New PCR rapid test from Bosch for detection of sexually transmitted pathogens

• New real-time PCR rapid test for detection of four STI
• First Vivalytic test in cooperation with development partner BioGX
• Positive test results available within an hour directly at the point of care

Waiblingen – Bosch Healthcare Solutions has received CE-label for the new Vivalytic MG, MH, UP/UU, developed in partnership with BioGX, a US-based global molecular diagnostics company. The test is now available as part of the Vivalytic analyser test portfolio and can thus be used directly at the point of care. This real-time PCR rapid test can detect four pathogens of sexually transmitted infections (STIs): Mycoplasma genitalium (MG), Mycoplasma hominis (MH), Ureaplasma parvum (UP), and Ureaplasma urealyticum (UU). After taking the sample and starting the analysis, a positive result is available in as little as an hour, making the test particularly suitable for use in direct patient care at doctors’ offices and clinics. Here, it can enable STI differential diagnosis directly at the point of sampling without delays due to transportation or logistics. For example, the test can detect in case of infectious urethritis (non-gonorrheal urethritis, NGU) (1), if one of the four pathogens is responsible for the infection. However, rapid diagnosis also helps to counteract the further spread of STI pathogens. The Vivalytic MG, MH, UP/UU test saves a lot of time compared to diagnostics by cultivation of the pathogenic germs. In the case of MH, UP, and UU, cultivation can take one to three days, and up to six months for MG (2).

One million new infections per day

More than 30 different pathogens can cause STIs. The WHO estimates that one million people worldwide become infected with sexually transmitted pathogens every day (3). Even though in most cases infections are asymptomatic, if not detected they can lead to serious health problems and also to impaired sexual health. The four pathogenic germs that the new test detects also belong to the set of human STI pathogens, even though the two ureaplasmas in particular can often occur as commensals (4).

Vivalytic analyser: Simple application at the point of sampling

The advantages of PCR rapid tests carried out using the Bosch Vivalytic analyser are not only faster test results, but also ease of use: Once the sample has been taken using a swab, it is placed in the test cartridge. The cartridge, which contains all the reagents required for the respective test, is then inserted into the Vivalytic analyser for automated evaluation. Operation is simple and medical staff can learn how to use it in no time. The length of time needed for the respective analysis depends on the complexity of the test. In addition to the new MG, MH, UP/UU, the Vivalytic product portfolio includes tests for viral respiratory infections (VRI), tests for SARS-CoV-2 – which can also be carried out as a pooling variant and as a lollipop test – as well as a multiplex test for sexually transmitted infections (STIs).

Sources

(1) G. Bonkat et al., EAU guidelines on urological infections; European Association of Urology 2020

(2) CDC (Centers for Disease Control and Prevention) Guidelines 2021, Publication: Workowski et al., Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187

(3) https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis), at: 15.03.2022

(4) Waites et al., J Mol Diagn. 2012 Sep;14(5):437-50

Press contact Bosch Healthcare Solutions:
Thomas Berroth
Marketing & Communication
Thomas.berroth2@de.bosch.com
+49 (0) 711 805-44360