Specificity and sensitivity of FTD Hepatitis E assay proven in comparison study


17.02.2016, Luxembourg, Prompt diagnosis of hepatitis E is essential, and for accurate results it is important to chose a sensitive and specific assay. A recent comparison study has confirmed the success of a diagnostic assay from Fast-track diagnostics for the detection of hepatitis E virus. The results of the study have led a senior physician and assistant professor at Hannover Medical School to select the Fast-track diagnostics Hepatitis E RNA assay, to assist in the fast and accurate diagnosis of hundreds of patients.

Every year an estimated 20 million individuals are infected by the hepatitis E virus. Of the 3.3 million symptomatic cases, 56,600 deaths occur as a result. Hepatitis E is usually self-limiting and is not considered to be fatal. However, in pregnant, transplant and immunosuppressed patients, there is a possibility of acute liver failure, which can cause death. For prompt treatment options to be engaged, it is essential that diagnostic methods utilised are sensitive and specific.

Real-time polymerase chain reaction is becoming the gold standard to efficiently diagnose hepatitis E, and an important factor is choosing an assay offering specific and accurate results. With a range of assays from various manufacturers on the market, it is important to determine their efficiency. Internal evaluations performed by Fast-track diagnostics showed 100% of samples tested were correctly detected by the Fast-track diagnostics hepatitis E assay. The success of the results prompted an external comparison study, in which the assay was compared with an in-house and competitor assay. Sensitivity of the Fast-track diagnostics assay was detected at 100% for EDTA, serum and CPDA samples.

“The positive results of the internal evaluation, and the external comparison study between competitor assays, are extremely encouraging,” said Dr Bill Carmen – CEO of Fast-track diagnostics. “As hepatitis E can be fatal, correct and prompt diagnosis is imperative. The Fast-track diagnostics kit has proven sensitivity and specificity, allowing clinicians to trust the results obtained from the lab, and treat patients effectively.” 


Read the full comparison article here


This article also features in LabMate online :

Lab Asia, volume 23, issue 1/International Labmate, volume 41, issue 1.