NEW WORLD, NEW GUIDELINES: TB TESTING IN HEALTH CARE WORKERS

Transcription

1 NEW WORLD, NEW GUIDELINES: TB TESTING IN HEALTH CARE WORKERS AOHP Sept. 8, 2018 Glendale, AZ Wendy Thanassi MA, MD Chief, Occupational Health Service Veterans Administration Health Care System

2 THE EVOLUTION OF THE POLICIES 1) Global, local TB Rates 2) Quick Review of the Tests 3) New Policies based on the rates and tests

3 South Africa Kiribati Gabon Central African Republic Djibouti Botswana Philippines Sub-Saharan Africa Madagascar South Asia Haiti Laos Thailand Middle income Chad Cabo Verde Burundi Morocco Niger Malaysia Romania Palau Turkmenistan Sri Lanka Brunei Darussalam Rwanda Ecuador Nicaragua Honduras Armenia Libya Qatar Venezuela Bulgaria Mauritius Syrian Arab Republic Bahrain Japan Egypt, Arab Rep. Lebanon Saudi Arabia United Kingdom Sweden American Samoa Austria St. Vincent and the Grenadines Jordan Norway Denmark Finland St. Kitts and Nevis Curacao United Arab Emirates Monaco TUBERCULOSIS IN THE WORLD: INCIDENCE PER 100, Cambodia, Zambia USA = < % of global TB burden United States (2.9) Iceland (2.4)... British Virgin Islands (0)

4 TSPOT.TB NATIONAL POSITIVE RATES Note this is all hospital patients, public health, HCW test results combined

5 TB Case Rates, United States 2016 NYC DC *Cases per 100,000; as of June 21, DC, District of Columbia; NYC, New York City (excluded from New York state) 2.9 (2016 national average) >2.9

6 TB IS NOT AN OCCUPATIONAL RISK FOR HCW TB among HCWs, U.S L Lambert et al, Infect Control Hosp Epidemiol 2012;33:1126 Annual incidence of TB (per 100,000 population) in US: US-born HCW: 4.2 US-born person: Foreign born HCW: ~20 US foreign born person TB in HCWs in New York State, C. Driver et al Am J Infect Ctrl 2005;33:519 NY incidence of TB in 2002 (per 100,000 population) US-born HCW in NY: 2.0 US-born person in NY: 3.2 Foreign born HCW in NY 17.5 Foreign born person in NY 23.8

7

8 2,065 cases of active TB 92 cases were in HCW SO 4.5% of TB cases in CA are HCW 95.5% of TB in CA is not in HCW 21 cases HCW TB in L.A >400,000 tested

9 WASTE IN CALIFORNIA 1.2 M HCW w/ mandated annual testing 19 counties in CA have no TB 92 HCWs had active TB Those were unlikely to have been picked up on annual screening Estimated cost $90M/year Over-testing is expensive Over-testing low-risk people for lowprevalence disease leads to false positives. False-positives cause harm.

10 WHEN REACTIVATION OCCURS

11 WHO HAS TB?

12 RECAP There s very, very, very, very little TB in the US Within the US, TB is mostly in CA, HI, AK and NY HCWs have lower TB rates than the general public HCWs are not getting occupational TB ~80% TB is in the foreign born

13 BACKGROUND: HOW WE TEST FOR TB Tuberculin Skin Test (TST) Purified Protein Derivative (PPD) Tubersol, Aplisol Interferon Gamma Release Assays (IGRA) Enzyme-linked Immunoassay (ELISA) QuantiFERON (QFT) Ficoll separation assay TB.TSPOT (TSPOT)

14 TUBERCULIN SKIN TEST A. Inaccurate (BCG/NTMs) B. Time-intensive C. Subjective D. Poor patient compliance * E. Poor training compliance F. Lacking controls G. Manual data entry H. Outdated In January 2009, we eliminated TST. * Wrighton-Smith, Sneed, Humphrey, Tao, Bernacki Screening health care workers with interferon-γ release assay versus tuberculin skin test: impact on costs and adherence to testing (SWITCH) J Occup Environ Med. Vol. 54 (7), pp , Jul 2012

15 CAUSES OF FALSE-POSITIVE TST Tuberculosis strains ESAT-6 CFP- 10 TB-7.7 TST Environmental Strains ESA T-6 CFP- 10 TB-7.7 M. tuberculosis M. abcessus M. africanum M. avium M. bovis M. branderi BCG Strains ESAT-6 CFP- 10 TB-7.7 TST M. celatum Gothenberg M. chelonae Moreau M. fortuitum Tice M. gordonii Tokyo M. intracellulare Danish M. kansasii Glaxo M. malmoense Montréal M. marinum Pasteur M. scrofulaceum TST M. szulgai

16 (EXTINCT) IGRA: ELISA QUANTIFERON GOLD IN-TUBE (QFT, QIAGEN)

17 ELISA: QFT-PLUS APPROVED FOR USE JUNE 2017 The ELISA remains largely the same Nil = same negative control Mitogen = same positive control TB1 (green) detects CD4+ T-cell response TB2 (yellow) detects CD4+, CD8+ T-cell response (ESAT-6, CFP-10) * OR use a single green-top tube

