The United States Senate unanimously confirmed Dr. Regina Benjamin, a former member of  COLA's Board of Directors, as the nation's next Surgeon General on Oct. 29.

Dr. Benjamin, a family physician from rural Bayou La Batre in coastal Alabama, was nominated to the post in July by President Barak Obama. A member of COLA's Board of Directors in the mid-1990s, Dr. Benjamin has a unique understanding of laboratory accreditation issues and offers a wealth of varied experiences and qualifications to this position.

Verlin Janzen, MD, chair of the COLA Board said, "The United States Senate is to be commended for unanimously confirming this superb physician to this critical post, especially at this challenging time as our nation confronts the H1N1 virus. COLA congratulates Dr. Benjamin or her new position, and is confident that she will bring awareness and understanding of the important roles of both medical laboratories and CLIA."

Dr. Benjamin is well-known for her Alabama non-profit clinic which was destroyed by Hurricane Katrina, rebuilt, and then destroyed again by fire. Undaunted, the practice was rebuilt yet again, where Dr. Benjamin spent several days a week caring for patients in addition to making house calls to shut-ins.

In the mid 1990s, Dr. Benjamin was the first African American woman to serve on the Board of Trustees of the American Medical Association (AMA). She has also served as chair of the AMA Council on Ethical and Judicial Affairs.

She is a member of the Institute of Medicine of the National Academy of Sciences, and also serves on the Board of the Robert Wood Johnson Foundation. Dr. Benjamin is immediate past chair of the Federation of State Medical Boards. Last fall, she was a recipient of the prestigious McArthur Foundation "Genius Award" for her ongoing work in providing health care to underserved populations.

www.cola.org

Maternal cells found in infants could point to a mechanism for autoimmune disease, according to a report published in the latest issue of Pediatric and Developmental Pathology.

Microchimerism is the harboring of cells originating in one individual by another individual, usually exchanged between mother and child. Maternal microchimerism is the discovery of the mother's cells in the child, sometimes lasting through adulthood. 

Maternal microchimerism's connection to autoimmune disease has been established. However, there is a growing body of literature that suggests the key to understanding this connection lies not in the maternal hematopoietic stem cells but rather in the maternal parenchymal cells and the organs in which they are found. This study addresses not only the prevalence of parenchymal cells in infected tissue, but also their frequency and phenotype in normal tissue.

Samples were obtained from tissues from all available organs of seven autopsied males from the archives of the Department of Pathology at The Seattle Children's Hospital. Simultaneous fluorescence in situ hybridization was performed on all samples. Maternal cells were found in all subjects and constituted 0.017% to 1.9% of all parenchymal cells. In addition, in all subjects, parenchymal cells were found in the bladder, kidney, liver, lung, pancreas, skin and spleen. However, these cells were not present in areas of inflammation or injury, and only the hearts of infants with neonatal lupus contained maternal hematopoietic cells.

The authors suggest that maternal microchimerism may well be a part of normal tissue differentiation in early gestation, but could stimulate the immune response when the body later considers the cells to be foreign.

www.pedpath.org

Ortho Clinical Diagnostics (OCD) announces the launch of a first-of-its-kind 24/7 central command center in Strasbourg, France, that continuously tracks the condition of clinical laboratory instrument performance.  The Remote Monitoring Center in Strasbourg provides unique predictive monitoring services to laboratories throughout Europe and the Asia-Pacific region by continuously detecting and tracking potential instrument problems up to 30 days in advance, before they interrupt the ability of the lab to deliver quality test results.

"The Remote Monitoring Center in Strasbourg enables us to connect customers with multilingual technical support specialists and engineers, 24 hours a day, before a potential problem arises," says Troy Taylor, vice president, Worldwide Customer Technical Service, Ortho Clinical Diagnostics. "The Remote Monitoring Centers advance instrument servicing from the old 'break-fix' model to a new 'predict-and-maintain' model to help laboratories deliver timely and accurate results to benefit patients' lives."

With laboratories facing skilled labor shortages, budget reductions and increasing test volumes, Ortho Clinical Diagnostics identified an unmet need for new technologies that reduce the potential for instrument failures and workflow interruptions.

