Archive for December, 2005

Vaccine-Preventable Diseases – Zoster vaccine reduces neuralgia by 66.5%

Source: Infectious Disease News – June 2005

Study showed the investigational live-attenuated VZV vaccine reduced incidence, severity and duration of herpes zoster pain.

by Tara Grassia – Staff Writer

An investigational live-attenuated varicella zoster virus (VZV) vaccine (Zostavax, Oka/Merck) significantly reduced the burden of illness and incidence of postherpetic neuralgia (PHN) and herpes zoster (HZ) in older adults, according to a recently published study.

The phase-3 Shingles Prevention Study compared the vaccine with a placebo in men and women ages 60 and older. Researchers found that the zoster vaccine reduced the burden of illness and discomfort caused by HZ by 61%, the incidence of HZ by 51% and the incidence of PHN by 67%.

“We are delighted that the results from this study … met or exceeded the predefined criteria for success,‿ said lead researcher Michael N. Oxman, MD, an infectious disease specialist at the San Diego Veterans Affairs Healthcare System and the University of California, San Diego. “For those people who develop the most common complication of shingles, PHN, pain can last for weeks, months or even years. Even the touch of one’s own shirt against the affected area can be very painful for someone suffering from PHN.‿

The Department of Veterans Affairs conducted the study in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and Merck at 22 research sites across the United States over a period of more than five years.

“This is a monumental study in size and significance,‿ said Philip A. Brunell, MD, chief medical editor of Infectious Diseases in Children, a sister publication of Infectious Disease News, and one of the 38,546 participants in the study. “Although as pediatricians we are concerned about chickenpox, the other illness caused by this virus, zoster, is a much more significant problem. It is disabling to many elderly, and that is why I was the first volunteer as well as the principal investigator at the NIH site for the study. Unfortunately, I just learned that I have received the placebo!‿

Evaluating the vaccine

Researchers conducted the randomized, double-blind, placebo-controlled study between November 1998 and September 2001. They completed follow-up in April 2004. The aim was to determine whether vaccination with a single dose of the vaccine would decrease the incidence and/or severity of HZ and PHN in people 60 and older who had no previous history of HZ.

This investigational zoster vaccine is about 14 times more potent than the standard pediatric vaccine (Varivax, Merck), but contains exactly the same Oka strain. Participants were randomized into two study cohorts: a placebo group and a vaccine group. Researchers followed both groups for an estimated 3.12 years of surveillance through the development of HZ.

Polymerase chain reaction assay, viral culture and a five-physician member evaluation committee consisting of HZ experts assessed suspected cases of HZ. Oxman and colleagues offered participants with clinically diagnosed HZ antiviral treatment with famciclovir (Famvir, Novartis) as appropriate and standard-of-care treatment for pain.

The primary endpoint of the study was the burden of illness caused by HZ over the first six months after rash onset, a measure affected by the incidence, severity and duration of pain.

Oxman and colleagues evaluated and compared severity of pain and the incidence of PHN and HZ using the Zoster Brief Pain Inventory questionnaire. Zero indicated no pain and 10 indicated the worst pain. HZ-associated pain that persisted or appeared more than 90 days after the onset of rash defined PHN. Researchers assigned a score of zero to participants who did not develop HZ. The burden of illness score represented the average severity of illness among all people in both groups.

Illness and incidence reduced

Oxman and colleagues found significant reductions in the burden of illness and incidence of PHN and HZ. Findings indicated efficacy with vaccine use on all measured endpoints compared with the placebo group. According to the findings, as explained in a release, the vaccine significantly reduced the incidence, severity and duration of pain and discomfort associated with HZ by 61.1%. The overall burden of illness score was 2.21 for the vaccine group (n=19,254) compared with 5.68 in the placebo group (n=19,247). HZ incidence was reduced by 51.3%: 315 cases of HZ occurred in the vaccine group compared with 642 cases in the placebo group.

Overall incidence of PHN significantly reduced by 66.5%. PHN occurred in 27 participants in the vaccine group compared with 80 cases in the placebo group.

Five participants had serious adverse events. After evaluation, site investigators determined they were possibly vaccine related. Exacerbation of asthma and polymyalgia rheumatica occurred in the vaccine group and anaphylactoid reaction, polymyalgia rheumatica and Good pasture’s syndrome occurred in the placebo group.

