☆ 4.7 Article

The Health-System Benefits and Cost-effectiveness of Using Mycobacterium Tuberculosis Direct Nucleic Acid Amplification Testing to Diagnose Tuberculosis Disease in the United States

CLINICAL INFECTIOUS DISEASES (2013)

Journal

CLINICAL INFECTIOUS DISEASES

Volume 57, Issue 4, Pages 532-542

Publisher

OXFORD UNIV PRESS INC

DOI: 10.1093/cid/cit336

Keywords

tuberculosis; diagnosis; molecular; cost; nucleic acid amplification

Funding

Tuberculosis Epidemiologic Studies Consortium (TBESC) of the US Centers for Disease Control and Prevention

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Abstract

Background. The utility of Mycobacterium tuberculosis direct nucleic acid amplification testing (MTD) for pulmonary tuberculosis disease diagnosis in the United States has not been well described. Methods. We analyzed a retrospective cohort of reported patients with suspected active pulmonary tuberculosis in 2008-2010 from Georgia, Hawaii, Maryland, and Massachusetts to assess MTD use, effectiveness, health-system benefits, and cost-effectiveness. Results. Among 2140 patients in whom pulmonary tuberculosis was suspected, 799 (37%) were M. tuberculosis-culture-positive. Eighty percent (680/848) of patients having acid-fast-bacilli-smear-positive specimens had MTD performed; MTD positive-predictive value (PPV) was 98% and negative-predictive value (NPV) was 94%. Nineteen percent (240/1292) of patients having smear-negative specimens had MTD; MTD PPV was 90% and NPV was 88%. Among patients suspected of tuberculosis but not having MTD, smear PPV for lab-confirmed tuberculosis was 77% and NPV 78%. Compared with no MTD, MTD significantly decreased time to diagnosis in patients with smear-positive/MTD-positive specimens, decreased respiratory isolation for patients having smear-positive/MTD-negative/culture-negative specimens, decreased outpatient days of unnecessary tuberculosis medications, and reduced resources expended on contact investigation. While MTD generally cost more than no MTD, incremental cost savings occurred in patients with human immunodeficiency virus (HIV) or homelessness to diagnose or to exclude tuberculosis, and in patients with substance abuse having smear-negative specimens to exclude tuberculosis. Conclusions. MTD improved diagnostic accuracy and timeliness and reduced unnecessary respiratory isolation, treatment, and contact investigations. It was cost saving in patients with HIV, homelessness, or substance abuse, but not in others.

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Minimally instrumented SHERLOCK (miSHERLOCK) for CRISPR-based point-of-care diagnosis of SARS-CoV-2 and emerging variants

Helena de Puig, Rose A. Lee, Devora Najjar, Xiao Tan, Luis R. Soekensen, Nicolaas M. Angenent-Mari, Nina M. Donghia, Nicole E. Weckman, Audrey Ory, Carlos F. Ng, Peter Q. Nguyen, Angelo S. Mao, Thomas C. Ferrante, Geoffrey Lansberry, Hani Sallum, James Niemi, James J. Collins

Summary: The miSHERLOCK is a low-cost CRISPR-based POC diagnostic platform that can rapidly detect SARS-CoV-2 and its variants with high sensitivity in just 1 hour. This modular system can be quickly adapted to different viruses and variants, and is complemented by a smartphone application for output interpretation and result reporting.

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