Biotest Diagnostics awarded agreements with Premier healthcare alliance for its advanced serology solutions

Biotest Diagnostics Corp. recently announced a multi-year agreement with Premier Purchasing Partners, L.P., the group purchasing unit of Premier Inc., for its advanced serology solutions, including traditional blood bank reagents, and the TANGO optimo automated blood bank system.

The agreement offers Premier members access to specialized pricing on Biotest's full line of traditional and automated blood bank products. Biotest has also been selected as a sole source supplier under Premier's Accelerated Supply Chain Endeavor (ASCEND) program.

"Through our contractual relationship, Biotest and Premier are taking a strategic approach to providing hospitals and laboratories with access to cost-effective blood banking solutions to enhance performance and productivity in blood group serology testing. We look forward to being part of such a strong industry community and valued resource," said Candace Williams, vice president of Biotest's Diagnostics Division.

3M, St. Paul, MN announced today the introduction of the 3M Rapid Detection RSV Test. Respiratory Syncytial Virus (RSV) infects the lungs and breathing passages and is a common cause of bronchitis and pneumonia in children under 1 year.

The Rapid Detection RSV Test is designed to detect the presence of RSV F-protein antigens in nasopharyngeal swab, nasopharyngeal aspirate or nasal wash/aspirate specimens. The test can detect the presence of RSV in 15 minutes or less using the 3M Rapid Detection Reader, manufactured by Response Biomedical, which is also used with the 3M Rapid Detection Flu A+B Test introduced in 2008, according to a 3M press release. The Rapid Detection Reader is fully automated.  

“RSV, like influenza, can be a serious respiratory illness that, if not properly diagnosed and treated, could have consequences for a very vulnerable population,” said Brian Anderson, Global Marketing Manager.  “The Rapid Detection RSV Test helps clinicians quickly and reliably detect infections, which in turn, guides treatment decisions.  Because it’s used on the same instrument platform as the Rapid Detection Flu A+B Test, clinicians will also have the ability to test for both viruses using just one specimen, making it more convenient for patients.”

A clinical study conducted by the North Shore-LIJ Health System (NS-LIJHS) Laboratories evaluated the 3M Rapid Detection RSV Test and compared its sensitivity, specificity, positive and negative predictive values to the leading hospital rapid antigen test brand and two conventional methods of diagnosing RSV, R-Mix culture and direct fluorescent antibody staining (DFA). 

A total of 338 samples were taken from nasal washings and nasopharyngeal swabs. Results showed for all ages, the 3M Rapid Detection RSV Test demonstrated greater sensitivity for the detection of RSV (86 percent) compared to the leading brand (59 percent) and R-Mix culture (65 percent); like the other tests, it was less sensitive than DFA. In children under 6, the 3M Rapid Detection RSV Test was even more sensitive (89 percent) than R-Mix (64 percent) and the leading brand (61 percent). 

“The results show the 3M Rapid Detection RSV Test demonstrated greater sensitivity than the BinaxNOW brand in detecting RSV in the test population,” said Christine Ginocchio, PhD, MT(ASCP), senior director of Microbiology, Virology and Molecular Diagnostics, Department of Pathology and Laboratory Medicine, North Shore–LIJ Health System. “We further concluded the Rapid Detection Reader provides laboratorians with objective results that do not require further interpretation while providing data management capabilities, which helps busy hospital laboratories enhance productivity.” 

Cooperative Diagnostics LLC, Greenwood, SC, recently announced the availability of a new diagnostic assay for Xenotropic Murine Leukemia-Related Virus (XMRV) to assist physicians in the diagnosis of chronic fatigue syndrome and other disorders potentially caused by the virus. Testing services will also be made available to the general public, according to a company press release.

The Simplex XMRV test identifies patients infected with XMRV. XMRV has been recently identified in 95 percent of chronic fatigue syndrome patients, in addition to large numbers of patients with fibromyalgia, atypical multiple sclerosis and other clinical conditions.

