Uniogen GenomEra GBS Assay Kit: an easy solution for GBS testing

Antti-Heikki Tapio, a member of Uniogen’s R&D team, shares his inspiring journey in biotechnology and the background of the GenomEra GBS Assay Kit. Antti-Heikki started studying at Turku University of Applied Sciences in 2002 and continued his studies at the biotechnology department of the University of Turku. He found his way to Uniogen somewhat by chance and through his thesis work. “After starting at Uniogen, I’ve been working on many different tasks, from product development to IT and test production,” he states. 

The development of Uniogen’s GenomEra GBS Assay Kit began in 2013, responding to the customer’s need for a GBS test suitable for enriched samples. “However, the need for direct testing at the time of delivery grew, and we responded to that by developing a new type of test,” explains Antti-Heikki. With this, Uniogen aimed to address the challenges of detecting Group B Streptococcus (GBS), especially during delivery, where cultures taken in earlier weeks of pregnancy may not provide up-to-date results. Antti-Heikki emphasizes the significance of the GBS test: “It makes it possible to get reliable results within an hour, which is a significant difference from traditional methods.” 

The development process focused on creating a sensitive, specific, and comprehensive test chip and an efficient sample processing method. “Verification and validation of the method were also key steps,” he adds. The product development faced both challenges and successes, such as learning from the lack of strain coverage in other tests and achieving good performance from direct swab samples without complex sample processing. 

“Seeing the test work in practice, especially when it was adopted in maternity wards, was particularly rewarding,” Antti-Heikki enthuses. Technically, the GenomEra GBS Assay Kit stands out by using lanthanide chelate probes, which enable the testing of challenging samples. “This eliminates the problem of background fluorescence, a typical challenge in swab samples,” he clarifies. 

The sensitivity and specificity of the test have been validated in independent laboratories. Comparative studies have shown that the performance of the GenomEra GBS test is comparable to other direct PCR tests. Uniogen’s GenomEra GBS Assay Kit offers sensitive and fast detection of GBS during pregnancy and at the time of delivery.

The GenomEra® GBS Assay Kit is a qualitative molecular assay indicated for the rapid identification of antepartum and intrapartum colonization of Group B Streptococcus (GBS, Streptococcus agalactiae) in pregnant women. The assay simplifies and speeds up GBS testing by providing reliable results from vaginal-rectal swab samples in less than one hour. 
Read more:

Koliwer-Brandl H, Nil A, Birri J, et al. Evaluation of two rapid commercial assays for detection of Streptococcus agalactiae from vaginal samples. Acta Obstet Gynecol Scand. 2023;102(4):450-456. 

Nielsen SY, Møller JK, Khalil MR. A comparison of GenomEra® GBS PCR and GeneXpert ® GBS PCR assays with culture of GBS performed with and without broth pre-enrichment. Eur J Clin Microbiol Infect Dis. 2020;39(10):1945-1950. 

Andreasen T, Kjølseth Møller J, Rohi Khalil M. Comparison of BD MAX GBS and GenomEra GBS assays for rapid intrapartum PCR detection of vaginal carriage of group B streptococci. PLoS One. 2019;14(4):e0215314. 

Abacus Diagnostica, Kaivogen and Labrox are now Uniogen

Uniogen is a global pioneer in clinical diagnostics, point-of-care testing, and instrumentation for life sciences.

Uniogen – Enabling diagnosis and care at first appointment