winter 2009 volume 20 no. 1

Transcription

1 winter 2009 volume 20 no. 1 BD Lab O Celebrating 20 Years of Microbiology News & Ideas In This Issue 1 TechniTopics Introducing BD Phoenix AP Overview of the BD Phoenix and BD EpiCenter Systems Advances in the Laboratory Diagnosis of C. difficile Infections 7 Product Highlights BD EZ Flu A+B and EZ RSV Tests Have a New Look New BD BBL Sensi-Disc Antifungal Susceptibility Discs BD BACTEC Culture Club New Members and a New List 11 FYI Study Highlights from ICAAC 2008 Trends in Vaginitis Testing Medicare Announces 2009 Lab Fee Schedule Update 13 Micro Happenings BD Sponsors Campaign to Raise Awareness of XDR-TB BD LabO 20 Years Young and Still Counting Introducing BD Phoenix AP Automated Nephelometry for the BD Phoenix ID/AST System BD Diagnostics is pleased to announce the worldwide availability of the new BD Phoenix AP instrument. BD Phoenix AP is a companion to the BD Phoenix Automated Microbiology System (see sidebar on page 3) that uses state-of-theart technology to provide laboratories with workflow efficiency and standardized isolate inoculum. It is the first instrument to incorporate automated nephelometry for inoculum preparation one of the most time-consuming steps associated with isolate preparation. rack and loaded onto the instrument for preparation. The estimated per rack processing time is less than 8 minutes. Each BD Phoenix AP is capable of processing up to 200 ID/AST sets in less than 4.5 hours. BD Phoenix AP incorporates BD EpiCenter Barcode Printing Software into the workflow (see sidebar on page 3). Each ID broth may be identified with an EpiCenter-generated barcode label that includes sample accession number, Phoenix panel type and isolate number. Utilizing EpiCenter barcode labels eliminates the need for additional keystrokes by the technologist further streamlining the panel loading process. Continued on page 2 To inoculate a panel using BD Phoenix AP, laboratory technologists simply make a heavy suspension of the isolate to be tested in Phoenix ID broth. BD Phoenix AP is capable of processing a starting Mc- Farland between 0.20 to 4.0 to the appropriate testing McFarland. The ID broth and corresponding AST broth are placed in a Phoenix AP Incorporates state-of-the-art nephelometry

2 TechniTopics Introducing BD Phoenix AP Continued from page 1 The first BD Phoenix AP instrument was installed on September 29, 2008, at Franklin Square Hospital Center in Baltimore, Md. Franklin Square Hospital Center is a 380- bed facility providing a variety of healthcare services and is a member of MedStar Health. The Microbiology Laboratory began using the BD Phoenix Automated Microbiology System with manual upfront workflow in May, We met with the BD Phoenix AP implementation staff approximately two months after routine use of the instrument began to find out how the BD Phoenix AP affected their workload. The implementation staff included: Michael Sidlak, Supervisor; Beth Prior, Team Leader; and Laural Farabaugh, Medical Technologist. Franklin Square Hospital staff (left to right): Michael Sidlak, Beth Prior, Patrick Gibson and Pat Gardner. BD: How has incorporation of the BD Phoenix AP instrument changed your workflow versus manual Phoenix? Beth Prior: It is a lot faster, a lot easier easier to incorporate into the laboratory workflow. We can keep doing other things in the lab while the instrument is setting up the isolates. We can go on to other projects. BD: Can you describe your current BD Phoenix AP workflow? BP: We still batch isolates but we will go in and put on one run while we are getting the other run ready instead of spending an hour or two hours setting up isolates. So it is only a matter of 10 minutes. We get one isolate run going and we start working on the next run. So it is a much smoother flow and a lot less time. Laural Farabaugh: We perform inoculations at the end of reading plates. For example, the current tech is setting up 19 isolates all together versus setting up inoculations one at a time. BP: This is a lot faster. The tech performing inoculations sets up 5 isolates on the AP and then starts the next set of 5. It is a continual flow. The flow is much faster than manual Phoenix. BD: Have you seen any workflow efficiencies with AP and the rest of the Microbiology Laboratory? BP: We are able to catch up on work in other areas of the lab because it is not taking all day to do inoculations. Previously, it was taking us the better part 2 BD Lab O volume 20 number 1 of one day to do inoculations. Now, the techs can move on and do Mycology or Mycobacteriology, which are disciplines that can t be automated. So this is where the AP has really helped us. BD: What system were you using prior to Phoenix? BP: We used VITEK Legacy and the main thing we like about Phoenix is the quality of the results compared to the VITEK. And now with Phoenix AP, we are even faster setting up than we were using VITEK. EpiCenter has become quite a learning tool... They (the med techs) are able to learn on their own... BD: How long did you use the VITEK system? BP: More than 22 years. LF: We trust Phoenix a lot more than we did the VITEK. The BDXpert rules help. The flags that we get help bring your attention to things we might have overlooked before using the BD EpiCenter Data Management System (see sidebar). BP: We use most of the rules in the system. We will be building EpiCARE rules in the future. Michael Sidlak: Most of the rules that are in the system that are CLIA-defined are perfect. We use those and they really bring attention to things like ESBLs and what needs to be reported to Infection Control. It really helps the techs. BP: It is also an education source for the med techs. They now learn. With the VITEK system, they were not learning how the antibiotics were used and what to look for. EpiCenter has become quite a learning tool for them. That eases up time for me also, as the Team Leader, that they are able to learn on their own with this system rather than me sitting and having to keep teaching them about markers to look for. I have found that very helpful and it creates even more of an interest in what they are doing. They are learning every day as they are posting the results. The rules are right there for them. There are some techs more aware of the rules depending on how long they have been in Microbiology, but every day they are learning. BD: Tell us how you generate barcodes for the isolates being tested on BD Phoenix AP. BP: We use EpiCenter barcode labels for isolates. We put it in SOFT (LIS software from SCC Soft Computer) and EpiCenter automatically generates the labels. In addition, we have created filters through EpiCenter that are geared to each section urines, stools, blood bench, miscellaneous, etc. so that the labels do not all print out together. In other words, they are separated out by bench. The filters are under the Favorites menu so we do not have a lot of steps to generate the barcode labels.

