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VersaTREK® Mycobacteria Detection and PZA Susceptibility Testing
Pyrazinamide (PZA)
Introducing PZA (# 7116-70) to the antitubercular
susceptibility agents offered by TREK Diagnostic
Systems!
PZA, a critical component of a multi-regimen therapy used to treat tuberculosis, now joins
TREK ’s family of other antimicrobial agents including, Rifampin, Isoniazid, and Ethambutol.
With
the inclusion of PZA, the VersaTREK System offers…
- Comprehensive full line of primary Mycobacterium tuberculosis antimicrobics
- Rapid, reliable, qualitative results
- Easy-to-interpret results
The proof of our products is in our customer testimonials…
“By identifying isolates directly from positive Myco bottles and using growth from
the bottle as the inoculum source for the susceptibility test, we now average 21 days
for reporting the identification and susceptibility results on smear positive specimens
containing Mtb.
The reliability of the VersaTREK system can be demonstrated by looking at our record
for the New York proficiency test survey results. Since we went live with the system in
2001, we have had perfect scores on our mycobacterial susceptibility PT surveys. That
says something for this mycobacteria system.”
Dr. Vincent
LaBombardi
St. Vincent’s Hospital
Manhattan, New York
VersaTREK Myco Susceptibility Kit
Rapid detection of M. tuberculosis and its susceptibilities is critical for effective patient
management. For pyrazinamide susceptibility testing of M. tuberculosis, the VersaTREK
system combines a liquid culture medium (VersaTREK Myco Broth), a growth supplement
(VersaTREK Myco
GS) and a specific concentration of pyrazinamide with a detection system that automatically
incubates and continuously monitors culture bottles inoculated with isolates of M.
tuberculosis from various specimen sources.
| Interpretation of Results |
| For susceptibility testing using the
VersaTREK/ESP System, a test
isolate is interpreted as being susceptible or resistant to a drug based on the
following formula: |
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Susceptible
No growth or time to
detection in the
drug bottle is greater than the time to detection of
the drug-free control bottle (rounded to
the nearest whole number)
plus three days.
Growth after three days of
the control bottle should
be disregarded because it
is not considered to be an indication of resistance.
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Resistant
Time to detection of drug bottle is less
than or
equal to the time to
detection of the drugfree
control bottle (rounded to the nearest whole number) plus three days.
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Performance Characteristics CDC Challenge Strains:
Ten well-characterized strains of M. tuberculosiswere tested and compared to BACTEC
460 TB** and to expected results. Eight strains were susceptible and two were resistant
to PZA. There was an overall 100% agreement with BACTEC and expected results.
Clinical Isolate Results:
VersaTREK Myco PZA susceptibility test compared to BACTEC 460TB susceptibility from
seed and primary inocula sources.*
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BACTEC 460 TB
System** |
ESP/VersaTREK System |
| Expected Results |
Susceptible |
Resistant |
| Source |
# Tests |
S |
R |
# Agree |
Category
Agreement
%
(95%Cl)a |
# Agree |
Category
Agreement
%
(95%Cl) |
Primary
|
40 |
37 |
3 |
37 |
100 |
3 |
100 |
| Seed |
21 |
15 |
6 |
14 |
93.3
|
6 |
100 |
| All |
61 |
52 |
9 |
51 |
96.7 |
9 |
100 |
* LaBombardi, V.J., 2002. Comparison of the ESP and BACTEC systems for Susceptibility
Testing of Mycobacterium tuberculosisComplex. Journal of Clinical Microbiology, 40:6, 2238-2239.
** Product of Becton-Dickinson, Sparks, MD
a Lee, Eric W. and Dubin, N. Estimation and Sample Size Considerations for Clustered
Binary Responses, 1994. Statistics in Medicine, Vol. 13, 1241-1252.
Request more information on the VersaTREK System>>
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