Trends in Testing for Mycobacterium tuberculosis Complex from US Public Health Laboratories,

Trends in Testing for Mycobacterium tuberculosis Complex from US Public Health Laboratories, 2009 2013 Frances Tyrrell, MT (ASCP), MPH Laboratory Consultant Laboratory Capacity Team (LCT)/DTBE ftyrrell@cdc.gov 10 th APHL National Laboratory Aspects of Tuberculosis Meeting April 18, 2017 National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of Tuberculosis Elimination

Trends in Testing for Mycobacterium tuberculosis Complex From US Public Health Laboratories, 2009 2013. Public Health Reports, Vol 132, Issue 1, 2017 Frances Tyrrell, MPH, Cortney Stafford, MPH, Mitchell Yakrus, MS, MPH, Monica Youngblood, MPH, Andrew Hill, PhD, Stephanie Johnston, MS http://journals.sagepub.com/doi/pdf/10.1177/0033354916679989

Sources of Data TB Elimination Cooperative Agreement Applications Required elements Workload Turnaround times Narratives Methods Algorithms Site Visits More details regarding laboratory operations National TB Surveillance Data How much TB testing is performed in PHL?

Trends Analyzed Workload Turnaround Times Testing Methods and Algorithms Comparisons to Surveillance Data

112,453 114,700 107,144 103,475 97,631 272,157 257,005 239,892 237,761 223,370 Workload Trends, 2009 2013 Specimens Processed/Patients Tested 2009 2010 2011 2012 2013 Total no. specimens processed No. patients tested

112,453 114,700 107,144 103,475 97,631 272,157 257,005 239,892 237,761 223,370 Workload Trends, 2009 2013 Specimens Processed/Patients Tested 2009 2010 2011 2012 2013 Total no. specimens processed No. patients tested Linear (Total no. specimens processed) Linear (No. patients tested )

7,531 7,217 6,822 6,854 6,431 14,081 15,827 15,077 14,720 16,610 Workload Trends, 2009 2013 DSTs/NAATs 2009 2010 2011 2012 2013 No. patient DSTs No. patient NAATs

7,531 7,217 6,822 6,854 6,431 14,081 15,827 15,077 14,720 16,610 Workload Trends, 2009 2013 DSTs/NAATs 2009 2010 2011 2012 2013 No. patient DSTs No. patient NAATs Linear (No. patient DSTs) Linear (No. patient NAATs)

National Workload and Mycobacterium tuberculosis complex Data from 58 U. S. Public Health Laboratories Receiving Support through CDC Cooperative Agreements: Years 2009 2013 Variable Total No. or Percent (Range Among 58 Laboratories Reporting) 2009 2010 2011 2012 2013 2013 Compared to 2009 No. or Percent (% change) Clinical specimens received 272,157 (288 21,862) 257,005 (251 23,250) 239,892 (283 21,943) 237,761 (273 21,082) 223,363 (239 19,275) -48,784 (-17.9) Patients specimens submitted 112,453 a (88 8,555) 114,700 (126 10,404) 107,144 (94 10,057) 103,475 (152 10,695) 97,632 (107 11,487) -14,821 (-13.2) Patients culture positive for MTBC 5,005 (1 628) 4,285 (0 599) 4,399 (2 586) 4,270 a (1 560) 4,210 (1 584) -795 (-15.9) Patient DSTs performed 7,531 (2 883) 7,217 (0 758) 6,822 (1 705) 6,854 (1 685) 6,429 (0 752) -1,102 (-14.6) Patients tested by NAAT 15,827 (0 772) 14,081 (0 6,253) 15,077 (0 6,450) 14,720 (2 5,599) 16,610 (1 5,197) 783 (4.7) Patients NAAT positive for MTBC 2,355 (0 177) 2,507 (0 408) 2,430 (0 361) 3,045 (0 706) 2,918 (1 382) 563 (19.3) Percent patients culture positive for MTBC b Percent patients NAAT positive for MTBC c 4.4 (0.2 23.9) 14.9 (0 90.1) 3.7 (0 27.8) 17.8 (0 71.0) 4.1 (0.2 21.1) 16.2 (0 64.9) 4.2 (0.3 19.9) 16.6 (0 75.0) Note. MTBC = Mycobacterium tuberculosis complex. DST = Drug susceptibility test for MTBC. NAAT = Nucleic acid amplification test. a Number based on 57 sites reporting. b Percent culture-positive for MTBC of patient specimens received for smear and culture. c Percent positive for MTBC of those patients tested by NAAT. 4.3 (0.2 19.8) 17.6 (1 90.9) -0.1 (-2.2) 2.7 (18.1)

NO. OF DSTS RANGE OF PATIENT DSTs PERFORMED, 2013 750 700 650 600 550 500 450 400 350 300 250 200 150 100 50 0

PERCENT CULTURE POSITIVE FOR MTBC 20 CULTURE POSITIVITY, 2013 18 16 14 12 10 8 6 4 National Culture Positivity = 4.3 % 2 0

