens, is beyond the routine testing available in most hospital laboratories. The Johns Hopkins Hospital Mycobacteriology Laboratory offers the following testing: • Culture/smear • Speciation • Mycobacterial blood culture • Routine susceptibility testing for M. tuberculosis • Susceptibility testing for select non-specific mycobacteria upon request • PCR for M. tuberculosis from smear positive respiratory (only) specimens

• Mycology • Most clinical laboratories can only identify common fungi, but the Hospital's diverse patient base gives the Microbiology Laboratory experience testing for speciation of unusual organisms and for performing yeast in vitro susceptibility testing. • Fungal identification (yeast, dimorphics, filamentous) 真 菌鉴定 • Cryptococcus antigen detection (隐球菌抗原检测） • Fungal culture （真菌培养） • Direct microscopic examination （直接镜检） – KOH – Calcofluor white （荧光染色，用于鉴别孢子虫) – Giemsa

• Yeast in vitro susceptibility testing 酵 母菌体外药敏试验 – Amphotericin B 二性霉素B – Itraconazole 伊曲康唑 – Voriconazole 伏立康唑 – Fluconazole 弗康唑 – 5 -fluorocytosine 5 -弗胞嘧啶 – Caspofungin卡波芬净

• Parasitology • The Microbiology Laboratory has extensive experience diagnosing problems in international populations exposed to unfamiliar parasites, cancer patients who are immune-suppressed, and HIV-infected patients who are prone to develop unusual infections. • Malaria and other blood parasites detection and identification 疟原虫和其他血寄生虫的鉴别 – Cryptosporidium and Isospora identification 隐孢子虫 – Microsporidium ssp. identification 小孢子虫 – Pneumocystis carinii identification 卡氏肺囊虫 – Giardia lamblia identification肠兰伯式鞭毛虫 •

• Virology • The Virology Laboratory within the Division of Medical Microbiology uses many different cell lines for culture, applies new methodologies for rapid and early identification of pathogenic viruses, and performs viral susceptibility determinations rarely performed in other laboratories. • Respiratory virus (respiratory syncytial virus (RSV), influenza A, influenza B, parainfluenza viruses 1 -3, adenovirus) rapid antigen detection and culture 呼吸道 病毒 • Herpes simplex culture单纯疱疹 • Cytomegalovirus (CMV) culture巨细胞病毒 • Cytomegalovirus (CMV) culture--early antigen • Cytomegalovirus (CMV) quantification by PCR

• Varicella-Zoster virus (VZV) culture水 痘-带状疱疹病毒 • Enterovirus culture 肠道病毒 • Adenovirus culture 腺病毒 • Other Viral cultures 其他病毒 • Viral susceptibility 病毒药敏 • Molecular Virology (see Molecular Microbiology)分子病毒学

• 游离脂肪酸（Free fatty acids, FFA） • 3 -甲氧基-4羟基苦杏仁酸（ Vanillylmandelic acid, VMA） • 抗酒石酸酸性磷酸酶（Tartrate resistant acid phosphatase-5 b, TRAP-5 b） • 人巨细胞病毒载量（HCMV viral load） • 沙眼衣原体DNA（CT-DNA） • 淋球菌DNA（NG-DNA） • 疱疹病毒I、II DNA（HSV I&II-DNA）

• HLA抗体特异性试验 （PRA） • HLA抗体筛查试验( HLA I、II antibody screening test) • HLA抗原DNA分型（HLA antigen detection）

• 尿轻链定量（κλ） • 循环免疫复合物（circulating immune complex, CIC） • 抗凝血酶 3 ( Antithrombin Ⅲ, AT 3 ) • 新碟呤（Neopterin） • 白细胞介素-2（IL-2） 4, 6, 8, 10, 12, 13 • 结合珠蛋白 ( Haptoglobin，HPT ) • 自然杀伤细胞（Natural Killer Cells, NK）

• 血管内皮生长因子（VEGF） • 肝纤 PCⅢ CⅣ LN HA MAO FN • ALA* δ-氨基-γ酮戊酸（δ-amino levulinic acid, ALA） • 亮氨酰氨基肽酶（leucine aminopeptidase，LAP） • 冷球蛋白（cryoglobulins cryo） • 酸性磷酸酶（acid phosphatase，ACP） 　

• 磷脂（phospholipid，PL） • VWF胶原结合分析（v. WF collogen binding assay ） • v. WF抗原测定 ( v. WF antigen determination ) • X因子活性测定 ( factor X activity determination • Ⅱ因子活性测定 ( factor II activity determination

• Ⅶ因子活性测定 ( factor VII activity determination ) • Ⅷ因子活性测定 ( factor VIII activity determination ) • Ⅸ因子活性测定 ( factor IX activity determination ) • 抗碱血红蛋白(Alkali-resistant hemoglobin) • 血红蛋白电泳和Hb. A 2测定（hemoglobin electrophoresis and mensuration for Hb. A 2）

• 高铁血红蛋白还原试验(methemoglobin reduction test)

• 质量保证是基础，包括设备/试剂 • Hepatitis B surface antigen mutant detection on four immunoassay analysers. • ARCHITECTi 2000 AXSYM Elecesys Vitros Mutant detection 12/12 7/12 6/12 Turn-around time 30 m 30 m 20 m 38 m Calibtation stability 28 d 23 d 28 d Cost per reportable(us )2. 19 2. 38 1. 94 1. 88 • • The five discordant mutants were Pro 142 -Ser+Gly 145 -Arg; Gly 145 -ARG; Asp 144 Ala+Gly 145 -Arg; Thr 126 -Ser+Gly 145 -Arg; Pro 142 -Leu+Gly 145 -Arg S. L. Saw, et al. National University Hospital Singapor