ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Ultrasound Therapy for Fibromyalgia and Lyme Disease

Curcumin: The All In One Solution, Part 2

What Are the Benefits of Vitamin K2?

Vitamin D deficiency + high fat diet = metabolic syndrome

Why You Should Take Your Apple Cider Vinegar at Night

Use Burdock Oil to Promote Healthy Hair Growth

Meet Your Weight Loss Goals

AMA journal associates iron deficiency with hearing loss

People with forms of early-onset Parkinson's disease may benefit from boosting niacin in diet, resea...

Lutein linked to preservation of crystallized intelligence

 
Print Page
Email Article

FDA Approves New Rapid HIV Test Kit

  [ 73 votes ]   [ Discuss This Article ]
www.ProHealth.com • November 18, 2002


The U.S. Food and Drug Administration (FDA) has approved a new rapid HIV diagnostic test kit that provides results with 99.6 percent accuracy in as little as 20 minutes, according to a recent announcement by the U.S. Department of Health and Human Services (HHS) Secretary Tommy G. Thompson.

Using less than a drop of blood, this new test can quickly and reliably detect antibodies to HIV-1, the HIV virus that causes infection in most cases in the U.S. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings. The newly approved HIV test is called The OraQuick Rapid HIV-1 Antibody Test, manufactured by OraSure Technologies, Inc., Bethlehem, Pennsylvania.

"Each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results," Secretary Thompson said. "With this new test, in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus."

To perform the test, a fingerstick sample of blood is collected from an individual and transferred to a vial where it is mixed with a developing solution. The test device, which resembles a dipstick, is then inserted into the vial. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device. Although the results of rapid screenings will be reported in point-of-care settings, as with all screening tests for HIV, if the OraQuick test gives a reactive test result, that result must be confirmed with an additional specific test. The OraQuick test has not been approved to screen blood donors.

The Centers for Disease Control and Prevention (CDC) has estimated that one fourth of the approximately 900,000 HIV-infected people in the U.S. are not aware that they are infected. Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services (CMS) are working with state and other health officials to make the test widely available and to offer technical assistance and counseling training for its use.

"This test will be a great help in identifying pregnant HIV-infected women going into labor who were not tested during pregnancy so that precautionary steps can be taken to block their newborns from being infected with HIV," said FDA Deputy Commissioner Dr. Lester M. Crawford. "It will also be a critical resource in helping identify HIV infection in health-care and emergency workers who are accidentally exposed to HIV-infected blood while doing their job."

The FDA currently categorizes the OraQuick test as "moderate complexity" under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Under CLIA, new tests are categorized as either moderate or high complexity. This designation means that the OraQuik test can only be given in CLIA-approved labs by CLIA-certified laboratory technicians or medical staff. If the test manufacturer applies for a CLIA waiver, the FDA can evaluate it for use under less stringent conditions.

"I strongly urge the OraSure company to apply for a CLIA waiver," said Secretary Thompson, "If the FDA finds that the company's data proves that the OraQuick test is both easy and safe to use, it can get a CLIA waiver. Then the test could be given in many more health care settings, perhaps even administered by social workers in HIV counseling centers."



Post a Comment

Featured Products From the ProHealth Store
Optimized Curcumin Longvida® Ultra ATP+, Double Strength Energy NADH™ 12.5mg

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

Coconut Oil - Healthy Gifts from the 'Tree of Life' Coconut Oil - Healthy Gifts from the 'Tree of Life'
Enhance Eyelashes Naturally Enhance Eyelashes Naturally
Restore Youthful Cognition and Well-Being Restore Youthful Cognition and Well-Being
Block food Cravings At Their Molecular Root Block food Cravings At Their Molecular Root
When a Negative is Positive - Goodnighties Recovery Sleepwear When a Negative is Positive - Goodnighties Recovery Sleepwear

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map