Clinical Diagnostics Research Consortium (CDRC)
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1 Clinical Diagnostics Research Consortium (CDRC) Funded through a contract from U.S. National Institute of Allergy and Infectious Disease, National Institutes of Health Mission: to evaluate novel TB diagnostics relatively early in their development, in order to guide subsequent use and/or development Clinical sites Infectious Diseases Institute in Kampala, Uganda University of Cape Town, South Africa International Tuberculosis Research Center, South Korea Federal University of Espirito Santo, Vitoria, Brazil
2 Multicenter study of the Alere Determine TB-LAM lateral flow test for diagnosis of TB in adults with HIV infection Susan Dorman, M.D. For the NIH TB Clinical Diagnostics Research Consortium (CDRC) November 14, 2012 FIND Symposium
3 Disclosure: Alere donated Determine TB-LAM lateral flow assays and Clearview TB ELISA kits for this study Alere had no role in study design, or in analysis or interpretation of study results
4 Background Liparabinomannan (LAM) 17.5 kd glycolipid of MTB outer cell wall Heat stable, detectable in urine in some animal models Attractive diagnostic target Bacterial product (not human immune response) Urine lacks infection control risks of blood, sputum Amenable to inexpensive POC platforms (e.g. lateral flow) Clearview TB ELISA (Inverness) assay for urine LAM Direct sandwich immunoassay Uses polyclonal antibodies against LAM In HIV+ adults, sensitivity 56%, specificity 91-95% (Minion et al, ERJ Express July 2011)
5 Background Determine TB-LAM lateral flow assay (Alere) uses Determine testing platform No sample processing; results in 25 minutes Analytical sensitivity reported to be 0.25 ng/ml Reporting scale: no band; band of intensity 1+ to 5+ sample application pad patient result window control window
6 Main Study Objectives Estimate sensitivity and specificity of Determine TB- LAM lateral flow assay in adult HIV-positive TB suspects Compare sensitivity and specificity of Determine TB- LAM lateral flow vs Clearview TB ELISA LAM assay Determine operating characteristics of Determine TB-LAM lateral flow assay (test failures, betweenreader variability) Determine clinical characteristics associated with a positive LAM test
7 Study Design Mainly cross-sectional; limited longitudinal f/u Population: HIV-positive adults Settings Kampala, Uganda (Mulago Hospital & outpatient clinics) Cape Town, South Africa (Jooste Hospital & Kayelitsha Town Two outpatient clinic) Target sample size 1000 participants
8 Study Design Inclusion Criteria Age 18 years Informed consent Suspected active TB At least one of cough, fever, night sweats, weight loss HIV positive Exclusion Criteria More than 2 days of TB treatment within past 60 days Unwilling or unable to provide urine specimen
9 Schema Screen, enroll Any LAM test positive but no culture positive for MTB Interview Sputum x 2 for smear, MGIT cx, LJ cx Blood for mycobacterial cx CD4 count, CXR Urine for LAM ELISA, lateral flow All others in-person f/u visit at 2 months: Interview Record review Same tests as at enrollment Review of medical records at 2 months, Attempt to contact via phone/home visit Classification of TB status
10 Final TB status: Definitions Microbiologically-confirmed TB (primary group for SENSITIVITY) Mtb cultured from any specimens Possible TB No culture positive plus 1 of following: Sputum smear microscopy positive Caseous necrosis or granulomas on biopsy, if done Started on TB tx with documented clinical improvement Dx of active TB per a non-study clinician Death reported to be due to active TB per medical source Not TB (primary group for SPECIFICITY) Does not meet criteria for either of above, plus each of: No TB treatment given At f/u was confirmed to be alive or to have died from cause other than TB Not classifiable Does not meet any of above classifications
11 LAM assay procedures Determine TB-LAM lateral flow: per manufacturer instructions with following additional specification: Test performed & completed within 24 hours of urine being obtained Clearview TB ELISA: per manufacturer instructions with following additional specifications: Urine processed (heated, cooled, centrifuged) within 24 hours of urine being obtained Supernatant stored up to 24 hours at 2-4 C, or up to 28 days at -20 C prior to ELISA
12 Participant Flow Screened N=1037 Enrolled N=1013 Not enrolled N=24 Analysis eligible N=997 Not analysis eligible (no sputum) N=16 Final TB Status Microbiologically Confirmed TB N=361 (36%) Possible TB N=60 (6%) Not TB N=444 (45%) Unable to Classify N=132 (13%) sensitivity specificity
13 Characteristics of 1013 enrolled participants Characteristic N (%) Female 641 (63) Median age, years (IQR) 33 (9) Enrollment site Uganda Cape Town Signs & symptoms Cough Fever Weight loss 506 (50) 507 (50) 993 (98) 845 (83) 939 (93) Enrolled in hospital 560 (55) Hx of prior TB treatment 191 (19)
14 Characteristics of 1013 enrolled participants Characteristic N (%) CD4/mm 3 median (IQR) 160 (303) CD4/mm 3 < (28) 107 (11) 185 (18) 425 (42) On ART at enrollment 330 (33) On TMP-SMX at enrollment 586 (58)
