Characteristics of the
m
2000 Automated Sample Preparation and Multiplex Real-Time PCR System for Detection of
Chlamydia trachomatis
and
Neisseria gonorrhoeaeJournal Articles
Overview
Research
Identity
Additional Document Info
View All
Overview
abstract
ABSTRACT
We evaluated a new real-time PCR-based prototype assay for the detection of
Chlamydia trachomatis
and
Neisseria gonorrhoeae
developed by Abbott Molecular Inc. This assay is designed to be performed on an Abbott
m
2000 real-time instrument system, which consists of an
m
2000
sp
instrument for sample preparation and an
m
2000
rt
instrument for real-time PCR amplification and detection. The limit of detection of this prototype assay was determined to be 20 copies of target DNA for both
C. trachomatis
and
N. gonorrhoeae
, using serially diluted linearized plasmids. No cross-reactivity could be detected when 55 nongonococcal
Neisseria
isolates and 3 non-
C. trachomatis Chlamydia
isolates were tested at 1 million genome equivalents per reaction. Concordance with the Roche Amplicor, BDProbeTec ET, and Gen-Probe APTIMA Combo 2 tests was assessed using unlinked/deidentified surplus clinical specimens previously analyzed with these tests. For
C. trachomatis
, concordance for positive results ranged from 93.7% to 100%, while concordance for negative results ranged from 98.2% to 100%. For
N. gonorrhoeae
, concordance for positive and negative results ranged from 91.4% to 100% and 99.3% to 100%, respectively. A workflow analysis of the prototype assay was conducted to obtain information on throughput under laboratory conditions. At 48 samples/run, the time to first result for both
C. trachomatis
and
N. gonorrhoeae
was 4.5 h. A total of 135 patient specimens could be analyzed in 8.9 h, with 75 min of hands-on time. This study demonstrated the technical and clinical feasibility of the new Abbott real-time PCR
C. trachomatis
/
N. gonorrhoeae
assay.
