Research Article| Volume 16, ISSUE 3, P677-695, September 1996

Work Flow and Optional Protocols for Laboratories in Industrialized Countries

  • Phyllis Della-Latta
    Address reprint requests to: Phyllis Della-Latta, PhD, Clinical Microbiology Service, Columbia-Presbyterian Medical Center, 622 West 168 Street, New York, NY 10032
    From the Clinical Microbiology Service and the Mycology Resource Center, Columbia- Presbyterian Medical Center; and the Department of Clinical Pathology in Medicine, The College of Physicians and Surgeons of Columbia University, New York, New York
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      The algorithm of the mycobacteriology laboratory of the 1990s relies heavily on growth-dependent procedures that are slow and labor-intensive. The introduction of nucleic acid-based direct amplification tests portends the development of laboratories in which molecular diagnostic assays will prevail. Financial constraints mandate an interdisciplinary approach to establishing clinical pathways and rational tailoring of current protocols to curtail expensive overuse of dwindling resources.
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        • Albright R.E.
        • Graham C.B.
        • Christensen
        • et al.
        Issues in cerebrospinal fluid management. Acid-fast bacillus smear and culture.
        Clin Microbiol 95. 1990; 3: 418-423
        • American Thoracic Society
        Levels of laboratory services for mycobacterial diseases: Official statement of the American Thoracic Society.
        Am Rev Respir Dis. 1983; 128: 213
      1. Association of State and Territorial Public Health Laboratory Directors and Centers for Disease Control and Prevention. Mycobacterium tuberculosis: Assessing your laboratory. ASTPHLD no. U60-CCU303019, CDC Public Health Practice Program Office, 1995

        • Aznar J.
        • Hassan S.
        • Romero J.
        • et al.
        Nosocomial transmission of tuberculosis infection in pediatrics wards.
        Pediatr Infect Dis J. 1995; 14: 44-48
        • Babakhani F.K.
        • Warren N.G.
        • Henderson D.P.
        • et al.
        Effect of transportation and acid neutralization on recovery of mycobacteria from processed specimens.
        Am J Clin Pathol. 1995; 104: 65-68
        • Bartlett R.C.
        Medical Microbiology: Quality Cost and Clinical Relevance. John Wiley and Sons, New York1974: 24-31
        • Biehle J.R.
        • Cavalieri S.J.
        • Saubolle M.A.
        • et al.
        Evaluation of E test for susceptibility testing of rapidly growing mycobacteria.
        J Clin Microbiol. 1995; 33: 1760-1764
        • Bloom B.R.
        Tuberculosis: Back to a frightening future.
        Nature. 1992; 358: 538-539
        • Brudney K.
        • Dobkin J.
        Resurgent tuberculosis in New York City: Human immunodeficiency virus, homelessness, and the decline of tuberculosis control programs.
        Am Rev Respir Dis. 1991; 144: 745-749
        • Centers for Disease Control and Prevention
        Biosafety in Microbiological and Biomedical Laboratories. ed 3. US Government Printing Office, Washington, DC1993 (HHS publ no (CDC) 93-8395.)
        • Centers for Disease Control
        Essential components of a tuberculosis prevention and control program screening for tuberculosis and tuberculosis infection in high-risk populations. Recommendations of the advisory council for the elimination of tuberculosis.
        MMWR Morb Mort Wkly Rep. 1995; 44: 1-34
        • Centers for Disease Control
        Exposure of passengers and flight crew to Mycobacterium tuberculosis on commercial aircraft 1992-1995.
        MMWR Morb Mortal Wkly Rep. 1995; 44: 137-140
        • Centers for Disease Control
        Nosocomial transmission of multidrug-resistant tuberculosis among HIV-infected persons—Florida and New York, 1988-1991.
        MMWR Morb Mort Wkly Rep. 1991; 40: 585-591
        • Centers for Disease Control
        Tuberculosis morbidity—United States, 1992.
        MMWR Morb Mort Wkly Rep. 1993; 42: 363
        • Cernoch P.L.
        • Enns R.K.
        • Saubolle M.A.
        • Weissfeld A.S.
        • et al.
        Laboratory Diagnosis of the Mycobacterioses. American Society for Microbiology, Washington, DC1994
      2. City Health Information.
        Tuberculosis Treatment. 1992; 11: 1-4
        • Clancy L.
        • Rieder H.L.
        • Enarson D.A.
        • et al.
        Tuberculosis elimination in the countries of Europe and other industralized countries.
        Eur Resp J. 1991; 4: 1288-1295
        • Clarridge J.E.
        • Shawar R.M.
        • Shinnick T.M.
        • et al.
        Large-scale use of polymerase chain reaction for detection of Mycobacterium tuberculosis in a routine mycobacteriology laboratory.
        J Clin Microbiol. 1993; 31: 2049-2056
      3. National Jewish Center for Immunology and Respiratory Medicine: Clinical Management and Control of Tuberculosis. New York Academy of Medicine. New York, March 9-11, 1992

