ODM Best Carbohydrate antigen 125 test Reagent Factory – HCV – Aehealth

Performance Characteristics

Detection Limit : 1.0 ng/ mL ;

Linear Range: 1.0-1000.0ng/ mL;

Linear correlation coefficient R ≥ 0.990;

Precision: within batch C.V. is ≤ 15%; between batches C.V. is ≤ 20%;

Accuracy: the relative deviation of the measurement results shall not exceed ± 15% when the accuracy calibrator prepared by Ferritin national standard or standardized accuracy calibrator are tested.

1. Store the detector buffer at 2～30℃. The buffer is stable up to 18 months.

2. Store Aehealth Ferritin Rapid Quantitative test cassette at 2～30℃, shelf life is up to 18 months.

3. Test cassette should be used within 1 hour after opening the pack.

Hepatitis C virus (HCV) is an envelope, single stranded positive sense RNA (9.5 kb) virus belonging to the family of Flaviviridae. Six major genotypes and series of subtypes of HCV have been identified. Isolated in 1989, HCV is now recognized as the major cause for transfusion associated non-A, non-B hepatitis. The disease is characterized with acute and chronic form. More than 50% of the infected individuals develop severe, life threatening chronic hepatitis with liver cirrhosis and hepatocellular carcinomas. Since the introduction in 1990 of anti-HCV screening of blood donations, the incidence of this infection in transfusion recipients has been significantly reduced. Clinical studies show that significant amount of HCV infected individuals develop antibodies to NS5 non-structural protein of the virus. For this, the tests include antigens from the NS5 region of the viral genome in addition to NS3 (c200), NS4 (c200) and the Core (c22).