Evaluation of the cobas 4800 CT/NG test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae.
OBJECTIVE
To investigate the performance of the fully automated cobas 4800 CT/NG test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.


METHODS
The study was conducted using 900 clinical specimens (496 urine and 404 swab specimens) for C trachomatis testing, of which 498 specimens (318 urine and 180 swab specimens) were also tested for N gonorrhoeae. The results of the cobas 4800 CT/NG test were compared with those obtained from the Roche COBAS AMPLICOR CT/NG and COBAS TaqMan CT assays. N gonorrhoeae-positive specimens were further tested using in-house, real-time PCR assays. A panel of 223 Neisseria isolates was used to further investigate the performance of the cobas 4800 N gonorrhoeae assay.


RESULTS
For urine specimens, the sensitivity, specificity and negative and positive predictive values of the cobas 4800 CT/NG test were 94.5%, 99.5%, 98.8% and 97.7%, respectively, for C trachomatis, and 92.9%, 100%, 99.7% and 100%, respectively, for N gonorrhoeae. For swab specimens, the sensitivity, specificity and negative and positive predictive values were 92.0%, 100%, 99.5% and 100%, respectively, for C trachomatis, and 100%, 99.4%, 100% and 90.0%, respectively, for N gonorrhoeae. All N gonorrhoeae isolates were positive and all non-gonococcal Neisseria strains were negative by the cobas 4800&emsp14;N gonorrhoeae assay.


CONCLUSIONS
The cobas 4800 CT/NG test is suitable for high through-put identification of C trachomatis and N gonorrhoeae infections.
Rockett
Rebecca
R
Queensland Paediatric Infectious Diseases Laboratory, Sir Albert Sakzewski Virus Research Centre, Queensland Children's Medical Research Institute, Children's Health Service District, Queensland, Australia.
Goire
Namraj
N
Limnios
Athena
A
Turra
Mark
M
Higgens
Geoffrey
G
Lambert
Stephen B
SB
Bletchly
Cheryl
C
Nissen
Michael D
MD
Sloots
Theo P
TP
Whiley
David M
DM
D001331:Automation; D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis / Q000235:genetics*; D004269:DNA, Bacterial / Q000302:isolation & purification*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000235:genetics*; D021141:Nucleic Acid Amplification Techniques / Q000592:standards; D016133:Polymerase Chain Reaction; D011237:Predictive Value of Tests
D004269:DNA, Bacterial