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
Open Access
- 15 January 2019
- Vol. 9 (1), e022510
- https://doi.org/10.1136/bmjopen-2018-022510
Abstract
Objective We evaluated the performance of nucleic acid amplification tests (NAATs) using vaginal specimens in comparison to specimens from the cervix or urine in their ability to detect chlamydia and gonorrhoea infection in women based on patient infection status (PIS). Design Systematic review. Data sources EMBASE and Ovid MEDLINE databases were searched 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 Performance is defined as the sensitivity of a NAAT using a specimen site and PIS 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 gonorrhoea 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 traditionally used specimens.Funding Information
- National Institute for Health Research
- Medical Research Council
- Wellcome Trust
This publication has 35 references indexed in Scilit:
- 2012 European guideline on the diagnosis and treatment of gonorrhoea in adultsInternational Journal of STD & AIDS, 2013
- Assessment of self taken swabs versus clinician taken swab cultures for diagnosing gonorrhoea in women: single centre, diagnostic accuracy studyBMJ, 2012
- Assessment of best single sample for finding chlamydia in women with and without symptoms: a diagnostic test studyBMJ, 2012
- The first performance report for the Bio-Rad Dx CT/NG/MG assay for simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium in urogenital samplesJournal of Microbiological Methods, 2012
- QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy StudiesAnnals of Internal Medicine, 2011
- Evaluation of One-Sample Testing of Self-Obtained Vaginal Swabs and First Catch Urine Samples Separately and in Combination for the Detection of Chlamydia trachomatis by Two Amplified DNA Assays in Women Visiting a Sexually Transmitted Disease ClinicSexually Transmitted Diseases, 2011
- Performance of the Abbott RealTi m e CT/NG for Detection of Chlamydia trachomatis and Neisseria gonorrhoeaeJournal of Clinical Microbiology, 2010
- Evaluation of Self-Collected Vaginal Swab, First Void Urine, and Endocervical Swab Specimens for the Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Adolescent FemalesJournal of Pediatric and Adolescent Gynecology, 2008
- Cost-Effectiveness of Screening Strategies for Chlamydia trachomatis Using Cervical Swabs, Urine, and Self-Obtained Vaginal Swabs in a Sexually Transmitted Disease Clinic SettingSexually Transmitted Diseases, 2008
- Evaluation of Use of a Single Intravaginal Swab to Detect Multiple Sexually Transmitted Infections in Active‐Duty Military WomenClinical Infectious Diseases, 2001