Exploring 'best practice' for nucleic acid detection of Neisseria gonorrhoeae.
Nucleic acid detection tests (NADT) have considerable benefits for the detection of Neisseria gonorrhoeae (GC), including high sensitivity across a range of specimen types and use under widely differing settings and conditions. However, sexual health practitioners and others who use data generated by NADT for GC should be aware of some important limitations of these tests. False-positive results caused by cross reaction with commensal Neisseria species have been observed in many assays, and have lead to unacceptably low positive-predictive values in some patient populations. Further, false-negative results can be caused by GC sequence variation, with some gonococci lacking certain NADT target sequences. This review examines the issues associated with gonococcal NADT and considers best practice for use of these assays based on current knowledge. We emphasise the need for supplementary testing and extensive assay validation, and suggest appropriate strategies for these requirements irrespective of the setting in which they are used. Further, we highlight the need to maintain culture-based testing for certain specimen sites as well as for antimicrobial resistance surveillance.
Whiley
David M
DM
Queensland Paediatric Infectious Diseases Laboratory, Sir Albert Sakzewski Virus Research Centre, Royal Children's Hospital and Health Service District, Brisbane, Qld 4029, Australia.
Garland
Suzanne M
SM
Harnett
Geoffrey
G
Lum
Gary
G
Smith
David W
DW
Tabrizi
Sepehr N
SN
Sloots
Theo P
TP
Tapsall
John W
JW
D019985:Benchmarking; D015342:DNA Probes; D004269:DNA, Bacterial / Q000302:isolation & purification; D003955:Diagnostic Tests, Routine / Q000379:methods; D024881:Drug Resistance, Bacterial; D005188:False Negative Reactions; D005189:False Positive Reactions; D006069:Gonorrhea / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology*; D006801:Humans; D025202:Molecular Diagnostic Techniques; D009344:Neisseria gonorrhoeae / Q000235:genetics* / Q000302:isolation & purification; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011634:Public Health; D011785:Quality Assurance, Health Care
D015342:DNA Probes; D004269:DNA, Bacterial