      4. Clinical Management in Tuberculosis: Issues for the 1990s and Beyond. The New York Academy of Medicine, The New York State Department of Health, The New York City Department of Health, May 6, 1994

        • Curione C.J.
        • Kaneko G.S.
        • Voss L.J.
        • et al.
        Gram stain evaluation of the quality of sputum specimens for mycobacterial culture.
        J Clin Microbiol. 1977; 5: 381-382
        • D’Amato R.F.
        Can clinical microbiologists be fiscally responsible and not compromise patient care?.
        Clin Microbiol Updates. 1990; 2: 1-3
        • D’Amato R.F.
        • Wallman A.A.
        • Hochstein L.H.
        • et al.
        Rapid diagnosis of pulmonary tuberculosis by using Roche AMPLICOR Mycobacterium tuberculosis PCR test.
        J Clin Microbiol. 1995; 33: 1832-1834
      5. Della-Latta P, Waithe E, Whittier S, et al: Direct detection of M. tuberculosis from sequential specimens by the Gen-Probe amplified system and PCR [poster C-335]. Presented at the 94th General Meeting of American Society of Microbiology. Las Vegas, 1994

        • Della-Latta P.
        The tuberculosis lab in an era of cultural and molecular renaissance.
        Clin Microbiol Updates. 1995; 7: 1-6
        • Edlin B.R.
        • Tokars J.I.
        • Grieco M.H.
        • et al.
        An outbreak of multidrug-resisiant tuberculosis among hospitalized patients with the acquired immunodeficiency syndrome.
        N Engl J Med. 1992; 326: 1514-1521
      6. Federal Register 1992. Final guidelines for clinical laboratory improvement amendment of 1988, 42 CFR Part 493

        • Findlay J.B.
        • Atwood S.M.
        • Bergmeyer L.
        • et al.
        Automated closed-vessel system for in vitro diagnostics based on polymerase chain reaction.
        Clin Chem. 1993; 39: 1927-1933
        • Frieden T.R.
        • Fujiwara P.I.
        • Washko R.M.
        • et al.
        Tuberculosis in New York City—turning the tide.
        N Engl J Med. 1995; 333: 229-233
        • Gomez-Flores R.
        • Gupta S.
        • Tamez-Guerra R.
        • et al.
        Determination of MICs for Mycobacterium avium-M. intracellulare complex in liquid medium by a colorimetric method.
        J Clin Microbiol. 1995; 33: 1842-1846
        • Greenbaum M.
        • Beyt B.E.
        • Murray P.R.
        The accuracy of diagnosing tuberculosis at a large teaching hospital.
        Am Rev Respir Dis. 1980; 121: 477-481
      7. Gross W: Second National Conference on Laboratory Aspects of Tuberculosis, Atlanta, Centers for Disease Control and Association of State and Territorial Public Health Laboratory Directors, 1995

        • Hamburg M.A.
        • Frieden T.R.
        Tuberculosis transmission in the 1990’s.
        N Engl J Med. 1994; 330: 1750-1751
        • Havlik D.
        • Woods G.L.
        Screening sputum specimens for mycobacterial culture.
        Lab Med. 1995; 26: 411-413
        • Huebner R.E.
        • Good R.C.
        • Tokas J.I.
        Current practices in mycobacteriology: Results of a survey of state public health laboratories.
        J Clin Microbiol. 1993; 31: 771-775
        • Inderlied C.B.
        Antimycobacterial susceptibility testing: present practices and future trends.
        Eur J Clin Microbiol Infect Dis. 1994; 13: 980-993
        • Jones V.
        • Alden M.
        • Kamisango K.
        • et al.
        Detection and identification of Mycobacterium tuberculosis directly from sputum sediments by amplification of rRNA.
        J Clin Microbiol. 1993; 31: 4210-4216
      8. Kent PT, Kubica GP: Public Health Mycobacteriology. A guide for the level III laboratory. US Department of Health and Human Services, Public Health Service. Atlanta, Centers for Disease Control, 1985

