Specificity and sensitivity of Fast-track diagnostics 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.”
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