3 TechniTopics BD: How was your BD Phoenix AP installation and training experience? BP: Excellent! Raiza Rondon (BD Application Specialist) is an excellent teacher. We have all been pleased with her. She worked with me to do the training the way I wanted to organize the training. We trained almost everybody on the AP instrument. She took a couple of us, which is what I wanted, to train us on everything software, maintenance etc. I was very pleased with it! We did not just train four people, we trained almost every tech in a week. We trained a few of them to be experts. 1 2 BD Phoenix AP Workflow 3 4 BD: Is there anything else you would like to share? 5 LF: I think everybody has been happy with the AP. Raiza can teach us just about anything. She makes it seem so user friendly you can do this! We love the EpiCenter system and the fact that whenever you contact BD with a problem, you can go right in there and see the arrow move when BD is logged on (i.e., the EpiCenter remote troubleshooting feature). BP: Everybody that has talked to me is real pleased with the AP! They comment on how much time it saves. We also like the Strep IDs. 1. Prepare Inoculum Label ID tube with EpiCenter or LIS barcode Select colonies and make a heavy suspension in ID Broth Place in rack with AST broth 2. BD Phoenix AP Performs automatic nephelometry to 0.5 or 0.25 McFarland Adds AST indicator to AST broth Transfers isolate to AST broth Mixes both samples 3. Remove Processed Tubes and Place on Inoculation Station with Phoenix Panels Single or batch inoculation Central or individual work stations 4. Scan Barcodes into BD EpiCenter and Inoculate Panels Provides rapid, efficient batch login of samples Supports single-handed barcode scanning Provides positive sample ID for Phoenix isolate 5. open BD Phoenix Door and Place Panels in Any available carrier MS: In fact, we are a resource for Strep ID among the other MedStar facilities. MS: The AP standardizes the inoculum. The techs do not have to worry about the variability. Because of the standardization, the results are much cleaner. There are no conflicts with identification and the susceptibility profiles are very consistent. It is a lot more standardized and predictable. It eliminates tech error and variability from tech to tech. For more information on the BD Phoenix AP instrument, mark the appropriate box on the reader response card. Overview of the BD Phoenix and BD EpiCenter Systems The BD Phoenix Automated Microbiology System is an automated system for identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacteria. Identification results are available within 3 hours with the majority of susceptibility results available in 6 to 10 hours. Unlike most automated identification systems, the BD Phoenix System incorporates multiple time point databases, static and dynamic measurements, and 45 substrates that employ both chromogenic and fluorogenic detection methods in the same panel. This technology gives rise to the potential of more than 175 trillion biochemical profiles of an extensive 300-organism database, leading to a very high degree of identification accuracy with virtually no off-line tests and less than 1% no identification results. Continued on page 16 BD Lab O volume 20 number 1 3

4 TechniTopics Advances in the Laboratory Diagnosis of C. difficile Infections Tobi Karchmer, MD, MS, Medical Director, BD Diagnostics Clostridium difficile is a gram-positive, spore-forming anaerobic bacillus, first linked to disease in 1978, when it was identified as the causative agent of pseudomembranous colitis. Transmission of the organism occurs primarily in healthcare facilities. 1 It is the most common cause of antimicrobialassociated diarrhea 2 and it is the first organism suspected when a hospitalized patient develops diarrhea. 3 C. difficile is also the most common infectious cause of acute diarrheal illness in long-term care facilities. 1 The term CDAD refers to C. difficileassociated disease; however, a newer term now being used is CDI or C. difficile infection. Clinical Presentation of CDI The signs and symptoms of C. difficile infection include: diarrhea; abdominal cramps (22% of cases); fever (28% of cases); elevated white blood cell count; mucus in the stool; ileus; gross blood (rare); and pseudomembranous colitis. In addition to recent treatment with antimicrobials, patients who have undergone recent abdominal surgery are also at risk of developing CDI. Complications of CDI include toxic megacolon which may require colectomy, septic shock and death. CDI: Increasing Problem for Healthcare Institutions There are an estimated 500,000 cases of CDI per year. In 2005, the number of deaths in U.S. hospitalized patients caused by CDI exceeded 28,000 and 9.5% of patients with CDI died during their hospital stay. 4 The financial and clinical burden of disease due to C. difficile is significant, with estimated hospital costs in excess of $1 billion annually. 5 The epidemiology of CDI has been changing with increases in both disease incidence and severity. Patients with CDI had an increased length-of-stay in the hospital of nearly three fold and increased mortality in the hospital of approximately 4.5 fold. 4 Transmission to patients occurs primarily via the hands of healthcare personnel or from a contaminated environment. Risk Factors for CDI Traditional risk factors for CDI include disruption of normal intestinal flora, usually due to treatment with antimicrobials. In general, acquisition of the organism occurs during hospitalization or in a long-term care facility. Co-morbid conditions, such as impaired immune status or abdominal surgery, and other host factors, such as advanced age, contribute to development of CDI. 6,7 New risk factors for CDI have been observed in populations previously at low risk: young, otherwise healthy patients and peripartum patients. 8 These community-associated cases may not be linked to treatment with antimicrobials. The epidemiology of community-associated CDI appears to have regional variability, is not well-established and is being investigated by the CDC and other researchers. CDI pressure has also been described as an important risk factor. 9 Similar to colonization pressure as a known risk factor for acquisition of methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE), CDI pressure is based on the observation that presence of a CDI patient on the same ward increases other patients risk of acquiring CDI. Unlike MRSA and VRE colonization pressure, to date CDI pressure has only been described based on the presence of a symptomatic patient with C. difficile infection. NORMAL COLON PSEUDOMEMBRANOUS COLITIS (severe CDI) The above photos show how a normal colon looks compared to the colon of a patient with severe C. difficile infection. Changing Epidemiology of CDI In 2002, Quebec experienced a CDI outbreak with high numbers of severe cases of CDI and high mortality rates. A new strain known as BI/NAP1/027 was found to be causing this outbreak. This strain continued to spread leading to subsequent outbreaks in adjacent hospitals in 2003 to Ultimately, the same strain was found in the U.S., the U.K. and the Netherlands. This epidemic strain was shown to be present in two U.S. hospitals before its appearance in the Canadian outbreaks and it was first isolated in However, the new strain had become resistant to a class of antibiotics known as fluoroquinolones. The BI/NAP1/027 strain produces an additional toxin, known as the binary toxin, and also carries a deletion in the tcdc gene, which is a gene that regulates production of toxin A and toxin B. The Role of Toxins in Pathogenesis The majority of toxigenic C. difficile strains produce both toxins A and B (Table 1). Toxin A variants (toxigenic C. difficile strains that do not produce toxin A) have been described and account for approximately 10% of cases of CDI. 3 The clinical spectrum of disease due to toxin A variants is 4 BD Lab O volume 20 number 1

