1. Product Description
The HCV Hepatitis C Virus Rapid Test Strip (Whole Blood/Serum/ Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in whole blood, serum or plasma specimens. The test strip comes with all essential accessories to perform the test as an aid to the clinicians for STAT usage.
2. Clinical Sensitivity, Specificity and Accuracy
The HCV Hepatitis C Virus Rapid Test Strip (Whole Blood/Serum/ Plasma) has correctly identified specimens of a panel and has been compared to a leading commercial ELISA HCV test using clinical specimens. The results show that the relative sensitivity of the HCV Hepatitis C Virus Rapid Test Strip (Whole Blood/Serum/ Plasma) is >99.0% and the relative specificity is 98.6%.
3. Interpretation of Results
(The interpretation is for reference only. It may not be the standard for clinical diagnosis. )
(1)Positive:Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the test region (T).
(2)Note: The intensity of the color in the test line region (T) will vary depending on the concentration of HCV antibody present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
(3)Negative:One colored line appears in the control region (C). No apparent colored line appears in the test region (T).
(4)Invalid:Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test strip. If the problem persists, discontinue using the test strip immediately and contact your local distributor.
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China