A profile of the cobas® CT/NG assay on the cobas® 6800/8800 system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae

ABSTRACT

Introduction: Chlamydia trachomatis and Neisseria gonorrhoeae infection rates continue to rise worldwide. Increasing screening of the largely asymptomatic infections is critical for timely and effective disease control. Laboratory solutions that can handle increasing volumes and generate highly accurate test results are needed in reference labs that provide the majority of chlamydia/gonorrhea testing.

Areas covered: This review will describe the Roche cobas CT/NG assay performed on the cobas 6800/8800 system. The instrument features will be described as will the performance of the assay.

Expert opinion: The high throughput cobas 6800/8800 can be integrated with clinical chemistry, hematology and immunology systems which will increase reference lab efficiency. The broad menu, ease of expansion with lab developed tests, in combination with features that support lab efficiencies and cost management while assuring high sensitivity and specificity, make this a uniquely effective diagnostic tool.

KEYWORDS:

• Chlamydia trachomatis
• Neisseria gonorrhoeae
• molecular diagnostics
• sexually transmitted infections
• laboratory diagnostics

Article Highlights

• Integration of the high-through-put instrumentation with automating aliquoting/accessioning instrumentation and clinical chemistry, hematology and immunology systems will increase reference lab efficiency.

• The ability to combine the cobas CT/NG with several other molecular assays and the stability of onboard reagents will also help manage laboratory costs.

• The moderate complexity rating of the assay will result in cost savings by supporting the use of less specialized technical staff.

• The design features of the assay that include evidence of successful extraction and amplification, reduction of the possibility of carry-over contamination, and the use of dual targets to lessen the diagnostic impact of mutations while assuring high specificity make this a uniquely effective diagnostic tool.

Declaration of interest

BVDP reports receiving research support to her institution, honorarium or consulting fees from: Abbott Molecular, BD Diagnostics, binx health, BioFire, Cepheid, Hologic, NeuMoDx, Rheonix, Roche Molecular and SpeeDx . The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers Disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.