5 Table 1. Role of Toxins Found in all toxigenic Toxin C. difficile? Absent from non-toxigenic C. difficile? Useful for diagnosis of CDI? Toxin A No Yes Yes, when present Toxin B Yes Yes Yes Binary Toxin No No No tcdc deletion No Yes No similar to CDI caused by strains that produce both toxins A and B, ranging from mild to severe disease including fatal pseudomembranous colitis, which supports the idea that toxin A may not be essential in the disease process. In contrast, toxin B is produced by virtually all toxigenic C. difficile strains and has demonstrated a 1000-fold greater cytotoxicity than toxin A in tissue culture. Toxigenic C. difficile strains that do not produce toxin B are extremely rare, with only two reports in the literature. Recently, Lyras et al. 10 presented compelling evidence using genetically modified C. difficile strains which demonstrated that toxin B is the major virulence factor and is responsible for CDI disease pathology. Peterson et al. have demonstrated a strong correlation between detection of the toxin B gene (tcdb) and clinical disease. 11 The importance of binary toxin as a virulence factor in C. difficile infection has not been demonstrated and it is absent in most toxigenic C. difficile strains. Patients who are infected with toxigenic C. difficile strains that harbor the tcdc deletion, including BI/NAP1/027, can present with mild to moderate disease that does not significantly differ from disease caused by strains that lack the deletion. Given the wide distribution among toxigenic and nontoxigenic C. difficile strains, the binary toxin and tcdc gene deletion lack specificity as diagnostic tools for CDI. The best genetic target for detection of toxigenic C. difficile is the toxin B gene because it is the major virulence factor in CDI and is present in virtually all toxigenic C. difficile. Diagnosis of CDI The diagnosis of CDI includes a combination of clinical signs and symptoms and laboratory findings. A patient with CDI will have diarrhea or toxic megacolon without other known etiology and one or more of the following criteria: 12 Stool specimen positive: C. difficile toxin A and/or B, or Toxin-producing C. difficile organism by culture or other means Pseudomembranous colitis seen on: Endoscopic examination or surgery Histopathological examination Current laboratory testing for detection of toxigenic C. difficile lacks a single method that is sensitive, specific and rapid (Table 2). Toxigenic culture is the most sensitive method available but takes several days to report results and is labor intensive and technically challenging. Cytotoxicity is less sensitive than toxigenic culture and also is technically challenging with a long turn around time. Toxin A/B immunoassays lack sensitivity. GDH (glutamate dehydrogenase) immunoassays appear to be less sensitive than originally thought. In addition, GDH is not specific and does not differentiate between toxigenic and nontoxigenic C. difficile; therefore, it must be combined with a second method that detects only toxigenic C. difficile. Lack of a single method that is rapid, accurate and commercially available leads to missed CDI cases and delayed diagnosis. Repeat testing is often performed in patients whose symptoms continue despite a negative result and patients are treated empirically in the absence of a definitive diagnosis, which can lead to the unnecessary use of antibiotics in patients who are actually not infected with C. difficile. Diagnosis of CDI also impacts infection control and antimicrobial stewardship efforts. Preemptive isolation of patients based on clinical suspicion (i.e. diarrhea) leads to isolation of patients who do not have CDI. Since physicians may not trust Table 2. Current Lab Methods for Detection of Toxigenic C. difficile Method Sensitivity Specificity References Toxigenic Culture Tissue Culture Cytotoxicity Toxin A/B Immunoassay GDH Immunoassay 100% 71% to 90% 48% to 73% 71% to 93% 93% to 96% 97% to 100% 97% to 99% 91% to 93% Peterson CID 45:1152 Peterson CID 45:1152 Delmee EJCMID 11:246 Sloan JCM 46:1996 Peterson CID 45:1152 Fenner JCM 46:328 Sloan JCM 46:1996 TechLab C. DIFF CHEK -60 and C. DIFF QUIK CHEK package inserts a negative EIA result, these patients may remain in isolation unnecessarily. Institutions that isolate only laboratoryconfirmed cases of CDI are missing positive patients (due to low sensitivity) who should be isolated. Lack of trust in negative results (due to low sensitivity) can also lead to empiric treatment being continued despite negative test results. Real-time PCR is a new solution because it combines speed and accuracy in a single test. This allows for quick and definitive detection of toxigenic C. difficile in patient samples. Peterson et al. developed a home-brew real-time PCR assay for detection of the toxin B gene (tcdb) that is located in the Pathogenicity Locus (PaLoc) found only in toxigenic C. difficile. They included a clinical correlation in the reference standard and demonstrated excellent performance (93.3% sensitivity and 97.4% specificity) for the toxin B gene PCR assay. 11 Continued on page 6 NEWS FLASH! The BD Geneohm cdiff Assay has been cleared by the FDA. For more information contact your local BD sales representative. BD Lab O volume 20 number 1 5 Photo Courtesy of CDC/ Lois S. Wiggs. Photo Credit: Janice Carr