18 IGRA: ELISPOT (TSPOT.TB, OXFORD) > 8 spots = Positive 5-7 spots = Borderline < 4 spots = Negative

19 IGRA: TSPOT.TB T-CELL SELECT Available in US ~ 1 yr Automated processing? Room temp storage to 54 hours

20 Predictive Value of QFT (Diel et al AJRCCM Aug 2010) CONTACT INVESTIGATION WITH IGRA 954 close contacts 198 QFT-positive 756 QFT-negative 142 TST-positive 5 TST-negative 51 QFT-positive 49 TST-positive 413 TSTpositive 343 TSTnegative Not treated Not treated ROF or INH Not treated Not treated 17 developed active TB 2 developed active TB No active TB Mean follow-up >4 yrs No active TB No active TB

21 2005 CDC MMWR TB PREVENTION GUIDELINES: WHERE WE VE BEEN

22 FOR THE PAST 12 YEARS

23 STUCK. Stuck in CDC facility risk rubrik: Thanassi MD, 2017

24 2010 CDC MMWR IGRA GUIDELINES

25 SCREENING FOR LATENT TUBERCULOSIS INFECTION IN ADULTS: US PREVENTIVE SERVICES TASK FORCE RECOMMENDATION STATEMENT, 2016 First consensus guideline to recommend IGRA over TST in almost all settings Repeat positive tests Testing recommendations are based on individual exposure risk

26 CDC MMWR: UPDATED RECOMMENDATIONS FOR TUBERCULOSIS SCREENING AND TESTING OF HEALTH CARE PERSONNEL, UNITED STATES, 2018 Lynn Sosa MD Bob Belknap MD and the Healthcare Worker Screening Guidelines Working Group

27 SEARCH FOR EVIDENCE Working group created in Summer 2015 Systematic review commenced in January 2017 We conducted a search for studies that screened and/or tested healthcare workers for LTBI Electronic databases included: MEDLINE, EMBASE, and Scopus Search period: January 2006 November 2017 (MEDLINE only) Language restriction: English only

28 SEARCH RESULTS Original Search Period Jan Feb (n = 1129) Update Search Period Feb Nov (n = 18) Duplicates (n=2) Not relevant (n=1047) Not relevant (n=14) Ordered Full Text (n=80) Ordered Full Text (n=4) Did not meet inclusion criteria (n=37) Unable to retrieve full text (n=8) Modelling study (n=1) Type of QFT test used (n=1) LTBI Screening & Testing in HCW Articles (n=35) LTBI Screening & Testing in HCW Articles (n=2) Limited quality of execution (n=1 Limited quality of execution (n=0) Included in Analysis (n=34) Included in Analysis (n=2) Total Included in Analysis (n=36)

29 RELEVANT FINDINGS U.S. HCWs have a lower or equal rate of LTBI compared with the general population. <1% of US HCWs convert from a negative baseline test to positive when tested with TST during serial testing ; 4% (transiently) convert with when serially tested with IGRA. ~62% of U.S. HCWs who test TST positive at baseline revert to a negative test during serial TST testing; 48% revert when tested with IGRA. Zero HCWs developed active TB from a work-related exposure in the included studies.*

30 UPDATED RECOMMENDATIONS: POST-OFFER AND POST-EXPOSURE Category 2005 Recommendation 2018 Recommendation Baseline (on hire) Screening and Testing TB screening of all HCP including a symptom evaluation and test (IGRA or TST) for those without documented prior TB or LTBI TB screening of all HCP including a symptom evaluation and test (IGRA or TST) for those without documented prior TB or LTBI (unchanged) *; Individual TB risk assessment (new) Postexposure Screening and Testing Symptom evaluation for all HCP when an exposure is recognized. For HCP with a baseline negative TB test and no prior TB or LTBI, perform a test (IGRA or TST) when the exposure is identified. If that test is negative, do another test 8 10 weeks after the last exposure Symptom evaluation for all HCP when an exposure is recognized. For HCP with a baseline negative TB test and no prior TB or LTBI, perform a test (IGRA or TST) when the exposure is identified. If that test is negative, do another test 8 10 weeks after the last exposure (unchanged)

31 BASELINE (PRE-EMPLOYMENT) SCREENING AND TESTING Baseline screening on hire should include: TB risk assessment (new) Symptom evaluation (unchanged) IGRA or TST (IGRA preferred (new))* Low risk HCW testing positive should have retest Consistent w/ MMWR 2010 and TB Diagnostic Guidelines 2016

32 INITIAL/BASELINE TB RISK ASSESSMENT Foreign travel or residence of 1 month consecutively in a country with an elevated TB rate OR (any country other than United States, Canada, Australia, New Zealand, or a country in Western or Northern Europe) Current or planned immunosuppression including HIV infection, organ transplant recipient, treatment with a TNF-alpha antagonist, chronic steroids (= prednisone 15 mg/day for 1 month) or chemotherapy OR Close contact with person with infectious TB disease since your last TB test If yes to any they should be considered at increased risk for TB.

