PRODUCT NEWS 01/2015

Ultra-sensitive 4 h incubation time POC GBS test has been now CE IVD marked!

Group B streptococcus (GBS) continues to be an important cause of neonatal sepsis and meningitis. To prevent these life threatening Strep B infections, CDC recommends to screen all pregnant women at weeks 35-37. Several European countries (Italy, Spain, France, Germany, Switzerland, Belgium, the Czech Republic and Poland) have also launched their own national guidelines for GBS prevention. The CDC guideline recommends screening to be done after 18-24h incubation to get as sensitive and reliable results as possible. 

Abacus has now validated the point of care GenomEra GBS test with 4h incubation time which achieved the same performance as with 18-24h incubation time. Fast 4h incubation allows to use ultra-sensitive molecular diagnostic methods even at the time of delivery. The high performance of the test is achieved with the time-resolved fluorometry technology and lanthanide labels. It is good to note that the test does not require any sample purification or extraction step. Also based on the validation data the test is able to detect strains over Cepheids GeneXpert test. Protocol is very easy to perform:

20μl enrichment broth to Z-tube

Vortex 5 min

Pipet 35μl to test chip

All GenomEra users are very welcome to ask for a free test kit of our new ultra-sensitive 4h GBS test!