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Nemours Biomedical Research

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Clinical Diagnostics

The Center for Clinical Diagnostics

The Center for Clinical Diagnostics provides diagnostic testing services in support of patient care in a variety of medical specialties — to clinicians inside and outside of Nemours.

Our center’s various labs address diagnostic work performed in the Delaware Valley and at Nemours Children’s Hospital in Orlando, Florida.

The labs also pursue and establish collaborative investigations with our physicians. These investigations seek to evaluate and develop new lab-based tests to provide new or improved information that will help diagnose and monitor treatment of pediatric patients.

Center for Clinical Diagnostics

In Delaware, under the direction of Paul Fawcett, PhD, the center is represented by four labs certified by the Clinical Laboratory Improvement Amendments (CLIA) and/or College of American Pathologists (CAP):

  • Cardiac Diagnostics
  • Gastroenterology
  • Immunology
  • Transplant

These laboratories use highly sophisticated technology to provide diagnostic tests for autoimmune disorders, Lyme disease, viral load determination, immune cell function, gastrointestinal dysfunction and ventricular function. The Center is actively involved in several collaborative investigational projects with physician groups.

In Florida, clinical diagnostic research is performed under the direction of Terri Finkel, MD, PhD, Of special note is the work being performed in Orlando on optical and/or quantitative diagnostic pathology research by Kamran Badizadegan, MD.

Current Projects

The Center for Clinical Diagnostics recently completed a wide range of work, and much more is ongoing. Here’s a look at just a few of our labs’ projects.

 
Cardiac Lab

The Cardiac Lab has been working to validate and implement a new test panel for an increase in test volume. The lab completed participation in the funded National Institutes of Health (NIH) Centers of Biomedical Research Excellence (COBRE) initiative (#1 P20 RR020173-01) for a model of myocardial injury, assessment of the response to injury and the development of heart failure.

 
Diagnostic Pathology Lab

Researchers working with Kamran Badizadegan, MD, are developing quantitative methods for surgical pathology and diagnostic decision-making. Dr. Badizadegan’s work has revolved around diagnostic spectroscopy ("optical biopsy") and quantitative microscopy. His ongoing work includes the development and translation of simple and practical optical and quantitative methods as adjunct diagnostic tools in everyday practice of diagnostic pathology.  

 
Gastroenterology Lab

In 2012, the lab performed 16,427 different tests on 3,963 specimens.

In addition:
  • Serological tests for celiac disease were validated in 2012 and added as a new test to our catalog of tests.
  • The lab has made major progress in developing a pepsin ELISA assay, and full validation is expected to be completed in 2013.
  • The lab developed three new research projects on understanding the role of gastric aspiration in upper airway diseases.
  • We’ve begun a new study on celiac disease, with the goals of identifying new markers for wheat allergy in patients who don’t have celiac disease but are symptomatic, and understanding the development of latent onset of celiac disease in children.
 
Immunology Lab

Research efforts of the Immunology Research Lab focus on the study of infectious and inflammatory diseases affecting Nemours patient populations. The lab's approach to these investigations emphasizes the effect the immune system has and its indications of disease in these disorders.

Current investigations include:
  • Studies of rheumatic diseases (in collaboration with Rheumatology and Orthopedics) and gastrointestinal inflammatory diseases (in collaboration with Gastroenterology) of idiopathic and infectious etiologies. The two infectious agents we are currently studying are Borrelia burgdorferi (the bacteria that causes Lyme disease)  and Helicobactor pylori (the leading cause of ulcers).
  • Studies about the role of the immune system in initiation and perpetuation of inflammatory joint and soft-tissue disease associated with both rheumatic and gastrointestinal disorders. We’refocused on detecting various antibodies and cytokines using immunoassays and a cell culture system, as well as on identifying relevant antigenic determinants of the infectious agents and pinpointing immune markers that may serve as diagnostic and prognostic indices of disease.
  • Studies in collaboration with the Transplant Lab and the hospital’s physicians that include the development of a series of in-vitro culture techniques and serologic assays that enable us to examine cells and blood from patients with inflammatory joint diseases (in an effort to determine the cause of this class of disease). We’re studying samples from patients with both autoimmune (idiopathic) and infectious (Lyme disease) causes of inflammatory joint disease.
  • Development of a modified high-sensitivity screening test for Lyme disease, and validation of an allergy-immunology (mannose binding lectin) assay.

