INTRODUCTION TO TB LAMP

TB LAMP Training Workshop

Department of Health
RESEARCH INSTITUTE FOR TROPICAL MEDICINE
National Tuberculosis Reference Laboratory
 Recent WHO-Recommended Rapid
Diagnostics for TB Detection

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 About TB LAMP

Degree of Complexity:

Moderate

Intended Setting of Use:

Peripheral/Point of Care

Use of Test:

TB diagnosis

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 About TB LAMP

Also known as PURE TB LAMP for its

two main modules

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 About TB LAMP

ADVANTAGES DISADVANTAGES

Fast (>1 hour) Cannot provide

resistance
Low biosafety information
level requirements
Cannot be used
More affordable for treatment
equipment monitoring

Medium Investments
throughput needed for
training and QA

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 About TB LAMP
Recommendations for Use (WHO)
Replacement test for
sputum smear microscopy
for diagnosis of pulmonary
TB in adults with signs
and symptoms consistent
with TB

Follow-on test to smear

microscopy in adults with
signs and symptoms
consistent with pulmonary
TB, especially when further
testing of smear-negative
specimens is necessary

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 About TB LAMP
Research Collaboration Program Official Launch

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 About TB LAMP

Local Evaluations Under Research Collaboration

PHASE ONE PHASE TWO

Diagnostic Diagnostic
performance performance
evaluation evaluation
at central at peripheral
laboratory level laboratory level in a
proposed diagnostic
algorithm

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 Phase One Findings
Diagnostic Performance Comparison, TB LAMP vs. Smear Microscopy

In raw, unprocessed samples, PURE TB LAMP sensitivity was found

to be better than smear microscopy (86.1% vs. 66.3%; p<0.001).
In NALC-NaOH-treated samples, smear microscopy and PURE TB
LAMP performed similarly (84.5% vs. 81.4%;p=0.617). The tests
have comparable specificities for both unprocessed and NALC-
NaOH-treated samples.

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 Phase One Findings
Diagnostic Performance Comparison, TB LAMP vs. Xpert® MTB/RIF
Sputum with results (n=276)

In raw, unprocessed samples, PURE TB LAMP sensitivity was found

to be comparable to Xpert® MTB/RIF (93.0%; p=0.109). The tests
also have comparable specificities for both unprocessed and NALC-
NaOH-treated samples.

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 Phase One Findings
End User Assessment Feedback
General positive feedback with few perceived limitations

+ PROS
• Ease of interpreting the results
• Shorter time needed to perform
the test compared to microscopy
• Less difficult compared to smear
microscopy
• Less strain to eyes
- CONS
• Limited visibility in the pipetting tip
provided with the assay for sputum
transfer
• Perceived risk of cross
contamination
• Complexity of some of the steps of
the assay

• Shorter hands-on time

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 Phase One Findings
Summary
The PURE TB LAMP assay has good diagnostic performance
and has received positive feedback from its end-users.

Diagnostic performance is comparable, if not better, to those

observed from studies conducted in other countries.
Observed diagnostic performance is consistent with those in
the WHO policy guidance.

Further study validating its diagnostic performance at the point-

of-care setting and with a larger number of samples
involved is recommended for a more precise and robust
measure of how PURE TB LAMP will perform in local field
conditions.

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 Phase Two Overview
Outcome Measures for TB LAMP

Performance indicators
– Sensitivity
– Specificity
– Positive predictive value
– Negative predictive value

No. of TB cases detected vs. tools in current

algorithm (smear microscopy and Xpert)

End user assessment

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 TB LAMP and the Proposed New Algorithm
ALGORITHM FOR ADULTS (15 YEARS AND ABOVE)

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 THANK YOU!

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INTRODUCTION TO TB LAMP

TB LAMP Training Workshop

Department of Health
RESEARCH INSTITUTE FOR TROPICAL MEDICINE
National Tuberculosis Reference Laboratory