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EVALUATION OF REALTIME PCR OF PATIENT

PLEURAL EFFUSION
FOR DIAGNOSIS OF
TUBERCULOSIS
Rosso F et al, 2011

Background
Pleural tuberculosis diagnosis often requires
invasive procedures such as pleural biopsy.

Objective
To evaluate the role of real-time polymerase
chain reaction (PCR) for the IS6110
sequence of M. tuberculosis in pleural fluid
specimens as a rapid and non-invasive test
for pleural TB diagnosis.

Method
Cross-sectional study
Sample : 150 consecutive patients with pleural
effusion. Overall, 98 patients had pleural TB and 52
had pleural effusion secondary to other disease.

Criteria
Age > 18 years old
Absence of known history or clinical or radiographic
evidence of renal, cardiac or liver failure and no
known diagnosis of cancer or TB at the moment of
enrollment.

Results
PCR

TB

NONTB

SEN
S

SPEC PPV

+ (n=45)

42

42.8

93.3

- (n=101)

52

49

Inhibited (n=4)

Total (n=150)

98

52

94.2

NPV

48.5

PCR test accuracy was calculated using the inhibition results only in the denomi

Conclusion
The real-time PCR test of pleural fluid
specimens is an useful and non-invasive
additional assay for fast diagnosis of pleural
TB.

Diagnosis Worksheet
Was there an
independent, blind
comparison with a
reference (gold)
standard of diagnosis?

Yes. The absence of

known history of clinical
or radiographic evidence
of renal, cardiac, or liver
failure and no known
diagnosis of cancer or TB
at the moment of
enrollment.

Was the diagnostic test

evaluated in an appropriate
spectrum of patients (like
those whom it would be used
in practice)?

Yes. Because all patients

presenting with pleural
effusion on chest radiography.

Was the reference standard

applied regardless of the
diagnostic test result?

Yes. Because there are

negative controls and positive
controls that were included
for each sets of PCRs.

Was the test (cluster of tests)

Yes. In Brazil.

Are the results of this

diagnostic study
important?
PCR

C.
Positive
Diagnosis
of Cultures
Negative
and HP

Totals

Present

Absent

42

45

56

49

105

98

52

150

Sensitivity : 42,85%
Specificity : 94,23%
LR+ : 7,4
LR - : 0,6
PPV : 93,33%
NPV : 48,5%
Prevalence : 65,3%
Pretest Odds : 1,88
Post-test Odds : 13,912
Post-test probability : 93,3%
Post-test Prob Pre-test Prob : 28%

Is the diagnostic test available,

accurate and precise in your
setting ?

No. Because pleural fluid

specimens in 4 patients with
positive culture for TB and
demonstration of granuloma in
pleural biopsy repeatedly
demonstrated inhibition of the
nucleic acid amplification.

Can you generate a clinically sensible

estimate of your patients pre-test
probability ?
Are the study patients similar to
your own?
Is it unlikely that the disease
possibilities or probabilities have
changed since the evidence was
gathered?

Yes
No. It is likely to be changed since
the difference between post-test
probability and pre-test probability
more than 20%

Will the resulting post-test

probabilities affect your management
and help your patient?
Could it move you across a testtreatment threshold?
Would your patient be a willing
partner in carrying it out?

Yes, because rapid diagnosis and

initiation of chemotherapy are
essential to prevent secondary
fibrothorax and to avoid subsequent
pulmonary or extrapulmonary TB
development.
Yes, since its non-invasive and not
really different with biopsy procedure.

Thank you