Custom Search

Wednesday, June 30, 2010

US FDA Approves Rapid Test for emergency detection of Antibodies to Hepatitis C Virus.

US FDA Approves Rapid Test for emergency detection of Antibodies to Hepatitis C Virus.
The Unites States FDA on 25-06-2010 in their press release have announced that they have approved the first rapid blood test for detection of hepatitis C virus (HCV) for peoples aged about 15 years and above.
The Brand Name of the test kit is OraQuick ® HCV Rapid Antibody and it is manufactured by
This test is used to test individuals who are at a risk of getting hepatitis C virus (HCV) infection and in the people with signs or symptoms of hepatitis.

This test make use of oral fluid, whole blood, serum and plasma detection of hepatitis C virus (HCV) infection. It is said that it has 99 % accurate with whole blood, serum or plasma.

It can be used in any places like , Laboratories , Emergency clinics and in Accidental Exposure Situations.
OraQuick ® is manufactured by pharmaceutical company in USA,Bethlehem, Pennsylvania.-based OraSure Technologies Inc.It is one of the diagnostic kits and pharmaceuticals manufacturing company , who also has similar diagnostic kits for detection of antibodies for the HIV virus.
OraQuick ® consists of portable a test strip which do not require any other instrument for diagnosis , and results can be obtained just in 20 Minutes , US FDA has also mentioned in the press release that the OraQuick is not approved for HCV screening of the general population.

Early diagnosis of virus (HCV) infection is very important, in providing healthcare , doctors can start further treatment for virus (HCV) infection immediately after the test.

Information about Hepatitis C
Hepatitis C , is a disease caused by infection of hepatitis C virus (HCV), hepatitis C virus is spread by blood-to-blood contact, through infected intravenous needles,the virus can be transferred from an infected mother to her child.

Hepatitis C infection mainly results in to liver inflammation and dysfunction and, over time, to liver disease and liver cancer, liver inflammation results in to liver fibrosis and in advance stage becomes life threatening resulting in to liver cirrhosis,and bleeding in lower esophagus and gut , the condition known as esophageal varices and gastric varices respectively.
In advance liver cirrhosis requires may require a liver transplant , hepatitis C virus infection may recurs after transplantation.
Hepatitis C virus infection can be treated with medication, like ribavirin in conjugation with peginterferon alfa-2b or peginterferon alfa-2a.

=======================================================================
What is What is 510(k) Clearances ?
What is 510(k) Clearances, Premarket Notification for medical devices - PMN or 510(k)


Antibiotic Definition and classification


Antibiotic resitance and Drug resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?


Enzyme linked immunosorbent assay ELISA

Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Eletronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates


Here is an intresting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry

Here are some interesting articles on Quality assurance systems for pharmaceutical company
1.Quality assurance in pharma industry
2.Quality by designe concept for pharmaceutical industry
3.Quality by designe concept in pharmaceutical industry an  explanation

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org