“Reactions at the injection site were more frequent among vaccine recipients but were generally mild,‿ the researchers wrote in their abstract, published in The New England Journal of Medicine. They found that erythema occurred in 35.8% of the vaccine group compared with 7.0% of the placebo group, pain or tenderness occurred in 34.5% compared with 8.5%, swelling occurred in 26.2% compared with 4.5% and pruritus occurred in 7.1% compared with 1%.

A subject-by-subject chart review revealed no differences between the two cohorts in the pathophysiology, nature, timing, intensity or outcome of these adverse events.

For more information:
Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. New Eng J Med. 2005:352;2271-2284.

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December 25, 2005 at 6:10 pm Leave a comment

Vaccine-Preventable Diseases – FDA approves first pertussis booster

Source: Infectious Disease News – June 2005

GlaxoSmithKline’s Boostrix will be used in children and adolescents between the ages 10 and 18.

The FDA approved the first combination vaccine designed to boost immunity to pertussis in adolescents.

The tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap; Boostrix, GlaxoSmithKline), is a single-dose active booster immunization for adolescents between the ages of 10 and 18.

“The introduction of [Tdap] marks a milestone in the fight against pertussis in the United States, particularly among adolescents who are an important reservoir for the disease and are often the source of infection for infants,‿ said Gary Marshall, MD, professor of pediatrics at the University of Louisville School of Medicine in Kentucky, in a press release. “Adding pertussis to the current tetanus and diphtheria booster shot for teens is a logical strategy to prevent this disease in adolescents – without additional injections.‿

Reported cases of pertussis have risen nearly 20 times since 1976. According to the CDC, there were almost 20,000 cases in 2004, the highest number of reported cases in more than 40 years. Although booster vaccines for adolescents containing tetanus and diphtheria are currently licensed and marketed for use in this age group, none contain a pertussis component. Boostrix has the same components as GlaxoSmithKline’s Infanrix, a DTaP vaccine for infants and young children, but in reduced quantities.

Clinical trials

The immune response measured the efficacy of the vaccine through antibody concentrations. The response to the tetanus and diphtheria components was at least as good as the response to a licensed Td vaccine.

In one phase-3 clinical trial, 4,114 healthy 10- to 18-year-old adolescents were vaccinated with one dose of the vaccine or a U.S.-licensed Td vaccine. Each adolescent had completed his or her routine childhood vaccinations against diphtheria, tetanus and pertussis according to the current routine immunization schedule.

In both groups, 99.9% or more of adolescents had anti-diphtheria and anti-tetanus concentrations of 0.1 1U/mL or higher, indicating seroprotection against the two diseases.

In the Tdap vaccine group, the levels of anti-pertussis antibodies, anti-PT, anti-FHA and anti-PRN were measured and were statistically higher than pertussis antibody concentrations observed in infants, following primary immunization with a DTaP vaccine. The overall safety profile was comparable between the two vaccine groups.

Adverse events included pain, redness and swelling at the injection site. The frequency of redness and swelling after the new vaccine was similar to what is expected following administration of a Td vaccine; however, pains at the injection site were more frequent with those who received the new vaccine.

Other side effects included headache, fever and fatigue for a short period after injection.

Down the line

Recommendations for use of the vaccine could be decided at the Advisory Committee on Immunization Practices meeting in Atlanta this month. The FDA, as of press time, had not acted on an application for a Tdap vaccine from Sanofi Pasteur called Adacel. Although the applications were not filed at the exact same time, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave both vaccines the go-ahead at a meeting in March.

The Sanofi Pasteur vaccine is a single-dose active booster immunization for adolescents and adults between the ages of 11 and 64. VRBPAC reviewed the results of four principle clinical studies that included more than 7,200 people who were evaluated for safety regarding the Sanofi Pasteur vaccine. The immunogenicity profile of the Sanofi Pasteur vaccine was documented in a randomized subset of participants enrolled in the studies. Across the four trials, 4,342 recipients of either the Sanofi Pasteur product or the Td vaccine were evaluated for their immune responses to vaccination.

