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Using Xpert to discontinue airborne isolation –
The Consensus Statement
Neha Shah, MD MPH
Tuberculosis Control
California Department of Public Health
Centers for Disease Control and Prevention
NAR February 2017
Disclosures
• No affiliation or financial relationship with any of the tests or companies mentioned in this presentation
• This presentation does not necessarily represent the official position of the US Centers for Disease Control and Prevention
Removing Patients from A.I.I.
• Infectious TB disease is considered unlikely AND
EITHER
– another diagnosis explains the clinical syndrome
OR
– 3 consecutive, negative sputum smears with at least one is an early morning specimen
• For negative sputum smear results, release from A.I.I in 2 days.
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Removing Patients from A.I.I.
• Traditionally 3 sputum smears collected early morning on 3 consecutive days
– Took a long time: average 5-7 days in isolation
– Not sensitive 50-60%
– Not specific 70-90% (depending on NTM and TB prevalence)
Abad et. al. J of Hosp Infection 2010:97; Swai et al. BMC Research Notes 2011 4(475); Cattamanchi et al. BMC Infect Dis. 2009; 9: 53.
Singhal et al. Intl J of Mycobacteriology 2015: 4 (1)
Problems with Isolation
• Limited number of A.I.I. rooms
• Systemic review showed patients in isolation tend to:
– Be seen less by HCWs
– Have an 8 fold increase in adverse effects
– Have a negative perspective of their care*
– Delay in getting the proper procedure performed
*Abad et. al. J of Hosp Infection 2010:97
Summary ACTG trial
Overall Smear positive
Smear Negative
NPV
1 Xpert 85.2% 96.7% 59.3% 99.7%
2 Xperts 91.1% 100% 71.4% 100%
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Summary of trial data
• Improved sensitivity and specificity of NAA versus sputum AFB smear
• Cost savings by reducing time in A.I.I. and length of hospital stay
* Luetkemeyer, et al. ACTG and TBTC. Clin Infect Dis. epub 2/2/2016
FDA Approval of Xpert for A.I.I.
Either one or two sputum specimens can be used as an alternative to examination of serial acid-fast stained sputum smears to aid in the decision to discontinue A.I.I. for patients with suspected pulmonary TB
Purpose:
To provide guidance on the use of the Xpert to discontinue airborne infection isolation (A.I.I.) for persons with suspected, infectious pulmonary tuberculosis (TB)
Consensus Statement
• IS DOES NOT ADDRESS
– The diagnosis of TB
– When a TB case/suspect can be released from the hospital
• IT IS
– To help predict infectiousness
– To help determine clinical appropriateness to be removed from isolation
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Case 1
• 91 year old male from Philippines
• Remote history of TB per patient
• Hemoptysis but no other TB symptoms
• Xpert positive
• Discontinue Isolation?
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Case 2
• 18 year old male from China
• IGRA negative
• CXR with LUL calcification consistent with granuloma disease
• Xpert negative
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Case 2
• 18 year old male from China
• IGRA negative
• CXR with LUL calcification consistent with granuloma disease
• Xpert negative x 2
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Case 3
• 18 year old male from China
• IGRA positive
• CXR with LUL calcification consistent with granuloma disease
• Nonproductive cough
• Xpert negative
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Case 3
18 year old from China
IGRA positive
CXR with LUL calcification consistent with granuloma disease
Dry cough
• Discontinue isolation?
• What if he had hemoptysis instead of dry cough?
• What if it was winter time and everyone in dorm had a cough?
• What if he was smear positive?
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Case 4
• 40 year US-born individual
• TST positive
• Had minimal contact to TB case
• Nonproductive cough
• CXR: minimal infiltrates RML
• Xpert negative
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Infectiousness
• Coughing
• Cavity in the lung
• TB disease of the lungs, airway, or larynx
• Undergoing cough-inducing or aerosol-generating procedures
• Not receiving adequate therapy
Xpert and A.I.I. Labelling Change: Operational Considerations
• Communication and coordination between clinicians and patient service providers are essential
– Nursing
– Respiratory Therapy
– Medical providers
– Laboratory
– IT / reporting platforms
– Institutional Infection Control
• Recognition of this process as independent of diagnostic protocol: Smears and cultures still must be obtained, followed-up
In The END, This Is Just The Beginning
• Data Collection and Analysis
– Infection Control programs should collaborate with the TB Laboratory and public health to collect and analyze data to evaluate the effectiveness methods used to determine discharge from A.I.I.
– Periodic analysis of protocol performance should be used to improve and/or modify policies and procedures
Summary
• Historically 3 smears used to determine discontinue of AII
• Can now use Xpert
• Consensus statement developed to assist with determining criteria to discontinue isolation
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Summary
• DO NOT use consensus statement as a diagnostic algorithm
• If smells like TB, it is still TB
• Keep public health TB program aware of any suspected TB cases
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