6 TechniTopics Advances in the Laboratory Diagnosis of C. difficile Infections Continued from page 5 Table 3. Summary of Clinical Trial Data and Poster Presentations on the BD GeneOhm Cdiff Assay Authors Reference Performance Clinical Trial Data Fuller et al. Alcabasa et al. Fuller et al. Fuller et al. Loo et al. BD GeneOhm Cdiff Assay package insert ECCMID 2008 Poster No ASM 2008 Poster No. C-104 ASM 2008 Poster No. C-105 ICAAC 2008 Poster No. D-2280 ICAAC 2008 Poster No. D % Sensitivity 95.5% Specificity Fresh specimens versus cytotoxicity. 100% Sensitivity 97.7% Specificity Frozen specimens versus cytotoxicity. 93.6% Sensitivity 98.4% Specificity Versus cytotoxicity, after resolution with toxigenic culture. 98.1% Sensitivity 98.3% Specificity Versus cytotoxicity, after resolution with toxigenic culture. 92.3% Sensitivity 95.4% Specificity Versus a GDH algorithm, after resolution with cytotoxicity and toxigenic culture. 100% Sensitivity 97.4% Specificity Versus cytotoxicity. 92.0% Sensitivity 98.1% Specificity Versus toxigenic culture. The BD GeneOhm Cdiff Assay is a real-time PCR method for the rapid detection of the toxin B gene of toxigenic C. difficile directly from stool samples. From fresh specimens, the assay sensitivity is 93.8% and specificity is 95.5% and from frozen specimens, the assay sensitivity is 100% and specificity is 97.7%. It is more sensitive than the cytotoxicity assay and can be performed in the same timeframe as an immunoassay. Greater sensitivity means detecting positives that are missed by immunoassays. Laboratory testing can be completed in hours versus days using one single method, thereby avoiding multi-method algorithms and complicated reporting of results. Table 3 summarizes the performance of the BD GeneOhm Cdiff Assay from clinical trial data and as presented in posters at various meetings. Improving Patient Management The BD GeneOhm Cdiff Assay may help physicians quickly reach a definitive diagnosis by enabling rapid, same-day test results. The benefits of definitive diagnosis of CDI include elimination of treatment delay in infected patients to reduce severe outcomes of CDI. 13 CDI-confirmed patients can be placed in isolation sooner to reduce transmission and prevent outbreaks of CDI. 6,13 Definitively ruling out CDI can help avoid empiric treatment and unnecessary exposure to antibiotics in negative patients. This allows the physician to focus on other causes of patient symptoms and avoid unnecessary isolation of negative patients. Summary CDI is an increasing problem for healthcare institutions and the epidemiology of the disease is changing. Diagnosis of CDI requires a combination of clinical factors and detection of toxigenic C. difficile. Current laboratory tests are limited by sensitivity, specificity, and/or turnaround time. PCR methods offer a new approach to the detection of C. difficile *Not for sale in the U.S.; BD GeneOhm Cdiff assay under review by the FDA. incorporating high sensitivity, high specificity and rapid turnaround time. REFERENCES 1 Sunenshine and McDonald Cleveland Clin. J. Med. 73: Blossom and McDonald Clin. Infect. Dis. 45: Wilkins and Lyerly J. Clin. Microbiol. 41: Elixhauser and Jhung AHRQ Statistical Brief #50 April Dubberke et al Clin. Infect. Dis. 46: McFarland et al Amer. J. Infect. Cont. 35: Bartlett Annals Int. Med. 145: CDC MMWR. 54: Dubberke et al Arch. Int. Med. 167: Lyras Presentation at Anaerobe Conference, June 2008, Long Beach, Calif. 11 Peterson et al Clin. Infect Dis. 45: Dubberke et al Infect. Cont. Hosp. Epidemiol. 29:S81-S Kuijpers et al Clin. Microbiol. Infect. 12 (Suppl. 6):2-18. About the author Tobi B. Karchmer, MD, MS, is Medical Director for BD Diagnostics. She was previously an Assistant Professor of Medicine in the Section of Infectious Diseases at Wake Forest University School of Medicine and Hospital Epidemiologist at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina from She is board-certified in infectious diseases. Dr. Karchmer received her medical degree from Harvard Medical School and Master of Science from the University of Virginia. She completed an internship and residency in internal medicine at the University of Washington in Seattle. Dr. Karchmer then completed a fellowship in infectious diseases at the University of Virginia Health System in Charlottesville. Dr. Karchmer is a member of the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) as well as an Associate of the American College of Physicians. She was a Member of the Board (Academic Councilor) of SHEA, , and has served on various committees of SHEA and IDSA. Dr. Karchmer has written numerous articles and two book chapters on infectious diseases and hospital epidemiology, and has presented many local and national invited lectures. 6 BD Lab O volume 20 number 1 Photo Courtesy of CDC/ Lois S. Wiggs. Photo Credit: Janice Carr

7 Product Highlights BD EZ Flu A+B * and BD EZ RSV * Tests Have a New Look BD is enhancing the BD EZ Flu A+B and BD EZ RSV tests with new easier-to-read printed cassettes. The new cassettes, which will have dark blue printed lettering rather than embossed lettering, will make it easier for our customers to see the important indicators such as how many drops of extracted sample to add and the location of the Control and Test lines. This fresh appearance will now allow customers to easily and clearly read the letters, numbers and symbols on the test cassette just as easily as the test result itself. The new BD EZ Flu A+B and BD EZ RSV cassettes are pictured at left. Additionally, the color of the BD EZ RSV cassette has been changed (from purple to white) to match the color of the BD EZ Flu A+B cassette. This change in color will provide a better contrast for the dark blue printed lettering and will provide a more consistent and distinguished look for the BD EZ family of tests. NOT ACTUAL SIZE You will begin to see the printed cassettes within the next couple of months. A bright orange sticker on the outside of the kit box will let you know that the new look test cassettes are contained inside the kit. The new look for the BD EZ Flu A+B and BD EZ RSV tests was implemented based on feedback from you our valued customers. BD is committed to listening to input and helping our customers meet the increasing demands of the laboratory. Customer feedback based on prototypes of the new cassettes was very positive; however, we would like to hear back from you. Please contact your BD sales representative or BD Technical Services and let us know how you like the new look of the BD EZ Flu A+B and BD EZ RSV test cassettes. * BD Directigen EZ Flu A+B and BD Directigen EZ RSV Announcing New BD BBL Sensi-Disc Antifungal Susceptibility Discs The BD BBL Sensi-Disc line has a complete offering of antimicrobial susceptibility test discs to meet your susceptibility testing needs. At this time we are expanding the Sensi-Disc product family to include antifungal discs. We are pleased to introduce the following two new antifungal BBL Sensi-Disc products: Fluconazole (DIFLUCAN : Pfizer Pharmaceuticals) Fluconazole is a triazole antifungal agent. Voriconazole (VFEND : Pfizer Pharmaceuticals) Voriconazole is a new second-generation triazole antifungal agent. Cat. No. Antimicrobial Disc Code Concentration Unit Fluconazole FcA 25 µg 1 cartridge voriconazole vor 1 µg 1 cartridge For a complete listing of our products, visit our web site at SensiDisc. For a copy of our BBL Sensi-Disc Antimicrobial Susceptibility Test Discs Wall Chart, listing antimicrobial agents by their generic and trade names and other useful information, contact your local BD sales representative or BD Technical Services at BD Lab O volume 20 number 1 7

