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Bosch’s Vivalytic platform offering new PCR rapid test for MRSA

The Vivalytic test MRSA/SA provides a quick diagnosis of methicillin resistance at the point of care

MRSA cartridge with Vivalytic analyser
  • As a real-time PCR rapid test at the point of care (POC), the Vivalytic test MRSA/SA can detect two of the most important pathogens associated with hospital-acquired infections.
  • Differentiation as to whether the bacterial strain is methicillin-resistant or methicillin-sensitive promotes targeted therapy.
  • The result is available in under one hour, which makes the test a useful addition for determining cultures, especially in emergency situations.
  • Unnecessary, costly isolation measures that are stressful for patients can be avoided.

Waiblingen – The new Vivalytic test MRSA/SA for Bosch’s Vivalytic platform is now available. Bosch Healthcare Solutions has once again expanded the test portfolio of this universal PCR system. The Bosch test, developed in cooperation with partner r-biopharm, detects methicillin-resistant staphylococcus aureus (MRSA), one of the most important pathogens for hospital-acquired infections and therefore for associated complications and mortalities. In under an hour, the Vivalytic test MRSA/SA delivers a reliable result1 directly at the point of care and is therefore particularly suitable for use in accident and emergency units. Since the result of diagnostics with cultures is only available after one to three days, this PCR test for the point of care is ideal as an additional tool when speed is of the essence. The quick and reliable diagnosis of whether the bacteria strain is methicillin-sensitive (MSSA) or -resistant is also important in emergency situations. Waiting times for operations can, on the one hand, be reduced, while on the other enabling a decision on effective antibiotic treatment on this basis. This ability contributes to preventing contamination, breaking the chain of infection, and avoiding other resistances, which can, in turn, positively impact the treatment procedure and costs. Last but not least, unnecessary isolation measures, which are not only complex and expensive2, but also put patients under even more pressure, can be avoided.

MRSA risk

The WHO3 estimates that the mortality rate of patients infected with MRSA is around 50 percent higher compared with patients who have been infected by non-resistant Staphylococcus aureus strains. Moreover, the period of hospitalization, morbidity, and the medical expenses increase significantly with an MRSA infection.4 In Europe, approximately 149,000 MRSA clinical infections and around 7,000 deaths occur each year.5 Prevention and control measures, such as testing for MRSA, are aimed at reducing or avoiding infections in hospital settings.

Vivalytic platform: simple application at the point of care

The advantages of PCR rapid tests administered with the aid of Bosch’s Vivalytic platform lie not only in the quick analysis time, but also in the ease of handling: Once the sample has been collected, the swab is inserted into the test cartridge. The cartridge, which holds all reagents necessary for the respective test, is then inserted into the Vivalytic analyser for automated analysis. Handling and utilisation are simple and medical professionals require only minimal training. Along with the new Vivalytic test MRSA/SA, the Vivalytic product portfolio also includes various tests for viral respiratory infections, such as SARS-CoV-2 – also as a pooling variant and as a lollipop test – as well as a multiplex test for sexually transmitted infections (STI).

Sources:

1) Instructions for Use Vivalytic MRSA/SA:

Based on the validation study as part of the conformity assessment procedure, the following diagnostic sensitivity and specificity have been ascertained for the Vivalytic test MRSA/SA: MRSA: sensitivity 93.5% and specificity 97%. (95% confidence interval: sensitivity: 82.1% – 98.63%; specificity: 91.56% – 99.38%) MSSA: sensitivity 85.96% and specificity 95.12%. (95% confidence interval: sensitivity: 74.21% – 93.74%; specificity: 83.47% – 99.4%). A high consistency of the test results using the Vivalytic MRSA/SA test was observed in comparison to cultures as the gold standard.

2) Hübner et al.: Analysis of MRSA-attributed costs of hospitalized patients in Germany, 2014

3) World Health Organization: Health care without avoidable infections: the critical role of infection prevention and control, 2016

4) World Health Organization: Antimicrobial resistance: global report on surveillance (GLASS). Geneva; 2014.

5) Cassini et al, Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis, Lancet Infect. Dis. 19:56–66., 2018