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

3

guidelines

4

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.

5

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

8

Luetkemeyer Clin Infect Dis. 2016 May 1;62(9) 9

Luetkemeyer Clin Infect Dis. 2016 May 1;62(9) 10

Luetkemeyer Clin Infect Dis. 2016 May 1;62(9) 11

Luetkemeyer Clin Infect Dis. 2016 May 1;62(9) 12

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%

13

Campos, Am J Respir Crit Care Med. 2008 Aug 1;178(3 14

Campos, Am J Respir Crit Care Med. 2008 Aug 1;178(3 15

Chaisson CID 2014: 59 16

Chaisson CID 2014: 59 17

Lippincott, Clin Infect Dis. 2014 Jul 15;59(2): 18

Lippincott, Clin Infect Dis. 2014 Jul 15;59(2): 19

Lippincott, Clin Infect Dis. 2014 Jul 15;59(2): 20

Lippincott, Clin Infect Dis. 2014 Jul 15;59(2): 21

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 Response

23

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

27

28

Case 1

• 91 year old male from Philippines

• Remote history of TB per patient

• Hemoptysis but no other TB symptoms

• Xpert positive

• Discontinue Isolation?

29

Case 1

30

Case 2

• 18 year old male from China

• IGRA negative

• CXR with LUL calcification consistent with granuloma disease

• Xpert negative

31

Case 2

32

Case 2

• Second Xpert negative

33

Case 2

34

Case 2

• 18 year old male from China

• IGRA negative

• CXR with LUL calcification consistent with granuloma disease

• Xpert negative x 2

35

Case 3

• 18 year old male from China

• IGRA positive

• CXR with LUL calcification consistent with granuloma disease

• Nonproductive cough

• Xpert negative

36

Case 3

37

Case 3

• Second Xpert negative

38

Case 3

39

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?

40

Case 3

41

Case 3

• Discontinue isolation?

• REPORT TO HEALTH DEPARTMENT

42

Case 4

• 40 year US-born individual

• TST positive

• Had minimal contact to TB case

• Nonproductive cough

• CXR: minimal infiltrates RML

• Xpert negative

43

Case 4

44

Case 4

• Second Xpert positive

45

Case 4

46

47

48

49

50

51

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

55

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

56

Acknowledgements

• National Tuberculosis Controllers Association

• California Tuberculosis Control

• Slides borrowed from John Bernardo and Dave Ashkin

• The Consensus Committee

57

NAAT