In vitro assessment of the APTIMA Combo 2 assay for the detection of Chlamydia trachomatis using highly purified elementary bodies

Ikeda-Dantsuji, Yurika; Konomi, Ichiro; Nagayama, Ariaki

doi:10.1099/jmm.0.45911-0

Cited by 19 publications

(13 citation statements)

References 24 publications

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“…Serial 10-fold dilutions of C. trachomatis EBs showed that the AC2 test was able to detect positive swab samples which were 10-to 1,000-fold more dilute than those detected by PT or AMP. Ikeda-Dantsuji et al (11) found similar large differences in C. trachomatis endpoint detection rates between AC2 and AMP. Chong et al (5) showed that the AC2 test was able to detect C. trachomatis diluted to 0.01 EBs (10 Ϫ9 dilution) compared to 12 EBs (10 Ϫ5 dilution) detected by an LCx assay.…”

Section: Discussionmentioning

confidence: 58%

High Analytical Sensitivity and Low Rates of Inhibition May Contribute to Detection of Chlamydia trachomatis in Significantly More Women by the APTIMA Combo 2 Assay

et al. 2006

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The clinical sensitivity of nucleic acid amplification tests may be determined by analytical sensitivity and inhibitors in patient samples. We established endpoints for detection of propagated Chlamydia trachomatis L2 434, diluted according to swab and urine protocols for APTIMA Combo 2 (AC2), ProbeTec ET (PT), and Amplicor (AMP) assays. AC2 was 1,000-fold more sensitive than PT and 10-fold more sensitive than AMP on mock swab specimens. For urine, AC2 analytical sensitivity was 100-fold greater than those of the other assays. Spiking an aliquot of each clinical-trial sample from 298 women demonstrated inhibition rates in first-void urine (FVU), cervical swabs (CS), and vaginal swabs (VS) of 12.1%, 12.8%, and 10.4% for AMP; 27.2%, 2%, and 2%, for PT; and 0.3%, 1.7%, and 1.3% for AC2. Inhibition of our C. trachomatis spike and the PT or AMP amplification controls from the manufacturers showed less than 50% correlation. Using an infected-patient reference standard (a specimen positive in at least two tests or a single test positive in two of three samples) in AC2, the VS identified 68/69 (98.6%) infected women compared to CS (89.9%) or FVU (81.2%). Significantly fewer women were identified by PT (65.2%, 63.8%, and 66.7%) or AMP (65.2%, 59.4%, and 56.5%) with the three specimens. By individual specimen type, AC2 confirmed virtually all PT-and AMP-positive specimens, but rates of AC2 confirmation by AMP or PT ranged from 62.9 to 80.3%. The AC2 test identified significantly more women infected with C. trachomatis (P ‫؍‬ 0.001). Vaginal swabs appear to be the specimen of choice for screening.Chlamydia trachomatis is one of the most common sexually transmitted infections in the United States and worldwide (17), largely due to high rates of asymptomatic infection in the lower genital tracts of women and men (24). Early diagnosis followed by treatment of this infection can prevent upper genital tract infection, such as pelvic inflammatory disease (21).For the past 10 years, a great deal of research has led to the development and evaluation of sensitive and specific diagnostic tests for C. trachomatis. These newer nucleic acid amplification tests (NAATs) have been commercialized and are now in routine use in many parts of the world. The important aspect of these assays is their capacity to be used on less invasive specimens, such as vaginal swabs (VS) and first-void urine (FVU), which can be self-collected. Studies have shown that NAATs performed on these less invasive samples are able to detect as many or more infected patients than traditional swabs from the urethra or cervix (2-4, 6-10, 19-22, 25-27, 31).The analytical sensitivity of each test and its susceptibility to inhibitors in different specimen types may determine the clinical sensitivity of each test. We compared detection thresholds and determined the inhibitor and infection rates in three different specimens from 298 women by using three commercial assays for C. trachomatis. MATERIALS AND METHODSSpecimens. Three cervical swabs (CS), three VS, and the first 3...

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Section: Discussionmentioning

confidence: 58%

High Analytical Sensitivity and Low Rates of Inhibition May Contribute to Detection of Chlamydia trachomatis in Significantly More Women by the APTIMA Combo 2 Assay

et al. 2006

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“…Furthermore, a 0.23% rate of equivocal result generated by combined-gender urine specimens contributes to the overall robustness of the assay. Benefits of paramagnetic target capture for removal of endogenous inhibitory substances, especially those found in urine, have been described (5,11,17,21). Despite this phenomenon, the proportion of female-tomale T. vaginalis screening in this demographic did not change significantly over the 3-year interval (Fig.…”

Section: Discussionmentioning

confidence: 94%

“…However, past studies used DNA amplification methods that, in a general sense, have been shown clinically (6,26) and in vitro (5,17) to be less sensitive than TMA-based, target capture-supplemented methodology. Interestingly, the study published by Andrea and Chapin (1) focused on co-collections of vaginal swabs plus either endocervical swabs or urine.…”

