HAV HBV HCV ONE STEP SIMPLE RAPID ACCURATE. Rapid, accurate way to Diagnosis of. Hepatitis Disease

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1 ONE TEP IPLE RAPID AURATE HBV HV Rapid, accurate way to Diagnosis of Hepatitis Disease

2 HBV Hepatitis B Virus One step Hepatitis B virus test Hepatitis B is a contagious liver disease that results from infection with the Hepatitis B virus. It can range in severity from a mild illness lasting few weeks to a serious, lifelong illness. Hepatitis B can be either acute or chronic. Acute Hepatitis B virus infection is a short-term illness that occurs within the first 6 months after someone is exposed to the Hepatitis B virus. Acute infection can but does not always lead to chronic infection. hronic Hepatitis B virus infection is a longterm illness that occurs when the Hepatitis B virus remains in a person s body. hronic Hepatitis B is a serious disease that can result in long-term health problems, and even death. The best way to prevent Hepatitis B is by getting vaccinated. Hepatitis B serologic markers HBsAg Hepatitis B surface antigen A protein on the surface of HBV; it can be detected in high levels in serum during acute or chronic HBV infection. The presence of HBsAg indicates that the person is infectious. The body normally produces antibodies to HBsAg as part of the normal immune response to infection. anti-hbs Hepatitis B surface antibody The presence of anti-hbs is generally interpreted as indicating recovery and immunity from HBV infection. Anti-HBs also develops in a person who has been successfully vaccinated against Hepatitis B. HBeAg Hepatitis B e antigen A secreted product of the nucleocapsid gene of HBV that is found in serum during acute and chronic Hepatitis B. Its presence indicates that the virus is replicating and the infected person has high levels of HBV. Prevalence of chronic infection with hepatitis B virus 2 P a c i f i c O c e a n Prevalence of Hepatitis B urface Antigen A t l a n t i c O c e a n High 8% Intermediate 2% 7% I n d i a n O c e a n Adapted from : Lo w < 2 %

3 D BIOLINE HBV Hepatitis B Virus WHO Evaluation Result : D BIOLINE HBsAg Reference result D BIOLINE HBsAg Total Pos. Neg. Pos Neg ensitivity : 100% (98/98) pecificity : 100% (178/178) ensitivity (95% I) 100% ( %) pecificity (95% I) 100% ( %) Test Procedure Interpretation Negative 20min. Positive Ordering Information at. No. Description Type Pack size 01FK10 HBsAg Device 1Tx30/Kit 01FK11 HBsAg ulti-device 10Tx10/Kit 01FK12 HBsAg Fast trip 25Tx4/Kit 01FK10W HBsAg W/B Device 1Tx30/Kit 01FK11W HBsAg W/B ulti-device 10Tx10/Kit at. No. Description Type Pack size 01FK20 Anti-HBs Device 1Tx30/Kit 01FK21 Anti-HBs ulti-device 10Tx10/Kit 01FK22 Anti-HBs Fast trip 25Tx4/Kit 01FK30 HBeAg Device 1Tx30/Kit

4 HV Hepatitis Virus One step Hepatitis virus Antibody test What causes the disease? Liver cells infected with the hepatitis virus Hepatitis is caused by infection with the hepatitis virus(hv). The virus infects liver cells and can cause severe inflammation of the liver with longterm complications (anorexia, vague abdominal discomfort, nausea and vomiting, fever and fatigue) progressing to jaundice in about 25% of patients ( less frequently than hepatitis B), of those exposed to HV, about 40% recover fully, of these, 20% develop cirrhosis, of those with cirrhosis, up to 20% develop liver cancer. How is HV spread? haring infected needles with a carrier. From accidental exposure to infected blood. exual transmission in persons with high risk behavior, although transmission of HV is less common than that of HBV and HIV When is HV contagious? All HV positive persons are considered potentially infectious. HV positive persons are those who : Have anti-hv antibodies in their blood. Have HV RNA or HV core antigen detected in their blood.

5 D BIOLINE HV Hepatitis Virus linical performance : D BIOLINE HV Reference assay D BIOLINE HV Positive Negative Total Results RT-PR Positive Negative ensitivity : 100 % (157/157) pecificity : 99.4 % (1024/1030) ensitivity (95% I) 100% ( %) pecificity (95% I) 99.4% ( %) Test Procedure Interpretation Negative HV 4drops Assay diluent 5~20min. Positive HV HV HV Ordering Information at. No. Description pecimen Type Pack size 02FK10 HV erum/plasma/whole blood Device 1Tx30/Kit 02FK11 HV erum/plasma ulti-device 10Tx10/Kit 02FK12 HV Fast erum/plasma trip 25T/Kit

6 Hepatitis A Virus One step Hepatitis A virus Antibody test What is? Hepatitis A, one of the oldest diseases known to humankind, is a self-limited disease which results in fulminant hepatitis and death in only a small proportion of patients. But, it is a significant cause of morbidity and socio-economic losses in many parts of the world. Transmission Transmission of is typically by the faecal-oral route. Occur in life in areas where sanitation is poor and living conditions are crowded. Direct person to person spread is common under poor hygienic conditions. Transmission by sexual contact(anal-oral) and blood transfusions is rare. ymptoms Loss of appetite, fatigue, abdominal pain, nausea and vomiting, fever, diarrhoea, dark urine and pale stools Prevention Improved sanitation and hygiene, vaccine for Infection ymptom Humoral antibody response Ig anti- Fecal IgA anti- Ig anti- viremia onths linical Findings Virologic Events in Infection 3 In acute phase, anti- Ig is detectable about 3 weeks after exposure, Increases over 4 to 6 weeks, then declines to nondetectable levels within 6 months of infection. Anti- IgA and Ig are detectable within a few days of the onset of symptoms. Ig antibodies persist for years after infection and provide lifelong immunity. Adapted from: :

7 D BIOLINE Hepatitis A Virus linical Performance : D BIOLINE Ig/Ig D BIOLINE Ig Positive. Negative. Total onfirmed by ELIA Positive Negative ensitivity : 97.6 % (122/125) pecificity : 98.0 % (147/150) ensitivity (95% I) 97.6% ( %) pecificity (95% I) 98.0% ( %) Test Procedure icropipette Interpretation Negative Ig/Ig Ig/Ig Assay diluent 4 drops 20 mins. Ig Positive Ig/Ig apillary pipette Ig/Ig Ig Positive Ig/Ig Ig/Ig Positive Ig/Ig Ig/Ig Ordering Information at. No. Description pecimen Type Pack size 13FK10 Ig/Ig erum / Plasma Device 25T/Kit

8 Innovative lobal Leader of in vitro diagnostics tandard Diagnostics, Inc. Total supplier of in vitro diagnostics test kits for Point of are Testing with the highest quality standards. Reference 1. ensitivity and pecificity are extracted from the Instruction for use of each product. 2. Recommendations for Identification and Public Health anagement of Persons with hronic Hepatitis B Virus Infection. [Online] 3. Do Hepatitis A Antibodies Indicate Infectivity? [Online] tandard Diagnostics, Inc. is an Alere company Alere. All rights reserved. The Alere Logo and Alere are trademarks of the Alere group of companies. All other trademarks referenced are trademarks of their respective owners. 65, Borahagal-ro, iheung-gu, Yongin-si, yeonggi-do, Republic of Korea Tel : Fax : KRproductsupport@alere.com at. No. LEF01EN Rev