In addition to its pivotal study, Sanofi Pasteur presented data on the concomitant administration of the hepatitis B and influenza vaccines. Investigators found that the vaccine could be given concomitantly with hepatitis B and influenza vaccines, but with influenza vaccine there was a lower response rate to the pertussis components of the Tdap vaccine.

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December 25, 2005 at 6:05 pm Leave a comment

HIV/AIDS & STDs – Screen HIV patients for kidney disease

Source: Infectious Disease News – June 2005

by Tara Grassia – Staff Writer

HIV caregivers should screen newly diagnosed patients early for kidney disease in order to identify those patients at risk for chronic kidney disease, a serious complication of HIV, according to newly released guidelines.

“Kidney disease, like many other chronic conditions in the HAART [highly active antiretroviral therapy] era, is increasingly common.

Armed with a little knowledge, the HIV caregiver can make a huge difference in preventing the need for dialysis,? said Samir K.

Gupta, MD, MS, lead author of and one of the clinical experts who assembled the guidelines.

“Guidelines for the management of chronic kidney disease in HIV-infected patients? are the first set of guidelines to address the management of HIV-related nephropathy in HIV patients, he told Infectious Disease News.

The HIV Medicine Association of the Infectious Diseases Society of America issued the guidelines. They focus on the clinical issues of HIV-related renal diseases among adults and children and provide an understanding of the causes, epidemiology, screening methods and therapeutic strategies associated with chronic kidney disease in HIV patients.

“We’re trying to shift gears from how you treat the HIV-infected patient with severe kidney disease to how do we look for the ones who are at risk of developing severe kidney disease and taking care of them early, so they don’t have to end up going on dialysis,? said Gupta, also assistant professor of medicine, division of infectious diseases at Indiana University School of Medicine.

Screening recommendations

“The main recommendation is screening for renal disease, and not just with a serum creatinine,? Gupta said. “It’s important to remember that a serum creatinine is an imperfect measure of kidney function.?

Therefore, he suggested using a formula that incorporates serum creatinine, like the Cockcroft-Gault equation or the simplified modification of diet in renal disease equation in adults and the Schwartz equation in children, to examine the patient’s kidney status.

Variables such as age, race, sex, weight and serum creatinine, are important to consider when estimating kidney function, Gupta said, because knowing a patient’s renal function directly influences antiretroviral and prophylaxis medication, drug dosing and disease progression.

The guidelines recommend HIV caregivers assess all diagnosed patients for kidney disease by means of a urine analysis to check for an abnormal amount of proteinuria and also to evaluate kidney function. If patients have either reduced renal function or a dipstick urine analysis with proteinuria grade greater than or equal to 1+, the guidelines recommend collaboration with a nephrologist for additional evaluation, such as renal ultrasound, proteinuria quantification and, if needed, renal biopsy.

“Therapy for HIV-associated renal diseases should be individualized to the patient’s clinical circumstances and to the underlying renal histology findings,? they recommended in the guidelines.

According to the guidelines, those at high risk of kidney disease include black people, those with low CD4+ cell counts (less than 200 cells/L) or high viral loads (greater than 4,000 copies/mL), those with a family history of kidney disease or a history of nephrotoxic medications and people with comorbidities such as diabetes mellitus, hypertension or hepatitis C.

High-risk patients should undergo annual or periodic screening, even if there is no initial evidence of proteinuria, they suggested.

HIV-related nephropathy

Up to one-third of HIV patients have abnormal amounts of protein in their urine, a warning sign of potential kidney trouble.

“Even though the incidence of [HIV-related nephropathy] appears to have slowed considerably with the availability of combination antiretroviral therapies, there appears to be an increasing prevalence of all stages of [chronic kidney disease,? Gupta said.

He speculated that kidney disease has become more of a concern for people living with HIV/AIDS since the beginning of the HAART era.

“Before HAART was available, we needed to help patients survive first. These other conditions, although of concern, took a back seat,? Gupta said. “But now, as patients are living longer and are doing relatively well because of HAART, we’re starting to see these other chronic conditions emerge and become more prevalent.?

Upon diagnosis, patients with HIV-related nephropathy should be treated with HAART, the guidelines advise, and treatment should not be withheld because of the severity of patients’ renal function.