8 ULTURE CLUB Product Highlights The BD BACTEC Culture Club New Members and a New List The BD BAcTec culture club was created to inform BAcTec System users of unusual organisms recovered from BAcTec fluorescent series instruments and BAcTec media. As newly isolated organisms are reported to us, the reports are published in LabO. At this time, we are pleased to add two new members of the club. In addition, we have prepared an updated list of all the organisms recovered on the BAcTec fluorescent series instruments. Since the last list was published in the Spring 2005 issue of LabO, 29 organisms have been added for a grand total of 301 organisms! Laboratory Site Northern Plains Laboratory Bismarck, N. Dak. Semmelweis University Transplantation Clinic Budapest, Hungary Underlying Disease/ Diagnosis BACTEC Instrument Cancer 9240 Chronic pancreatitis 9120 BACTEC Media* Lytic 10/ Anaerobic/F Plus Aerobic/F Plus Anaerobic/F * BD Diagnostics does not claim recovery of the isolates listed in the table with the associated media. See package inserts for the expected organism recovery. why don t you join the club? If you have an unusual organism isolated from any of the BAcTec fluorescent series instruments (9240, 9120, 9050, 9000MB and Fx), see if it is listed on the BAcTec culture club form enclosed in this issue of LabO. If it s not listed, complete the form and send it in to receive your complimentary BD Portfolio! There is no limit to the number of forms that can be submitted. For more information on the BD BAcTec culture club or to obtain additional forms, visit our web site at Time to Detection Organism Detected 36 hours Leptotrichia trevisanii 12 hours Pseudomonas (Flavimonas) oryzihabitans 8 BD Lab O volume 20 number 1

9 Aerobic Gram-Negative Organisms Acinetobacter baumannii Acinetobacter lwoffi Acinetobacter sp. Aeromonas hydrophila Aeromonas sp. Alcaligenes faecalis Alcaligenes xylosoxidans subsp. xylosoxidans Bartonella quintana Bordetella holmesii Bordetella pertussis Brevundimonas diminuta Brevundimonas vesicularis Brucella abortus Brucella melitensis Brucella suis Brucella sp. Burkholderia cepacia Burkholderia pickettii Burkholderia pseudomallei Campylobacter fetus Campylobacter (Bacteroides) gracilis Campylobacter jejuni subsp. jejuni Campylobacter sp. Capnocytophaga canimorsus Capnocytophaga cynodegmi Cardiobacterium hominis Chromobacterium violaceum Chryseobacterium indologenes Chryseobacterium meningosepticum Chryseomonas luteola Citrobacter amalonaticus Citrobacter diversus Citrobacter freundii Citrobacter sp. Comamonas acidovorans Delftia acidovorans Eikenella corrodens Enterobacter aerogenes Enterobacter agglomerans Enterobacter cancerogenus Enterobacter cloacae Enterobacter sakazakii Escherichia coli Escherichia vulneris Flavobacterium sp. Haemophilus aphrophilus Haemophilus influenzae Haemophilus parainfluenzae Haemophilus paraphrophilus Haemophilus sp. Helicobacter rappini Kingella kingae Kingella sp. Klebsiella oxytoca Klebsiella ozaenae Klebsiella pneumoniae Kluyvera ascorbata Kluyvera sp. Leclercia adecarboxylata Methylobacterium mesophilicum CULTURE CLUB The BD BACTEC Culture Club Methylobacterium sp. Moraxella catarrhalis Moraxella nonliquefaciens Moraxella sp. Morganella morganii Neisseria gonorrhoeae Neisseria meningitidis Neisseria mucosa Neisseria sicca Neisseria subflava Neisseria sp. Ochrobactrum anthropi Pasteurella multocida Plesiomonas shigelloides Proteus mirabilis Proteus penneri Proteus vulgaris Providencia alcalifaciens Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas cepacia Pseudomonas fluorescens Pseudomonas fluorescens group Pseudomonas (Flavimonas) oryzihabitans Psychrobacter immobilis Ralstonia (Pseudomonas) pickettii Rhizobium (Agrobacterium) radiobacter Rhizobium sp. Riemerella anatipestifer Roseomonas sp. Salmonella arizonae Salmonella paratyphi A Salmonella typhi Salmonella serotype Montevideo Salmonella sp., Grp B Salmonella sp., Grp D Salmonella sp., Grp G Salmonella sp. Serratia liquefaciens Serratia marcescens Serratia plymuthica Shewanella putrefaciens Shigella sonnei Shigella sp. Sphingobacterium (Flavobacterium) multivorum Sphingomonas paucimobilis Stenotrophomonas maltophilia Streptobacillus moniliformis Vibrio cholerae, non-01 Vibrio fluvialis Vibrio mimicus Vibrio vulnificus Wautersia (Ralstonia) paucula Yersinia enterocolitica Aerobic Gram-Positive Organisms Aerococcus sp. Arcanobacterium haemolyticum Arthrobacter sp. Aureobacterium sp. Bacillus anthracis Bacillus cereus Bacillus licheniformis Bacillus subtilis Bacillus sp. Brevibacterium casei Brevibacterium paucivorans Cellulomonas sp. Corynebacterium Grp B-1 Corynebacterium Grp D-2 Corynebacterium afermentans subsp. afermentans Corynebacterium aquaticum Corynebacterium jeikeium Corynebacterium resistens Corynebacterium striatum Corynebacterium urealyticum Corynebacterium xerosis Corynebacterium sp. Dermabacter hominis Enterococcus avium Enterococcus casseliflavus Enterococcus durans Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus sp. Erysipelothrix rhusiopathiae Facklamia hominis Gardnerella vaginalis Gemella morbillorum Granulicatella adiacens Granulicatella sp. Kytococcus (Micrococcus) schroeteri Lactococcus sp. Leuconostoc mesenteroides subsp. mesenteroides Leuconostoc pseudomesenteroides Leuconostoc sp. Listeria monocytogenes Micrococcus sp. Oerskovia sp. Paenibacillus sp. Pediococcus sp. Rhodococcus equi Rhodococcus sp. Roseomonas sp. Rothia dentocariosa Rothia mucilaginosa Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus cohnii Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus lugdunensis Staphylococcus saccharolyticus Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus warneri Staphylococcus xylosus Stomatococcus mucilaginosus Stomatococcus sp. Streptococcus acidominimus Streptococcus anginosus Streptococcus bovis Streptococcus constellatus Streptococcus intermedius Streptococcus milleri Streptococcus mitis Streptococcus mutans Streptococcus pneumoniae Streptococcus salivarius Streptococcus sanguis Streptococcus uberis Streptococcus vestibularis Streptococcus Grp A Streptococcus Grp B Streptococcus Grp C Streptococcus Grp D Streptococcus Grp F Streptococcus Grp G Streptococcus sp., gamma hemolytic Streptococcus sp., nutritionally variant Streptococcus sp., viridans Weissella confusa Anaerobic Organisms Anaerobiospirillum succiniciproducens Bacteroides caccae Bacteroides fragilis Bacteroides fragilis group Bacteroides melaninogenicus Bacteroides ovatus Bacteroides splanchnicus Bacteroides thetaiotaomicron Bacteroides ureolyticus Bacteroides vulgatus Bacteroides sp. Bifidobacterium sp. Brachyspira sp. Clostridium butyricum Clostridium clostridioforme Clostridium difficile Clostridium innocuum Clostridium limosum Clostridium paraperfringens Clostridium perfringens Clostridium ramosum Clostridium septicum Clostridium sordellii Clostridium sporogenes Clostridium tertium Clostridium sp. Eubacterium lentum Eubacterium limosum Eubacterium sp. Fusobacterium mortiferum Fusobacterium necrophorum Fusobacterium nucleatum Fusobacterium varium Fusobacterium sp. Lactobacillus casei Lactobacillus rhamnosus Lactobacillus sp. Leptotrichia buccalis Leptotrichia trevisanii Leptotrichia sp. Peptococcus sp. Peptostreptococcus anaerobius Peptostreptococcus asaccharolyticus Peptostreptococcus prevotii Peptostreptococcus sp. Porphyromonas endodontalis Porphyromonas gingivalis Prevotella bivia Prevotella buccae Prevotella oralis Prevotella oris Propionibacterium acnes Propionibacterium sp. Streptobacillus moniliformis Veillonella parvula Veillonella sp. Yeast/Fungi Organisms Alternaria sp. Aspergillus niger Candida albicans Candida guilliermondii Candida kefyr Candida krusei Candida lusitaniae Candida parapsilosis Candida stellatoidea Candida tropicalis Coccidioides immitis Cryptococcus neoformans Fusarium sp. Histoplasma capsulatum Malassezia furfur Prototheca sp. Rhodotorula rubra Rhodotorula sp. Torulopsis glabrata Trichophyton rubrum Actinomycetes Actinomyces israelii Actinomyces odontolyticus Actinomyces viscosus Actinomyces sp. Nocardia asteroides Nocardia farcinica Streptomyces sp. Mycobacteria Mycobacterium avium-intracellulare Mycobacterium chelonae Mycobacterium flavescens Mycobacterium fortuitum Mycobacterium malmoense Mycobacterium mucogenicum Mycobacterium neoaurum Mycobacterium simiae Mycobacterium sp. Mycobacterium terrae Mycobacterium tuberculosis Mycobacterium xenopi BD Lab O volume 20 number 1 9

