A study to evaluate the correlation of the cobas 4800 CT/NG test with the Abbott m2000 CT/NG test

Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG) are the most prevalent
sexual transmitted diseases worldwide and and a serious public health problem.
Detection of CT/NG infections are currently carried out by molecular techniques
in routine molecular laboratories. The most commonly used clinical specimens
are urine and vaginal/endocervical swabs.
Development in the field of molecular detection apparatus is moving rapidly and
new requirements for high specificity and sensitivity are being implemented in
new generation machines. In addition, new variants as well as reduced NG
specificity (as a conscequency of improved detection methods) has lead to the
development of a new cobas 4800 system by Roche to replace the first generation
cobas amplicor system. This study is being conducted to provide performance
evaluation data for the cobas 4800 CT/NG test which meet the present
requirements for molecular diagnostic tests.

This study is being conducted to provide performance evaluation data for the
cobas 4800 CT/NG Test. This data will be used as part of the cobas 4800 CT/NG
Test CE submission package. Comparison with a 'state of the art' technique
(Abbott m2000 system) will provide the data needed for registration of this new
cobas 4800 system and use in patient care.

This non-clinical study is designed to obtain a clinical specimen correlation
analysis between the cobas 4800 CT/NG Test and the Abbott m2000 CT/NG Test.
This study will include the co-collection of vaginal as well as endocervical
swab specimens for both the Abbott m2000 CT/NG Test and the cobas 4800 CT/NG
Test, each requiring test-specific collection devices. This study will also
include the collection of male and female urine specimens, in which the single
specimen will be used with the appropriate collection devices for both testing
methods. The VU University Medical Center will receive urine and vaginal swab
specimens from the Groningen Laboratory of Infectious Disease and endocerviacl
swabs specimen from the USA. All clinical specimens collected into the Roche
specimen collection devices will be stored at 2-8°C and tested at the VU
University Medical Center using the cobas 4800 CT/NG Test. Swab and urine
clinical specimens collected into the Abbott specimen collection devices will
be stored at -20°C and tested at the site of collection as part of routine
diagnostics using the Abbott m2000 CT/NG Test. All invalid specimens will be
retested at the initial testing site using an additional aliquot of the
original clinical specimen. All specimens found to be discrepant between the
Roche and Abbott tests will be analyzed at the VU University Medical Center
using an in-house home brew CT/NG test, the results of which will be used for
final resolution. All specimen retains at the Abbott testing site will be
stored at that site and made available for additional testing if required. All
specimens collected into the Roche collection devices will be stored at the VU
University Medical Center and made available for retesting if required.
Retains from the specimens collected into Roche collection devices will be sent
to Roche at the completion of the study.
After testing is completed, the remaining testing materials will be returned to
Roche. All test results from both testing systems will be de-linked from
patient identification and transferred to Roche Molecular Systems, Assay
Development in Pleasanton, California. Electronic raw data files from the
cobas 4800 CT/NG testing together with Abbott m2000 CT/NG results will be
transferred to Roche for analysis and comparison for each specimen tested.

The nature and extent of the burden and risks associated with participation
will be almost zero. For urines residual specimen can be used and for vaginal
and endocervical co-collection a second swab will be taken in 1200 patiënts/
swab type during routine speciemen colllection for detection of CT and/or NG
infection.