We’re also working to develop a test for graft-versus-host disease in collaboration with E. Anders Kolb, MD, of the Nemours Center for Cancer and Blood Disorders (NCCBD).

 
Transplant Molecular Diagnostics Lab

We perform clinical testing to monitor transplant and other immunocompromised pediatric patients.

The lab:
  • Introduced new test assays, including one for adenovirus in transplant patients.
  • Has nearly completed validation of a test for the detection and monitoring of BK polyomavirus (BKV) quantitative real-time PCR (polymerase chain reaction) — BKV is the primary agent behind irreversible graft loss in 1 percent to 10 percent of kidney transplants.

 

Labs & Facilities

The Center for Clinical Diagnostics includes labs that provide diagnostic testing services in support of a variety of medical specialties and patient care at Nemours.

They include:
 
Cardiac Diagnostic Lab in Delaware

We perform basic science research on cardiac tissue, including the investigation of heart injury, assessment of the body’s response to that injury and the development of heart failure. The lab is working to validate and implement a new test panel for an increase in test volume.


Contact
Robert E. Akins, Jr., PhD

(302) 651-6811
robert.akins@nemours.org

Cardiac Diagnostic Lab

Nemours/Alfred I. duPont Hospital for Children
1600 Rockland Road, ARB-283
Wilmington, DE 19803

 
Diagnostic Pathology Lab in Orlando

This lab works on developing quantitative methods for surgical pathology and diagnostic decision-making, especially involving diagnostic spectroscopy ("optical biopsy") and quantitative microscopy. We’re developing simple and practical optical and quantitative methods as adjunct diagnostic tools in everyday practice of diagnostic pathology.


Contact
Diagnostic Pathology Lab

Nemours Children’s Hospital
13535 Nemours Parkway
Orlando, FL 32827

 
Gastroenterology Clinical Lab in Delaware

This lab is a CLIA (Clinical Laboratory Improvement Amendments)-certified lab that provides services to develop research projects for industry and research institutions. Current research collaborators include Mayo Clinic, Fla.; Cooper University Hospital, N.J.; and Digestive Care, Inc., Pa. We also accept samples for research studies and clinical trials.

We offer the following tests:
Disaccharidase Determination, Small Bowel Biopsy

The activity of disaccharidases (including lactase, maltase, sucrase, palatinase and glucoamylase) can be determined from an intestinal biopsy with approximately 2 to 5 mg of wet weight.
If you’re submitting a sample for testing, please:

  • Avoid contamination with traces of the fixative used for surgical pathology biopsies.
  • Upon collection, place the specimen in a small, tightly capped plastic tube and immediately freeze it on dry ice or stored in a freezer at -20°C to -70°C (no automatic defrost cycles). The biopsy should not be placed on gauze or a toothpick, nor should any solutions be added.
  • Ship the sample with enough dry ice to remain frozen. Enzyme activity may be affected if the sample thaws.
Pancreatic Enzyme Activities, Duodenal Aspirate

Amylase, lipase, trypsin, chymotrypsin and elastase activities can be determined from duodenal fluid. A minimum of 0.2 ml of fluid is required to analyze the five enzymes, protein content and pH. The sample can be a single fluid or multiple fluids.
If you’re submitting a sample for testing, please:

  • Place the fluid in a small, tightly capped, plastic tube. Keep the sample frozen and ship on dry ice.
Gastric Pepsin Assay

Gastric pepsin detected in the airway of patients is a specific and sensitive marker to assess pulmonary aspiration. The GI Clinical Lab at Nemours offers a sensitive, reliable enzymatic test to detect gastric pepsin in the airway samples. The assay has high specificity as it detects pepsin A that is exclusively expressed in the gastric mucosa.

  • To collect tracheal secretion: Attach a LUKI trap to a suction catheter, pass the catheter down the endotracheal tube and apply suction to the catheter as the catheter is withdrawn. If the secretion is too thick to be withdrawn, instill saline (2 cc) to the tracheal tube prior to aspirating the secretion.
  • To collect bronchial secretion: Bronchial secretion can be collected using a standard collection protocol. Collect 1-2 cc bronchial washing fluid in a plain specimen tube. Please avoid over-diluting the secretion with a large amount of saline during the collection. A minimum of 0.5 cc fluid is required to determine gastric pepsin activity, protein content and pH. The airway fluid should be transferred to a small, tightly capped plastic tube and frozen immediately after collection. Keep sample frozen and ship on dry ice.