        • Klein N.
        • Duncanson F.
        • Lenox T.
        • et al.
        Use of mycobacterial smears in the diagnosis of pulmonary tuberculosis in AIDS/ARC patients.
        Chest. 1989; 95: 1190-1192
        • Kline S.E.
        • Hedemark L.L.
        • Davies S.F.
        Outbreak of tuberculosis among regular patrons of a neighborhood bar.
        N Engl J Med. 1995; 333: 222-227
        • Macher A.
        • Goosby E.
        PCR and the misdiagnosis of active tuberculosis.
        N Engl J Med. 1995; 332: 128-129
        • MacIntyre C.R.
        • Plant A.J.
        • Hulls J.
        • et al.
        High rate of transmission of tuberculosis in an office: impact of delayed diagnosis.
        Clin Infect Dis. 1995; 21: 1170-1179
        • Mangels J.I.
        Cost containment in the clinical microbiology laboratory.
        in: Helman EZ Cost Containment in the Clinical Laboratory. Berkeley Scientific Publication, Denver1995: 142-226
        • McAdam J.M.
        • Brickner P.W.
        • Scharer L.L.
        • et al.
        The spectrum of tuberculosis in a New York City men’s shelter clinic (1982-1988).
        Chest. 1990; 97: 798-805
        • McKenna M.T.
        • McCray E.
        • Onorato I.
        The epidemiology of tuberculosis among foreign-born persons in the United States, 1986 to 1993.
        N Engl J Med. 1995; 332: 1071-1076
        • Menzies D.
        • Fanning A.
        • Yuan L.
        • et al.
        Tuberculosis among health care workers.
        N Engl J Med. 1995; 332: 92-97
        • Metchock B.
        • Diem L.
        Algorithm for use of nucleic acid probes for identifying Mycobacterium tuberculosis from BACTEC 12B bottles.
        J Clin Microbiol. 1995; 33: 1934-1937
      9. Murtagh JJ, Mathukutty J, Kimani AP, et al: Detection and speciation of mycobacteria by immunomagnetic and bioluminescent techniques [abstract]. In Abstracts of 1995 International Conference of the American Thoracic Society, 1995

        • Musser J.M.
        Antimicrobial agent resistance in mycobacteria: molecular genetic insights.
        Clin Microbiol Rev. 1995; 8: 496-514
      10. National Committee for Clinical Laboratory Standards: Molecular Diagnostic Methods for Infectious Diseases. Approved guidelines, NCCLS document MM3-A, 1994

        • Noordhoek G.T.
        • Kolk A.H.J.
        • Bjune G.
        • et al.
        Sensitivity and specificity of PCR for detection of Mycobacterium tuberculosis: A blind comparison study among seven laboratories.
        J Clin Microbiol. 1994; 32: 277-284
      11. Perry JL: Utility of cytocentrifugation for direct examination of clinical specimens. Clin Microbiol Newsletter 17:29-32