"This may well be the fulfillment of a promise I made a number of years ago to two good friends, who both became ill from chronic fatigue syndrome. I saw firsthand the mental anguish they endured by those closest to them, including the medical community, as they were told their condition could be psychological," said Brent C. Satterfield, PhD, president and CEO of Cooperative Diagnostics LLC. "When we learned XMRV might have such a high association with chronic fatigue syndrome, we immediately became interested in developing a test. Now, my two friends and everyone else who has suffered from the condition can take testing for XMRV into their own hands."

The Cooperative Diagnostics XMRV test is based on its proprietary real-time PCR nucleic acid detection technologies. It is capable of detecting the virus inside of blood cells. The test is available to the public at www.codiagnostics.com/XMRV/index.php for $399.

In order to provide quality testing in a high throughput environment, Cooperative Diagnostics has contracted Clinical Reference Laboratory (CRL) Inc. to process these assays.

CRL's Executive Director of Molecular Diagnostics, Dr. Heather Newkirk, said, "This unique technology from Cooperative Diagnostics enables a powerful detection product which synergizes well with CRL's expertise in offering quality molecular services. We look forward to working with Cooperative Diagnostics to provide quality services."

A recent Science Daily article discussed a study that found blood tests for syphilis diagnosis produce false negatives 20-30 percent of the time.

The study also found most health professionals don't have access to more reliable tests methods using fluorescent antibody testing or darkfield microscopy.

A CDC professional noted a need for a point-of-care syphilis test.

What is syphilis testing like in your lab? Do you have access to these testing methods?

About a month ago, I was visiting with my sister. During our conversation, she brought up that her boyfriend had swine flu. I was concerned for him (and, additionally, for her) but also intrigued because he was the first person I knew who had H1N1. Working for a healthcare magazine, I've read a lot about H1N1 and I bombarded Emily with questions. Turns out, her boyfriend went to the doctor but didn't actually get tested for H1N1. Matt's doctor just told him because he had the symptoms, he probably had swine flu.

Matt was "banished" to his basement for 3 days. Thankfully, he's a healthy 20-year-old and is now back at college and running track. My sister never contracted H1N1.

My second possible "brush" with H1N1 came last week when my roommate came down with flu-like symptoms. After a day of feeling pretty poorly, I encouraged Christine to call her doctor. She did, and her doctor told her there wasn't a point of her coming in to get tested. She just encouraged the regular flu recovery regime -- lots of fluids, lots of rest and lots of Advil for her body aches.

It's been a week and Christine is still not 100 percent, though she has gotten markedly better. We still don't know for sure if she had a flu, or even whether it was "regular" or "swine." So far, my other roommate and I have been feeling fine (knock on wood)!

Keeping Matt and Christine's experiences in mind, I watched this video on MSNBC's Web site. A 20-year-old named Kelsey from Columbus, OH died a week after giving birth to her daughter from H1N1. She was tested twice for H1N1 and the tests came back negative; the doctors wouldn't put her on Tamiflu despite insistence from her parents. The video stated rapid H1N1 tests are wrong 50 percent of the time.

Weeks later, CDC tests showed Kelsey did have H1N1, but it was too late. She delivered her baby and died so soon afterwards.

I know laboratorians have been flooded with H1N1 testing in the past few months. I felt a little angry when Matt and Christine's doctors wouldn't test them, just so they at least knew what they had. But seeing Kelsey's story reminds me even if you are tested, that doesn't mean the test results are accurate.

What is your view on rapid H1N1 testing?

To the Editor:
Since ASCP and NCA issued their press release announcing they had reached agreement on combining their lab personnel certification programs, I have, in my capacity as executive director, been asked by our members and the outside world for AMT’s views on this recent announcement, and what its implications are for AMT and its MT and MLT certificants.

In my view, what is significant is not what the announced deal is, but what it is not: It does not represent the creation of a brand new certification agency. ASCP is, in fact, the putative “new” agency, with a cosmetic name change applied to its Board of Registry. ASCP continues on while NCA is going out of business. It does not represent a merger between “equals.” After leaving ASCP some 30 years ago, NCA evidently decided it no longer chose to try to make a go of independent existence. NCA certification activity has always been relatively small; certainly in recent years smaller than AMT in annual numbers certified. In many respects, the resulting entity looks to be very much an “ASCP show.”