15 Results of conventional mycobacteriology among 997 analysis eligible participants MTB in sputum and/or blood ( micro-confirmed TB case ) OVERALL N (%) 352 (35.3) MTB in sputum 306 (30.7) MTB in blood 98 (9.8) Sputum smear positive among TB cases 211/352 (59.9%)
16 Determine TB-LAM lateral flow assay: distribution of band intensities % % 16.5% No band Band intensity
17 Operational characteristics for Determine TB- LAM lateral flow and Clearview TB ELISA assays Valid test result on initial attempt Lateral Flow ELISA 997/997 (100%) 876/997 (87.9%)* Any band present vs no band present Agreement 95.6 kappa 0.90 n/a Band intensity Agreement 84.5 kappa 0.79 n/a *Remaining 121 samples had valid result achieved on 2 nd attempt
18 Effect of positivity cut-point on sensitivity and specificity of Determine TB-LAM lateral flow 100 cut-point 1+ cut-point 2+ % Sensitivity % Specificity %
19 ROC Curve for Determine TB-LAM lateral flow test CT and Uganda Lateral LAM flow: bar intensity band intensity Specificity Area under ROC curve = Cut-point of 1+ maximizes sensitivity at expense of specificity If cut-point set above 2+, sensitivity decreases with little specificity gain
20 Accuracy of Determine TB-LAM lateral flow (cutpoint 2+) and Clearview TB ELISA assays 100 Determine TB-LAM lateral flow Clearview TB ELISA % p= Sensitivity % Specificity %
21 Accuracy of Determine TB-LAM (cut-point 2+), by CD CD4 100 % CD4 > Sensitivity % Specificity % Sensitivity 68.7% for CD4 <50 Sensitivity 52.6% for CD
22 Factors associated with a positive Determine TB-LAM lateral flow result among micro-confirmed TB cases Risk Factor LAM positive OR AOR Sputum smear positive 71 (51.8) 2.8 (1.8, 4.5) 2.8 (1.5, 5.1) CD4 < Hospitalized at enrollment? not hospitalized hospitalized Karnofsky score 80 (normal activity with effort) (61.2) 31 (54.4) 12 (15.0) 8 (9.1) 22 (18.2) 111 (46.3) 37 (23.6) 96 (47.3) 15.8 (6.1, 40.6) 11.9 (4.2, 33.6) 1.8 (0.67, 4.6) ref Ref 3.9 (2.2, 6.7) ref 2.9 (1.8, 4.7) 9.1 (3.7, 22.8) 10.8 (3.9, 30.2) 1.5 (0.53, 4.4) ref Ref 2.8 (1.2, 6.5) ref 2.9 (1.8, 4.7) Not significantly associated: sex, age, TMP/SMX, ART, symptoms, CXR findings, prior TB 71 (72.5%) of participants with Mtb mycobacteremia were positive by Determine TB-LAM
23 Association of LAM antigenuria with unfavorable clinical outcome Determine TB-LAM lateral flow Total Alive at f/u OR Test positive (9.9) 0.25 (0.17, 0.35) Test negative (90.1) ref Clearview TB ELISA Total Alive at f/u OR Test positive (12.0) 0.28 (0.20, 0.39) Test negative (88.0) ref
24 Participant Flow Screened N=1037 Enrolled N=1013 Not enrolled N=24 Analysis eligible N=997 Not analysis eligible (no sputum) N=16 Microbiologically Confirmed TB N=361 (36%) Possible TB N=60 (6%) Not TB N=444 (45%) Unable to Classify N=132 (13%) LF LAM POS ( 2+) 133 (36.8%) 10 (16.7%) 10 (2.3%) 11 (8.3%)
25 Discussion (I) Determine TB-LAM cut-point of 2+ optimized sensitivity and specificity Using cut-point of 2+, Determine TB-LAM had similar specificity and sensitivity c/w Clearview ELISA Determine TB-LAM sensitivity highest in individuals with CD4 100; specificity high, not affected by CD4 Positive Determine TB-LAM result associated with mycobacteremia, being hospitalized, poor physical performance status, low CD4 LAM antigenuria associated with unfavorable clinical outcome
26 Discussion (II) Methodological approaches to determine specificity as accurately as possible in our study: Optimized sensitivity of reference standard dx procedures Study-specified reference standard dx tests performed using SOPs Liquid culture used (in addition to solid culture) All participants had mycobacterial blood cultures (did not rely solely on sputum) Incorporated follow-up of participants to the extent our budget allowed Attempted to minimize any possible effect of urine sample contamination by testing within 24 hours (quality monitored)
27 Discussion (III) Analyses underway: characteristics of participants with grade 1+ results on Determine TB-LAM testing Additional work needed to assess: Operational feasibility of using 2+ positivity threshold in routine care circumstances Impact of POC Determine TB-LAM testing on patientcentered outcomes Determine TB-LAM test may have narrow indication (HIV positive, CD4 100?), but proof of principle achieved and research needed around: more sensitive target detection systems more specific recognition molecules biodistribution of Mtb antigens
28 Conclusions Determine TB-LAM is the first true POC TB test, and it uses a readily accessible clinical specimen type (urine) Determine TB-LAM test detected TB in well over half of TB patients with CD4 100: the group at highest risk for mortality and with the greatest benefit from prompt ART Determine TB-LAM specificity was quite good but not perfect
29 Funding Support This project was funded with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract no. HHSN C, TB Clinical Diagnostics Research Consortium
30 With thanks to In Cape Town, South Africa: Mark Nicol, Mischka Moodley, Widaad Zemanay In Kampala, Uganda: Yukari Manabe, Lydia Nakiyingi, Moses Joloba, Willy Ssengooba, Olive Mbabazi In U.S.: Molly Holshouser, Derek Armstrong, Aletta Nonyane, Jerry Ellner, David Hom, David Alland, Westat Inc. FIND: Mark Perkins, Catharina Boehme Alere: donated Determine TB-LAM and Clearview TB ELISA kits
31
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