The Remote Monitoring Centers use proprietary e-Connectivity^™ Technology to continuously track a steady stream of data sent by the instrument on its performance. This secure two-way broadband Internet connection allows OCD technical support specialists and engineers to perform remote system analysis, as well as monitor, review and upgrade system configuration, data and performance information. Predictive alerts generated by this stream of data from instruments helps technical support specialists and engineers identify specific service needs before they cause an interruption in laboratory operations. This remote diagnostic capability also allows OCD technical support specialists and engineers to diagnose known issues remotely and, when required, schedule service at a customer's convenience, allowing laboratories to optimize instrument uptime.

The new Strasbourg Remote Monitoring Center supports 18 countries around the world, including the United Kingdom, Ireland, France, Germany, Spain, Italy, Portugal, The Netherlands, Belgium, Poland, Denmark, Norway, Australia, India, Japan, Singapore, Korea and Thailand. The first Remote Monitoring Center in Rochester, NY, was launched in July 2009 and focuses on the needs of North American laboratories.

The Strasbourg Remote Monitoring Center is housed in Ortho Clinical Diagnostics' European Support Center, which has been operating in the Strasbourg area for almost two decades. Approximately 150 people are currently employed at the European Support Center, with a multicultural workforce comprised of 13 nationalities. Additionally, more than half of service department employees are fluent in more than three languages, ensuring that Ortho Clinical Diagnostics caters to the needs of international customers. 

www.orthoclinical.com

Scientists from ViraCor-IBT Laboratories have been selected to provide four oral presentations and one poster presentation at this year's American College of Allergy, Asthma and Immunology's Annual Scientific Meeting in Miami, FL. Michelle Altrich, PhD, HCLD (ABB), and Michael Ling, PhD, will present data on a wide range of topics including Filaggrin, Pneumococcal Antibody Avidity, Chronic Urticaria, Drug Hypersensitivity Reactions and T-Cell Excision Circles.  

"We are pleased to participate in the American College of Allergy, Asthma and Immunology's annual meeting," says Maureen Loftus, chief business officer for ViraCor-IBT. "Being selected to present our work among this group is a true testament to the emphasis our company places on scientific expertise, quality and research and development, and we are delighted to share and discuss our findings."

The five presentations Drs. Altrich and Ling will conduct are as follows:  

• "Development and Validation of an Assay to Detect the Loss of Function Mutations in Filaggrin": ViraCor-IBT is the first lab to develop a test that can detect six loss-of-function mutations in Filaggrin. The presentation will cover how the lab developed and validated the test.
• "Evaluation of Pneumococcal Antibody Avidity and Concentration in Patients with Suspected Immunodeficiency": This presentation will cover a new way to evaluate the immune system so a physician can better determine if the patient has mounted a significant response to the pneumococcal vaccine.
• "Development and Validation of a Test to Measure IgG Antibodies to the IgE Receptor I Protein for Evaluation of Autoimmune Chronic Urticaria": This presentation will cover how ViraCor-IBT's newly developed ELISA Binding assay may complement functional chronic urticaria (CU) assays with higher overall sensitivity for evaluating autoimmune CU.
• "Development and Validation of a T cell Activation Assay to Evaluate Delayed (Type IV) Drug Hypersensitivity Reactions": This presentation will cover the development and validation of an assay that will aid in the evaluation of patients who have suffered adverse drug reactions, particularly skin reactions.
• "Qualifications of T-Cell Excision Circles (TREC) for Diagnosis of Immunodeficiency and Post-Bone Marrow Transplant Monitoring": This poster will demonstrate how TREC can be quantified in bone marrow transplant recipients.

www.viracor-ibt.com

The American Association for Clinical Chemistry (AACC) announces results of the elections recently held. These eight individuals will take up their positions on Jan. 1, 2010:

President-Elect : Ann M. Gronowski, PhD, is an associate professor at Washington University School of Medicine (St. Louis, MO) in the departments of Pathology and Immunology, and Obstetrics and Gynecology, and associate medical director of the Clinical Chemistry, Serology and Immunology laboratories at Barnes-Jewish Hospital. Dr. Gronowski received her doctorate in endocrinology reproductive physiology from University of Wisconsin, and is a diplomate of the American Board of Clinical Chemistry. In 1996, Dr. Gronowski was granted the AACC Young Investigator Award for her research, which examined the early intracellular signaling events that follow in vivo growth hormone treatment. Dr. Gronowski has been an active AACC member since 1994, and has served in a number of capacities including chair of the Midwest section, chair of the membership committee, chair of the awards committee, chair of the 2008 annual meeting organizing committee, and AACC board of directors. Dr. Gronowski helped to form AACC's Society for Young Clinical Laboratorians, a special program to serve the needs of AACC's younger members, and served two terms as its senior advisor. Currently, Dr. Gronowski is secretary/treasurer of the Commission on Accreditation in Clinical Chemistry. She has also served on the National Academy of Clinical Biochemistry's awards committee and long-range planning committee. Her research focuses primarily on the laboratory diagnostics of endocrinology and reproductive physiology with a particular emphasis on maternal fetal medicine. Recently, she edited a book titled "Handbook of Clinical Laboratory Testing During Pregnancy". Dr. Gronowski's term as AACC President commences Jan. 1, 2011.

Treasurer: D. Robert Dufour, MD, consultant pathologist at the VA Medical Center, and Emeritus Professor of Pathology at George Washington University Medical Center in Washington, D.C.

Board of Directors: David D. Koch, PhD, associate professor of Pathology, department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA, and director of Clinical Chemistry, Toxicology, and Point-of-Care Testing at Grady Memorial Hospital in Atlanta, GA; and Gregory J. Tsongalis, PhD, associate professor of Pathology, Dartmouth Medical School and Director of Molecular Pathology, Dartmouth Hitchcock Medical Center, Lebanon, NH.

An Oct. 28 study in the Journal of the American Medical Association (JAMA) assessing the performance of liquid-based cytology (LBC) compared with conventional cytology in detecting histologically confirmed cervical intraepithelial neoplasia (CIN) has found that LBC "does not perform better than conventional Pap tests in terms of relative sensitivity and positive predictive value (PPV) for detection of cervical cancer precursors."

Dutch researchers used a cluster randomized controlled trial involving 89,784 women 30-60 years of age at 246 family practices. A total of 122 practices were assigned to use LBC and screen 49,222 patients and 124 practices were assigned to use the conventional Pap test and screen 40,562 patients between April 2004 and July 1, 2006. Patients were followed up for 18 months through Jan. 31, 2008.

The introduction phase for LBC started with a three-day training course for cytotechnologists and pathologists provided by the manufacturer of the LBC system used in the study (Hologic's ThinPrep Pap Test). During the learning stage, a minimum of 200 LBC slides were taken from the routine workload and screened.

All slides were rescreened by another cytotechnologist. Primary screening was not allowed before a final test was passed. A training course for the technical operators of the processor was also provided. One study site had been using LBC slides for a year. The other study site had no prior experience with the screening method. Smears were screened and classified by cytotechnologists according to the CISOE-A classification system, easily translated into the Bethesda 1991 subcategories.

Screen-positive cases had follow-up tests in accordance with the guidelines of the Dutch Society of Pathologists and the Dutch Society of Obstetrics and Gynecology.

"As shown in a previous publication, no differences were found in the cytological test positivity rates between methods," the study says. "Nevertheless, these cytological findings contribute to insufficient evidence to claim equal diagnostic accuracy. Both the intention-to-treat and per-protocol analyses demonstrated that liquid-based cytology was not superior to Pap test regarding detection rates of histologically confirmed outcomes. The same was found for the PPVs."

But the study and resulting media coverage is not telling the whole story, according to R. Marshall Austin, MD, PhD, professor of Pathology, and director of Cytopathology at Magee-Womens Hospital of the University of Pittsburgh Medical Center, Pittsburgh.

"What the articles and commenters are missing is that LBC performance depends in part on training, experience, motivation, how fast the slides are reviewed and use or non-use of computer-assisted imaging devices," Dr. Austin says. "The Dutch study is the second international study (one previous study came from Italy) that has shown that relatively inexperienced labs can fail to achieve improved results with LBC. Critics have lept on these studies to claim LBC is not an advance. Most of these critics have very little practical experience in the field."

HPV testing data provide new insight on the issue. HPV DNA testing is about 90-95 percent sensitive for cervical precancer (CIN2/3/AIS) or cervical cancer, and international trials have shown that the conventional Pap smear varies from 20 percent sensitive (in Germany) to 77 percent sensitive (in England), Dr. Austin says. No conventional smear study has shown sensitivity equivalent to HPV testing, although four studies with optimally performed ThinPrep have shown sensitivity for cervical precancer and cancer that is equivalent to HPV, he adds.

