Dataset Information

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.

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.

SUBMITTER: Ronn MM

PROVIDER: S-EPMC6340625 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Rönn Minttu M MM Mc Grath-Lone Louise L Davies Bethan B Wilson Janet D JD Ward Helen H

BMJ open 20190117 1

<h4>Objective</h4>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).<h4>Design</h4>Systematic review.<h4>Data sources</h4>EMBASE and Ovid MEDLINE databases were searched through 3 October 2017.<h4>Eligibility criteria for selecting studies</h4>We included studies that tested samples from t ...[more]

PMID: 30659036

Similar Datasets

Project description:BackgroundNucleic Acid Amplification Tests (NAATs) are the recommended test type for diagnosing Chlamydia trachomatis (chlamydia). However, less sensitive diagnostic methods-including direct immunofluorescence (IF) and enzyme-linked immunoassay (ELISA)-remain in use in lower resourced settings. We estimate the risk of pelvic inflammatory disease (PID) following undiagnosed infection in women tested with non-NAATs and estimate the health gain from using accurate diagnostic tests.Methods and findingsWe used Denmark's national Chlamydia Study dataset to extract all chlamydia tests performed in women aged 15-34 years (1998-2001). Tests were categorised as non-NAAT (IF/ELISA) or NAAT and limited to each woman's first test in the study period. We linked test data to hospital presentations for PID within 12 months from the Danish National Patient Register. The study included 272,105 women with a chlamydia test, just under half (44.78%, n = 121,857) were tested using NAATs. Overall, 6.38% (n = 17,353) tested positive for chlamydia and 0.64% (n = 1,732) were diagnosed with PID within 12 months. The risk of PID following a positive chlamydia test did not differ by test type (NAAT 0.81% [95% CI 0.61-1.00], non-NAAT 0.78% [0.59-0.96]). The risk of PID following a negative test was significantly lower in women tested with NAATs compared to non-NAATs (0.55% [0.51-0.59] compared to 0.69% [0.64-0.73]; adjusted odds ratio (AOR) 0.83 [0.75-0.93]). We estimate that 18% of chlamydia infections in women tested with a non-NAAT were undiagnosed and that the risk of progression from undiagnosed chlamydia infection to PID within 12 months was 9.52% (9.30-9.68). Using non-NAATs could lead to an excess 120 cases of PID per 100,000 women tested compared to using NAATs. The key limitations of this study are under ascertainment of PID cases, misclassification bias in chlamydia and PID exposure status, bias to the association between clinical presentation and test type and the presence of unmeasured confounders (including other sexually transmitted infection [STI] diagnoses and clinical indication for chlamydia test).ConclusionThis retrospective observational study estimates the positive impact on women's reproductive health from using accurate chlamydia diagnostic tests and provides further evidence for restricting the use of inferior tests. Women with a negative chlamydia test have a 17% higher adjusted risk of PID by 12 months if they are tested using a non-NAAT compared to a NAAT.

Project description:Human intestinal nematode infections are a global public health issue as they can result in considerable morbidity in infected individuals, mainly in developing countries. These infections continue to go undiagnosed, as they tend to be mainly endemic in resource-poor communities where there is a shortage of experienced laboratory staff and relevant diagnostic technologies. This is further exacerbated by the nature of intermittent shedding of eggs and larvae by these parasites. Diagnostic methods range from simple morphological identification to more specialised high-throughput sequencing technologies. Microscopy-based methods, although simple, are labour-intensive and considerably less sensitive than molecular methods which are rapid and have high levels of accuracy. Molecular methods use nucleic acid amplification (NAA) to amplify the deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) fragments of the parasite to detect and determine its presence using different technologies (NAAT). They have increased the sensitivity of detection and quantitation of intestinal nematode infections, especially in low infection intensity settings. The absence of a gold standard test limits current diagnosis and, in turn, restricts intervention measures and effective control efforts. The objective of this review is to determine the accuracy of NAATs in detecting human intestinal nematode infections using Kato-Katz as the reference test for the most common soil-transmitted helminth (STH) infections and the scotch tape test for enterobiasis and Baermann method for strongyloidiasis. Relevant studies will be identified by searches in electronic databases. Two reviewers will independently screen the literature against eligibility criteria. The methodological quality of studies will then be appraised by two reviewers using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Discrepancies will be addressed by a third reviewer. The true positives, false positives, true negatives and false negatives of all the studies will be extracted into contingency tables. In paired forest plots, study-specific sensitivity and specificity with a 95 per cent confidence interval will be displayed. The systematic review of this protocol will report the diagnostic accuracy of currently available NAATs for the detection of human intestinal nematode infections. This will help healthcare providers and administrators determine the diagnostic method to be used in different clinical and preventive settings. Trial registration: PROSPERO registration number for this protocol is CRD42022315730.

Project description:Background Sexually Transmitted Infections, including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem. Increased access to point-of-care-tests (POCTs) could help detect infection and lead to appropriate management of cases and contacts, reducing transmission and development of reproductive health sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into routine care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings. Methods We conducted a systematic review of peer-reviewed primary research and conference abstract publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Results were extracted into EndNote software and initially screened by title and abstract by one author according to the inclusion and exclusion criteria. Articles that met the criteria, or were unclear, were included for full-text assessment by all authors. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition for multiple stakeholders and settings. Findings The systematic review search returned 440 articles; 28 were included overall. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all test guidance criteria, however, studies of test implementation showed multiple values for test use across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a “bridge” between the two. Conclusions Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets