Zhang Lei*, Yang Feng, Zhu Junzhe
Background: Hepatitis C virus (HCV) infection is mostly asymptomatic in its early stages, but long-term infection can lead to liver fibrosis, cirrhosis, and even liver cancer. Traditional antibody serology test for detecting a HCV infection in the window, real-time fluorescent quantitative PCR operation is relatively complicated. Moreover, clinical laboratory technicians require advanced training and large capital investments are required to procure and operate laboratory equipment. Therefore, it is important to establish a new rapid test method for HCV with high accuracy, sensitivity and specificity for early diagnosis of HCV.
Purpose: This evaluation aimed to evaluate the accuracy and performance of the All Test HCV Rapid Test Cassette. It is a rapid chromatographic immunoassay for the qualitative detection of antibody to HCV in whole blood, serum or plasma to aid in the diagnosis of HCV infection.
Method: Run a rapid in vitro diagnostic test device for detection of antibody to HCV in whole blood, serum or plasma and compare to a leading commercial ELISA HCV test using clinical specimens for validation of the performance.
Results: The assay showed that the relative sensitivity of the HCV Rapid Test Cassette (Whole Blood/Serum/Plasma) is 98.8%, the relative specificity is 99.1%, and the relative accuracy is 99.0%.
Conclusion: The All Test HCV Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibody to HCV in whole blood, serum or plasma. The test is accurate with simple operation, low contamination risk, easy visual interpretation and fast results. The HCV Rapid Test Kits manufactured by All Test are an important diagnostic tool for the early diagnosis of HCV.
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