Abstract:IMPORTANCERates of chlamydial and gonococcal infection continue to increase in the United States, as do the associated costs of untreated infections. Improved diagnostic technologies that support testing and treating in 1 clinical visit are critical to advancing efforts to control the rates of chlamydial and gonococcal infection. OBJECTIVE To evaluate the clinical performance of a point-of-care (POC) molecular diagnostic assay for the detection of chlamydia and gonorrhea.
“…Recently, some new molecular POC diagnostic technology (such as the io CT/NG Assay, the Visby Medical Sexual Health Test and the rapid multiplex PCR assays.) has been developed and meets many of the requirements of the TPP for a POC device (sensitive, specific, rapid), which could represent important advances in the development of rapid diagnostics for sexually transmitted infections [ 61 , 62 , 64 ].…”
Background
Chlamydia trachomatis
(CT) is one of the most prevalent bacterial sexually transmitted infections (STIs) globally but has been inadequately detected for intervention. Introduction of point-of-care tests (POCTs) for CT is critical for filling the intervention gaps. We conducted a systematical review and meta-analysis on diagnostic performance of POCTs for CT to assist in guiding the application of these assays in CT screening and detection.
Methods
We searched PubMed/Medline and Embase databases, from January 2004 to May 2021, for studies reporting the performance of POCTs for identifying CT using specimens collected from urethral, vaginal, cervical, anorectal, or pharyngeal site or of urine. Two investigators independently screened and extracted data for controlling the quality of data extraction. Any discrepancies in study selection and data extraction were resolved through consensus. We only included studies with sufficient data to estimate sensitivity and specificity, and used laboratory-based nucleic acid amplification test (NAAT) as the reference standard. The main outcomes were pooled sensitivity, specificity, and diagnostic odds ratio (DOR) and their corresponding 95% confidence intervals (CIs). Summary estimates were calculated using a random-effects model and summary receiver operator curves (SROCs) were generated using the Moses-Littenberg method. STATA 14.0 and Meta-DiSc 1.4 were used for statistical analysis. The study protocol is registered with PROSPERO, number CRD42019140544.
Findings
Of 3,038 records identified, 39 studies (42,336 specimens) were included in the study, including 14 studies on evaluation of antigen detection (AD)-based and 25 on NAAT-based POCTs. The overall pooled sensitivity, specificity and DOR were 56% (95% CI 45%–67%), 99% (95% CI 98%–99%) and 86 (95% CI 46–163), respectively, for AD-based POCTs and corresponding values for NAAT-based POCTs were 94% (95% CI 91%–96%), 99% (95% CI 99%–99%) and 1,933(95% CI 1,018–3,669), respectively. The pooled sensitivity of AD-based POCTs varied across the types of specimens, indicating 46% for cervical swabs (95% CI 37%–56%; range 22.7%–71.4%), 52% for vaginal swabs (95% CI 34%–70%; range 17.1%–86.8%) and 57% for male urine (95% CI 36%–75%; range 20.0%–82.6%). For NAAT-based POCTs, the pooled sensitivity was 94% (95% CI 90%–96%) for cervical swabs, 94% (95% CI 86%–98%) for vaginal swabs, 95% (95% CI 91%–97%) for urine specimens and 93% (95% CI 87%–96%) for anorectal swabs.
Interpretation
NAAT-based POCTs for CT have a significantly better performance particularly in sensitivity for diagnosing the infection with CT than the AD-based POCTs. Screening strategy with AD-based POCTs may potentially result in a substantial under-detection of the infections.
“…Recently, some new molecular POC diagnostic technology (such as the io CT/NG Assay, the Visby Medical Sexual Health Test and the rapid multiplex PCR assays.) has been developed and meets many of the requirements of the TPP for a POC device (sensitive, specific, rapid), which could represent important advances in the development of rapid diagnostics for sexually transmitted infections [ 61 , 62 , 64 ].…”
Background
Chlamydia trachomatis
(CT) is one of the most prevalent bacterial sexually transmitted infections (STIs) globally but has been inadequately detected for intervention. Introduction of point-of-care tests (POCTs) for CT is critical for filling the intervention gaps. We conducted a systematical review and meta-analysis on diagnostic performance of POCTs for CT to assist in guiding the application of these assays in CT screening and detection.
