TY - JOUR
T1 - A new rapid molecular point-of-care assay for Trichomonas vaginalis
T2 - Preliminary performance data
AU - Pearce, David M.
AU - Styles, David N.
AU - Hardick, Justin P.
AU - Gaydos, Charlotte A.
PY - 2013/9
Y1 - 2013/9
N2 - Objective Trichomonas vaginalis infection is the most prevalent treatable sexually transmitted infection (STI) in the world. An accurate point-of-care (PoC) molecular test would enable patients to be tested and treated for T vaginalis in a single visit to the genitourinary medicine clinic, community STI clinic, pharmacy or doctor's office. In this report, we describe a rapid prototype assay for T vaginalis designed for use in conjunction with the Atlas io PoC platform, and initial verification of its performance using 90 clinical samples. Methods A rapid prototype T vaginalis assay was designed. The test, featuring novel electrochemical endpoint detection, used a multi-copy region of the T vaginalis genome as the assay target. Ninety clinical vaginal swab samples were used to verify the performance of the prototype assay. Results The assay demonstrated a sensitivity and specificity of 95.5% (42/44) and 95.7% (44/46), respectively, when tested using clinical samples. Assay inclusivity was demonstrated for a number of geographically diverse T vaginalis isolates, and the test showed no cross-reactivity with either human DNA or a panel of DNAs isolated from common cross-reactants. Conclusions The sensitivity and specificity achieved using this prototype assay is comparable with that achieved for existing central laboratory nucleic acid amplification tests used for screening patients for T vaginalis.
AB - Objective Trichomonas vaginalis infection is the most prevalent treatable sexually transmitted infection (STI) in the world. An accurate point-of-care (PoC) molecular test would enable patients to be tested and treated for T vaginalis in a single visit to the genitourinary medicine clinic, community STI clinic, pharmacy or doctor's office. In this report, we describe a rapid prototype assay for T vaginalis designed for use in conjunction with the Atlas io PoC platform, and initial verification of its performance using 90 clinical samples. Methods A rapid prototype T vaginalis assay was designed. The test, featuring novel electrochemical endpoint detection, used a multi-copy region of the T vaginalis genome as the assay target. Ninety clinical vaginal swab samples were used to verify the performance of the prototype assay. Results The assay demonstrated a sensitivity and specificity of 95.5% (42/44) and 95.7% (44/46), respectively, when tested using clinical samples. Assay inclusivity was demonstrated for a number of geographically diverse T vaginalis isolates, and the test showed no cross-reactivity with either human DNA or a panel of DNAs isolated from common cross-reactants. Conclusions The sensitivity and specificity achieved using this prototype assay is comparable with that achieved for existing central laboratory nucleic acid amplification tests used for screening patients for T vaginalis.
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U2 - 10.1136/sextrans-2012-051000
DO - 10.1136/sextrans-2012-051000
M3 - Article
C2 - 23605852
AN - SCOPUS:84884534595
VL - 89
SP - 495
EP - 497
JO - Sexually Transmitted Infections
JF - Sexually Transmitted Infections
SN - 1368-4973
IS - 6
ER -