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FDA approves 60-second HIV test
  December 3, 2010 2:11 PM PST
The test, which, at 60 seconds, will be the fastest-working on the U.S. market (others tend to take between 10 minutes and 20 minutes) is already available in more than 50 countries. In Canada's Ontario province, the kits have been available since they were first commercialized in 2006, and in British Columbia, where BioLytical is based, health authorities plan to use them for the new $48 million pilot project called Seek and Treat for the prevention of HIV and AIDS.
The Insti kit requires pricking a finger to draw a blood sample, then mixing the sample with a reagent and color developer. One blue "control spot" reveals the absence of HIV antibodies (nonreactive results), two spots reveal the presence of such antibodies (reactive), and the absence of a spot indicates that the results are invalid.
Because this is a first-line test, all reactive (HIV-positive) results must be confirmed by a second testing system, the company advises, and all invalid tests should be conducted again with a new blood sample.
"Insti represents a significant improvement for point-of-care rapid HIV testing," Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors, said in a statement. "By eliminating the 15- to 30-minute wait for results, Insti streamlines the testing process. It allows for increased flexibility, as providers can conduct the test in whatever manner best suits their work flow."
Breaking into the U.S. market wasn't easy; Rick Galli, chief technical officer at BioLytical, told the Vancouver Sun that "we affectionately call [market approval in the U.S.] the holy grail for this particular product."
He added that the Insti device has been endorsed by the Centers for Disease Control and Prevention, and that the timing is ideal, as U.S. medical officials have recently been shifting from lab tests to rapid point-of-care tests.
FDA Approves bioLytical Laboratories' INSTI™ Rapid HIV Test Innovative screening assay detects antibodies to HIV in as little as 60 seconds
Chicago, IL (PRWEB) December 1, 2010
"The convenience of waiting only one minute compared to waiting 20 minutes is more desirable for both the patient and the physician." Niel Constantine, Ph.D., University of Maryland School of Medicine Institute of Human Virology"
bioLytical Laboratories announced today, recognized globally as World AIDS Day, that it has received U.S. Food and Drug Administration (FDA) approval to market its INSTI™ rapid HIV antibody test in the United States. INSTI is the first new rapid HIV test approved by the FDA through its Premarket Approval (PMA) process for point-of-care use in nearly five years. Unlike currently available lateral-flow technology, which requires approximately 15 to 30 minutes to generate results, INSTI utilizes flow-through technology, which produces results in as little as 60 seconds.
The FDA approved INSTI for the detection of antibodies to HIV-1 in whole blood, finger stick blood, or plasma specimens. U.S. clinical trial data showed minimum sensitivity and specificity of 99.8% and 99.5% respectively, in finger stick, venipuncture blood and plasma samples. bioLytical is seeking approval for HIV-2 in the U.S via PMA supplement.
INSTI includes a unique antigen construct comprised of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36). "These unique antigens ensure that the test will be a critical addition to any rapid testing algorithm," said Rick Galli, bioLytical chief technical officer. As with all rapid HIV tests, positive results are considered preliminary and must be confirmed before establishing a diagnosis of HIV infection.
"The unique antigen is important because the HIV testing community appears to be headed toward a multi-rapid test algorithm, eliminating the need for the more costly and time-consuming Western Blot and Indirect Fluorescent Antibody (IFA) tests," said Niel Constantine, Ph.D., professor of pathology, University of Maryland School of Medicine Institute of Human Virology, an INSTI clinical trial investigator. "Using a multi-test rapid algorithm, we must deploy tests with different antigens, so bioLytical's use of a unique antigen satisfies that requirement. And since INSTI also utilizes a novel flow-through technology, it would be a strong addition to a rapid/rapid algorithm."
INSTI also includes a unique, enhanced procedural control, utilizing a true human IgG sample addition feature. The test will only react when the correct quantity of human blood is added, reducing user error that can lead to inaccurate results. The test is highly stable and does not require refrigeration or specialized storage.
"We believe the speed, accuracy, and unique technology of our 60-second HIV test will make the testing and early treatment of HIV/AIDS more efficient in all patient settings, including hospital emergency rooms and public health clinics," said bioLytical Laboratories President Philip Bligh. "Additionally, our high-volume, automated manufacturing capability makes INSTI one of the most cost-effective solutions available for providers of HIV rapid testing."
