Preliminary data suggest a chlamydia, gonorrhea and trichomonas (CT/NG/TV) multiplex test is feasible on a molecular point-of-care (POC) test system with time to result in less than 30 minutes
Ability to effectively lyse challenging fungal pathogens, including Candida, in under four minutes on Talis One® system positions Company to develop POC vaginal infection panel
“The COVID-19 pandemic accelerated the development of numerous molecular point-of-care platforms to bring rapid respiratory testing closer to patients. Unfortunately, very few are designed to effectively address the needs of women’s and sexual health,” said
Data Highlights from Talis Biomedical Presentations at IDSOG Annual Meeting
Feasibility and preliminary performance of development-stage CT/NG/TV test for Talis One® system
A series of analytical studies were conducted to characterize preliminary analytical sensitivity, exclusivity, inclusivity and clinical performance of a development-stage CT/NG/TV test as part of Talis Biomedical’s planned test menu.
To determine preliminary analytical sensitivity of its sample-to-answer test in development to detect CT/NG/TV in less than 30 minutes, company scientists co-spiked 20 self-collected vaginal swabs and 7 male urine samples with live CT serovar D, NG 19424, and TV G3 for testing on the Talis One system. In females, CT and TV were detected in 19/20 contrived vaginal swab samples at concentrations of 1 IFU/mL and 5 cells/mL, respectively. NG was detected in 20/20 vaginal swabs at a concentration of 50 CFU/mL. In males, CT, NG, and TV were detected in 7/7 urine samples at concentrations of 1.5 IFU/mL, 50 CFU/mL, and 5 cells/mL, respectively.
To characterize exclusivity, closely related target organisms tested at 1E6 units/mL or 1E5 genome copies/mL were not detected by the Talis One development-stage CT, NG, or TV assays. Conversely, the assays were inclusive of all strains and serovars.
Preliminary clinical performance of the Talis One development-stage CT/NG/TV test was assessed using residual clinical samples initially tested by widely used, on-market molecular tests that require up to 90 minutes to generate a result. In neat male urine, positive percent agreement (PPA) was 100% for CT, NG and TV. Negative percent agreement (NPA) was 100% for CT and NG, and 98% for TV. In female vaginal swabs where only positive samples were tested, PPA was 100% for CT and NG, and 90% for TV.
“As we approach this new era of STI testing, it is encouraging to see a development-stage point-of-care CT/NG/TV assay achieve clinical performance that is comparable to widely used on-market tests being run at central laboratories,” said
On-cartridge bead beating differentiates Talis One lysis for future development of vaginal panel
Company scientists performed initial experiments to determine lysis efficiency with and without beads added to the Talis One’s on-cartridge mechanical (stir bar containing) lysis chamber. The lysis conditions were evaluated and selected using intact Candida albicans as a model pathogen. With stir bar mixing alone, target nucleic acids were only detected 100% of the time (3/3) at 1000 CFU/mL. When beads (bead-beating) were added to the stir bar containing lysis chamber on the Talis One cartridge, target nucleic acids were detected 100% of the time (6/6) at concentrations as low as 125 CFU/mL, delivering an 8-fold increase in lysis efficiency. The lysis time was as short as 4 minutes.
Additional experiments performed to further challenge the Talis One system included using contrived specimens of five different Candida species diluted in a DNA/RNA transport and storage medium at concentrations of 100,000, 10,000 and 1000 CFU/ml. The contrived specimens were lysed using the Talis One’s bead beating, mechanical lysis system. On bench detection was demonstrated down to the lowest concentration tested (1000 CFU/ml in 3/3 replicates) for all five Candida species.
These studies demonstrate that incorporating mechanical lysis on the Talis One system led to lysing fungal cells and releasing target nucleic acids for detection at a concentration level that is comparable to the limits of detection (LODs) of three on-market vulvovaginal candidiasis in vitro diagnostic (IVD) tests. Based on these positive early results,
“The availability of accurate and reliable point-of-care testing for vaginitis will be invaluable in the women’s healthcare space. More than 30 percent of women of all ages suffer from symptoms of a vaginal infection and often receive deferred treatment with delays in diagnosis,” said
About the Talis One System
The Talis One system is a compact, sample-to-answer molecular testing platform designed to enable rapid, highly accurate point-of care infectious disease testing in non-laboratory settings. The Talis One test cartridge is a fully self-contained, closed device that includes all the necessary reagents to perform a Talis One test. When loaded into the Talis One instrument, each cartridge fully automates sample lysis, nucleic acid extraction and purification, isothermal amplification, and target detection. The Talis One test system is not authorized, cleared, or approved by the FDA and is not available for sale.
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