New PCR test for Chlamydia trachomatis and Neisseria gonorrhoeae

Beginning December 6, 2010, the Microbiology and Molecular Pathology Laboratories will begin providing combination Chlamydia trachomatis and Neisseria gonorrhoeae molecular testing using the CT/NG RealTimeassay (from Abbott Diagnostics), an automated FDA-approved in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae from a single specimen collected using the Abbott Multi-Collection Swab and transport container.

Specimens must be collected using the multi-Collect Specimen Collection Kit (Hospital Stores No. 46161). Refer to the Laboratory Handbook regarding the multi-Collect package for detailed sample collection instructions.

The Abbott RealTime CT/NG assay is designed to detect the presence of CT and NG in clinician collected vaginal and male urethral swabs and patient-collected vaginal swabs from symptomatic individuals and male and female urine from symptomatic and asymptomatic individuals. Performance with specimens other than those collected with the multi-Collect Specimen Collection Kit has not been evaluated.

For swab specimen collections, use only the orange shaft swab provided in the Abbott multi-Collect Specimen Collection Kit. A transport tube containing multiple swabs, or a combination of swab and urine cannot be used in the Abbott RealTime CT/NG assay.

For urine specimen collections, ensure that the urine level falls within the clear window of the Specimen Transport Tube label.

After collection, specimens may be stored and transported at 2°C to 30°C for up to 14 days. If longer storage is needed, store at –10°C or colder for up to 90 days. Thaw specimens at 2°C to 30°C.

Specimens should not undergo more than four freeze/thaw cycles. Time and temperature conditions for storage must be adhered to during transport. It is recommended that each tube be placed in an individual sealable bag prior to transport.

Questions may be directed to Dan Diekema, MD, Sandra Richter, MD, or Aaron Bossler, MD, PhD, Director of the Molecular Pathology Laboratory (4-9566, pager 4703).