This does not mean there is now only one certification agency. The news articles ignore the existence of AMT, and, for that matter, AAB—other agencies certifying MTs and MLTs. The implication in the news reports is “where there were two certifying bodies there is now one.” In reality, where there were four there are now two major ones (AMT and ASCP) and a smaller third (AAB). The “new” certification agency will not automatically be significantly larger in terms of numbers of certificants than ASCP BOR had been pre-merger. Many, if not most, NCA certificants already possessed dual certification with ASCP. The NCA credential was an add-on. The NCAers will eventually lose their NCA credential and just maintain the ASCP credential they already had. What surprises us a little is ASCP agreed to a change in designation for MTs and MLTs.

Instead of MT, or CLS (a suffix to which ASCLS and NCA had devoted much advocacy and energy over the years), the two organizations (ASCP and the soon-to-be-defunct NCA) decided to issue an edict that henceforth, the designation shall be medical laboratory scientist (MLS). Never mind that the rest of the world calls them MTs, or CLSs in some cases. This intriguing development will, in the coming weeks and months, likely overshadow the relative insignificance of the so-called “merger” as the lab industry scratches its head as to whether and how anyone might go about implementing such a nomenclature change.

How will this new credential be greeted by the lab world? Will it be a big hit? Or will it follow in the footsteps of “the new Coke” and “the Edsel” and prove to be a bust soon withdrawn? Normally, certification bodies have to follow the lead of the workplace. If educational programs for lab techs and employers all agree on a new name for a particular profession, then that is what the new credential should be called. For now, AMT plans to continue to offer the time-honored “MT” credential until we perceive the workplace is calling it something different. The ASCP-NCA announcement provides AMT with the opportunity to reiterate its belief in the principle of non-physician laboratory technologists running their own certification program—something the sponsors of NCA also used to believe in, but apparently no longer do.

We want the word to go forth to lab science students, currently credentialed MT/CLSs and MLT/CLTs, and employers of lab professionals that freedom of choice still exists in the world of laboratory personnel certification. We at AMT hold to the same belief on which NCA was originally founded—undertaking a certification and credentialing program for the clinical laboratory profession that is peer-based; a program by, of and for the non-physician clinical laboratory professionals themselves, and governed by them.

To celebrate our commitment to this peer-based ideal of our profession standing on its own with its own identity, AMT is extending a hand to lab professionals holding the certification credential of the NCA. From our Web site, any NCA-credentialed CLS or CLT can download and complete an application for MT or MLT, and with documentation of having passed an NCA generalist exam for CLS or CLT, we will extend MT(AMT) or MLT(AMT) certification and 1-year of membership free of charge. AMT is only providing this offer until Dec. 31, 2009. As has already been pointed out, “unity” is perhaps an overstatement because there are more than just those two lab credentialing agencies. But more importantly, the BOR-NCA agreement only deals with one aspect of laboratory professionalism: certification. Advocacy efforts on behalf of MTs and CLSs will continue to be made by the usual variety of groups: AMT, ASCLS, AAB, CLMA, AACC, ASCP and the lab subspecialty organizations.

One final note: In the Sept. 7 issue of ADVANCE, Glen McDaniel wrote on pg. 6 ASCP and NCA “together have certified more than 95 percent of the MLT/CLT and MT/CLS professionals currently practicing.” Standing alone and out of context, this “95 percent” has struck many of us as counterintuitive and misleading. For one thing, it would not seem to take into account those working as MT or MLTs who are not certified by anyone. Also, in recent years, AMT’s slice of the annual new MT/CLS certificant “pie” (combined ASCP-NCA-AMT new certifications) has been on the order of 25 percent. This overstated percentage is an unfortunate anomaly in McDaniel’s otherwise well-reasoned column.

—Christopher Damon, JD,
Executive Director,
American Medical Technologists

ADVANCE reserves the right to edit submissions for clarity and brevity. To write a letter to the editor, contact: ADVANCE for Medical Laboratory Professionals, 2900 Horizon Dr., King of Prussia, PA 19406, Attention: Matthew T. Patton; e-mail mpatton@advanceweb.com or fax to 610-278-1425.

