in the detection and diagnosis of sexually transmitted and other vaginal infections
With the utilization of multiplex Polymerase Chain Reaction (PCR) based on proprietary technology, GenPap is able to identify multiple pathogens from a single vial. Our PCR DNA amplification technique provides high specificity and sensitivity compared to other methods.
One Collection, Multiple Detections
GenPap offers the simplicity of collection with one universal liquid preparation vial. No need for multiple collection devices.
High Sensitivity, High Specificity
GenPap definitively identifies pathogens to allow for more targeted treatment. It is especially useful for detecting mixed infections and its performance is not affected by collection variables, i.e. menses.
Convenience of Testing
With GenPap, Pap results and sexually transmitted infection (STI) results come from one laboratory in one concise, easy-to-read report.
Virtually No QNS Issues
Our proprietary technology virtually eliminates QNS issues for out-of-vial testing.
Fast Turn-around Time
Our PCR method is significantly faster than culture.
Clinically Relevant Profiles
GenPap profiles can be ordered based on history provided by the patient as well as clinical signs and symptoms.
High Risk STI Profile
PID/Infertility/Pregnancy Loss Profile
STI Lesion Profile
Methodology Comparison for Select Pathogens
|Candida species, Trichomonas vaginalis, Bacterial Vaginosis||Wet mount has low sensitivity (35% for Candida, 38% for Trichimonas), requires technical expertise||Requires special media for each pathogen, low sensitivity||-Specificity is >99%
-Sensitivity is 96%-100%
|Neisseria gonorrhoeae||Gram stain has low sensitivity for endocervical smears (50%-70%), requires technical expertise||Stringent handling to assure viability, low sensitivity||-Less invasive specimens for testing|
|Treponema pallidum||Dark fields are insensitive, requires extensive training and special equipment to perform||Cannot be cultured in vitro or stained with standard techniques||-Detection of multiple organisms using one sample|
|Chlamydia trachomatis||Uses technically difficult cell culture techniques, low sensitivity||-Allows testing of patients using single collection|
|Herpes simplex virus||Tzanck smear cannot distinguish between HSV1, HSV2, or any other herpes virus including CMV, EBV, and VZV||Uses technically difficult cell culture techniques, low sensitivity||-Easier to collect and transport|
*References: 1.Kurth A, Whittington WLH, Golden MR, et al. Performance of a new, rapid assay for detection of Trichomonas vaginalis. J Clin Microbiol 2004; 42(7):2940-2943. 2.Huppert JS, Batteiger BE, Braslins P, et al. Use of an immunochromatographic assay for rapid detection of Trichomonas vaginalis in vaginal specimens. J Clin Microbiol 2004; 43(2):684-687. 3.WHO. Laboratory Tests for the Detection of Reproductive Tract Infections, 1999 4.Gilbert, Jeffrey M.D. A Monograph of Sexually Transmitted Infections, 2008 5.CDC Sexually Transmitted Diseases Treatment Guidelines, 2010 T. Horii, et. al. Use of a dual priming oligonucleotide system to detect multiple sexually transmitted pathogens in clinical specimens. Letters in Applied Microbiology, 2009.