Comparison of the BD Viper System with XTR Technology to the Gen-Probe APTIMA COMBO 2 Assay using the TIGRIS DTS system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens.
BACKGROUND
Performances of the BD ProbeTec Chlamydia trachomatis (CT)/Neisseria Gonorrhoeae (GC) Q(x) Amplified DNA Assay reagents on a BD Viper System with XTR Technology and APTIMA COMBO 2 Assay reagents on a TIGRIS DTS platform, for detection of both CT and GC were compared.


METHODS
A total of 1018 first-void urine specimens were tested for the presence of CT and GC DNA using the 2 assays.


RESULTS
CT was detected in 143 specimens (14%). Eight specimens exhibited discordant results, and they were divided equally between the 2 assays. Based on the original results, the overall agreement for CT was 99.2%, with 97.1% and 99.5% in agreement with positive and negative specimens, respectively. Cohen's Kappa was 0.967. GC was detected in 27 specimens (2.6%). Two specimens exhibited discordant results, and they were divided equally between the 2 assays. Based on the original results, the overall agreement was 99.8%, with 96.2% and 99.9% in agreement for positive and negative specimens, respectively. Cohen's Kappa was 0.961.


CONCLUSIONS
There was a high level of agreement between the systems for both CT and GC detection.
Saskatchewan Disease Control Laboratory, Regina, Saskatchewan, Canada.
Linda M
LM
Mushanski
Ken
K
Brandt
Nicolette
N
Coffin
Paul N
PN
Levett
Gregory B
GB
Horsman
Elliot L
EL
Rank
D000465:Algorithms; D057205:Automation, Laboratory / Q000295:instrumentation / Q000379:methods; D015373:Bacterial Typing Techniques / Q000379:methods; D002690:Chlamydia Infections / Q000382:microbiology / Q000652:urine*; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D006069:Gonorrhea / Q000382:microbiology / Q000652:urine*; D006801:Humans; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques / Q000295:instrumentation / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012525:Saskatchewan; D012680:Sensitivity and Specificity
D011933:Reagent Kits, Diagnostic