33 POST-EXPOSURE SCREENING AND TESTING Definition: Known exposure to Active TB w/o PPE No history of positive TB test Symptom assessment (new) TB test, IGRA preferred (new) Retest 8 10 weeks after exposure (unchanged) History of positive TB test regardless of treatment Symptom assessment, no test (I disagree*) Symptom assessment after 8-10 weeks, refer if sxs

34 UPDATED RECOMMENDATIONS: SERIAL TESTING AND POSITIVE RESULTS Category 2005 Recommendation 2018 Recommendation Serial Screening and Testing Based on a healthcare facility and setting risk assessment. Not recommended for HCP working in low-risk healthcare settings. Recommended for HCP working in medium-risk healthcare settings and settings with potential ongoing transmission. Not routinely recommended, no facility risk assessment (new); Can consider for select HCP groups (unchanged); Recommend annual TB education of all HCP (unchanged) Follow-Up of Positive Test Results Referral to determine whether LTBI treatment is indicated. LTBI treatment is strongly recommended for all HCP diagnosed with LTBI unless contraindications exist (new)

35 SERIAL SCREENING AND TESTING No routine testing of HCW at any interval in the absence of known exposure or ongoing transmission (new) Healthcare facilities can choose routine testing of specific HCW (e.g. pulmonologists, respiratory therapists) or staff in specific settings based on ongoing transmission (e.g. emergency departments) This decision should be individualized to each facility and may be made in consultation with state/local health department Education regarding TB disease, prevention and transmission should continue

36 FOLLOW-UP OF POSITIVE TEST RESULTS HCW w/ positive (repeated or post-exposure) TB test: Chest imaging Symptom assessment Further evaluation for TB disease if warranted All HCW w/ LTBI should be offered and encouraged to complete LTBI treatment unless contraindicated (new) Short-course treatments are preferred

37 NTCA WORKGROUP CDC/DTBE Staff Gibril Njie Sapna Bamrah Morris Amera Khan Neela Goswani Jerry Mazurek CDC Partners Megan Casey, NIOSH David Kuhar, DHQP Partners Bob Belknap, Denver Public Health, NTCA Lynn Sosa, Connecticut DPH, NTCA Lorna Will, NTCA William Buchta, ACOEM MaryAnn Gruden, AOHP Bobbi Jo Hurst, AOHP David Lewinsohn, Oregon University Mark Lobato, NTCA Trini Mathew, Beaumont Hospital Lisa Paulos, NTCA Randall Reeves, Denver Public Health, NSTC Wendy Thanassi, U.S. Dept of Veterans Affairs Annie Wiest, AOHP Silvia Quevedo, APIC

38 SUMMARY There s very, very, very, very little TB in the US Within the US, TB is mostly in CA, HI, AK and NY Within the US and those states, ~80% TB is in the foreign born HCWs have lower TB rates than the general public HCWs are not getting occupational TB IGRAs are more accurate than TST ~ 96% of the TB tests we do on HCWs are negative; it s expensive 80% of active TB in HCWs is reactivation of untreated TB THEREFORE Annual TB testing of HCWs is Not Recommended IGRAs are preferred Positive tests should be repeated Facility risk assessments are not needed Those positive at hire should be strongly encouraged to get treated

39 THANK YOU, AOHP!

40 3HP n = >7,500 LTBI in 4 countries Completion rate: 82 % 3HP group 69 % INH group (P<0.001) Hepatotoxicity rate: 0.4% 3HP group 2.7% INH group (P<0.001) Discontinued due to adverse events = non-significant

41 IGRA: ELISA (QUANTIFERON GOLD PLUS ) Nil Negative (<8.0) Negative Negative NO TB EXPOSURE Mito Positive (>0.50) Nil Negative (<8.0) Positive Negative + OR + Negative Positive TB EXPOSURE Mito Positive (>0.50)

42 INDETERMINATES Nil too high (>8.0 IU/ml) INDETERMINATE INDETERMINATE Mitogen too low (<0.5 IU/ml)

43 BACKGROUND: According to the manufacturer, the QFT-Plus offers higher sensitivity and specificity in patients at highest risk for TB-infection and in immunocompromised patients n = 161 contacts The difference in IFN-γ production between the two antigen tubes (TB2-TB1) was used as an estimate of CD8+ stimulation TB2-TB1 values >0.6 IU ml-1 were significantly associated with proximity to the index case Suggests a possible role in identifying individuals with recent infection.

44 BACKGROUND CDC MMWR guidelines on preventing TB transmission in healthcare settings published in 2005 PPD shortage and concerns about serial testing in low risk persons (lots of false-positives) raised questions about the usefulness of serial TB testing Joint NSTC-NTNC session at 2015 NTCA conference to discuss issue Working group created in Summer 2015 Systematic review commenced in January 2017

45 We have decades of data that support national guidelines to decrease TB testing in HCWs Practicing Good Medicine can mean Doing Less