Rapid point of care test for detecting urogenital <i>Chlamydia trachomatis</i> infection in nonpregnant women and men at reproductive age

Grillo‐Ardila, Carlos Fernando; Torres, Marcela; Gaitán, Hernando

doi:10.1002/14651858.cd011708.pub2

Cited by 6 publications

(4 citation statements)

References 60 publications

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“…Current NAATs take hours or a day or more for results ( 16 , 17 ). While some C. trachomatis diagnostic tests take only 15 to 30 min, they are based on immunoassays that have an unacceptably low sensitivity of 17% to 83% ( 17 , 18 ) and are not recommended for use by the WHO ( 17 ).…”

Section: Introductionmentioning

confidence: 99%

Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji

et al. 2021

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Rapid and precise detection of Chlamydia trachomatis —the leading global cause of sexually transmitted infections (STI)—at the point-of-care (POC) is required for treatment decisions to prevent transmission and sequelae including pelvic inflammatory disease, ectopic pregnancy, tubal-factor infertility and preterm birth. We developed a rapid POC test (POCT), termed LH-POCT, which uses Loop-mediated AMPlification (LAMP) of nucleic acids, and performed a head-to-head comparison with the Cepheid Xpert® CT/NG assay using clinician-collected de-identified paired vaginal samples from a parent study that consecutively enrolled symptomatic and asymptomatic females over age 18 years from the Ministry of Health and Medical Services Health Centers in Fiji. Samples were processed by the Xpert® CT/NG assay and LH-POCT, blinded to the comparator. Discrepant samples were resolved by qPCR. De-identified clinical data and tests for Trichomonas vaginalis , Candida and bacterial vaginosis (BV) were provided. There were a total of 353 samples from 327 females. C. trachomatis positivity was 16.7% (59/353) while the prevalence was 16.82% (55/327) after discrepant resolution. Seven discrepant samples resolved to: four false negatives, two false positives and one true positive for the LH-POCT. The sensitivity of the LH-POCT was 93.65% (95% CI: 84.53% to 98.24%) and specificity 99.31% (95% CI: 97.53% to 99.92%). Discrepant samples clustered among women with vaginal discharge and/or BV. The prototype LH-POCT workflow has excellent performance, meeting many World Health Organization ASSURED criteria for POC tests, including a sample-to-result time of 35 minutes. Our LH-POCT holds promise for improving clinical practice to prevent and control C. trachomatis STIs in diverse health care settings globally.

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Section: Introductionmentioning

confidence: 99%

Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji

et al. 2021

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“…In additional comparative analyses, there were no significant differences in detection accuracy between 4 commonly used IC-RDTs (Table 5). In a previous meta-analysis, including 19 studies with 13,676 participants, the mean sensitivity of IC-RDTs for detecting urogenital infection was 48% 18 . In some studies performed with vaginal swabs or endocervical swabs, the sensitivity of IC-RDTs for the detection of C. trachomatis ranged from 11.6% to 41.2% 19–21 .…”

Section: Discussionmentioning

confidence: 96%

“…In a previous meta-analysis, including 19 studies with 13,676 participants, the mean sensitivity of IC-RDTs for detecting urogenital infection was 48%. 18 In some studies performed with vaginal swabs or endocervical swabs, the sensitivity of IC-RDTs for the detection of C. trachomatis ranged from 11.6% to 41.2%. [19][20][21] In the current study, the sensitivity of NAATs was similar to those reported in studies by Cheng et al 22 (99.6% in urine samples and 98.8% in cervical swab samples) and Marshall et al 23 (93.7%-100%).…”

Section: Discussionmentioning

confidence: 99%

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

Qin²,

Chen

et al. 2020

Sexual Trans Dis

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Background: Chlamydia trachomatis detection plays a crucial role in early diagnosis and treatment of C. trachomatis infection. In the current study, the capability of sexually transmitted disease (STD) laboratories to detect C. trachomatis was investigated in Guangdong, China.Methods: An external quality assessment panel, including 5 positive samples with different C. trachomatis loads and 2 negative samples was distributed to 654 participating laboratories in October 2019, and the test results were analyzed by Guangdong Central STD Laboratory. The use of various C. trachomatis detection methods in Guangdong from 2015 to 2019 was also retrospectively investigated.Results: Of the 654 participating STD laboratories, 559 (85.47%) used immune chromatographic-rapid diagnostic tests (IC-RDTs) to detect C. trachomatis in 2019, and 95 (14.53%) used nucleic acid amplification tests (NAATs). The rate of NAATs use increased approximately 4-fold from 2015 to 2019. The sensitivity of IC-RDTs decreased markedly from 97.32% to 30.89% with decreasing C. trachomatis load, whereas that of NAATs was 97.62% to 100% in all positive samples. With respect to negative samples the specificity of IC-RDTs was 97.13% to 97.30% and that of NAATs was 98.95% to 100%. Laboratories using IC-RDTs were less likely to detect C. trachomatis than those using NAATs in samples with C. trachomatis loads of 20000 copies/mL or less (P < 0.0001). Further analysis indicated no significant difference (P > 0.05) in detection rate among the 4 IC-RDT assays commonly used by the participating laboratories.

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“…But As rapid NAAT tests have recently come out with improved sensitivity, NAATs such as Gene Xpert have been recommended as rapid tests. However, rapid test are still not thought to be effective for diagnosing chlamydia in men of reproductive age and nonpregnant women because of a high false-negative rates [37].…”

Section: Rapid Testmentioning

confidence: 99%

AAUS guidelines 2021 revision sexually transmitted infection (STIs) diagnostic strategy for STI

Bae

Lee

2022

Journal of Infection and Chemotherapy

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Rapid point of care test for detecting urogenital Chlamydia trachomatis infection in nonpregnant women and men at reproductive age

Abstract: Rapid point of care test for detecting urogenital Chlamydia trachomatis infection in nonpregnant women and men at reproductive age.

Cited by 6 publications

References 60 publications

Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji

Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji

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

AAUS guidelines 2021 revision sexually transmitted infection (STIs) diagnostic strategy for STI

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