Culture Positivity Stratified by Testing Volume 7.0 Low- volume laboratories 6.0 6.5 6.3 High- volume laboratories 5.0 4.0 4.9 5.1 5.1 Mid-volume laboratories 5.4 4.3 4.3 4.6 3.0 3.6 3.2 3.7 3.3 3.4 3.9 2.0 1.0 0.0 <2000 specimens per year- Tier 1 2001-6000 specimens per year -Tier 2 2009 2010 2011 2012 2013 >6000 specimens per year - Tier 3

Percent Within Recommended Time National Trends in TAT 89 71 87 88 89 89 82 75 78 74 49 43 54 60 46 45 56 47 49 45 2009 2010 2011 2012 2013 Specimen Receipt: % w/in 1-day ID in 21 days Smear: % w/in 1-day DST in 28 days

Percent Within Recommended Time National Trends in TAT 89 71 87 88 89 89 82 75 78 74 43 46 45 47 45 48 2009 2010 2011 2012 2013 Specimen Receipt: % w/in 1-day Smear: % w/in 1-day ID in 21 days DST: % rifampin w/in 17 days of ID

Trends in Primary Identification Methods 1 1 1 2009 Accuprobe HPLC 3 2 2013 3 1 Accuprobe HPLC 14 InnoLiPA InnoLiPA 13 Sequencing Sequencing 34 PCR 38 other/unknown other/unknown

Comparisons to Surveillance Data 100 Percentage of TB Testing Performed in PHL 45 Percentage culture confirmed TB (+) for MTBC by NAAT in PHL 90 80 89 89 88 94 90 40 35 40 40 70 60 50 40 56 51 55 56 57 30 25 20 27 30 30 30 15 20 10 10 5 0 2009 2010 2011 2012 2013 Proportion culture confirmed TB tested in PHL 0 2009 2010 2011 2012 2013 Proportion DST performed in PHL Chart 1: Denominators: Number of culture confirmed TB, and number of culture-confirmed TB that had DST performed, U.S., 2013. Numerators, number of patients (+) for MTBC by culture in PHL, and number of patient DSTs performed in PHL, 2013. Chart 2: Denominator: Number of culture confirmed TB cases, U.S,. 2013. Numerator: Number of patients (+) for MTBC by NAAT in PHL, 2013

Limitations Only the 58 PHL receiving cooperative agreement funding included 76 PHL in the U.S. perform TB testing TAT data 18 laboratories not funded are local/county PHL many in CA Private sector not included Measured as % of test results reported within a recommended time Might impact PHLs with low denominators for benchmarks Difficult to compare to older studies measured differently Self-reported Subject to differences in recording capabilities within laboratories Proportional estimates of PHL contributions taken from different data sources May not account for duplicate testing

Importance of PHLs Discussion Identified as principal partners in the recently announced National Action Plan for Combating Multidrug-Resistant TB 1 TB diagnosis is only one of many functions that PHLs provide Assessing relative infectiousness of TB patients Determining presence of antibiotic resistance Monitoring treatment response Investigating and validating new methodologies Providing confirmatory and referral testing for other laboratories Providing consultation and interpretation of results to TB Control and other submitters 1 USAID, December, 2015: https://www.usaid.gov/what-we-do/global-health/tuberculosis/national-action-plan-combating-mdr-tb

Discussion (2) Public health compared to private sector Hospitals provide 55% of public health assessment activities related to diagnostic needs 1 Less likely to contribute to assurance activities e.g. regular evaluations of effects of public health services on community health status Assurance activities achieved by ongoing, frequent communication with providers, TB health practitioners, program officials Vital to successful TB Control PHLs continually engage in theses activities, private sector less so However, public health programs experiencing falling share of US health spending 2 Determination of cost-effective yet accurate and high-quality testing will continue to be critical 1 Hogg RA, Mays GP, Mamaril CB. Hospital contributions to the delivery of public health activities in US metropolitan areas: national and longitudinal trends. Am J Public Health. 2015;105(8):1646 1652 2 Himmelstein DU, Woolhandler S. Public health s falling share of US health spending. Am J Public Health. 2015;106(1):56 57.

Conclusions Volume of TB diagnostic testing is declining in the United States However, NAAT volume is on the rise Substantial proportion of TB testing is contributed by PHLs Culture and DST proportion has remained relatively stable NAAT proportion significantly increased from 2009 PHLs are diverse in their roles Demonstrated by wide ranges in culture positivity, testing volumes, and proportions of all TB testing within jurisdictions PHLs are adaptive Uptake of rapidly changing technologies, changes in data-driven algorithms, and increased collaborations with partners

Acknowledgements All of our TB Elimination Cooperative Agreement Public Health Laboratory Professionals Association of Public Health Laboratories CDC/DTBE/Laboratory Capacity Team For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: http://www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of Tuberculosis Elimination