Gupta noted that patients who already have advanced renal disease may also benefit from antiretroviral therapy. “A lot of people say, ‘Well, I have to tackle somebody’s HIV first and then worry about the kidneys next.’ You may be doing both at the same time,? he said.

For more information:

Gupta SK, Eustace JA, Winston JA, et al. Guidelines for the management of chronic kidney disease in HIV-infected patients: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2005;40:1559-1585.

www.idsociety.org

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December 25, 2005 at 5:55 pm Leave a comment

HIV/AIDS & STDs – HAART not affected by hormonal contraceptives

Source: Infectious Disease News – June 2005

No association found between hormonal birth control use and CD4+ cell count or viral load suppression after HAART initiation.

by Tara Grassia – Staff Writer

Estrogen and progesterone hormones in contraceptives do not influence the effectiveness of highly active antiretroviral therapy (HAART), according to a recent study.

Researchers at the Johns Hopkins Bloomberg School of Public Health and other institutions investigated the possible influence of hormonal contraceptive use on CD4+ cell count and viral load and its response to HAART.

“Our main conclusion was that we did not find an association between hormonal contraceptive use and changes in CD4+ cell count or time to viral load suppression after initiation of HAART,? said Stephen J. Gange, PhD, a study researcher and an associate professor in the department of epidemiology at the Bloomberg School of Public Health.

Gange and colleagues also did not find any connection between those outcomes and the duration of hormonal contraception use before HAART initiation.

“From a public health perspective, our findings alleviate concerns regarding suspected negative effects of hormonal contraceptive use on the response to HAART,? he told Infectious Disease News.

Contraceptive’s connection

Researchers examined the role of hormonal contraceptive usage and the effectiveness of HAART among 77 contraception users and 77 nonusers, using data collected from the Women’s Interagency HIV Study (WIHS). WIHS is a large, ongoing cohort study of about 3,700 women living with HIV and high-risk women in the United States, said Gange, also principal investigator of WIHS.

Of the hormonal contraceptive users, 64% took oral contraceptives and 27% used depomedroxy progesterone acetate (Depo-Provera, Pfizer). The remaining participants used Norplant (Wyeth) or a combination, Gange said.

Researchers matched participants according to age, race and pre-HAART CD4+ cell counts and viral load, and followed them from onset of HAART initiation. Hormonal contraceptive use or nonuse and cell count and viral load response to HAART were all compared.

The researchers did not find a “statistically significant difference in CD4+ cell counts and log viral load responses by hormone use after HAART initiation,? according to the study. No relationship between those outcomes and the duration of hormonal contraception use before HAART initiation was found.

“The study results also reinforce the strong effects of HAART on HIV-disease progression,? he said. Women who used HAART continuously were almost three times more likely to experience a CD4+ cell count increase of 50 cells/mm3, over 3.5 times more likely to achieve a CD4+ cell count increase of 100 cells/mm3 and approximately 2.7 times more likely to achieve an undetectable viral load than contraceptive nonusers.

Gange and colleagues recommended follow-up data collection in the future in order to assess the effects of potential long-term exposure to hormonal contraceptives.

For more information:
Chu JH, Gange SJ, Anastos K, et al. Hormonal contraceptive use and the effectiveness of highly active antiretroviral therapy. Am J of Epidemiol. 2005;161:881-890.

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December 25, 2005 at 5:50 pm Leave a comment

CDC suggests limiting use of IgM anti-HAV testing to curb false positive results

Source: Infectious Disease News – June 2005

Physicians should only use IgM anti-HAV testing for people who meet the clinical criteria for hepatitis A infection.

Three investigations into the use of the immunoglobulin M (IgM) anti-hepatitis A virus (HAV) serologic test suggest that the positive tests reported recently are not representative of acute HAV infections.

“To improve the predictive value of a positive IgM anti-HAV test, clinicians should limit laboratory testing for acute HAV infection to persons with clinical findings typical of hepatitis A or to persons who have been exposed to settings where HAV transmission is suspected,? CDC officials wrote in a recent Morbidity and Mortality Weekly Report (MMWR).

The investigations

The Connecticut Department of Public Health conducted telephone interviews with patients and health care providers concerning 127 positive IgM anti-HAV tests reported between January 2002 and April 2003 and found 108 had an illness consistent with the criteria for hepatitis A infection.