Please contact us for more information and individual test prices.


Contact
Paul T. Fawcett, PhD

(302) 651-6826
paul.fawcett@nemours.org

Gastroenterology Clinical Lab

Nemours/Alfred I. duPont Hospital for Children
1600 Rockland Road, ARB-250
Wilmington, DE 19803

 
Clinical Immunology Lab in Delaware

The Clinical Immunology Lab is a College of American Pathologists (CAP)-certified lab that specializes in the serologic detection of Lyme disease and autoimmune disorders.

The lab currently provides immunodiagnostic testing services for several medical divisions, especially Gastroenterology and Rheumatology. These areas of study were identified in response to the need for improved ability to diagnose and formulate a prognosis for related diseases. The lab’s approach to these investigations emphasizes the role of the immune system as both an effector/modulator and as an indicator of disease in these disorders.

We provide diagnostic testing services as requested by our hospital physicians. Available tests include assays for auto-antibodies and for infectious diseases. We have developed a series of in-vitro culture techniques and serologic assays that enable us to examine cells and blood from patients with inflammatory joint diseases (in an effort to determine the cause of this class of disease).

Paul T. Fawcett, PhD, has been the head of the research and clinical immunology laboratories since 1986. He also is a member of the Institutional Review Board (IRB).

Our team also includes:
  • Lisa Loftus, BS, MT(ASCP)
  • Victoria L. Maduskuie, BS, MT (ASCP)
  • Marjorie Postell, BT, MLT
  • Timothy G. Stetson
  • Pamela Rullo, administrative secretary

Contact
Paul T. Fawcett, PhD

(302) 651-6826
paul.fawcett@nemours.org

Clinical Immunology Lab

Nemours/Alfred I. duPont Hospital for Children  
1600 Rockland Road, ARB-250
Wilmington, DE 19803

 
Transplant Molecular Diagnostics Lab in Delaware

Transplant Molecular Diagnostics is a CLIA-certified lab that performs clinical testing to monitor transplant and other immunocompromised pediatric patients. Most of our tests incorporate quantitative real-time PCR (polymerase chain reaction) technology that rapidly links amplification with detection and quantification of viral DNA.

Currently, our real-time PCR tests detect viral DNA loads that may be indicative of an active infection that may warrant the institution of antiviral therapies and/or a decrease of immunosuppressive therapies. Antiviral therapy is instituted upon viral DNA detection, followed by close monitoring of quantitative viral titers to assess and maintain the balance between immunosuppression and anti-infective therapies.

Available tests include:
  • The detection and monitoring of BK polyomavirus (BKV) quantitative real-time PCR (polymerase chain reaction)
  • Epstein-Barr Virus (EBV) Quantitative Real-Time PCR
  • Cytomegalovirus (CMV) Quantitative Real-Time PCR. Monitoring CMV DNA levels in blood by quantitative real-time PCR in these patients may allow timely recognition of virus reactivation and permit installment and assessment of antiviral treatment (ganciclovir) and/or a decrease of immunosuppressive therapies.
  • Adenovirus (AdV) Quantitative Real-Time PCR. Monitoring AdV DNA levels of blood by quantitative real-time PCR in these patients may allow timely recognition of virus reactivation and permit installment and assessment of antiviral treatment (IVIG and also cidofavir in severe cases) and/or decrease of immunosuppressive therapies. Depending on a patient’s symptoms, other specimens may be tested, such as respiratory and stool samples.
For ordering information:
Carrie Paquette-Straub, MS

Clinical Research Assistant
(302) 651-6776/6818

For more about the testing available:
Victoria Maduskuie, BS, MT (ASCP)

Assistant Director and Immunology Supervisor
(302) 651-6776


Contact
Paul T. Fawcett, PhD

(302) 651-6826
paul.fawcett@nemours.org

Research Immunology

Nemours/Alfred I. duPont Hospital for Children  
1600 Rockland Road, ARB-250
Wilmington, DE 19803

Publications & Clinical Trials

Publications

Browse a listing of publications from Nemours researchers related to clinical diagnostics research.

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Current Clinical Trials:

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More on Cardiac Research

We’re actively involved in a wide variety of research work and studies on cardiovascular surgery, transplants, interventional cardiology procedures, preventive cardiology and the genetic causes of heart malformations. Learn More »

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