Evaluation and piloting of TB-LAMP assay for the
diagnosis of PTB in Lusaka
Eddie Samuneti Solo(BSC, MPH)
12.12.2019
LTWG meetingOutline➢Introduction➢Part 1. Evaluation study of TB-LAMP➢Part 2. Pilot study of TB-LAMP➢Conclusions➢Recommendations

Introduction
diagnostic tools in use

Zambia- 30 High TB burden countries

WHO 2019

Diagnostic tools (Microscopy)• Inexpensive• Poor sensitivity(20 – 60%)

• False negatives and missed
TB casesDiagnostic tools (Xpert MTB/RIF)• Molecular tool

• High sensitivity(> 80%)• High equipment maintenance cost
(air conditioned and dust free rooms,replacement of modules)

TB-LAMP assay ( WHO endorsed 2016)• Molecular tool
• High Sensitivity(>80%)• Low equipment maintenance cost(robust equipment )• WHO policy guidance-labs with inadequate infrastructure-replacement for smear microscopy

Part 1. Evaluation study of TB-LAMP inHospitals laboratories
January – July 2018

Results (2018)

Evaluation study results for TB-LAMP in Lusaka (2018)
25.00%
19.50%

20.00%
15.00%

20.00%

13.30%

15.00%

10.00%

11.50%

10.00%

5.00%

5.00%

0.00%

Smear positivity

TB LAMP positivity

0.00%
Smear positivity

UTH

24.20%

25.00%TB LAMP positivity

CDL

30.00%
20.00%

23.50%

25.00%

18.80%

25.00%
20.00%

15.00%

15.00%

22.40%
14.60%

10.00%

10.00%

5.00%

5.00%

0.00%

0.00%
Smear positivity
TB LAMP positivity
MateroSmear positivity
Overall

TB LAMP positivity

Conclusions of the evaluation study❑ TB-LAMP had demonstrated superior performance compared tomicroscopy in high level labs
❑ There was need to understand operational feasibility of TB-LAMP insettings of intended use (health center labs).
❑ MoH recommended pilot study in RHCs

Part 2. Piloting of TB-LAMP in RHCs
laboratories
August - September 2019

3 RHCs selected as pilot sites

Kanankantapa
HCLuangwa
Boma HC

LusituHC

3 Staff trained (one per pilot site)

Pilot outputs/ measurables

1. Clinical performance of TB-Lamp (detection rates)
2. Usability/acceptability by staff

3. Notification rates

Clinical performance (detection rates)

Overall detection

Usability/acceptability by staff➢Technical usability of TB-LAMP assay:
Basing on required expertise, TAT and efficiency, all the 3 staff declared that TBLAMP was technically usable.

➢Opinion on comparing TB-LAMP and microscopy:
When asked for a judgement between the two methods, all the 3 staff preferred
to use TB-LAMP method against microscopy➢Foreseen challenges:
2 staff highlighted safety concerns
1 staff indicated challenges with power interruption➢Repeat rate: no cross contamination and no indeterminate results
were reported.

Conclusions• TB-LAMP assay increased TB detection rate twice compared tomicroscopy (from 4 to 9 cases) during the two months of pilot• Staff that performed TB-LAMP testing expressed satisfaction
with this method and recommended for its adoption and roll out
to other HCs.

Recommendations• We recommend that NTP replaces smear microscopy with TBLAMP method for screening presumptive TB patients in HCs
without GeneXpert machines.
• Safety fears and power interruption challenges highlighted bystaff need to be addressed during roll out.

Acknowledgments
Staff at:• Kanakantapa RHC,
• Lusitu RHC• Lwangwa Boma RHCsJapanese Ministry of Health, Labourand Welfare.

Biogroup

Thank you/discussions