Performance of Sexually Transmitted Disease Laboratories for Chlamydia trachomatis Detection in Guangdong, China

Su, Xiao‐Tong; Qin, Xiaolin; Chen, Wentao; Yu, Xueyin; Liao, Yu-Cai; Xu, Qingqing; Xue, Yaohua; Huang, Jinmei; Zheng, Heping

doi:10.1097/olq.0000000000001348

Cited by 5 publications

(3 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although traditional NAATs [e.g., PCR, ligase chain reaction, SDA, and TMA] have been developed to improve the diagnosis of STI, disadvantages such as high costs, limited performance, and restricted accessibility in resource-limited areas ( 19 ). Moreover, long turnaround times delay treatment and result in ongoing transmission of STI.…”

Section: Discussionmentioning

confidence: 99%

“…The performance of NAATs for the detection of NG and CT has been reported, with 100% sensitivity for both CT and NG by Aptima Combo2 and Amplicor PCR, and approximately 80% sensitivity with ProbeTec strand displacement amplification (SDA) ( 18 ). However, these NAATs are heavily reliant upon special instruments and strict testing environments, which remain inaccessible in many resource-limited regions (e.g., low- and middle-income countries, rural and remote regions) ( 19 ). The isothermal amplification technique is an alternative NAAT that does not need a special thermocycler and is thus more convenient for detection and screening.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

An isothermal CRISPR-based diagnostic assay for Neisseria gonorrhoeae and Chlamydia trachomatis detection

Luo,

Zeng,

Yin

et al. 2023

Microbiol Spectr

Self Cite

View full text Add to dashboard Cite

The occurrence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) is increasing worldwide, particularly in low- and middle-income countries. In cases where most infections are asymptomatic and remain in a coinfection condition. It may cause missed detections or the severe subsequent symptoms. Accurate diagnosis and convenient screening are essential for disease control. However, molecular diagnostics for CT/NG predominantly rely on polymerase chain reaction (PCR)-based detection, which requires special devices and conditions. Here, we developed an isothermal CRISPR-based CT/NG dual-target detection system by pairing recombinase polymerase amplification (RPA) and CRISPR-Cas12a/13a detection. Multiplex RPA can amplify NG and CT simultaneously, and a single-pot reaction with the Cas12a/13a can be performed for further recognizing the amplified target, driving the cleavage of the corresponding fluorescence reporter separately; thus, the signal can be monitored in different channels. This CRISPR-based CT/NG detection system achieved analytical sensitivities of 10° copies/μL for both synthetic CT/NG dsDNA and exhibited no cross-reaction with other species. In tests on 88 clinical samples, our CRISPR-based assay showed excellent agreement with the commercial assay Roche Cobas 4800 (100% accuracy for NG, 94.32% accuracy for CT, and 97.73% accuracy for CT/NG coinfection) and showed higher positive percent agreement, negative percent agreement, and accuracy than those reported for TaqMan PCR in a previous study. In addition, the results of this CRISPR-based system could be acquired within 75 min. Our isothermal diagnostic method with promising performance provides more convenience than PCR-based methods for detection and screening. IMPORTANCE A method for Neisseria gonorrhoeae (NG)/ Chlamydia trachomatis (CT) detection is developed using multiplex-recombinase polymerase amplification and Cas12a/Cas13a. This method can detect NG and CT simultaneously with high sensitivity and specificity. This method has great potential to be further developed into larger-scale screening and point-of-care testing (POCT).

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An isothermal CRISPR-based diagnostic assay for Neisseria gonorrhoeae and Chlamydia trachomatis detection

Luo,

Zeng,

Yin

et al. 2023

Microbiol Spectr

Self Cite

View full text Add to dashboard Cite

show abstract

“…The article by Su and colleagues 1 in this issue of Sexually Transmitted Diseases once again raises the issue of the minimal performance requirements for a point-of-care (POC) test for Chlamydia trachomatis . More than 20 years ago, Gift et al 2 described the implications of test and treat facilitated by a theoretical POC with low sensitivity.…”

mentioning

confidence: 99%

When Is Any Test Better Than No Test for Chlamydia?

