Review Article

A Systematic Review of Point of Care Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis

Table 5

Summary of proof of concept articles on point of care tests for Neisseria gonorrhoeae from 2010 to 2015.

Study authors and yearSummary of results
(summaries are based on descriptions in abstracts and articles)
Performance

Cho et al. 2015 [49]Smartphone based microfluidic paper analytical device (µPAD): anti-N. gonorrhoeae antibodies are conjugated to submicron particles then preloaded and dried in the center of each paper microfluidic channel. The device simultaneously filters urine and performs the assay, so no pretreatment is necessary. The smartphone optically detects immunoagglutination to perform the assay. The total μPAD assay time is less than 30 seconds Spiked urine samples:
Detection limit of 10 CFU/mL

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

Samarawickrama et al. 2011 [50]The BioStar Optical ImmunoAssay: immunochromatographic strip test that detects a specific epitope on the L7/L12 ribosomal protein, reducing cross-reactivity with other neisseriae for a highly specific test. Visual results within 30 minutesA laboratory-based evaluation:
Sensitivity 99.4%, specificity 88.7%
7 false positives (six strains of N. meningitidis and one nonspeciated Neisseria sp.)
1 false negative

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 assayAble to detect a minimum of 10 copies of each of the four pathogens (N. gonorrhoeae, C. trachomatis, T. pallidum, and T. vaginalis)

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)Limit of detection was 10 genome copies per reaction. No false positives resulted, but four out of 11 Neisseria mucosa isolates and two of 42 Neisseria subflava isolates were positive in one (NG4) of two NG targets, which led to correct interpretation as negative