Biotest Diagnostics Corp., Rockaway, NJ, announced a multi-year agreement with Premier Purchasing Partners L.P., the group purchasing unit of Premier Inc., Charlotte, NC, for its advanced serology solutions, including traditional blood bank reagents, and the TANGO optimo Automated Blood Bank System.

In addition to this national contract, Biotest has also been selected as a sole source supplier under Premier's ASCEND (Accelerated Supply Chain Endeavor) program. This alliance will help healthcare providers participating in the program to further control and reduce costs of care without sacrificing quality of care through supply chain efficiencies and best practices networking, according to a Biotest press release.

The agreement, effective as of Sept. 16, 2009, offers Premier members--a network of more than 2,200 hospitals and 63,000 healthcare facilities--access to specialized pricing on Biotest's full line of traditional and automated blood bank products.

"As the impetus to improve our healthcare system continues to accelerate, so does the need to help maximize healthcare providers' investments in technology and supplies," said Candace Williams, vice president of Biotest's Diagnostics Division. "Through our contractual relationship, Biotest and Premier are taking a strategic approach to providing hospitals and laboratories with access to cost-effective blood banking solutions to enhance performance and productivity in blood group serology testing. We look forward to being part of such a strong industry community and valued resource."

Licensed in 2008 by the FDA, Biotest's traditional blood bank reagents include monoclonal rare antisera, ABO/Rh reagents, reagent red cells, antihuman-globulin, controls and potentiators. Biotest's TANGO optimo Automated Blood Bank System, used for blood group serology testing in donor centers and transfusion services, is already in use in select Premier alliance member hospitals, primarily to perform donor antibody screening and ABO/Rh testing. Additional assays, including weak D, antibody identification, Rh and Kell phenotyping, crossmatching and direct antiglobulin testing--also approved by the FDA in 2008 for use with TANGO--increase the utility of the technology.

Ortho Clinical Diagnostics, Raritan, NJ, announced today FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems.

This is the first HIV diagnostic assay approved for an integrated system in the United States, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples, according to a company press release.

“By providing a fast, cost-effective and reliable method for testing HIV, the VITROS Anti-HIV 1+2 Assay will help enhance the clinical laboratory’s ability to adhere to the CDC HIV screening guidelines, while at the same time increasing the lab’s productivity and efficiency,” said Mike Samoszuk, MD, chief medical officer, Ortho Clinical Diagnostics. “This approval underscores Ortho Clinical Diagnostics’ continuing commitment to providing clinical laboratories with tests that help detect diseases earlier for better patient outcomes.”

Abbott, Abbott Park, IL, has announced a $6.6 billion definitive agreement to acquire Solvay's pharmaceuticals business and full global rights to the fenofibrate franchise. The acquisition will provide Abbott with a large and complementary portfolio of pharmaceutical products and a significant presence in key global emerging markets, according to a company press release.

Abbott projects Belgium-based Solvay Pharmaceuticals will add more than $3 billion in annual sales, mostly outside the U.S. The acquisition will also add approximately $500 million to Abbott's annual pharmaceutical R&D investment.

The acquisition includes Solvay's vaccines business, which will provide Abbott entry into the expanding global vaccines market. Solvay also has a small molecular diagnostics unit that will become part of Abbott's diagnostics organization upon the transaction close.

bioMérieux, an in vitro diagnostics company, heightened its role in the fight against antimicrobial resistance by launching its Solutions to Manage the Antimicrobial Resistance Threat (SMART) Campaign at the 49th Annual Interscience Conference for Antimicrobial Agents and Chemotherapy (ICAAC) event in San Francisco.

bioMerieux's SMART Campaign (biomerieux-usa.com/smart) seeks to create more educational resources for the lab and to provide healthcare professionals with relevant tools and resources to identify, monitor, prevent and track resistance. Key areas of focus include:

• Identifying Resistance: help clinicians get clear actionable information, so they can begin effective antibiotic therapy as early as possible.
• Monitoring Resistance: surveillance of antimicrobial resistance patterns at all levels--national, local, hospital and ward level is essential to set up effective antimicrobial policies.
• Tracking Resistance: screening of patients and healthcare workers for multi-drug resistant organisms is a key measure to contain the spread of resistance
• Preventing Resistance: differentiation between viral and bacterial infections. 
• Educating Resistance: promote scientific forums, documents and agreements to promote further information exchange and education on this key public health issue.

