Implementation of the GenoType® MTBDRplus Assay in a Laboratory in Manila, Philippines: An Analysis of the Effect on Time to Diagnostic Results and Treatment Initiation Öffentlichkeit
To, Tu My (2012)
Published
Abstract
Implementation of the GenoType® MTBDR plus Assay in a Laboratory in Manila, Philippines:
An Analysis of the Effect on Time to Diagnostic Results and Treatment Initiation
Background: The steady rise in multidrug resistant
tuberculosis (MDR TB) cases
challenges global TB control efforts and strains national TB
control programs. However,
despite the increase, few patients are tested for drug
susceptibility and enrolled in
treatment regimens. Accurate and timely diagnosis of MDR TB is
critical in mitigating its
spread, but conventional tests (such as culture or sputum smear
microscopy) are slow and
do not provide drug susceptibility testing (DST). The WHO
recommends that line probe
assays (LPAs) be used for rapid TB detection and DST.
Methods: The GenoType® MTBDR plus LPA was
implemented into routine TB testing
in a mycobacteriology laboratory in Manila, Philippines. Patient
enrollment was divided
into validation (culture-based testing) and demonstration (LPA
testing) phases and
patients were tested for presence of TB and resistance to RIF and
INH. Performance
characteristics were calculated for LPA versus the gold-standard
culture-based methods.
Time from specimen collection to availability of diagnostic results
and to treatment
initiation were compared between the two phases. The association
between patient
characteristics and the two outcomes were also examined.
Results: The performance characteristics for detection of
RIF-resistance, INH-resistance,
and MDR TB status decreased from the validation to the
demonstration phase. Although
the time from sample collection to availability of diagnostic
results was significantly
shorter for the demonstration phase (p<0.0001), there was no
significant difference for
time to treatment initiation between the two phases (p=0.09).
Conclusion: This study suggests that the MTBDR plus
assay may serve as a suitable and
rapid test for public health practice that may reduce the waiting
period for diagnostic
results. However, appropriate and timely treatment depends on
factors other than
diagnostics, and TB control programs should be prepared to manage
changes associated
with the introduction a rapid diagnostic test.
Table of Contents
TABLE OF CONTENTS
BACKGROUND…………………………………………………………….......................…………….1
METHODS
Data
Source……………………………………………………………..........................…………..5
Performance
Characteristics……………………………………....................…………………6
Survival
Analyses……………………………………………………………..........................……7
RESULTS
Performance
Characteristics……………………………………….....................………………8
Survival
Analyses……………………………………………………….............................………9
DISCUSSION……………………………………………………………………........................………11
CONCLUSION………………………………………………………………………........................…..15
REFERENCES………………………………………………………………….........................………..16
TABLES AND FIGURES
Figure 1. Flow diagram depicting number of patients at various
stages of the
study, including their separation in validation and demonstration
phase……….....19
Table 1. Patient characteristics of those who were enrolled into
the study and
had valid laboratory test results, separated in validation and
demonstration
phase
accordingly………………………………………………………..….......................…...….20
Table 2. Performance characteristics for LPA testing versus gold
standard
culture based methods (either liquid or solid media), separated by
validation
and demonstration
phase……………………………………….....................……………...……21
Figure 2. Kaplan-Meier curves evaluating the difference in time to
availability
of diagnostic results for validation (culture-based testing) versus
demonstration
phase (LPA
testing)……………………………………………........................………………...…22
Figure 3. Kaplan-Meier curves evaluating the difference in time to
treatment for
validation (culture-based testing) versus demonstration phase (LPA
testing).....23
About this Master's Thesis
| School | |
|---|---|
| Department | |
| Degree | |
| Submission | |
| Language |
|
| Research Field | |
| Stichwort | |
| Committee Chair / Thesis Advisor | |
| Committee Members | |
| Partnering Agencies |
Primary PDF
| Thumbnail | Title | Date Uploaded | Actions |
|---|---|---|---|
|
|
Implementation of the GenoType® MTBDRplus Assay in a Laboratory in Manila, Philippines: An Analysis of the Effect on Time to Diagnostic Results and Treatment Initiation () | 2018-08-28 10:27:25 -0400 |
|
Supplemental Files
| Thumbnail | Title | Date Uploaded | Actions |
|---|