AIDS Patient

Serologic tests for Lyme disease, for example, are now being reviewed in consensus meetings in hopes of achieving better test systems. The consensus process des&ves a separate editorial, L the outcome could have significant implications for future resolution of problems with tests. The upshot is that tbe’range of tests systems that are supported commercially is limited, and some types of commercially supplied tests are not satisfactory for use. An alternative has always been for laboratories to develop and support their own test systems. During the 1989 to 1990 measles epidemic in the U.S., the two most effective diagnostic tests to detect measles cases-direct antigen c@ection and IgM antibody detectionwere not commercially supported. Only a few laboratories used these methods,

including laboratories that are not constrained by commercial test considerations, such as those at the Centers for Disease Control and Prevention. This alternative may be more difficult to pursue in the near future. The FDA has not regulated tests that are developed and used only within a specific laboratory, and are not marketed as packaged products. Although the details are not yet final, this process is beginning to change. Discussion of regulating the development and use of in-house tests has been taking place at the federal level for more than 2 yr now, and is expected to result in jurisdictional agreements between FDA and HCFA during the next year. State health department laboratories are the first to be subjected to FDA regulation. In California, test-reagent production by the

state Department of Health Services is now required to meet the good manufacturing practices standards for industry. Initially, the FDA is interested in regulating those test systems that have high public health impact, e.g., HlV tests. Eventually, the FDA and HCFA expect to have memoranda of understanding to cover regulation of other in-house clinical laboratory tests. HCFA laboratory inspectors will then require that such tests meet both CLIA ‘88 standards and FDA standards for evaluation of test performance. As a result, data collection for the development of an in-house test will need to be more thorough than before and it is likely that patient informed consent will be needed for any such test that is used for diagnosis and patient management.

Case Report

Mycobacterium genavense and Mycobacterium avium Mixed Infection in an

AIDS Patient

We report, however, a case in which

E. Tortoli M.T. Simonetti Laboratoryof Microbiology

D. Dionisio M. Meli G. Sterrantino Serviceof InfectiousDisease

Careggi Hospital 50139 Firenze, Italy

Several mixed nontuberculous myco-

bacterial infections have been reported in AIDS patients (l-5), and their prevalence is probably underestimated owing to the lack of differentiation of morphologically similar colonies in mixed cultures. Mixed infections are most difficult to detect when the coinfecting species, like Mycobacterium genavense, fails to grow on conventional solid media; according to Kirschner et al. (6), only the use of sequencing of PCR-amplified nucleic acids can detect such mixed infections.

Clinical Mcmbiology

Newsletter 17:22,1995

Mycobacterium avium and M. genavense were isolated from distinct

blood samples, drawn at different times of the same day, using BACTEC 13A medium (Be&on Dickinson, USA). While the isolation of M. avium was achieved in 2 wk, the recovery of M. genavkse required nearly 3 mo, with the growth index starting to rise at the end of the eighth week and with a further 25 d elapsing before microscopic detection. The M. avium isolate was identified by hybridization to commercial DNA probes (AccuProbe, USA), while the M. genavense was identified by E. B(ittger (Medizinische Hochschule, Hannover, Germany) by means of 16s rRNA sequencing. The AIDS patient, a severely immunocompromised (20 CD4’ cells/ml) 27yr-old homosexual man, presented with high fever, diffuse abdominal pain, hepatosplenomegaly, and confusion; the

Q 199.5 Elsevier Science Inc.

case closely resembled those of two previously described patients with dissemi,nated M. genavense infection, and the empirical therapy was based on the susceptibility patterns of those M. genavense strains (7). The regimen, a combination of amikacin, clofazimine, and rifampin, produced, as in a previous case of M. genavense infection (7), a rapid improvement with cessation of fever and recovery of normal mental _ status. Such a prompt response to the antimicrobial therapy is very unusual in disseminated M. avium infections and suggests that M. genavense was responsible for the patient’s symptomatblogy, as in the only other published report (6). Also, our M. avium isolate later was found to be resistant in vitro to clofazimine and rifampin, and only moderately susceptible to arnikacin. The impact of infections due to M. genavense in HIV-infected patients is surely greater than the paucity of re-

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ported case seem to suggest. The failure of IU. genavense to grow on conven-

tional solid media makes it undetectable in most clinical laboratories, even those using the BACTEC radiometric system, if a sufficient period of incubation is not allowed In the case of mixed infertion (most kquently with M. akm), M. genavense is missed because it is overgrown by the other species. In our case it was a matter of chance that the M. avium bactexcmia was not continuous, and only the practice of performing repeated blood cultures and our previous experience with M. genavense infections allowed us to initiate a prompt and effective therapy and to isolate what appears to be the organism mainly responsible for the clinical condition. . Every effort should be made to diagnose disseminated infections by M. genuvense in AIDS patients, because

Massenkell,G., et al. 1992. Disseminated coinfection with Mycobacterium

prompt and appropriate therapy can rapidly improve the otherwise severe and life-threatening symptomatology caused by this organism.

avium complex and Mycobacterium kunsasii in a patient with AIbS’kd liver abscess. Clm. Infect. Dis. 14:618

References 1 Torres, R.A., et al. 1991. Disseminated mixed Mycobacterium simiae-Mycobacterium avium complex infection in acquired immunodeficiency Infect. Dis. 164:432-433.

619. Gallant, J.E., K. Alw.ood, and R.E: Chaisson. 1994. Osteomyelitis

due to

Mycobacterium kansasii and Mycobacterium aviwn complex in an HIV-in-

syndrome. J.

fected patient. Infect. Dis. Clin. Pratt. 3:297.

Conville, P.S., J.F. Keiser, and F.G. Witebsky. 1989. Mycobacteremia caused by simultaneous infection with Mycobacterium avium and Mycobacterium intracellulare detected by analysis of a BACTEC 13A bottle with the Gen-Probe kit. Diagn. Microbial. Infect. Dis. 12:217-219.

Kirschner, P., et al. 1994. Bias of culture technique for diagnosing

mixed

Mycobacterium genavense and Mycobacterium avium infections in AIDS. J. Clin. Microbial.

32~828-831.

Tortoli, E., et al. 1994. Cultural studies on two isolates of “Mycobacterium

V., et al. 1987. Mycobacterium simiae and Mycobacterium avium-M. itiracellulare mixed infec-

genavense” from patients with acquired

tion in acquired immune deficiency syndrome. J. Clm. Microbial. 25:154-157.

Microbial.

L&y-Frkbault,

immunodeficiency

syndrome. Diagn.

Infect. Dis. 18:7-12.

General Information

Editors Mary

Jane Ferraro Paul A. Granato Josephine A. Morello R.J. Zabransky

Q 1995 Elsevier Science Inc. ISSN 0196-4399 CMNEEJ 17(22)169-176,1995

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Clinical Microbiology Newsletter 17~22.1995