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| Study authors and year | Summary of results
(summaries are based on descriptions in abstracts and articles) | Performance |
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Dean et al. 2012 [38] | Microfluidic Multiplex PCR Assay: microfluidic assay that simultaneously identifies nine CT genetic markers. The assay is based on microfluidic modules that purify DNA from clinical samples, performs highly multiplexed amplification, and separates the amplicons electrophoretically with laser-induced fluorescence detection | Comparison with Roche-AMPLICOR NAAT:
Multiplex sensitivity and specificity, PPV and NPV: 91.5% and 100%, 100% and 91%
AMPLICOR sensitivity and specificity, PPV and NPV: 62.4% and 95.9%, 94.1% and 68.6% |
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Doseeva et al. 2011 [39] | Thermophilic helicase dependent amplification (tHDA) assay: helicase unwinds double-stranded DNA at constant temperature. This is treated with a sequence-specific sample preparation on magnetic beads and homogeneous endpoint fluorescence detection using dual-labeled probes. | Not measured |
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Hesse et al. 2011 [40] | BioVei, Inc., vaginal swab prototype: self-contained, two-step enzyme-based detection system that contains a chromogenic substrate for the specific enzyme coupled to a fluorescent tag in an aqueous solution. When exposed to Chlamydia, the substrate undergoes an enzymatic reaction. Evaluators utilized rapid communication with the manufacturers to maximize performance | Of final prototype:
Sensitivity: 80% (CI 28%–99%)
Specificity of cervical swabs: 37% (CI 22–53%)
Specificity of vaginal swabs: 25% (CI 13–40%) |
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Jung et al. 2010 [41] | Simplified colorimetric detection method to identify PCR-amplified nucleic acids: after PCR amplification reaction, unmodified gold nanoparticles (AuNPs) are added to the reaction tube followed by the addition of NaCl to induce the aggregation of AuNPs. The PCR products strongly bind to the surface of AuNPs, preventing the salt-induced aggregation. The unaggregated AuNPs are red while aggregated change to blue. This color change is visible to naked eye and shown to be effective in human urine sample | Not measured |
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Krõlov et al. 2014 [42] | Recombinase polymerase amplification: a recombinase complex from T4 bacteriophage introduces primers to specific DNA sites to initiate an amplification reaction by the strand, displacing DNA polymerase. Results in 20 minutes using unpurified urine | Specificity of 100% (95% CI, 92%–100%) and a sensitivity of 83% (95% CI, 51%–97%)
Detection limit of 5 to 12 pathogens per test |
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Lehmusvuori et al. 2010 [43] | Rapid homogenous PCR assay with GenomEra technology: bacteria are first concentrated by a centrifugation-based urine pretreatment method, followed by a rapid closed-tube PCR performed by automated GenomEra technology and including time-resolved fluorometric detection of the target using lanthanide chelate labeled probes. Results in 1 hour | Sensitivity and specificity of 98.7% and 97.3%, respectively |
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Linnes et al. 2014 [44] | Paper-based molecular diagnostic: incorporates cell lysis, isothermal nucleic acid amplification, and lateral flow visual detection using only a pressure source and heat block on a paper-based test. Results in less than an hour | Limit of detection of 1000 cells, more sensitive than current rapid immunoassays used for chlamydia diagnosis |
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Melendez et al. 2013 [45] | Microwave-accelerated metal-enhanced fluorescence (MAMEF) assays: Microwave exposure accelerates the transport of DNA targets. Two assays were developed: the first targets the C. trachomatis 16S rRNA gene, and the second targets the C. trachomatis cryptic plasmid | Sensitivity 73.3%; specificity 92.9% if both assays are required to determine a positive
Sensitivity 82.2% for only cryptic plasmid assay
Sensitivity 75.5% for only 12S rRNA assay
(all tested with vaginal swabs) |
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Pearce et al. 2011 [46] | Velox™ electrochemical assay: a fully integrated fluidic card with a novel electrochemical label technique. Steps include extraction of DNA from a clinical sample, specific amplification of a small segment of the DNA sequence by PCR, and detection of the amplified DNA using an electrochemically labeled ferrocene-based DNA probe. Results in less than 25 minutes | Benchtop (non-POC) version of assay:
Sensitivity of 98.1% and specificity of 98.0% on genital swabs |
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Spizz et al. 2012 [47] | Rheonix CARD® STI CARD® assay: a patented lamination process incorporates all pumps, valves, microchannels, and reaction compartments into an inexpensive disposable plastic device that automatically performs all assay steps. Amplicons detected with Reverse Dot Blot assay | Able to detect a minimum of 10 copies of each of the four pathogens (N. gonorrhoeae, C. trachomatis, T. pallidum,and T. vaginalis) |
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Tabrizi et al. 2013 [48] | Cepheid GeneXpert CT/NG assay: amplifies one chromosomal target (CT1) for the detection of C. trachomatis, two chromosomal targets (NG2 and NG4) for detection of N. gonorrhoeae, a single-copy human gene which should be present in each specimen to act as a sample adequacy control (SAC), and Bacillus globigii DNA added to each cartridge to serve as a sample-processing/internal control (SPC) | All 15 serovars of C. trachomatis were detectable to 10 genome copies per reaction. The GeneXpert CT/NG assay was also able to detect the Swedish new variant of C. trachomatis (nvCT) and the L2b strain |
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