Point-of-Care Diagnostic for Trichomonas vaginalis, the Most Prevalent, Non-Viral Sexually Transmitted Infection

Abstract

A point-of-care (POC) diagnostic is needed for both women and men to establish universal screening and surveillance for the number one, non-viral sexually transmitted infection (STI) caused by Trichomonas vaginalis. We developed a POC diagnostic for this STI using the MedMira Rapid Vertical Flow (RVF®) Technology test cartridge with a membrane that includes a Vertical procedural/reagent control line (referred to as CVL) and spotted with 1 µg of a 72.4-kDa truncated version of α-actinin called ACT::SOE3. This protein is a specific diagnostic target for antibody in sera of individuals with trichomoniasis. Serum antibody to ACT::SOE3 is a positive reaction with the test spot. Specificity of ACT::SOE3 was revealed with monoclonal antibodies (MAbs) generated to ACT::SOE3. Addition of negative control serum with MAb 67B reactive to ACT::SOE3 shows detection of both ACT::SOE3 and the CVL. Only positive sera of individuals had antibody reactive with ACT::SOE3 and detected the presence of the spot and the CVL. Negative control sera were unreactive with ACT::SOE3 and only showed the presence of the CVL. Importantly, to show proof-of-principle for POC application, ACT::SOE3 was detected with the positive patient sera spiked with whole blood. Finally, packaged cartridges stored with desiccant packs at 37 °C for one year gave identical results with the positive and negative human sera. Our results show the validity of this new POC serodiagnostic for this STI.

Comparative membrane proteomic analysis of Tritrichomonas foetus isolates

“…And recently, a point-of-care (POC) for serodiagnosis using a truncated version of the α-actinin protein has been reported for Trichomonas vaginalis 63 .…”

The Past, Present, and Future in the Diagnosis of a Neglected Sexually Transmitted Infection: Trichomoniasis

“…The antigen used is a 72.4 kDa truncated version of α-actinin called ACT::SOE3 that can be detected by specific antibodies present in human sera. This immunochromatographic device stands out because it can be used in both men and women with trichomoniasis [ 119 ].…”

“…Moreover, both include an automated DNA extraction prior to the quantitative real-time PCR all in the same benchtop instrument [ 127 ]. The only difference is that Alinity also identifies rRNA from Mycoplasma genitalium [ 119 ]. BD Diagnostics has developed another NAAT system for the detection of T. vaginalis in self- and clinician-collected vaginal swabs, endocervical swabs, and female urine samples.…”

The Past, Present and Future in the Diagnosis of a Neglected Sexually Transmitted Infection: Trichomoniasis

“…The antigen used is a 72.4-kDa truncated version of -actinin called ACT::SOE3 that can be detected by specific antibodies present in human sera. This immunochromatographic device stands out because it can be used in both men and women with trichomoniasis [120].…”

“…Moreover, both includes and automated DNA extraction prior to the quantitative real-time PCR all in the same benchtop instrument [128]. The only difference is that Alinity also identifies rRNA from Mycoplasma genitalium [120]. BD Diagnostics has developed another NAAT system for the detection of T. vaginalis in self and clinician-collected vaginal swabs, endocervical swabs and female urine samples.…”