Successful Evaluation of Atlas io® Point-of-Care Test for Sexually Transmitted Infection, Trichomonas Vaginalis In Collaboration with Johns Hopkins University
Atlas Genetics Ltd (“Atlas” or the “Company”), a diagnostic company developing ultra-rapid point-of-care (POC) tests for a range of infectious diseases, today announces the results of a prototype test for the sexually transmitted infection (STI / STD), Trichomonas vaginalis (T. vaginalis), on its rapid POC io® molecular diagnostic platform.
The study, carried out in collaboration with Professor Charlotte Gaydos of the Johns Hopkins University Medical School, was published in the Journal of Sexually Transmitted Infections Online First (Pearce et al, 2013) on 20th April 2013. The sensitivity and specificity achieved using this prototype assay is comparable with that of existing central laboratory nucleic acid amplification tests used for screening patients for T. vaginalis.
Trichomoniasis is the most prevalent curable STI in the world, causing an estimated 248 million new cases annually of genital T. vaginalis infection (WHO, 2011). A rapid, accurate point-of-care, PCR-based molecular test would enable patients to be tested and treated for T. vaginalis in a single visit to the sexual health and STD clinics, pharmacy or physician’s office. The treatment for trichomoniasis is a single oral dose of either metronidazole or tinidazole. Current POC tests for T. vaginalis include wet mount microscopy, which is a subjective test and suffers from a lack of accuracy, and immuno-chromatographic assays that are less sensitive than molecular testing methods and require skilled personnel to carry out the test.
In this study, clinical sample testing was performed using 90 self-collected vaginal swab residual samples (44 positive, 46 negative) and demonstrated a sensitivity of 95.5% (42 positive /44 negative) and specificity 95.7% (44 positive /46 negative), respectively.
To meet the need for rapid POC diagnostics, Atlas is developing the io®, a platform technology capable of running molecular and immunoassays with a time-to-result of 30 min, which is within the acceptable waiting period for a POC diagnostic test result suggested in a recent study (Huang et al, 2012). The technology comprises a cartridge to which an unprocessed clinical sample is added. The Atlas on-cartridge reagents is a low-cost instrument that provides fluidic and temperature control, end-point electronics and software that can be automatically processed without user intervention. The Atlas io™ Trichomonas vaginalis test offers advantages to the patient including more rapid diagnosis combined with immediate treatment and sexual health advice. This time-to-result turnaround may eliminate the need for a return visit and potentially saving clinician’s time and money. The benefit to the wider population could include a decrease of onward transmission and new infections. Trichomoniasis can lead to vaginitis, cervicitis, and urethritis in females, leading to complications during pregnancy and can increase the risk of contracting HIV and other STDs.
John Clarkson, CEO of Atlas, said:
“The high accuracy of our proprietary T. vaginalis test provides strong support for its use in point-of-care testing for the diagnosis of this sexually transmitted infection and should facilitate rapid treatment for the patient, helping to reduce unnecessary burden on the healthcare system.”
Pearce DM, Styles DN, Hardick JP & Gaydos CA (2013). A new rapid molecular point-of-care assay for Trichomonas vaginalis: preliminary performance data. Sex Transm Infect; Published Online First: April 20, 2013. doi:10.1136/sextrans-2012-051000
World Health Organisation (2011). Global prevalence and incidence of selected sexually transmitted infections Chlamydia trachomatis, Neisseria gonorrhoeae, syphilis and Trichomonas vaginalis: methods and results used by WHO to generate 2005 estimates. Geneva: WHO.
Huang W, Gaydos CA, Barnes MR, et al (2012). Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting. Sex Transm Infect; 89:108–14.
Sexually Transmitted Infections; 89: 495-497.
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.