GenBio has received CE mark on its new rapid genital herpes test to join its rapid Mycoplasma pneumonia, test in the ImmunoFLOW product line. GenBio has been serving the global microbiology immunoassay markets since 1994 sold in the U.S. through Remel and internationally through a network of country specific distributors. This new addition to the ImmunoFLOW product line recently CE marked through GenBio’s agent in the EU, EMERGO, opens new markets globally for rapid testing of herpes simplex virus.

Key Features and Benefits of ImmunoFLOW

• The two new ImmunoFLOW Tests are rapid immunoassay’s providing highly sensitive and specific measurement of HSV type 2 specific antibody, HSV total antibody and M. pneumonia  specific IgM in human serum.
• High sensitivity and specificity developed to “Gold Standard” methods using recombinant and purified antigens.
• “Easy to use” and interpret requiring minimal training
• Results are available in just minutes for better patient management “close to patient”

ImmunoFLOW Herpes Simplex Virus (HSV) Test The ImmunoFLOW HSV Test detects IgG to HSV gG-2 (specific HSV type 2 and Total HSV (type 1 + type 2) for type specific classification which is not possible using whole virus lysate. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. There are three reactive dots on the ImmunoFLOW Herpes Simplex Virus cassette. An HSV type 2 recombinant gG2, an HSV 1 and HSV 2 (Total), and a positive control.

HSV type 2 sensitivity to ImmunoWELL™ HSV-2 IgG and HerpeSelect® 2 ELISA s is 100% with 100% specificity. Total HSV IgG relative sensitivity to ImmunoWELL™ HSV IgG Total and Captia™ Herpes Group IgG ELISA is 99% with 100% specificity.

*Reference package insert

ImmunoFLOW Mycoplasma (IgM) Antibody Test

The ImmunoFLOW Mycoplasma pneumoniae IgM Test detects human IgM. The same glycolipid antigen that is used in complement fixation which has long been the “gold standard” for Mycoplasma antibody detection, is utilized.

There are three reactive spots on the ImmunoFLOW Mycoplasma (IgM) cassette. A purified M. pneumonia complement fixation antigen (dilution 1), a purified Mycoplasma pneumoniae complement fixation antigen (dilution 2) *see package insert for interpretations, and a positive control.

Sensitivity, relative to EIA activity, is 100% (96/96). Reproducibility is 100% (144/144) for specimens reporting values significantly above or below clinical cutoff region.

*Reference package insert