Evidence map›Paper›PMID 17581933›Full record

ArticleJournal of clinical microbiology2007

Evaluation of Gen-Probe APTIMA-based Neisseria gonorrhoeae and Chlamydia trachomatis confirmatory testing in a metropolitan setting of high disease prevalence.

Erik Munson, Vivian Boyd, Jolanta Czarnecka, Judy Griep, Brian Lund, Nancy Schaal, Jeanne E Hryciuk

Abstract readComparative StudyEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Erik MunsonWheaton Franciscan and Midwest Clinical Laboratories, Wauwatosa, Wisconsin 53226, USA. Erik.Munson@wfhc.org
Vivian Boyd
Jolanta Czarnecka
Judy Griep
Brian Lund
Nancy Schaal
Jeanne E Hryciuk

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Prompted by reports challenging the validity of the low-positive Neisseria gonorrhoeae and Chlamydia trachomatis results generated by the APTIMA Combo 2 assay (Gen-Probe, Incorporated) and by a Centers for Disease Control and Prevention recommendation to confirm N. gonorrhoeae- or C. trachomatis-positive screens by using an alternative amplification target, we report on a comparison of this means of confirmation with an in-house algorithm of repeat testing. Primary clinical specimens yielding N. gonorrhoeae- or C. trachomatis-specific luminescent values between 100,000 and 1,000,000 were repeat tested in duplicate. A subset of specimens was forwarded for confirmatory assays (Gen-Probe) individualized for alternative N. gonorrhoeae or C. trachomatis targets. An 18-month audit revealed that 230 of 29,977 C. trachomatis screens (0.8%) and 41 of 29,064 N. gonorrhoeae assays (0.1%) yielded low-positive data. When a subset of 40 low-positive N. gonorrhoeae screens was repeat tested, 20 (50.0%) remained positive; 22 (55.0%) of the screens remained positive following performance of the confirmatory assay. In contrast, repeat testing of 153 low-positive C. trachomatis screens yielded a positive result for fewer specimens (n = 97; 63.4%) than when commercial confirmatory testing was used (n = 124; 81.0%). However, confirmation of the results for additional C. trachomatis screens by use of an alternative target did not translate into significant differences in the calculated overall C. trachomatis-positive screen rates (7.39% by repeat testing versus 7.52% by the confirmatory assay; P = 0.53). Furthermore, use of the confirmatory assay raised the positive predictive value only 1.8% over that of repeat testing. Molecular confirmatory testing did not significantly enhance the reliability of C. trachomatis- or N. gonorrhoeae-specific nucleic acid amplification testing in this metropolitan setting compared to the reliability of repeat testing.

Indexed as

Reagent Kits, DiagnosticBacteriological TechniquesChlamydia InfectionsChlamydia trachomatisGonorrheaHumansMolecular Diagnostic TechniquesNeisseria gonorrhoeaePredictive Value of TestsReagent Kits, Diagnostic

Identifiers

PMID17581933
PMCPMC2045308

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.