10 CULTURE CLUB The BD BACTEC Culture Club Recovery of Unusual Isolates with BD BACTEC /F Systems Laboratory Name: Institution Address: City/State/Zip: Submitted By: Telephone Number: *: PLEASE RETURN FORM TO: BD Diagnostics Marketing Manager, BACTEC, MC642 7 Loveton Circle Sparks, MD Organism Identification: BACTEC Instrument: MB FX Isolated from this Medium: Plus Aerobic/F: Peds Plus Aerobic: Standard Aerobic/F: Myco/F-Sputa: Plus Anaerobic/F: Lytic/10 Anaerobic/F: Standard Anaerobic/F: Myco F/Lytic: Number of Specimens from the Patient: Number of BACTEC Cultures that Were Positive with the Isolate: Time to Detection (Hours or Days): Was Patient on Antimicrobial Therapy When Specimens Were Taken?: _ Identification Method Used: Susceptibility Testing Method Used: Underlying Disease or Diagnosis (if any): Chemistry/Hematology Lab Results: Antimicrobial Therapy (if any): * The information you provide will not be shared with a third party vendor. By providing this information, I authorize Becton, Dickinson and Company to send me information via BD Lab O volume 20 number 1

11 FYI Study Highlights from ICAAC 2008 A wealth of information was presented at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC ) held October in Washington, D.C. Summaries of two ICAAC studies on BD BACTEC media and the ESwab specimen collection system are summarized below. D-306 Recovery of Staphylococcus aureus from BACTEC Plus Aerobic/F and VersaTREK REDOX 1 Blood Culture Media with Increasing Concentrations of Vancomycin, Daptomycin or Linezolid* 1 DiPersio et al., Summa Health System Hospitals, Akron, Ohio This study compared recovery rates and time to detection (TTD) of BD BACTEC Plus Aerobic/F and VersaTREK REDOX 1 blood culture media using two ATCC strains of S. aureus (MRSA and MSSA), banked blood and three levels of vancomycin, daptomycin and linezolid. Media were seeded in triplicate using a final organism concentration of CFU/10 ml of blood. Bottles were incubated for up to 5 days on the respective instruments. BACTEC Plus medium demonstrated: greater recovery of the S. aureus ATCC strains than VersaTREK medium in the presence of vancomycin, daptomycin and linezolid, especially at peak levels (see recovery results summarized in the table below); and a decreased TTD of organisms in the presence of each of the antibiotics tested, regardless of concentration. BACTEC Plus No. of Positives/Total (%) VersaTREK No. of Positives/Total (%) Control Bottles (no antibiotics) 18/18 (100%) 18/18 (100%) Test Bottles (with antibiotics) 52/54 (96%) 23/54 (43%) Total 70/72 (97%) 41/72 (57%) *Study was supported by a grant from BD. D-4015 Comparison of Gram Stain and Culture Performance of the Copan ESwab System and the BBL CultureSwab Plus 2 McCarter et al., University of Florida College of Medicine, Jacksonville, Fla. Nine organisms (aerobic and anaerobic) including Salmonella Enteritidis, Shigella sonnei, Yersinia enterocolitica, Camplyobacter jejuni, Bacteroides fragilis, Clostridium perfringens, Fusobacterium nucleatum, Prevotella loescheii and Proprionibacterium acnes were evaluated for viability after 24 and 48 hours of incubation at room temperature using the ESwab system (Copan) and the BBL CultureSwab Plus system. In addition, Gram stains were performed using the ESwab swab, 100 µl of ESwab medium and CultureSwab Plus at 0, 24 and 48 hours. ESwab was comparable to CultureSwab Plus for recovery of the aerobes tested and superior to CultureSwab Plus for the recovery of P. loescheii, C. perfringens and P. acnes. ESwab was comparable to CultureSwab Plus for recovery of B. fragilis at 24 hours, but CultureSwab demonstrated greater recovery at 48 hours. Neither system was able to maintain F. nucleatum or C. jejuni beyond time zero. Gram stain preparations using 100 µl of ESwab medium produced the highest quality Gram stains of the three methods tested. For more information on the BD BACTEC Blood Culture System or the ESwab Culture Collection System, mark the appropriate box(es) on the reader response card. REFERENCES 1 DiPersio et al Abstract D-306, presented at the 48th Annual ICAAC Meeting, October 25-28, 2008, Washington, D.C. In Abstracts, American Society for Microbiology, Washington, D.C. 2 McCarter et al Abstract D-4015, presented at the 48th Annual ICAAC Meeting, October 25-28, 2008, Washington, D.C. In Abstracts, American Society for Microbiology, Washington, D.C. BD Lab O volume number 31 11