Methods
We searched PubMed/Medline and Embase databases, from January 2004 to May 2021, for studies reporting the performance of POCTs for identifying CT using specimens collected from urethral, vaginal, cervical, anorectal, or pharyngeal site or of urine. Two investigators independently screened and extracted data for controlling the quality of data extraction. Any discrepancies in study selection and data extraction were resolved through consensus. We only included studies with sufficient data to estimate sensitivity and specificity, and used laboratory-based nucleic acid amplification test (NAAT) as the reference standard. The main outcomes were pooled sensitivity, specificity, and diagnostic odds ratio (DOR) and their corresponding 95% confidence intervals (CIs). Summary estimates were calculated using a random-effects model and summary receiver operator curves (SROCs) were generated using the Moses-Littenberg method. STATA 14.0 and Meta-DiSc 1.4 were used for statistical analysis. The study protocol is registered with PROSPERO, number CRD42019140544.
Findings
Of 3,038 records identified, 39 studies (42,336 specimens) were included in the study, including 14 studies on evaluation of antigen detection (AD)-based and 25 on NAAT-based POCTs. The overall pooled sensitivity, specificity and DOR were 56% (95% CI 45%–67%), 99% (95% CI 98%–99%) and 86 (95% CI 46–163), respectively, for AD-based POCTs and corresponding values for NAAT-based POCTs were 94% (95% CI 91%–96%), 99% (95% CI 99%–99%) and 1,933(95% CI 1,018–3,669), respectively. The pooled sensitivity of AD-based POCTs varied across the types of specimens, indicating 46% for cervical swabs (95% CI 37%–56%; range 22.7%–71.4%), 52% for vaginal swabs (95% CI 34%–70%; range 17.1%–86.8%) and 57% for male urine (95% CI 36%–75%; range 20.0%–82.6%). For NAAT-based POCTs, the pooled sensitivity was 94% (95% CI 90%–96%) for cervical swabs, 94% (95% CI 86%–98%) for vaginal swabs, 95% (95% CI 91%–97%) for urine specimens and 93% (95% CI 87%–96%) for anorectal swabs.
Interpretation
NAAT-based POCTs for CT have a significantly better performance particularly in sensitivity for diagnosing the infection with CT than the AD-based POCTs. Screening strategy with AD-based POCTs may potentially result in a substantial under-detection of the infections.
“…New developments in point-of-care tests, mobile health, home sampling and internet testing offer increasing opportunities to implement widespread testing to detect asymptomatic chlamydia infections, including extragenital infections. [6][7][8] However, the clinical and public health relevance of active case finding by testing for asymptomatic infections is under debate. [9][10][11] The balance between benefits and harms of testing for asymptomatic infections might be changing for three reasons: (1) empirical evidence does not support the claim that enhanced testing of asymptomatics reduces the incidence and prevalence of chlamydia infection; (2) the risk of long-term complications attributable to a chlamydia infection in particular the risk of tubal factor infertility (TFI) is considered low and there is uncertainty about the fraction that can be prevented by routine testing; (3) there is more acknowledgement of the harms related to overdiagnosis and overtreatment, including the potential for antimicrobial resistance in other pathogens.…”
ObjectivesThe clinical and public health relevance of widespread case finding by testing for asymptomatic chlamydia infections is under debate. We wanted to explore future directions for chlamydia control and generate insights that might guide for evidence-based strategies. In particular, we wanted to know the extent to which we should pursue testing for asymptomatic infections at both genital and extragenital sites.MethodsWe synthesised findings from published literature and from discussions among national and international chlamydia experts during an invitational workshop. We described changing perceptions in chlamydia control to inform the development of recommendations for future avenues for chlamydia control in the Netherlands.ResultsDespite implementing a range of interventions to control chlamydia, there is no practice-based evidence that population prevalence can be reduced by screening programmes or widespread opportunistic testing. There is limited evidence about the beneficial effect of testing on pelvic inflammatory disease prevention. The risk of tubal factor infertility resulting from chlamydia infection is low and evidence on the preventable fraction remains uncertain. Overdiagnosis and overtreatment with antibiotics for self-limiting and non-viable infections have contributed to antimicrobial resistance in other pathogens and may affect oral, anal and genital microbiota. These changing insights could affect the outcome of previous cost–effectiveness analysis.ConclusionThe balance between benefits and harms of widespread testing to detect asymptomatic chlamydia infections is changing. The opinion of our expert group deviates from the existing paradigm of ‘test and treat’ and suggests that future strategies should reduce, rather than expand, the role of widespread testing for asymptomatic chlamydia infections.
“…It is a molecular POC test for CT and NG. 30 ,31s A pilot study for detection of CT using the assay found high sensitivity and specificity and high patient acceptability, and indicated that 70% of women preferred to self-collect vaginal swabs if a POC test was available. 32s This POC assay is the first amplification assay to provide a sample to result in 30 minutes (including DNA extraction); this turnaround time would allow clinicians to treat infected patients before they leave most clinical encounters.…”
Point-of-care tests for rapid diagnosis and treatment of sexually transmitted infections are useful and highly desirable.
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