The 19 who did not meet the criteria for infection did not report recent exposure to a patient with hepatitis A and were either asymptomatic or did not have clinical signs of the illness.

Three of the 19 had elevated alanine aminotransferase (ALT) concentrations. In the four to 59 months leading up to the most recent test, three had a prior positive test. No one specific test brand or lot number was used for the tests, CDC officials said.

In Alaska, the Division of Public Health found that between 2002 and 2004, 27 reported cases of hepatitis A were consistent with the clinical definition of the infection and 10 were not.

Seven of the 10 had abnormal serum ALT concentrations, “indicating likely liver injury or disease,? CDC officials wrote. “However, six did not have an illness with acute onset and were considered unlikely to have hepatitis A.?

Of the 10, one patient was tested to examine the need for and response to vaccination. Another patient had tested positive in 2000.

The CDC examined data from its Sentinel Counties Study of viral hepatitis in the country for 2003 in response to requests from health departments for assistance in figuring out if those who were getting tested were truly infected. The study is a population-based surveillance in six U.S. counties; the six counties represent an age range and a racial ethnic composition similar to the entire country, CDC officials wrote.

One hundred forty people reported a positive IgM anti-HAV test in 2003, but 87 did not have criteria-consistent illness for hepatitis A infection. The CDC noted that those who did not have criteria-consistent illness were significantly older and female (P Test only when needed

“Test results indicating acute HAV infection among [people] who do not have clinical or epidemiologic features consistent with hepatitis A are a concern for state and local health departments because of the need to assess whether contacts need postexposure immunoprophylaxis,? the CDC said.

A lack of reason for testing on many of the people with false positive test results is one of the limitations of the study. Another limitation is that serum specimens without a criteria-consistent illness from Connecticut and Alaska were not available for further testing, while a limited number from the Sentinels Counties Study were available.

Still, the CDC said, “published guidelines for the workup of abnormal liver enzyme tests among asymptomatic patients do not include IgM anti-HAV testing.

“Health care providers should limit use of IgM anti-HAV testing to [people] with evidence of clinical hepatitis or to those who have had recent exposure to an HAV-infected person,? the CDC said.

“Persons who are IgM anti-HAV positive but who do not have illness consistent with the case definition for hepatitis A should not be reported to the CDC.?

For more information:
The CDC. Positive test results for acute hepatitis A virus infection among persons with no recent history of acute hepatitis — United States, 2002-2004. MMWR. 2005;54:453-456.

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December 25, 2005 at 5:48 pm Leave a comment

An FDA advisory committee voted yes with reservations for accelerated approval of tipranavir after evaluating safety and efficacy data.

Source: Infectious Disease News – June 2005

Investigational HIV PI recommended for accelerated approval

by Tara Grassia – Staff Writer

The Antiviral Drugs Advisory Committee of the FDA recommended accelerated approval of the investigational HIV protease inhibitor (PI) tipranavir (Aptivus, Boehringer Ingelheim) for the treatment of HIV in drug-resistant patients.

Last month the committee convened to review safety and efficacy data, and while the decision passed by an 11 to 3 vote in favor of accelerated approval, those who voted yes expressed caution and stressed that further studies should be conducted.

“As a committee, we have agreed there is efficacy demonstrated, but the exact usefulness of this drug needs to be monitored in the future,? said Janet Englund, MD, the committee’s chair and associate professor at the University of Washington in Seattle.

The committee specifically highlighted the need for future studies that focus on how to monitor and manage adverse events, such as long-term liver toxicities. Most members felt the benefits outweighed the potential risks, and physician monitoring could control them.

The FDA granted tipranavir priority six-month review in February 2005 after Boehringer Ingelheim submitted New Drug Application (NDA) 21-814 (tipranavir, 250 mg capsules) in December 2004. If approved, tipranavir would become the second marketed non-peptidic PI – nelfinavir (Viracept, Pfizer) was the first, approved in 1997.

Tipranavir requires boosting with low-dose (200 mg) ritonavir (Norvir, Abbott) and must be used in combination with other antiretroviral agents. It is currently in late phase-3 clinical development.

The committee based its recommendation on 24-week efficacy data from two phase-3 clinical trials, RESIST-1 and RESIST-2. RESIST-1 included 620 people and was conducted in Australia, Canada and the United States; RESIST-2, a sister-study, included 863 people from Europe and Latin America.

These trials found that tipranavir showed evidence of antiviral effect in PI-resistant patients over currently approved and available antiretroviral regimens.

Researchers conducted both studies in PI-resistant treatment-experienced patients. These patients had taken three classes of anti-HIV drugs and were failing their PI-based regimen at the time of study entry.

RESIST-1 and RESIST-2 examined the treatment response of tipranavir boosted with ritonavir vs. a comparator group, where patients received one of several marketed ritonavir-boosted PIs. In addition, patients in both arms received an optimized background regimen of other antiretroviral drugs.

Based on available clinical and in vitro data, tipranavir boosted with ritonavir appeared to retain activity against many strains of HIV that are resistant to available PIs; however, some adverse events were associated with use, and the committee had many concerns.

Tipranavir safety profile

Christopher Corsico, MD, head of drug surveillance information at Boehringher Ingelheim, elaborated on the risks and benefits of the drug usage by presenting tipranavir safety profile information to the committee. He said that the most common adverse events reported among participants in the RESIST trials were gastrointestinal illnesses (5%).

Other adverse events included fatigue, headache, dizziness and a mild rash occurred more often in women than in men, he added.

Andrea N. James, MD, primary medical reviewer for the division of antiviral drug products at the FDA, presented a safety summary of the trials as well and said there were three adverse events associated with tipranavir: hyperlipidemia, rash and hepatoxicity.

The research indicated that women consistently had a higher incidence of rash than men, James said, and the cause is unknown.

However, women comprised only an estimated 15% of the study population.

Patients treated with tipranavir boosted with ritonavir experienced a significantly higher rate of liver enzyme and lipid elevations.

According to trials, 6% of tipranavir patients showed grade-3 or -4 elevations in alanine transaminase/aspartate transaminase (ALT/ALS) liver enzymes compared with 2% of patients receiving an active control. However, most patients with liver abnormalities were asymptomatic, and most patients were successfully treated without discontinuation.

Regardless of the adverse events, James said she believes that “tipranavir boosted by low-dose ritonavir can offer significant benefits to those who have advanced HIV disease.? She told the committee that tipranavir had “superior activity over a suboptimal control group in treatment-experienced, advanced HIV patients.?

With the accelerated approval recommendation, the committee stressed the need for more information on how HIV caregivers can manage any long-term adverse events associated with tipranavir and drug-drug interactions.

Recommendations made

The committee advised that tipranavir used in combination with other medications, such as diabetic, cholesterol and oral contraceptive pills, should be further researched.

Research is also needed to determine which patients are most likely to respond to the therapy; researchers also need genotype data on patient response.

Committee members expressed their concerns to the company about possible liver damage, and they recommended future hepatoxicity studies and future studies that include a larger study population of women.

The FDA will consider the committee’s recommendations in its review of the NDA for tipranavir.

For more information:
To view the Antiviral Drugs Advisory Committee meeting presentation agenda from May 19, 2005, visit the FDA’s Web site at: www.fda.gov/ohrms/dockets/ac/05/slides/2005-4139-Web-Slide-Index.htm

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December 25, 2005 at 5:42 pm Leave a comment

Evaluation of Conventional Castaneda and Lysis Centrifugation Blood Culture Techniques for Diagnosis of Human Brucellosis

Source: Journal of Clinical Microbiology Sep 2004 p.4327-4328 Vol.42 N.9

Basappa G. Mantur* and Smita S. Mangalgi

Department of Microbiology, B.L.D.E.A’s Shri B. M. Patil Medical College, Bijapur, Karnataka, India

We investigated the role of the lysis centrifugation blood culture technique over the conventional Castaneda technique for the diagnosis of human brucellosis. The lysis centrifugation technique has been found to be more sensitive in both acute (20% higher sensitivity; P * Corresponding author. Mailing address: Department of Microbiology, B.L.D.E.A’s Shri B. M. Patil Medical College, Bijapur 586 103, Karnataka, India. Phone: (91) 8352-262770, ext. 2227. Fax: (91) 8352-263019. E-mail: drbgmantur@rediffmail.com.

December 24, 2005 at 4:11 pm Leave a comment

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