Pol¹

2021

Sexual Trans Dis

View full text Add to dashboard Cite

T he suboptimal performance of many antigen-based chlamydia detection assays had long been a concern of Dr Julius Schachter, an innovator in the field of chlamydia diagnostics. He had reviewed the submitted article and was in the process of writing a commentary to accompany the accepted article when he was suddenly struck by the SARS-CoV-2 virus and subsequently died of complications of this disease. His shoes are too large to fill, but in his memory, I have written this commentary to include the thoughts he and I discussed as well as my own perspective.The article by Su and colleagues 1 in this issue of Sexually Transmitted Diseases once again raises the issue of the minimal performance requirements for a point-of-care (POC) test for Chlamydia trachomatis. More than 20 years ago, Gift et al. 2 described the implications of test and treat facilitated by a theoretical POC with low sensitivity. In Gift's model, in a population with an 8% prevalence of chlamydia and a 74% return-for-treatment rate, a POC with sensitivity as low as 65% would result in an increase in cases treated if compared with using a 95% sensitive laboratory-based test when no cases were treated in the absence of diagnostic test results. The potential public health benefit in terms of rapid and accurate treatment is a function of population prevalence, return for treatment rates, and assay sensitivity. The "population" in question may be the general population or the specific population served by a particular health care setting. In a more recent model developed by Rönn and colleagues, 3 additional variables were considered, including test turnaround time, testing setting, and treatment delay. In this model, the authors used very conservative parameter estimates and still described public health benefits to the general population (prevalence <3%) with a theoretical POC that was 10% less sensitive than laboratory-based nucleic acid amplification tests (NAATs). Looking at this model of reduced incidence and reduced pelvic inflammatory disease to achieve general population benefits, a test with 65% sensitivity would likely not be useful.Both of these analyses were based on considerations in resource wealthy settings. However, most treatable sexually transmitted infections (STIs) occur in resource-limited settings. Syndromic management is often the standard of care in such settings, and Wi et al., 4 estimated that as many as 3.6% to 21.6% of infections are undertreated and 30.1% to 40.9% of patients are overtreated when using this management strategy. With syndromic management, people are assessed for STIs exclusively based on symptoms and clinical signs, so asymptomatic people are excluded from management by definition and therefore undertreated. The proportion undertreated as estimated by Wi et al. does not include these infections. For chlamydia, this is a serious concern because more than half of infections are estimated to be asymptomatic, and when left untreated, these infections can lead to pelvic inflammatory disease, tubal-factor infertility...

show abstract

Performance of Sexually Transmitted Disease Laboratories for Neisseria gonorrhoeae Detection in Southern China From 2020 Through 2022

Qin,

Chen,

et al. 2024

Infect Microb Dis

View full text Add to dashboard Cite

The rising incidence of gonorrhea presents a global public health challenge, emphasizing the importance of accurate Neisseria gonorrhoeae detection for effective diagnosis, treatment and prevention. This study assessed the performance of sexually transmitted disease laboratories for N. gonorrhoeae detection in Guangdong, southern China. A questionnaire about N. gonorrhoeae detection and external quality assessments (EQAs) with five samples for culture and five for nucleic acid amplification tests (NAATs) were conducted annually from 2020 through 2022. The questionnaire was responded to by 1047 laboratories, with the results showing that Gram staining and culture were most commonly used by 44.3% and 40.4% of the laboratories, respectively, whereas NAATs were adopted by only 11.7%. The number of clinical samples tested for N. gonorrhoeae increased from 536,369 in 363 laboratories in 2020 to 1,093,147 in 582 laboratories in 2022 (P > 0.05), with an overall male-to-female testing ratio of 1:3.4 and a positive ratio of 3.6:1. The EQA results revealed a concordance rate of 90.8% for gonococcal culture and 93.1% for NAATs. NAATs demonstrated a decreasing detection rate (from 100.0% to 84.5%) with reducing gonococcal DNA copies and 89.0% specificity with the interference-negative sample. The overall concordance rates of four widely used commercial NAAT kits ranged from 95.7% to 88.5%. Gram staining and culture were widely used to detect N. gonorrhoeae in Guangdong. NAAT has long been recognized as a highly sensitive and specific method for detecting gonorrhea and should be more widely implemented in China.

show abstract

Performance of Sexually Transmitted Disease Laboratories for Chlamydia trachomatis Detection in Guangdong, China

Cited by 5 publications

References 35 publications

An isothermal CRISPR-based diagnostic assay for Neisseria gonorrhoeae and Chlamydia trachomatis detection

An isothermal CRISPR-based diagnostic assay for Neisseria gonorrhoeae and Chlamydia trachomatis detection

When Is Any Test Better Than No Test for Chlamydia?

Performance of Sexually Transmitted Disease Laboratories for Neisseria gonorrhoeae Detection in Southern China From 2020 Through 2022

Contact Info

Product

Resources

About