1. Feasibility of using determine-TB LAM test in HIV-infected adults in programmatic conditions
Mathabire SC1, 2, Cossa L³, Mpunga J⁴ , Manhica I⁵, Amoros Quiles I², Molfino L⁶, Szumilin E⁷, Telnov A8, Huerga H¹
¹Clinical Research Department Epicentre, Paris France; ²Médecins Sans Frontières, Chiradzulu Malawi; ³Médecins Sans Frontières, Maputo Mozambique; ⁴National TB Control Program Malawi; ⁵National TB Control Program, Mozambique; ⁶Médecins Sans Frontières, Maputo Mozambique; ⁷Médecins Sans Frontières Paris France; ⁸Médecins Sans Frontières, Geneva Switzerland

2. No conflicts of interest to declare
Conflict of Interest
No conflicts of interest to declare

3. Background TB diagnosis is a challenge in resource-limited countries
Determine TB- Lipoarabinomannan (LAM):
performed on urine
results in 25 minutes
LAM test accuracy (only HIV-positive):
Sensitivity: % (depending on CD4 count)
Specificity: >98%
WHO policy guidance (Nov 2015) on LAM test for HIV-positive:
Low CD4 count or
Severely ill regardless of their CD4 count

4. Aim
To assess the feasibility of using the LAM test in programmatic conditions

5. Methods Design: Population: HIV-positive adult patients
Multi-centric prospective longitudinal studies
Malawi and Mozambique
2014 to 2016
Population: HIV-positive adult patients
Regardless of TB symptoms :
All hospitalized (Malawi)
Ambulatory with CD4<100/µl (Mozambique)
TB suspects:
Ambulatory with CD4 <200 /µl (Malawi and Mozambique)

6. Methods/ Context Malawi: Chiradzulu District
Hospital IPD
Hospital OPD
3 PHCs
Mozambique: Chamanculo District
Centre of Reference Alto-Maé (CRAM)
1 PHC
LAM performed in laboratory or consultation rooms

7. Methods/ Data collection & analysis
Mixed methods:
Minutes of trainings, interviews of trainees
Description of training required before using LAM test
Self administered standard questionnaire
Assessment of user acceptability of LAM
Study electronic databases
% agreement between 2 LAM readers , Kappa (95%CI)

8. Methods/ Data collection & analysis
LAM test Turnaround time (TAT)
Interval from urine request to clinician getting result
Health centre registers, interviews with LAM users
Estimate daily workload attributed to LAM test
Supervision notes, minutes of meetings, and personal observations
Space/ extra equipment required to perform LAM test
Strengths and challenges of using LAM

9. Results/ training Training time:
1.5 hours in Malawi
4 hours in Mozambique.
Prior reading of test SOP
minutes explanation of LAM
Practical
*Correct use of reference card challenging
Urine loading pad
Control window
Patient window

10. Results/space and equipment

11. Results/LAM ease of use
20/20: test easy or very easy to use
4/20: difficult to distinguish Grade 1 or lighter than Grade 1
No extra space required
Test arrived in field with 1 year expiry
No need for special storage as it is a small packet
Final result …
Positive or Negative?
18% Malawi & 8% Mozambique had line fainter than Grade 1

12. Results/LAM reader agreement
Test grade (no line to line Grade 4)
95.2%, kappa=0.91 (95%CI ) in Malawi
97.2%, kappa=0.95 (95%CI ) in Mozambique
Test interpretation (positive or negative)
98.9%, kappa=0.97 (95%CI ) in Malawi
98.3%, kappa=0.96 (95%CI ) in Mozambique

13. Results/ additional workload
Malawi
OPD/PHC: 27 minutes (11.3 %)
IPD: 66 minutes (25.4 %)
Mozambique
OPD: 26 minutes (9.5%)
*Workload calculation took into account the time used for clinical consultation only
Malawi
OPD: 27 minutes (11.3 %) (1x27)/(30x8)
IPD: 66 minutes (25.4 %) (2x33)/(13x20)
Mozambique
OPD: 26 minutes (9.5%) (1x26)/(11x25)

14. Results/ LAM Strengths
Rapid results
TB treatment on same day
Decreased visits before diagnosis → reduced cost for patients
Higher proportion of LAM results
TAT for LAM
Laboratory: min Bedside: min
TAT for sputum: 2 days
TAT chest X-ray: 4 days
Malawi lab IPD=140min
Malawi lab OPD=92 min
Malawi lab PHC= 222min
Moza lab CRAM=84
Moza OPD=46

15. Results/ LAM Challenges
Prior CD4 needed to identify LAM eligible patients
High demand for CD4 tests (Mozambique) → patients asked to come following day
CD4 test result TAT→ 2 hours
Test and Treat policy → CD4 tests stopped (Malawi)
Urine collection from very sick or unconscious patients
Reading card not used prior to study
Female patients reluctant to give urine during menses

16. Conclusions Can be implemented in hospital, PHCs
Feasible
Easy to perform
Results same day
Minimal logistics
Most submit urine
Minimal workload
Difficulty discriminate Grade1 line
Can be implemented in hospital, PHCs
Performed by nurses, clinical officers, doctors
Consider task shifting of LAM
Partial reliance on CD4 count
Retain and prioritize CD4 testing for LAM eligible patients

17. All staff who participated
Acknowledgements
NTP Malawi, Mozambique
Chiradzulu DHMT
Maputo DSCM
All staff who participated
The patients
Maputo DSCM “ direccao saude da cidade de