Nucleic acid amplification tests for the diagnosis ofNeisseria gonorrhoeaein low-prevalence settings: a review of the evidence: Table 1

Abstract

We were unable to find an evidence base to support widespread screening for gonorrhoea in the community. However, the increasing availability of dual NAATs may lead to more testing but this should be tempered by the public health need. Pilot studies and development of robust testing algorithms should be encouraged.

Gonorrhoea notifications and nucleic acid amplification testing in a very low‐prevalence Australian female population

“…Although endocervical culture is almost as sensitive as NAAT for that site, 2 only 10/25 of our NAAT‐positive samples had positive endocervical cultures for gonorrhoea, suggesting that most of the positive gonorrhoea NAATs (60%) are false positives. This finding is consistent with the product information and the screening recommendation from the US Preventive Services Task Force warning against routine screening for gonorrhoea with NAAT among individuals in a low‐prevalence population (ie, < 1%) 4 , 6…”

“…NAATs are more sensitive than culture, particularly for urine sampling, 2 which is the most common specimen type collected in Australia. However, NAATs for gonorrhoea are less specific than culture, and the specificity of NAAT varies by specimen type and testing platform, producing false‐positive results that reduce the positive predictive value (PPV) when the prevalence of infection is low 3 , 4 . The product information 5 and United States sexually transmitted infection (STI) treatment guidelines warn against the use of NAAT in low‐prevalence populations for this reason 6 .…”

Evaluation of the New BD Max GC Real-Time PCR Assay, Analytically and Clinically as a Supplementary Test for the BD ProbeTec GC Qx Amplified DNA Assay, for Molecular Detection of Neisseria gonorrhoeae

“…Nucleic acid amplification tests (NAATs) have increasingly replaced culture diagnostics internationally, due to their higher sensitivity, speed, automation, and use of noninvasive specimens (2-7). However, due to suboptimal specificity, especially of several early generation gonococcal NAATs, in several regions (e.g., Europe and Australia), it is recommended to verify positive samples with another NAAT targeting a different genetic sequence, particularly in low-prevalence populations and in pharyngeal infections (6,(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18). The psychological, social, and legal consequences of false-positive gonococcal test results can be substantial.…”

“…However, due to suboptimal specificity of several gonococcal NAATs, in several regions (e.g., Europe and Australia), it is recommended to verify positive samples with another NAAT targeting a different genetic sequence (6,(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18). This supplementary testing for verification of screening NAAT-positive specimens is particularly important in low-prevalence populations, if the positive predictive value (PPV) does not exceed 90%, and in pharyngeal infection.…”

Highlights from this issue

“…This reminds us of an Australian study by Wilson et al 3 in 2010, which argues that over-screening of sex workers to meet legislative requirements was wasteful of resource. On a related note, Fifer et al 4 report on the limited literature about testing with nucleic acid amplification tests for gonorrhoea in low prevalence settings. They warn of the likely high number of false positives—a real concern as these tests are being rolled out without targeting.…”