Section: Discussionmentioning

confidence: 99%

Three-Year History of Transcription-Mediated Amplification-Based Trichomonas vaginalis Analyte-Specific Reagent Testing in a Subacute Care Patient Population

Napierala

Munson

et al. 2011

J Clin Microbiol

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A total of 7,899 specimens submitted for live clinical Trichomonas vaginalis analyte-specific reagent (ASR) screening from 2008 to 2010 were audited on the basis of patient gender, specimen source, molecular Neisseria gonorrhoeae and Chlamydia trachomatis results, and relative light unit (RLU) data yielded by T. vaginalis ASR. Only 1.4% of the screening was ordered by emergency department clinicians. The screening volume in 2010 was 126% higher than that in 2008. The proportions of annual female and male screening remained consistent throughout the 3-year interval (ϳ92 and 8%, respectively). Although 71.8 and 9.5% of screening was performed on endocervical and vaginal specimens, respectively, over the 3-year period, no significant difference was noted in the T. vaginalis detection rates (8.9 and 8.6%, P ‫؍‬ 0.85). Increased T. vaginalis detection was derived from female urine specimens (12.6%) compared to female genital swabs (P ‫؍‬ 0.0004). The proportion of female urine screening increased during the 3-year interval (P < 0.0002). T. vaginalis detection rate in males was 6.6%, with no difference between urethral and urine T. vaginalis detection (P ‫؍‬ 0.53). The mean RLU value for 714 positive specimens was 3,971,441; analogous values for each female specimen source and combined male source testing showed no variance (P > 0.29). Combined-gender T. vaginalis detection rate (9.1%) was significantly greater than those of C. trachomatis (5.9%) and N. gonorrhoeae (1.5%; P < 0.0002). Equivocal results presented at a rate of 0.4%. T. vaginalis ASR is an increasingly utilized assay that yields higher detection rates than other sexually transmitted infection etiologies in this community subacute care setting.

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“…The value of our large data set also applies to age delineation of T. vaginalis detection. Past studies (11,27) showed increased T. vaginalis prevalence in older age groups but did not have the benefit of highly sensitive TMA (3,13,23). One account derived from TMA analysis (1) also reported this phenomenon but did not demonstrate C. trachomatis or N. gonorrhoeae detection in patients beyond ages 26 to 30.…”

Section: Epidemiology Of T Vaginalis In Femalesmentioning

confidence: 93%

Female Epidemiology of Transcription-Mediated Amplification-Based Trichomonas vaginalis Detection in a Metropolitan Setting with a High Prevalence of Sexually Transmitted Infection

et al. 2012

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bRecent literature has reported increased accuracy of Trichomonas vaginalis transcription-mediated amplification (TMA)-based analyte-specific reagent (ASR) testing in female populations. A retrospective investigation assessed 7,277 female first-void urine, cervical, or vaginal specimens submitted from a high-prevalence sexually transmitted infection (STI) community to characterize prevalence of disease etiologies. The most common STI phenotype reflected detection of solely T. vaginalis (54.2% of all health care encounters that resulted in STI detection). In females with detectable T. vaginalis, codetection of Chlamydia trachomatis and Neisseria gonorrhoeae occurred in 7.8% and 2.7% of health care encounters, respectively. The mean age of women with detectable T. vaginalis (30.6) was significantly higher than those for women with C. trachomatis or N. gonorrhoeae (22.3 and 21.6, respectively; P < 0.0001). T. vaginalis was the predominant sexually transmitted agent in women over the age of 20 (P < 0.0002). C. trachomatis was the most commonly detected agent in females under the age of 21, particularly from cervical specimens. However, first-void urine detection rates for T. vaginalis and C. trachomatis within this age demographic demonstrated no difference (P ‫؍‬ 0.92). While overall and cervical specimen-derived detection of T. vaginalis within African American majority geographical locales outweighed that within majority Caucasian geographical regions (P < 0.004), this difference was not noted with first-void urine screening (P ‫؍‬ 0.54). Health care professionals can consider TMA-based T. vaginalis screening for a wide age range of patients; incorporation of first-void urine specimens into screening algorithms can potentiate novel insight into the epidemiology of trichomoniasis.

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In vitro assessment of the APTIMA Combo 2 assay for the detection of Chlamydia trachomatis using highly purified elementary bodies

Cited by 19 publications

References 24 publications

High Analytical Sensitivity and Low Rates of Inhibition May Contribute to Detection of Chlamydia trachomatis in Significantly More Women by the APTIMA Combo 2 Assay

High Analytical Sensitivity and Low Rates of Inhibition May Contribute to Detection of Chlamydia trachomatis in Significantly More Women by the APTIMA Combo 2 Assay

Three-Year History of Transcription-Mediated Amplification-Based Trichomonas vaginalis Analyte-Specific Reagent Testing in a Subacute Care Patient Population

Female Epidemiology of Transcription-Mediated Amplification-Based Trichomonas vaginalis Detection in a Metropolitan Setting with a High Prevalence of Sexually Transmitted Infection

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