12 FYI Trends in Vaginitis Testing Labs are increasingly adopting molecular-based methods for diagnosing vaginitis. This stems from the growing focus on the clinical importance of the proper diagnosis of vaginitis, coupled with the limitations of current approaches and the move towards laboratory automation. Vaginitis accounts for more than 10 million office visits in the United States each year. 1 Approximately 90 percent of all vaginitis cases are caused by three pathogens: Gardnerella (surrogate for bacterial vaginosis, or BV), Candida and Trichomonas. Recent studies show that BV, which comprises 15% to 50% of vaginitis cases, 2,3 is associated with the acquisition of sexually transmitted infections, pelvic inflammatory disease, HIV and infections following gynecologic surgery. Trichomonas, which encompasses 15% to 20% of vaginitis cases, 4 is linked to increased risk of delivering low-birth-weight and pre-term babies. Traditional diagnostic approaches, including wet mount microscopy, ph tests and culture, lack sensitivity and may be subjective. Studies have shown that microscopy is only 40% to 60% sensitive for diagnosing Candida; 5 55% sensitive for diagnosing BV; 6 and 40% to 80% sensitive for identifying Trichomonas. 5 The sensitivity is even lower in mixed infections, 7 which account for nearly a quarter of vaginitis cases. 8 Undiagnosed or misdiagnosed vaginitis may result in delayed or incorrect treatments and multiple office visits, which are costly and frustrating to physician and patient. DNA probe technology identifies target organisms based on their genetic fingerprints. Studies have shown this technology to be significantly more sensitive than microscopy, and comparable to culture for Candida, Scored Gram Stain for Gardnerella and Diamond s culture for Trichomonas. DNA probe technology delivers accurate diagnoses even in cases of mixed infections and hard-to-diagnose patients. 9 This approach also increases lab efficiency because it can be automated and the turnaround is quick. The BD Affirm VPIII Microbial Identification System is the only direct specimen DNA probe test that conclusively identifies Trichomonas vaginalis, Gardnerella vaginalis and Candida species all from a single vaginal sample. Benefits of the Affirm VPIII test include: Detects mixed infections enabling proper therapy on the first visit Detection is not hampered by difficult samples Automated processing of up to six patients simultaneously Quick turnaround time approximately 45 minutes For more information on the BD Affirm VPIII Microbial Identification System, mark the appropriate box on the reader response card. REFERENCES 1 Kent Am. J. Obstet Gynecol. 165: Goldenberg et al Vaginal Infections and Prematurity Study Group. Am. J. Obstet Gynecol. 174: Gutman et al Obstet. Gynecol. 105: Wendel et al Clin. Infect. Dis. 35: Sobel Sexually transmitted diseases. Medical Clinics of North America, Vol. 74., No Hillier. Bacterial vaginosis and trichomoniasis. University of Pittsburgh, Magee-Women s Hospital (T613). 7 Ferris J. Family Practice, Dec Spiegel Clin. Microbiol. Newsl. 21:5. 9 BD Affirm VPIII Brochure, BD Diagnostics. Medicare Announces 2009 Lab Fee Schedule Update 4.5% Increase over 2008 Effective January 1, 2009, all diagnostic tests that are paid by Medicare from the clinical laboratory fee schedule will be paid 4.5% higher than last year. This is the fi rst update in fees since 2003, and only the second in the last twelve years. BD worked within the manufacturing industry, with lab associations, and with Congress over the past several years to help secure this necessary and long overdue increase. Some examples of affected tests and reimbursement changes include: Infl uenza tests (EIA methods) that were paid $16.76 will now be paid $17.52; direct probe molecular tests (e.g., CPT code Trichomonas vaginalis) that were paid $28.02 will now be paid $29.27; amplifi ed molecular tests (e.g., CPT code Chlamydia trachomatis) that were paid $49.04 will now be paid $ A link to the entire Medicare lab fee schedule can be accessed through BD s Reimbursement website, which is located at: IMPORTANT NOTES: CPT codes and descriptions only are copyright 2009 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The information contained in this document is for informational purposes only and does not constitute reimbursement or legal advice. BD makes no warranty or representation regarding the completeness, accuracy, or timeliness of the information provided. CPT coding selection is the sole responsibility of the provider of medical services. Moreover, payers have differing medical and payment policies, and laws, regulations and payer policies concerning reimbursement are complex and change frequently. Accordingly, BD strongly recommends that you consult with your payers, reimbursement specialist(s) and/or legal counsel regarding coding, coverage, and payment matters. BD cannot and does not guarantee or in any way represent that any codes or coding uses will be viewed as acceptable by the AMA, any private payers, any public payers including Medicare, Medicaid, and other governmental-based programs, or any other payer-related organization. BD provides no guarantee as to the reliability of the information contained herein and assumes no liability for any actions taken in reliance thereon. Any action taken in reliance on this document, and the information provided herein, shall be at the actor s own and sole risk. 12 BD Lab O volume 20 number 1

