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Dx Focus: MoBiTec and Bioneer Ebola Virus Kits; SeraCare Molecular Control for C. Diff IVDs


Germany's MoBiTec said this week announced the availability of the EBOV real time RT-PCR kit for the detection of Ebola virus.

The new kit contains a supermix for the specific amplification of Ebola virus RNA. Detection of the reverse-transcribed and amplified Ebola virus DNA fragment uses FAM fluorophore with BHQ1 fluorescent quencher. In addition, the kit contains a system to identify possible PCR inhibition by measuring HEX/VIC/JOE fluorescence of the internal control. The kit also contains an external positive control defined as 1×107 copies/ml which allows the determination of the viral gene load, MoBiTec said.

The new kit is manufactured by MoBiTec's partner company Shanghai ZJ Biotech and is available for use on either Roche's LightCycler platform or all other non-LightCycler real-time PCR systems.

Bioneer, a South Korean molecular diagnostics company, said this week that it has recently developed the AccuPower EBOV real-time RT-PCR kit.

The new kit is optimized for detection of the Zaire subtype of Ebola virus associated with recent outbreaks in Africa. Since April Bioneer has worked with the Nigerian National Biotechnology Development Agency (NABDA) to develop means to rapidly detect the Zaire subtype. The kit is currently in limited use by NABDA, and Bioneer plans to make it available for use throughout Africa, a company spokesperson said.

Bioneer recently presented details about the kit, as well as its ExiStation real-time PCR-based molecular diagnostics system, at an Ebola virus-related workshop held by NABDA in Abuja, Nigeria. The company's workshop outlined the workflow of its kits and instrument platform, and their use in early diagnosis of viral infection and quantitative analysis of viral load during treatment.

SeraCare Life Sciences this week announced the launch of its new ACCURUN 501 C. difficile Control, the company's first molecular control product targeting hospital-acquired infections.

The new control is formulated for use with in vitro diagnostic tests that detect Clostridium difficile DNA in human stool samples. The kit contains inactivated Clostridium bacteria of four different strains or species in a human synthetic stool matrix and delivered in a set of four vials. The control is ready to use in assays that detect C. difficile DNA with any transport system.

"Hospital-acquired infection assays present unique sample challenges which require dependable, whole-cell controls," Christopher Long, product manager at SeraCare, said in a statement. The company's new product, he added, "is a full process control that is intended to not only estimate laboratory testing performance but also immediately detect analytical errors and monitor the entire testing process. As a result, our customers have greater confidence in fulfilling their QC requirements."

SeraCare provides biological materials that help optimize diagnostic performance, reliability, and repeatability in IVD testing.