"A rapid, accurate, sufficiently sensitive and inexpensive field testing kit for HIV has been needed for a long time," said Robert Gallo, M.D., a co-discoverer of the Human Immunodeficiency Virus, a world leader in HIV/AIDS research, and currently the director of the Institute of Human Virology at the University of Maryland School of Medicine. "The Institute for Human Virology would be willing to collaborate with BioLytical to explore the use of the product in novel settings worldwide and in the USA by providing both the population and expertise necessary."
First commercialized in 2006, the INSTI rapid HIV test has been extensively field-tested and is the only point-of-care rapid HIV test approved by Health Canada. INSTI also has European CE mark approval, and is on the USAID PEPFAR waiver list. In time for World AIDS Day, the U.S. joins 56 other countries where INSTI is available to screen for HIV. Those who have worked so hard to combat the virus in the U.S. now have an important new tool. Additionally, nearly two million tests have been conducted worldwide, and the test is an essential component of the $48 million, cutting-edge Seek and Treat pilot announced in British Columbia, Canada earlier this year.
Jane Greer, administrator of the Hassle Free Clinic in the greater Toronto area noted, "INSTI represents a huge step forward in our fight against HIV/AIDS. We have been deploying INSTI for HIV screening since 2006 and have found it easy to use. It has improved the quality of our testing program, and has increased our testing throughput. INSTI has been tremendously beneficial for clients, allowing all clients to obtain virtually immediate results, which encourages testing and reduces client anxiety. Additionally, by combining pre and post-test counseling into one visit, INSTI has increased our capacity to provide HIV testing to more patients."
INSTI has been extensively studied, spending more than two years in clinical trials with Health Canada and FDA, comprising over 16,000 tests with matching finger stick blood, venipuncture blood, plasma and serum on more than 6,000 patients. bioLytical is currently applying for CLIA-waived status for INSTI. For more information on INSTI, call bioLytical at 888-316-0351 or visit
Testing for HIV/AIDS in the United States
In July, the Obama administration announced its national strategy on HIV, which calls for reducing the rate of new HIV infections by 25 percent over the next five years. Widespread testing and early diagnosis are critical to reducing the rate of new infections. The FDA approval of INSTI will allow patients to be diagnosed more quickly than ever before and will allow for testing in novel settings.
"With just two reagents, INSTI is very easy to perform, and its major advantage is speed," Dr. Constantine said. "You might find some physician offices now adopting HIV testing since they can now perform the test and obtain results so quickly. The convenience of waiting only one minute compared to waiting 20 minutes is more desirable for both the patient and the physician."
INSTI's speed allows HIV testing programs to be implemented in key high-prevalence / high-volume settings with minimal interruption of current workflows. It allows testing and counseling processes to fit more easily into many complex environments, particularly correctional settings and emergency rooms.
Public health officials have advocated for making HIV testing more widely accessible as increasing the number of people who know their status may be the most effective way to curb the spread of HIV/AIDS. It is widely accepted that when people are aware of their HIV status, they may be less likely to engage in risky behaviors and pass on the virus. Additionally, when HIV positive people are on antiretroviral therapy and have undetectable levels of the virus, their ability to transmit the virus may be significantly reduced.
According to Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors (NASTAD), "INSTI represents a significant improvement for point-of-care rapid HIV testing. By eliminating the 15- to 30-minute wait for results, INSTI streamlines the testing process. It allows for increased flexibility as providers can conduct the test in whatever manner best suits their workflow process."
The Premarket Approval Process (PMA)
As described on, "PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)."
About bioLytical Laboratories
bioLytical Laboratories is a leading developer and manufacturer of rapid, point of care diagnostic assays. bioLytical is a privately owned, federally incorporated Canadian company based in Vancouver, British Colombia with offices in Chicago. The company's INSTI test platform utilizes flow-through technology, which produces near instantaneous results. The platform also provides for multiplex testing capabilities, which means that rapid testing for more than one infectious disease can be conducted using one finger stick sample. bioLytical is the exclusive manufacturer of the INSTI™HIV Rapid Test kit. The company's fully automated 20,000 sq. ft. production facility is ISO 9001 and 13485 accredited and GMP compliant.
For more information, call bioLytical at 888-316-0351 or visit
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