13 Micro Happenings BD Sponsors One-of-a- Kind Campaign to Raise Awareness of XDR-TB BD, in cooperation with TED (Technology, Entertainment, Design), a group that supports ideas by forward thinking people, is supporting an unprecedented global awareness campaign on Extensively Drug-Resistant Tuberculosis (XDR- TB), a TB strain that is the result of inadequate diagnosis and treatment. As the lead sponsor, BD has played an instrumental role in the campaign, designed to use photography to inform and motivate individuals around the world, spreading the word about the urgent need to eradicate TB. The campaign was launched when images conveying the plight of people inflicted with TB were projected onto monumental outdoor spaces in major cities throughout the world on October 3, The photos, taken by world-renowned photojournalist James Nachtwey and assembled as a three-minute slideshow, appeared alongside high-impact messaging that talked about a disease that is sometimes impossible to cure. A website, XDRTB.org, has been developed by TED as a go-to point for viewing, downloading and sharing the slideshow. The site will also enlighten the public about XDR-TB and what s being done about it and how you can help. The awareness campaign is the result of Nachtwey being one of three recipients of this year s TED Prize. The Need for Improved TB Diagnostics in the Developing World The rapid and accurate diagnosis of symptomatic patients is the cornerstone of global strategies for TB control. TB is challenging to diagnose and difficult to treat, especially in the developing world which bears 95% of the global disease burden. Inaccurate diagnosis has spurred the rapid spread of TB and drug resistance especially in HIV/AIDS patients. According to the World Health Organization (WHO) there are an estimated nine million new cases of active TB reported each year. TB results in approximately two million deaths each year and is the leading cause of death among HIV/AIDS patients. Strains of TB that are resistant to both first-line and second-line drugs threaten the success of existing tuberculosis programs. The testing method used almost universally in the developing world is the sputum acid-fast smear. It is largely ineffective in identifying TB in HIV/AIDS patients. As a result, false negative tests are very common, leading to inappropriate treatment. This contributes to the continued rapid spread of TB and also expands the incidence of drug resistance. James Nachtwey is one of the world s greatest photojournalists and became one of the most respected photojournalists of this era. Acknowledged with numerous awards throughout his career, Nachtwey has been a contract photographer with Time magazine since 1984, and continues to be a regular contributor to National Geographic. As a winner of the 2007 TED Prize, James received one wish to change the world. His wish was to break a story that the world needs to know about in a way that will provide spectacular proof of the power of news photography. That story is TB. Specifically, XDR-TB. To find out more about this awardwinning photojournalist, go to www. jamesnachtwey.com. To find out more about TED go to To find out more about this TED prize, go to Continued on page 16 BD Lab O volume 20 number 1 13

14 Micro Happenings BD Lab O 20 Years Young and Still Counting... Please join us in celebrating the 20th anniversary of the BD LabO newsletter! First introduced in 1990, LabO was created to provide our customers with relevant information on our products, as well as useful information about the changing field of microbiology. During that time, 63 issues have been published covering a wide range of products and topics including CLIA 88, BACTEC case studies, bioterrorism, foodborne diseases, pandemic influenza, and healthcare-associated infections to name a few. In addition, we published over 40 articles written by our customers. But it hasn t been all business. Who can forget the crossword puzzles, word jumbles, word searches, Buddy Bronchiosaurus, the Culturette CDT Bear not to mention the BACTEC Culture Club! Since many of you may not have been recipients of all 63 issues, we would like to take this opportunity to present a snapshot of the last 20 years. As you can see LabO, itself, has changed over the years, adapting to the needs of our readers. And to further celebrate this special year, future issues will contain fun facts, games and quizzes based on the newsletter s past, present and future. Enjoy! 14 BD Lab O volume 20 number 1

15 BD Lab O volume number 31 15

16 Overview of the BD Phoenix and BD EpiCenter Systems Continued from page 3 The BD Phoenix AST Advantage assures that susceptibility results are not only rapid, but also accurate by combining a unique AST Indicator for oxidation-reduction detection, turbidometric growth detection, full on-panel antimicrobial concentrations and the BDXpert System for optimal and reliable detection of bacterial growth. The BDXpert System follows CLSI M100 standards to automatically verify and validate susceptibility interpretations. BDXpert incorporates: a Resistance Marker Detection system for beta-lactamase detection in staphylococci; confirmatory ESBL interpretations for E. coli, K. pneumoniae and K. oxytoca; definitive MRSA, meca, VRSA, VRE and HLAR detection; and provides additional assurance of accuracy by the utilization of specific delayed resistance algorithms. The AST Advantage assures that results are available to physicians without additional testing required for confirmation. The BD EpiCenter Microbiology Data Management System empowers the microbiologist to improve productivity, result consistency and investigate epidemiology trends on demand. BD EpiCenter interfaces with BD Phoenix, providing a convenient workstation to streamline the processing of new specimens and for analyzing the results from Phoenix. By incorporating two expert systems, BDXpert and BD EpiCARE, EpiCenter enables rapid and accurate reporting of Phoenix ID and AST results as well as monitoring for emerging resistance. The system contains over 170 pre-defined queries and reports that can be used immediately to communicate antibiograms, healthcare-associated infection event analysis and other trending reports. Furthermore, EpiCenter can be directly interfaced to a LIS for efficient data exchange through advanced host-query interface protocols. Lastly, EpiCenter includes an extensive epidemiology library designed to be used in realtime and simultaneously by laboratory personnel as well as physicians, infection control officers and pharmacists. For more information on the BD Phoenix System or the BD EpiCenter Microbiology Datat Management System, mark the appropriate box(es) on the reader response card. BD Sponsors One-of-a-Kind Campaign to Raise Awareness of XDR-TB Continued from page 13 While multiple drug-resistant forms of TB have been a problem for some time, a more recent and alarming trend is the emergence of XDR-TB, where patients do not respond to first- or second-line drug treatments for TB. The expanding TB/HIV epidemics and the increasing of drug resistant TB, have led to a need for access to improved diagnostics that complement each other. While no single diagnostic test provides all the information needed for patient care over the disease progression, several technologies exist today that can help reduce the spread of TB and its mortality rate. The ultimate goal of providing a simple, more up-to-date TB diagnostic tool for the 21st century is the focus of ongoing research and development. 16 BD Lab O volume 20 number 1 LabO is published three times per year by BD Diagnostics (Becton, Dickinson and Company), 7 Loveton Circle, Sparks, MD 21152, Editor: Mary Jo Zimbro, B.S., MT(ASCP). Send address changes and mailing list additions/deletions to BD Diagnostics, 7 Loveton Circle, Attn: Marketing Communications, Mail Code 634, Sparks, MD For technical information, call Technical Services, toll free, at Visit our web site at ATCC is a trademark of the American Type Culture Collection. CHROMagar is a trademark of Dr. A. Rambach. CPT is a registered trademark of the American Medical Association. ICAAC is a registered trademark of the American Society for Microbiology. TechLab, C. DIFF CHEK and C. DIFF QUIK CHEK are trademarks of TechLab, Inc. VersaTREK and REDOX 1 are registered trademarks of Trek Diagnostic Systems, Inc. VITEK is a trademark of biomérieux Inc. Microsoft and Windows are registered trademarks of Microsoft Corporation. Unless otherwise noted, BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. BD Diagnostics is an EN ISO registered manufacturer BD January 2009 Printed in USA