"This is a race against time, and the options are quite limited in the antimicrobial drug pipeline. bioMérieux's SMART Campaign's goal is to help healthcare professional with their daily battle to contain and reduce antimicrobial resistance, said Herb Steward, executive vice president and general manager, bioMérieux North America.

As part of its commitment to fight HAIs, bioMérieux has organized HAI symposia around the world including events in the U.S., Belgium, the Netherlands, Portugal, Spain, Japan and Korea throughout the past 2 years. 

So you've decided you want a career mentor in the laboratory. Some facilities have their own mentor programs and may assign you to a mentor. In other instances, you might be on your own to find a mentor.

If this is the case, there are a few pieces of criteria you should consider before asking someone to be your mentor. In her book The Mentee's Guide: Making Mentoring Work for You, Lois J. Zachary gave these tips:

1. Identify your goal and consider why you want a mentor.
2. Create a list of criteria or qualities you want in a mentor.
3. Determine qualities that are "must haves."
4. Rank the remaining criteria, or the "wants."
5. List possible mentor option.
6. Eliminate options not meeting the "musts."
7. Rate each remaining option against the "wants."
8. Make your decision and approach your potential mentor.

How have you picked a mentor in the laboratory? What has worked for you? Please share your stories.

The Journal of Clinical Oncology recently released study results from the Lombardi Comprehensive Cancer Center at Georgetown University in Washington, DC.

In this study, researchers found the use of a blood test helped doctors tailor therapy to metastic breast cancer patients. The test involves the use of Veridex's CellSearch technology, which measures the number of circulating tumor cells (CTC) in the blood. The physicians found a high correlation between the CTC results and radiographic tests.

Check out this article in Science Daily for more information on the study.

Quantimetrix Corp., Redondo Beach, CA, a company specializing in liquid quality control and urinalysis, has announced several newly added urine reagent strip values to its Dipper, Dropper, Dropper Plus and Dip&Spin inserts. Values for Accutest, Accustrip, Acon Mission, Henry Schein Urispec, Macherey Nagel Medi-Test and McKesson Medi-Lab Performance have been added to expand the utility of the urinalysis control line.

The Quantimetrix catalog features urinalysis, general and specialty chemistry controls, whole blood, electrophoresis systems, diagnostic assays and original equipment manufacturer products.

Quantimetrix also provides a comparative quality control program called Quantrol.  Free monthly reports are provided for participants allowing each lab to monitor test performance and trend analysis.

Visit www.4qc.com or call 310-536-0006 for more information. 

The FDA has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next 4 weeks.

All four firms manufacturing the H1N1 vaccines--CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc., used the same processes.

"The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," said Jesse Goodman, MD, FDA acting chief scientist.

The vaccines induce a robust immune response in most healthy adults 8 to 10 days after a single dose. As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.  

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

Vaccines against three seasonal virus strains are already available, but do not protect against the 2009 H1N1 virus.

Medical Precision Plastics Inc., Warminster, PA, an ISO-certified custom plastic extruded tubes manufacturer, has received an Export Achievement Certificate award from the United States Department of Commerce.

Medical Precision Plastics has also received the Best Small Company Export Excellence Award from the Bucks County International Trade Council of Pennsylvania for 2 consecutive years.

The company ships to 15 countries on five continents, is GMP compliant, has complete two-way product traceability, and can provide product certification on all shipments. Capabilities include tubing in various rigid and semi-rigid materials, custom compounds, and diameters between .058-1 inch. Its specialty is single lumen tubes with walls down to .004 inch.

The company markets its single-use Dropstirs transfer pipettes worldwide to the clinical and diagnostic markets, in both standard and printed versions. These pipettes can be economically and quickly produced in drop sizes from 5 to 100 microliters and packaged to specified kit requirements, the company noted.

As a single-source provider of custom extrusion services, the firm can supply coiled and cut-to-length tubing extruded and packaged to customer specification for medical or commercial use.   Co-extrusion and various value-added services are also available.