793. Diagnostic Accuracy of Single versus Multiple Gene Xpert for Discontinuation of Airborne Infection Isolation in Suspected Pulmonary Tuberculosis Patients at a US Safety-Net Hospital
Session: Poster Abstract Session: Tuberculosis and Other Mycobacterial Infections
Thursday, October 4, 2018
Room: S Poster Hall
Posters
  • idsa_pdf.pdf (632.2 kB)
  • Background:

    Patients suspected to have pulmonary tuberculosis (PTB) undergo serial sputum analysis under airborne infection isolation (AII). The US FDA approved the Cepheid GeneXpert-MTB-Rif® to support removing patients from AII. The FDA requires that “either one or two” separate sputum specimens be examined. To clarify this statement, the National Tuberculosis Controllers’ Association and the Association of Public Health Laboratories published guidelines that recommend that two sputum specimens be used and recommend that each institution examine their own data to determine if one specimen is sufficient. Most patients in low prevalence settings do not have PTB yet are tested several times; an optimal testing strategy will reduce unnecessary isolation and related expenses.

    Objective:                                   

    We sought to determine the diagnostic accuracy of a single versus two sputum samples for Xpert MTB/RIF in discharging suspected PTB patients from AII.

    Methods:  

    Retrospective review of patients admitted between September 2016 to January 2018 was undertaken to identify sensitivity, specificity, positive and negative predictive values, for MTB gene Xpert in comparison to Mycobacterial culture as the gold standard. We further analyzed whether a larger number of such tests improved diagnostic yield for PTB.

    Results:

    171 patients, 17.5% of whom were HIV+, mostly of non-US origins (64%), provided 312 samples for Xpert MTB/RIF, of which 26 were Xpert-positive. These 26 samples came from 15 patients, 14 of whom were diagnosed using the first sample tested with Xpert MTB/RIF. Sensitivity and specificity of the first sample tested with Xpert MTB/RIF was more than those for the first two samples considered together or for all tested samples. Of these 15 positive cases, 13 were confirmed on sputum culture; 10 were positive from the first, one from the second, and two from the third sputum samples cultured.

    Test details

    Sensitivity

    Specificity

    PPV

    NPV

    1st Sample PCR

    92.3% (63.97-99.81%)

    98.8% (95.74-99.85%)

    85.7%

    99.4%

    1st+2nd Sample PCR

    86.4% (65.09-97.09%)

    99.2% (97.16-99.90%)

    90.5%

    98.8%

    All Samples PCR

    88.9%

    99.3%

    92.3%

    98.9%

    Conclusion:

    Patients suspected to have PTB at our facility can be rapidly and accurately discharged from AII after testing a single sputum sample for MTB/RIF Xpert.

    Bhavna Seth, MD, Internal Medicine, Boston Univeristy Medical Center, Boston, MA, John Bernardo, MD, Boston University School of Medicine, Boston, MA and Carol Sulis, MD, FSHEA, Infectious Diseases, Boston Medical Center, Boston, MA

    Disclosures:

    B. Seth, None

    J. Bernardo, None

    C. Sulis, None

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