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Mycobacteriology Laboratory

TB Diagnosis

Beginning in the mid-1980s, our country experienced a resurgence of TB cases associated with a deteriorating public health infrastructure, outbreaks in congregate settings, the human immuno-deficiency virus infection epidemic, and the occurrence of multi-drug-resistant TB. In addition, the AIDS epidemic created increasing numbers of opportunistic diseases caused by Mycobacterium avium complex and other non-tuberculous mycobacteria (NTM). These NTM are indistinguishable by microscopic means from tubercle bacilli, making sputum smear results less specific for TB. In addition, many laboratories are not yet using gold standard methodologies, thus delaying the laboratory diagnosis of TB. This is especially harmful in the case of highly infectious, acid-fast bacilli (AFB) smear-positive TB patients.

Gold Standard

The gold standard for rapid and accurate TB testing methodologies combines radiometric growth detection (BACTEC) or an equivalent non-radiometric automated system, identification of the isolated AFB with species-specific molecular hybridization kits or other molecular assays, and radiometric susceptibility testing, or an equivalent non-radiometric automated system for all first-line anti-TB drugs, including Streptomycin. In 1996, the FDA approved the first nucleic acid amplification assay for direct detection of M. tuberculosis complex in acid-fast bacilli smear-positive sputum sediments. In 2001, the approval for one brand was extended to include smear-negative sputum sediments. A variety of resource issues appears to have delayed implementation of nucleic acid amplification technology in some TB laboratories.

Fast Track Program

The Fast Track program for TB testing was initiated in late 1993 to provide the most rapid identification and susceptibility testing of specimens from the priority group - highly infectious patients. This program is available to all health care providers and clinical laboratories in New York State that care for highly infectious smear-positive patients. Molecular assays, including nucleic acid amplification for rapid detection of TB in processed sputum, DNA probes for identification of AFB (M. tuberculosis complex, M. avium complex, M. gordonae and M. kansasii), and rapid molecular detection of rifampin resistance are essential components of the Fast Track program, thus providing benefits to all enrolled hospitals, clinics, and medical centers. As of December 2002, more than 160 institutions were enrolled.

The Five Main Characteristics of the Fast Track Program

  • Broader accessibility to state-of-the-art TB laboratory procedures enhances the health care of highly infectious patients by identifying and characterizing them earlier.
  • Infection control and public health officials can focus their efforts on highly infectious TB patients by providing ‘Directly Observed Therapy’ and contact investigations, both of which demand substantial resources.
  • For patients infected with NTM, the period of exposure to potentially toxic and unnecessary anti-TB drugs is dramatically shortened; these patients can also be released from respiratory isolation earlier, conserving health care resources.
  • Results are transmitted by mail and FAX to the sender, with copies to the local health unit and to the Bureau of Tuberculosis Control for New York City or New York State, as appropriate. Laboratory results generated by Wadsworth Center's Clinical Laboratory Information Management System (CLIMS) will be posted twice daily on the Health Information Network (HIN) and transferred via Electronic Clinical Laboratory Reporting System (ECLRS) to the New York State Bureau of Tuberculosis Control.
  • The mail report is accompanied by current information on case management to increase the likelihood of appropriate care.

Access to the Fast Track Program

  • Available to all physicians who provide health care for New Yorkers with newly diagnosed acid-fast bacilli, smear-positive sputum.
  • The New York State Department of Health’s Wadsworth Center is offering the Fast Track service at no charge.

State-of-the-art Laboratory Procedures

  • Nucleic acid amplification providing results within a working day
  • Radiometric detection
  • Species-specific hybridization kits
  • Radiometric susceptibility testing
  • Molecular detection of rifampin resistance

Administrative Speed

  • Sputum submission by overnight mail
  • Same day reporting by FAX
  • Seven-day-per-week reporting of susceptibility results

Enrollment

  • If you are interested in enrolling in the Fast Track Program please go to the enrollment form.