Evaluation of the performance of nucleic acid amplification tests (NAATs) in detection of chlamydia and gonorrhoea infection in vaginal specimens relative to patient infection status: a systematic review
File(s)
Published version
Author(s)
Ronn, Minttu
Mc Grath-Lone, Louise
Davies, Bethan
Wilson, Janet
Ward, Helen
Type
Journal Article
Abstract
OBJECTIVE: We aimed to assess the performance of NAATs using vaginal specimens in comparison to other urogenital specimens in their ability to detect chlamydia and gonorrhea infection in women.
DESIGN: Systematic review.
DATA SOURCES: EMBASE and Ovid MEDLINE databases through 3 October 2017.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included studies that tested samples from the vagina and ≥1 other site (cervix and/or urine) with ≥2 NAATs for chlamydia and ≥2 NAATs or 1 NAAT and culture for gonorrhoea for each site.
DATA EXTRACTION AND SYNTHESIS: We compared the performance of NAATs on specimens taken from the vagina to those from the cervix or urine in diagnosing chlamydia and gonorrhoea infection in women based on patient infection status (PIS). We analysed the performance using vaginal specimens compared to PIS. Performance is defined as the sensitivity of a NAAT using a specimen site and PIS status of the patient. We assessed risk of bias using modified QUADAS-2.
RESULTS: Nine publications met the inclusion criteria (eight for chlamydia; six for gonorrhoea) and were narratively reviewed. Pooled summary estimates were not calculated due to the variable methodology and PIS definitions. Tests performed on vaginal specimens accomplished similar performance to cervical and urine specimens for chlamydia (range of performance estimates: vaginal 65-100%, cervical 59-97%, urine 57-100%) and gonorrhoea (vaginal 64-100%, cervical 85-100%, urine 67-94%). Vaginal specimens were estimated to have a performance >80% for chlamydia and gonorrhoea infections in all but one study.
CONCLUSIONS: Performance of the NAATs for chlamydia and gonorrhea detection using vaginal specimens was similar to that of cervical and urine specimens relative
to PIS. As vaginal samples have a higher acceptability and lower cost, the study can support clinical testing guidelines by providing evidence that vaginal samples are a suitable alternative to traditional test sites.
DESIGN: Systematic review.
DATA SOURCES: EMBASE and Ovid MEDLINE databases through 3 October 2017.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included studies that tested samples from the vagina and ≥1 other site (cervix and/or urine) with ≥2 NAATs for chlamydia and ≥2 NAATs or 1 NAAT and culture for gonorrhoea for each site.
DATA EXTRACTION AND SYNTHESIS: We compared the performance of NAATs on specimens taken from the vagina to those from the cervix or urine in diagnosing chlamydia and gonorrhoea infection in women based on patient infection status (PIS). We analysed the performance using vaginal specimens compared to PIS. Performance is defined as the sensitivity of a NAAT using a specimen site and PIS status of the patient. We assessed risk of bias using modified QUADAS-2.
RESULTS: Nine publications met the inclusion criteria (eight for chlamydia; six for gonorrhoea) and were narratively reviewed. Pooled summary estimates were not calculated due to the variable methodology and PIS definitions. Tests performed on vaginal specimens accomplished similar performance to cervical and urine specimens for chlamydia (range of performance estimates: vaginal 65-100%, cervical 59-97%, urine 57-100%) and gonorrhoea (vaginal 64-100%, cervical 85-100%, urine 67-94%). Vaginal specimens were estimated to have a performance >80% for chlamydia and gonorrhoea infections in all but one study.
CONCLUSIONS: Performance of the NAATs for chlamydia and gonorrhea detection using vaginal specimens was similar to that of cervical and urine specimens relative
to PIS. As vaginal samples have a higher acceptability and lower cost, the study can support clinical testing guidelines by providing evidence that vaginal samples are a suitable alternative to traditional test sites.
Date Issued
2019-01-17
Date Acceptance
2018-10-19
Citation
BMJ Open, 2019, 9
ISSN
2044-6055
Publisher
BMJ Journals
Journal / Book Title
BMJ Open
Volume
9
Copyright Statement
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Sponsor
Medical Research Council
Subjects
chlamydia
gonorrhea
molecular diagnostics
patient infection status
Publication Status
Published
Article Number
e022510
Date Publish Online
2019-01-17