        • Perlman D.C.
        • Salomon N.
        • Perkins M.P.
        • et al.
        Tuberculosis in drug users.
        Clin Infect Dis. 1995; 21: 1253-1264
        • Pfyffer G.E.
        • Kissling P.
        • Wirth R.
        • et al.
        Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by a target-amplified test system.
        J Clin Microbiol. 1994; 32: 918-923
        • Pitchenik A.E.
        • Rubinson H.A.
        The radiographic appearance of tuberculosis in patients with the acquired immunodeficiency syndrome (AIDS) and pre-AIDS.
        Am Rev Respir Dis. 1995; 131: 393-396
        • Pohl A.D.
        • Keim A.C.
        Screening respiratory specimens for mycobacteria culture.
        Lab Med. 1993; 24: 25-27
        • Reichman L.B.
        The U-shaped curve of concern.
        Am Rev Respir Dis. 1991; 144: 741-742
        • Reisner B.S.
        • Gatson A.M.
        • Woods G.L.
        Evaluation of mycobacteria growth indicator tubes for susceptibility testing of Mycobacterium tuberculosis to isoniazid and rifampin.
        Diagn Microbiol Infect Dis. 1995; 22: 325-329
        • Ryan C.
        • Nguyen B.
        • Sullivan S.J.
        Rapid assay for mycobacterial growth and antibiotic susceptibility using gel microdrop encapsulation.
        J Clin Microbiol. 1995; 33: 1720-1726
        • Saceanu C.A.
        • Pfeiffer N.C.
        • McLean T.
        Evaluation of sputum smears concentrated by cytocentrifugation for detection of acid-fast bacilli.
        J Clin Microbiol. 1993; 31: 2371-2374
        • Sacks J.J.
        • Brenner E.R.
        • Breeden D.C.
        • et al.
        Epidemiology of a tuberculosis outbreak in a South Carolina junior high school.
        Am J Public Health. 1985; 75: 361-365
        • Salfinger M.
        • Pfyffer H.E.
        The new diagnostic mycobacteriology laboratory.
        Eur J Clin Microbiol Infect Dis. 1994; 13: 961-979
        • Schacter J.
        • Stamm W.E.
        • Quinn T.C.
        • et al.
        Ligase chain reaction to detect Chlamydia trachomatis infection of the cervix.
        J Clin Microbiol. 1994; 32: 2540-2543
        • Scott B.
        • Schmid M.
        • Nettleman M.D.
        Early identification and isolation of inpatients at high risk for tuberculosis.
        Arch Intern Med. 1994; 154: 326-330
        • Serafy N.
        • Kubala N.
        • Woods G.
        • et al.
        Laboratory practices for diagnosis of tuberculosis—United States, 1994.
        MMWR. 1995; 44: 587-590
        • Shinnick T.M.
        • Good R.C.
        Diagnostic mycobacteriology laboratory practices.
        Clin Infect Dis. 1995; 21: 291-299
        • Spargo C.A.
        • Haaland P.D.
        • Jurgensen S.R.
        • et al.
        Chemiluminescent detection of strand displacement amplified DNA from species comprising the Mycobacterium tuberculosis complex.
        Mol Cell Probes. 1993; 7: 395-404
        • Sprouse M.W.
        • Whitmore B.C.
        Developing a hospital policy for clinical pathways.
        J Healthcare Quality. 1995; 17: 40-47
      12. Stricof RL: NYS Department of Health, Bureau of Tuberculosis Control [personal communication]. 1995

        • Tenover F.C.
        • Crawford J.T.
        • Huebner R.E.
        • et al.
        The resurgence of tuberculosis: Is your laboratory ready?.
        J Clin Microbiol. 1993; 31: 767-770
      13. Tevere V, Appleman MD, Bankowski M, et al: Results of a multicenter clinical trial study for the direct detection of Mycobacterium tuberculosis in respiratory samples utilizing the AMPLICOR M. tuberculosis Test [poster U91]. Presented at the 95th General Meeting of American Society of Microbiology. Washington, DC, 1995

        • Wayne L.G.
        • Sramek H.A.
        Agents of newly recognized or infrequently encountered mycobacterial diseases.
        Clin Microbiol Rev. 1992; 5: 1-25
      14. Whittier S, Waithe E, Della-Latta P: Evaluation of Gen-Probe amplified MTD and Amplicor™ (Roche) for the direct detection of M. tuberculosis from respiratory specimens poster C-146. Presented at the 95th General Meeting of the American Society for Microbiology, Washington, DC, 1995

        • Woods G.L.
        • Pentony E.
        • Boxley M.J.
        • et al.
        Concentration of sputum by cytocentrifugation for preparation of smears for detection of acid-fast bacilli does not increase sensitivity of the fluorochrome stain.
        J Clin Microbiol. 1995; 33: 1915-1916
        • Yagupsky P.
        • Menegus M.A.
        Cumulative positivity rates of multiple blood cultures for Mycobacterium avium-intracellulare and Cryptococcus neoformans in patients with the acquired immunodeficiency syndrome.
        Arch Pathol Lab Med. 1990; 114: 923-925
        • Yajko D.M.
        • Nassos P.S.
        • Sanders C.A.
        • et al.
        High predictive value of the acid-fast smear for Mycobacterium tuberculosis despite the high prevalence of Mycobacterium avium complex in respiratory specimens.
        Clin Infect Dis. 1994; 19: 334-336