Journal article
Extragenital self-collection testing for gonorrhea and chlamydia: A feasibility study for expanding STI screening in the Veterans Health Administration
American journal of clinical pathology, Vol.163(3), pp.406-410
03/2025
DOI: 10.1093/ajcp/aqae135
PMID: 39394953
Abstract
Rectal and pharyngeal infections with gonorrhea and chlamydia are of concern because they are associated with higher risk of HIV acquisition. Extragenital screening in asymptomatic persons at high risk may have the potential to reduce the incidence of these sexually transmitted infections (STIs). Several testing platforms are available for the testing of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using nucleic acid amplification tests (NAATs). Self-collected extragenital samples are currently not approved by the US Food and Drug Administration in any NAAT platform. This study compares the analytical performance of self-collected extragenital specimens to that of clinician-collected specimens.OBJECTIVESRectal and pharyngeal infections with gonorrhea and chlamydia are of concern because they are associated with higher risk of HIV acquisition. Extragenital screening in asymptomatic persons at high risk may have the potential to reduce the incidence of these sexually transmitted infections (STIs). Several testing platforms are available for the testing of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using nucleic acid amplification tests (NAATs). Self-collected extragenital samples are currently not approved by the US Food and Drug Administration in any NAAT platform. This study compares the analytical performance of self-collected extragenital specimens to that of clinician-collected specimens.We performed a multicenter/multiplatform validation study as a National Veterans Health Administration Pathology and Laboratory Medicine quality improvement project, with 9 different participating sites. Self-collected specimens were obtained at the same time as clinician-collected specimens. Clinician-collected specimens were used as the gold standard to evaluate the sensitivity and specificity of self-collection.METHODSWe performed a multicenter/multiplatform validation study as a National Veterans Health Administration Pathology and Laboratory Medicine quality improvement project, with 9 different participating sites. Self-collected specimens were obtained at the same time as clinician-collected specimens. Clinician-collected specimens were used as the gold standard to evaluate the sensitivity and specificity of self-collection.A total of 2324 individual tests were analyzed (501 rectal and 661 oropharyngeal). The sensitivity was 94.44% for CT and 100% for NG for rectal specimens, whereas it was 100% for CT and 97.22% for NG for oral specimens. Specificity for oral specimens was 99.85% for CT and 99.36% for NG, whereas for rectal specimens, it was 99% for CT and NG.RESULTSA total of 2324 individual tests were analyzed (501 rectal and 661 oropharyngeal). The sensitivity was 94.44% for CT and 100% for NG for rectal specimens, whereas it was 100% for CT and 97.22% for NG for oral specimens. Specificity for oral specimens was 99.85% for CT and 99.36% for NG, whereas for rectal specimens, it was 99% for CT and NG.Self-collected specimens for extragenital CT/NG testing are highly sensitive and specific, with negative predictive values of 100%. Self-collection has the potential to overcome a major barrier for STI screening by providing an accessible, convenient, and patient-centered alternative.CONCLUSIONSSelf-collected specimens for extragenital CT/NG testing are highly sensitive and specific, with negative predictive values of 100%. Self-collection has the potential to overcome a major barrier for STI screening by providing an accessible, convenient, and patient-centered alternative.
Details
- Title: Subtitle
- Extragenital self-collection testing for gonorrhea and chlamydia: A feasibility study for expanding STI screening in the Veterans Health Administration
- Creators
- Maria E Navas - VA Northeast Ohio Healthcare SystemLewis Musoke - VA Northeast Ohio Healthcare SystemPuja Van Epps - Case Western Reserve UniversityKristen Allen - VA Northeast Ohio Healthcare SystemK C Coffey - VA Maryland Health Care SystemAndrea Appleby-Sigler - VA Maryland Health Care SystemKarla Peralta - VA Maryland Health Care SystemMark Del Pilar - VA Maryland Health Care SystemMarie DuBoisIqbal Kapadia - Bay Pines VA Healthcare SystemKaley Tash - Bay Pines VA Healthcare SystemJohn Vallone - VA Desert Pacific Healthcare NetworkAurelio BarreraJill Adams - VA Eastern Colorado Health Care SystemChitra Rajagopalan - VA Eastern Colorado Health Care SystemKaren Rexroth - Washington DC VA Medical CenterDebra Benator - Washington DC VA Medical CenterShelby D Melton - VA North Texas Health Care SystemMegan B Wachsmann - VA North Texas Health Care SystemJennifer Wais - VA North Texas Health Care SystemJelena Catania - Orlando HealthMinh Q Ho - Orlando HealthRuben Benitez EspinosaBradley Wigton - Minneapolis VA Health Care SystemAnjum S Kaka - Minneapolis VA Health Care SystemGloria Niehans - Minneapolis VA Health Care SystemJessica Wang-RodriguezJ Stacey Klutts - University of Iowa
- Resource Type
- Journal article
- Publication Details
- American journal of clinical pathology, Vol.163(3), pp.406-410
- DOI
- 10.1093/ajcp/aqae135
- PMID
- 39394953
- NLM abbreviation
- Am J Clin Pathol
- ISSN
- 1943-7722
- eISSN
- 1943-7722
- Publisher
- OXFORD UNIV PRESS INC
- Language
- English
- Electronic publication date
- 10/12/2024
- Date published
- 03/2025
- Academic Unit
- Pathology
- Record Identifier
- 9984722562502771
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