"Similar results have never been documented with any other cytology method," Dr. Austin says.

The FDA issued a second emergency use authorization (EUA) to Focus Diagnostics, the infectious disease diagnostics business of Quest Diagnostics Inc., for its 2009 H1N1 influenza virus test. With the EUA, Focus Diagnostics is the only company in the United States to offer test kits for detecting the pandemic 2009 H1N1 virus that the FDA has authorized for emergency use by CLIA high-complexity labs, which include certain hospital and regional labs. The test allows clinicians to quickly and definitively identify infected patients, differentiating from those who have similar symptoms.

The new EUA authorizes Focus Diagnostics to market and offer its Simplexa™ Influenza A H1N1 (2009) test for use on the 3M™ Integrated Cycler from 3M to CLIA high-complexity laboratories for the duration of the emergency. The 3M Integrated Cycler is a microfluidic molecular diagnostic testing system and is not FDA-cleared or approved. Used on the 3M platform, the test can provide increased capacity for 2009 H1N1 influenza virus testing to a wide range of CLIA high complexity laboratories, including many hospitals, coping with a surge in testing demand.

The new test offering is one outgrowth of an exclusive global distribution agreement formed between Focus Diagnostics and 3M under which Focus will develop and offer its first line of molecular diagnostic test kits, to be sold under the Simplexa brand name on the 3M Integrated Cycler. The 2009 H1N1 influenza test kit is the first offering from the Simplexa product line, and the company plans to launch additional Simplexa test kits on the 3M Integrated Cycler for infectious diseases in 2010.

"FDA's EUA for our new Simplexa H1N1 test on the 3M Integrated Cycler is a major advance for 2009 H1N1 influenza testing," says Jon R. Cohen, MD, senior vice president and chief medical officer, Quest Diagnostics. "Until now, many CLIA high-complexity labs didn't have the technology, space or expertise to perform molecular testing for the 2009 H1N1 flu virus. Our relationship with 3M means that not only will more labs be able to perform this type of testing, but they will also be able to fulfill higher levels of testing demand. Expanded lab capability may be critical to the nation's management of increased 2009 H1N1 testing this winter."

"Our exceptional collaboration with Focus Diagnostics underscores 3M's commitment to leading the industry in introducing new technologies in clinical diagnostics," says Debra Rectenwald, vice president, general manager, 3M Infection Prevention Division. "We are excited that Focus Diagnostics will be able to implement a real-time molecular technology that can improve the speed and meet the demand for H1N1 testing."

The Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) test, which employs real-time polymerase chain reaction (PCR), qualitatively detects RNA of the 2009 H1N1 flu virus in a patient's nasal or nasopharyngeal specimens. The test targets a separate region of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of the 2009 H1N1 flu virus from seasonal human influenza A virus.

The 3M Integrated Cycler is an instrument offering real-time PCR technology that provides results in 30-75 minutes. The compact instrument utilizes advanced data management software to help laboratories.

www.focusdx.com

www.questdiagnostics.com

AdvanDx announces it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its E. faecalis/OE PNA FISH® test. The faster protocol reduces the PNA FISH turnaround time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes. Clinical validation studies performed at hospitals in the United States and Europe demonstrated 100 percent  equivalence between the 90 minutes protocol and the original PNA FISH protocol, ensuring the faster protocol maintains the very high sensitivity and specificity required versus slower, conventional methods.

Since 2003, E. faecalis/OE PNA FISH has been a vital test providing species identification in hours, instead of days, allowing labs to quickly report results to physicians and pharmacists to help ensure optimal therapy for Enterococcal bloodstream infections. With the introduction of the 90 minutes PNA FISH protocol, laboratories will be able to further improve workflow flexibility and results reporting turnaround times. By providing even faster results, laboratories will help clinicians further improve antibiotic selection, care and outcomes for patients with Enterococcal bloodstream infections.

"We are very excited to launch the 90 minutes E. faecalis/OE PNA FISH protocol in the United States," says Thais T. Johansen, president and CEO of AdvanDx. "The faster protocol marks another milestone toward AdvanDx's goal of providing a fast, easy-to-use and broad molecular diagnostic platform for early identification of bloodstream pathogens. With results in 90 minutes, hospitals will be able to provide critical results as early as possible, enabling clinicians to improve care and outcomes for patients with life-threatening infections."

www.advandx.com